Federal Register Vol. 83, No.207,

Title: Citrus Greening and Asian Citrus Psyllid; Quarantine and Interstate Movement Regulations.

OMB Control Number: 0579-0363.

Type of Request: Revision to and extension of approval of an information collection.

Abstract: The Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) authorizes the Secretary of the U.S. Department of Agriculture (USDA), either independently or in cooperation with States, to carry out operations or measures to detect, eradicate, suppress, control, prevent, or retard the spread of plant pests and diseases that are new to or not widely distributed within the United States. Under the PPA, the Secretary may also issue regulations requiring plants and plant products moved in interstate commerce to be subject to remedial measures determined necessary to prevent the spread of the pest or disease, or requiring the objects to be accompanied by a permit prior to movement. The USDA's Animal and Plant Health Inspection Service (APHIS) administers the regulations to implement the PPA.

Citrus greening, also known as Huanglongbing disease of citrus, is considered to be one of the most serious citrus diseases in the world. Citrus greening is a bacterial disease that attacks the vascular system of host plants. This bacterial pathogen can be transmitted by grafting and, under laboratory conditions, by parasitic plants. The pathogen can also be transmitted by two insect vectors in the family Psyllidae, one of which is Diaphorina citri Kuwayama, the Asian citrus psyllid (ACP). ACP can also cause economic damage to citrus in groves and nurseries by direct feeding. Both adults and nymphs feed on young foliage, depleting the sap and causing galling or curling of leaves. High populations feeding on a citrus shoot can kill the growing tip.

Under the regulations in “Subpart—Citrus Greening and Asian Citrus Psyllid” (7 CFR 301.76 through 301.76-11), APHIS restricts the interstate movement of regulated articles from quarantined areas to control the artificial spread of citrus greening and ACP to noninfested areas of the United States. The regulations contain requirements that involve information collection activities including a compliance agreement, limited permit, Federal certificate, recordkeeping, labeling statement, the application of a tag to the consignee's waybill, 72-hour inspection notification, cancellation of certificates, permits, compliance agreements, and emergency action notification.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

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

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 0.127 hours per response.

Respondents: Commercial nurseries/operations in the United States or U.S. Territories quarantined for citrus greening or ACP.

Estimated annual number of respondents: 635.

Estimated annual number of responses per respondent: 25.

Estimated annual number of responses: 15,904.

Estimated total annual burden on respondents: 2,013 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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

This meeting is available to the public through the following toll-free call-in number: 877-260-1479, conference ID number: 3860554. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at [email protected]. Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meetings at https://facadatabase.gov/committee/meetings.aspx?cid=277. Please click on the “Meeting Details” and “Documents” links. Records generated from these meetings may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meetings. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Public Call Information: Dial: 877-260-1479, Conference ID: 6758358. This meeting is available to the public through the following toll-free call-in number: 877-260-1479, conference ID number: 6758358. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Alejandro Ventura at [email protected]. Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meetings at https://facadatabase.gov/committee/meetings.aspx?cid=235. Please click on the “Meeting Details” and “Documents” links. Records generated from these meetings may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meetings. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of the timeliness of completing the current activity.

As in previous censuses, the Post-Enumeration Survey (PES) for the 2020 Census will be conducted to provide estimates of census net coverage error and components of census coverage (such as correct enumerations, omissions, and erroneous enumerations, including duplicates) for housing units and people living in housing units (see Definition of Terms) for the United States and Puerto Rico, excluding remote Alaska. These coverage estimates provide insight into the quality and coverage of census results, which can be used to improve future censuses. The primary sampling unit is the Basic Collection Unit (BCU), which is the smallest unit of collection geography for 2020 Census listing operations. As in the past, the PES operations and activities must be conducted separate from and independent of the other 2020 Census operations.

The Independent Listing operation is the first field operation in the PES process. It will be conducted to obtain a complete inventory of all the housing unit addresses within the PES sample of BCUs in the United States (excluding remote Alaska) and in Puerto Rico before the 2020 Census enumeration commences. Group quarters addresses will not be listed as they are out of scope for PES.

During the Independent Listing operation, field staff, referred to as “listers,” will canvass every street, road, or other place where people might live in their assigned BCUs and construct a list of housing units using an automated data collection instrument on a laptop. The laptop will contain the data collection instrument with digital maps of the area that needs to be canvassed. Listers will attempt to contact a member of each housing unit they encounter on their route. If someone answers, the lister will provide a Confidentiality Notice and ask about the address in order to collect the address information, as appropriate. To ensure all units at an address are properly listed, the lister will then ask if there are any additional vacant or occupied units in the structure or on the property. If there are additional units, the lister will collect and update that information. To be classified as a separate unit, they must meet the housing unit definition requirement of having direct access from outside or through a common hallway, and must either have someone living there or be intended for occupancy, even if vacant at the time of the Independent Listing operation. Mobile homes and trailers, both in a park and not in a park, will also be listed, including any empty lots or pads in the parks in the BCU. Finally, any occupied camper, recreational vehicle, van, boat, tent or other location where people are living during the listing operation will also be listed as a housing unit.

If the lister does not find anyone at home after several attempts, he or she will try to collect the information from a proxy or add any found addresses to the address list by observation as a last resort. Listers will also identify the location of each housing unit by collecting map spots (i.e., Global Positioning System (GPS) coordinates). The lister will also collect information on the status of each housing unit, such as occupied, vacant, under construction, empty trailer park, etc. Completed Independent Listing BCUs will be automatically reviewed for abnormal characteristics (such as GPS information indicating that the lister was far from the units they were listing). BCUs with unusual characteristics may be subject to quality control wherein quality control listers return to the field to check a portion of units to ensure that the work performed meets Census Bureau quality standards.

Following the completion of listing for each BCU, the addresses are computer and clerically matched, on a flow basis, against the list of addresses considered valid for the census. Addresses that remain unmatched or have unresolved address status after matching will be sent to the Initial Housing Unit Followup operation, during which listers collect additional information that might allow a resolution of any differences between the Independent Listing and census address list results. Cases will also be sent to the field to resolve potential duplicates and unresolved housing unit status. The questions and procedures to be used in the Initial Housing Unit Followup phase of the Post-Enumeration Survey in the 2020 Census and all subsequent Post-Enumeration Survey phases will be published in separate Federal Register Notices.

The 2020 Census Evaluations and Experiments program will also be using the results of this PES Independent Listing for an evaluation, in conjunction with 2020 Census operations. The specific activities for this evaluation will be described in detail in future Federal Register Notices for additional 30-day comment periods for both the 2020 PES Independent Listing and the 2020 Census. These will be considered as substantive changes to both approved OMB packages.

Independent Listing field staff will use the Census Bureau's Listing and Mapping Application (LiMA) software on government furnished laptop devices.

Components of Census Coverage—The components of census coverage include correct enumerations, erroneous enumerations, whole-person imputations, and omissions. Correct enumerations are people or housing units that were correctly enumerated in the census. Erroneous enumerations are people or housing units that were enumerated in the census but should not have been. Examples of erroneous enumerations are duplicates, nonexistent housing units or people, and people or housing units that were enumerated in the wrong place. Omissions are people and housing units that were not correctly enumerated in the census but should have been. Lastly, whole-person imputations are census records for which all of the demographic characteristics were imputed. Many of these imputations represent people in housing units where we knew the household count but did not obtain sufficient information about the people residing at the housing unit.

Net Coverage Error—Reflects the difference between the true population and the census count. If the census count was less than the actual number of people or housing units in the population, then we say there was an undercount. If the census count was more than the actual number of people or housing units in the population, then we say there was an overcount.

For more information about the Post-Enumeration Survey Program, please visit the following page of the Census Bureau's website: https://www.census.gov/coverage_measurement/post-enumeration_surveys/.

For more information about the Evaluations and Experiments Program, please visit the following document in the Census Bureau's 2020 Census Memo Series: 2020 Census Evaluations and Experiments.

OMB Control Number: 0607-XXXX.

Form Number: NA.

Type of Review: Regular submission.

Affected Public: Individuals or Households.

Estimated Number of Respondents: 565,000 Housing Units (HUs) for Independent Listing and 85,000 HUs for Independent Listing Quality Control.

Estimated Time per Response: 5 min.

Estimated Total Annual Burden Hours: 54,167 hours.

Estimated Total Annual Cost: $0. (This is not the cost of respondents' time, but the indirect costs respondents may incur for such things as purchases of specialized software or hardware needed to report, or expenditures for accounting or records maintenance services required specifically by the collection.)

Respondent's Obligation: Mandatory.

Legal Authority: Title 13, U.S. Code, Sections 141 and 193.

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

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

I. Abstract

The Foreign-Trade Zone Application is the vehicle by which individual firms or organizations apply for foreign-trade zone (FTZ) status, for subzone status, production authority, modifications of existing zones, or for waivers. The FTZ Act and Regulations (19 U.S.C. 81b and 81f; 15 CFR 400.21-25, 43(f)) set forth the requirements for applications and other requests to the FTZ Board. The Act and Regulations require that applications for new or modified zones contain information on facilities, financing, operational plans, proposed production operations, need for FTZ authority, and economic impact, where applicable. Any request involving production authority requires specific information on the foreign status components and finished products involved. Applications for production activity can involve issues related to domestic industry and trade policy impact. Such applications must include specific information on the customs-tariff related savings that result from zone procedures and the economic consequences of permitting such savings. The FTZ Board needs complete and accurate information on the proposed operation and its economic effects because the Act and Regulations authorize the Board to restrict or prohibit operations that are detrimental to the public interest. The Regulations (15 CFR 400.43(f)) also require specific information for applications requesting waivers by parties impacted by 400.43(d). This information is necessary to assess the likelihood of the proposed activity resulting in a violation of the uniform treatment provisions of the FTZ Act and Regulations.

U.S. firms or organizations submit applications in paper format along with an electronic copy to the Office of Foreign-Trade Zones.

OMB Control Number: 0625-0139.

Form Number: N/A.

Type of Review: Regular submission.

Affected Public: State, local, or tribal governments or not-for-profit institutions applying for foreign-trade zone status, for subzone status, modification of existing zones, production authority or for waivers.

Estimated Number of Respondents: 291.

Estimated Time per Response: 4 to 131 hours (depending on the type of application).

Estimated Total Annual Burden Hours: 3,150.

Estimated Total Annual Cost to Public: $140,021.

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

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

Agenda

The Advisory Panel will discuss Framework Adjustment 58: Specifications/Management Measures—specifically discuss draft alternatives and Plan Development Team (PDT) analysis including: (1) Rebuilding plan options for several groundfish stocks, (2) 2019 total allowable catches for U.S./Canada stocks of Eastern Georges Bank (GB) cod, Eastern GB haddock, and GB yellowtail flounder, (3) minimum size exemptions for vessels fishing in Northwest Atlantic Fisheries Organization waters, and (4) temporary change to scallop fishery accountability measure policy for GB yellowtail flounder for fishing years 2019 and 2020, and make recommendations for preferred alternatives. The panel will also hold a discussion of possible priorities for 2019 and develop recommendations. Other business will be discussed as necessary.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

The committee will discuss Framework Adjustment 58: Specifications/Management Measures—specifically discuss draft alternatives and Plan Development Team (PDT) analysis including: (1) Rebuilding plan options for several groundfish stocks, (2) 2019 total allowable catches for U.S./Canada stocks of Eastern Georges Bank (GB) cod, Eastern GB haddock, and GB yellowtail flounder, (3) minimum size exemptions for vessels fishing in Northwest Atlantic Fisheries Organization waters, and (4) temporary change to scallop fishery accountability measure policy for GB yellowtail flounder for fishing years 2019 and 2020, and make recommendations for preferred alternatives. The committee will also hold a discussion of possible priorities for 2019 and develop recommendations. The committee will review Groundfish PDT, Groundfish Advisory Panel, and Recreational Advisory Panel recommendations and make recommendations to the Council. Other business will be discussed as necessary.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the date.

I. Abstract

The Consolidated Appropriations Act of 2018 directed NTIA to update the national broadband availability map in coordination with the Federal Communications Commission (FCC) and the states.1 Specifically, Congress directed NTIA to acquire and display available third-party data sets to the extent it is able to negotiate its inclusion to augment data from the FCC, other federal government agencies, state government, and the private sector.2 The objective of these updates is to identify regions of the country with insufficient broadband capacity, particularly in rural areas.

Presently, the only source of nationwide broadband availability data is that collected from broadband service provider responses to the FCC Form 477 Fixed Broadband Deployment data process. Form 477 data are submitted by voice and broadband telecommunications service providers semi-annually and include information on the services each provider offers, at the Census block level.3 While the Census block system provides a very high level of geographic granularity overall—the United States is divided into over 11 million blocks, 95 percent of which do not exceed 1 square mile in land area—it is possible that broadband availability may vary within a single block, (which is most common in rural areas). Additionally, broadband service providers who wish to share more granular data on broadband availability—including regulated and non-regulated entities—have no mechanism to do so. Further, a broadband service provider offering service to any homes or businesses in a Census block is instructed to report that block as served in its Form 477 filing, even though it may not offer broadband services in most of the block. This can lead to overstatements in the level of broadband availability, especially in rural areas where Census blocks are large or when services are only available near the boundaries of a Census block.

As a result of these constraints, NTIA intends to collect broadband availability data at a more granular level than that available via the FCC Form 477 process. This data will be used to better assess broadband availability across the country and particularly in rural areas. This information collection covers the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Island Areas of American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and the United States Virgin Islands.

NTIA intends to collect this information from two types of respondents that collect broadband data with more geographic granularity than the Census block level: (1) Owners and operators of broadband networks; and (2) industry associations, data aggregators, and researchers that study or analyze broadband availability. Respondents may include private companies, non-profits, cooperatives, educational institutions, tribal governments, and local, regional, or state governments. This information collection includes the use of both wireline and wireless technologies to deliver broadband services.

The data to be collected includes geographic information on service availability—such as address, address range, road centerline, land-parcel identification, or latitude/longitude—and corresponding broadband availability data (such as technology service type, upload and download speed, etc.). Data in a Geographic Information Systems (GIS) format that describe (a) wireless coverage areas based on a propagation model and (b) network infrastructure (such as fiber optic routes) is also responsive.

NTIA will not require that respondents modify appropriate data sets, with the exception that Personally Identifiable Information (PII) should be removed prior to transmission to NTIA. Data collection operations will result in respondent burden during: (1) Efforts to assemble their data for transmission to NTIA; (2) removal of PII; and (3) NTIA communications with respondent contacts to ensure NTIA correctly understands the data.

The information collection will be administered through an online file transfer tool.

OMB Control Number: None.

Form Number(s): None.

Type of Review: Regular submission.

Affected Public: Owners and operators of broadband networks, industry associations, data aggregators, and researchers.

Frequency: Annual.

Number of Respondents: 600.

Average Time per Response: 8 hours.

Estimated Total Annual Burden Hours: 4,800 hours.

Estimated Total Annual Cost to Public: $200,832.

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

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

I. Background

On August 29, 2016, the USPTO issued a notice seeking public feedback regarding how to efficiently utilize information from applicant's other applications having the same or substantially the same disclosure to provide examiners with relevant information at the earliest stage of examination. See Request for Comments and Notice of Roundtable Event on Leveraging Electronic Resources to Retrieve Information from Applicant's Other Applications and Streamline Patent Issuance, 81 FR 59197 (August 29, 2016). The notice announced a Roundtable that was held on September 28, 2016 and requested written comments by October 28, 2016. In response, the Office received twenty-six comments from a diverse group of stakeholders including intellectual property organizations, companies, law firms and individuals. Most of the stakeholders supported a program where the USPTO would automatically monitor related applications for relevant information therein for consideration during the examination of a U.S. application. However, stakeholder views varied on the optimal scope of the program and best method for implementation. Accordingly, the USPTO will implement the RPA Initiative in phases to consider and address public and examiner feedback at each phase. This feedback will be used to determine if the first phase needs adjustment, and how to expand the RPA Initiative effectively in future phases.

Applicants and other individuals substantively involved with the preparation and/or prosecution of a U.S. non-provisional application have a duty to submit to the USPTO information which is material to patentability as defined in 37 CFR 1.56. The provisions of 37 CFR 1.97 and 37 CFR 1.98 provide a mechanism by which patent applicants may comply with the duty of disclosure provided in 37 CFR 1.56. An information disclosure statement (IDS) filed in accordance with the provisions of 37 CFR 1.97 and 37 CFR 1.98 will be considered by the examiner assigned to the application. Citations listed in an IDS (e.g., on form PTO/SB/08 and equivalents) and considered by the examiner will be printed on the patent and distinguished from citations that were cited by the examiner and listed on a form PTO-892 (examiner citations will be marked with an asterisk). See Manual of Patent Examining Procedure, Rev. 08.2017, Jan. 2018 (referred to herein as “MPEP”) §§ 609 and 609.06.

Under current practice, when filing a continuing application that claims benefit under 35 U.S.C. 120 to a parent application (other than an international application for patent under the Patent Cooperation Treaty (PCT) that designated the United States), a listing of information which has been considered by the examiner in the parent application need not be resubmitted in the continuing application unless the applicant desires the information to be printed on the patent. Specifically, “(t)he examiner will consider information which has been considered by the Office in a parent application . . . when examining: (A) A continuation application filed under 37 CFR 1.53(b), (B) a divisional application filed under 37 CFR 1.53(b), or (C) a continuation-in-part application filed under 37 CFR 1.53(b).” MPEP § 609.02(II)(A)(2).

After careful consideration of the input from the public and examiners on the prior art initiative announced in the August 29, 2016 notice, the USPTO is implementing the RPA Initiative that will leverage electronic resources to improve examiner's access to relevant information from applicant's other related applications. As indicated previously, the USPTO will be implementing the RPA Initiative in phases to evaluate public and examiner feedback at each phase to address concerns and determine the ideal course for future expansion of the RPA Initiative.

In the first phase of the RPA Initiative, the USPTO will import the citations listed on forms PTO/SB/08 (or equivalents) and PTO-892 in the immediate parent application into the continuing application. If compliant with 37 CFR 1.98 in the parent application, the examiner will consider the documents that correspond to these citations and the citations will be printed on the patent. This will eliminate the need for applicant to submit an IDS in the continuing application for the purpose of having these citations printed on the patent. Additionally, an applicant's duty to disclose information under 37 CFR 1.56 in the continuing application will continue to be satisfied for information considered in the parent application and will be satisfied for any additional information made of record by the Office in the continuing application.

In subsequent phases of the RPA Initiative, the USPTO will consider providing examiners access to citation information from other sources such as other related U.S. applications, international applications under the PCT, and counterpart foreign applications of the same applicant. The selection of these sources and the timetable for expansion will be dictated, at least in part, by evaluating the first phase including feedback on the RPA Initiative from the public and examiners.

This first phase will also begin with a targeted release of a newly developed interface to a subgroup of examiners from a limited number of selected art units. In subsequent phases of the RPA Initiative, the USPTO plans to provide the interface to more examiners when the RPA Initiative proves scalable.

In the first phase of the RPA Initiative, applicants of a continuing application included in the RPA Initiative will not need to submit an IDS in a continuing application for information cited in the parent application in order for the corresponding citations to appear on the face of any patent issuing from the continuing application. Instead, IDS citations listed on form PTO/SB/08 (or equivalents) in the parent application, as well as citations listed on form PTO-892 (Notice of References Cited) in the parent application, will be imported into the continuing application. Those citations considered by the examiner in the continuing application will be printed on any patent issuing from the continuing application and distinguished from the other citations of record. This first phase will be targeted to a select group of examiners and limited to continuing applications filed on or after the effective date of November 1, 2018 with a single parent application.

An application included in the first phase of the RPA Initiative will meet the following conditions.

i. Types of Applications. The application is a non-reissue, non-provisional application filed under 35 U.S.C. 111(a) with a claim for benefit under 35 U.S.C. 120 or 121 of only a single prior U.S. application (i.e., immediate parent application, referred to herein as “parent application”). The parent application must have been filed under 35 U.S.C. 111(a) or have entered the national stage pursuant to 35 U.S.C. 371. The parent application can claim priority or benefit of other applications only under 35 U.S.C. 119. For example, it cannot include any claims for benefit under 35 U.S.C. 120, 121, 365(c) or 386(c).

ii. Art Unit Requirement. The application is assigned to one of the art units that will be listed on the RPA Initiative website https://www.uspto.gov/patents-getting-started/PriorArtAccess.

iii. Timing. The RPA Initiative will initially apply to a small group of continuing applications filed on or after the effective date of November 1, 2018. The RPA Initiative will then expand to a larger group of applications filed on or after January 1, 2019. This information will be listed on the RPA Initiative website https://www.uspto.gov/patents-getting-started/PriorArtAccess. The claim for benefit to a parent application must be made in the continuing application and reflected on the filing receipt before the continuing application completes pre-examination processing.

The USPTO cannot accept requests to have an application entered in the first phase of the RPA Initiative.

The first phase will begin with a small group of examiners on November 1, 2018, and increase to a larger group on January 1, 2019. The art units will be listed on the RPA Initiative website https://www.uspto.gov/patents-getting-started/PriorArtAccess before the November 1, 2018 effective date.

The art units participating in the first phase of the RPA Initiative will be chosen to ensure that within the first twelve months of the RPA Initiative, data is acquired on approximately 175 applications across the examining corps. Specifically, the USPTO is considering each art unit's current backlog of continuing applications and the projected number of continuing application filings expected in the first year of the RPA Initiative. This targeted selection of art units and the number of applications is designed to provide relevant feedback in a timely manner and allow the RPA Initiative to expand to the next phase in an expeditious manner.

Note, if the application is initially assigned to an art unit within the RPA Initiative and is later transferred to an art unit outside the RPA Initiative, the application will remain in the RPA Initiative and will be treated in accordance with this notice.

The USPTO will determine whether an application meets the conditions for inclusion in the first phase of the RPA Initiative after the Office of Patent Application Processing completes pre-examination processing of the continuing application. That is, a filing receipt has been issued, there are no outstanding pre-examination notices (e.g., Notice to File Missing Parts), and the application has completed classification. At this point, the continuing application will be evaluated for inclusion in the RPA Initiative. Once it has been determined that the continuing application meets the conditions for inclusion in the first phase of the RPA Initiative, the citations from the parent application, as specified herein, will be imported into the continuing application. Concurrent with the importation, a Notice of Imported Citations will be generated and provided to the applicant.

The Notice of Imported Citations will indicate that the continuing application has been entered in the first phase of the RPA Initiative and will list the citations that have been imported into the continuing application under examination. There is no requirement for the applicant to reply to the Notice of Imported Citations. However, applicant may inspect the Notice of Imported Citations to determine what citations have been imported into the continuing application under examination.

Applications included in the RPA Initiative will not be expedited or given special status due to inclusion into this RPA Initiative. The continuing application will be taken up for examination in the order it is filed in accordance with MPEP 708. Once the continuing application is taken up for action, the examiner will consider the imported information in due course, similar to the consideration of other IDSs filed in the application. There is no mechanism for removing an application from the RPA Initiative.

All citations, both considered and unconsidered in the parent application, will be imported into the continuing application. The citations are those corresponding to U.S. patent documents, foreign patent documents, and non-patent literature (NPL) documents, contained on an IDS listing (e.g., PTO/SB/08 or equivalents) or PTO-892 in the file wrapper record of the parent application at the time inclusion into the RPA Initiative is determined. If available in the parent application, the examiner will be provided ready access to copies of the foreign patent documents and NPL documents associated with the imported citations as well as any corresponding translations or explanations of relevance. Though copies of documents corresponding to the imported citations will not be available in the electronic file wrapper of the continuing application to applicants and the public, such copies can be accessed in the electronic file wrapper of the parent application by the applicant of the parent application through the USPTO's Private Patent Application Information Retrieval (PAIR) system (https://ppair.uspto.gov/TruePassWebStart/AuthenticationChooser.html), or by the public by obtaining a certified copy of file history of the parent application (http://ebiz1.uspto.gov/oems25p/index.html). This is consistent with current practice where a copy of a document considered by the examiner in the parent application (except where the parent is an international application) is not required to be filed in the continuing application for consideration, and, therefore, is not available in the electronic file wrapper of the continuing application. See 37 CFR 1.98(d) and MPEP § 609.02. Any citations in the parent application not contained on an IDS listing or PTO-892 form will not be imported, including, for example, citations in a third-party submission under 37 CFR 1.290, Office actions, applicant responses, citations listed in the specification, affidavits/declarations, etc.

Note that in the first phase of the RPA Initiative, the Office will perform only a single importation of citations from the parent application. Any citations from IDS listings or PTO-892 forms appearing in the parent application after this single importation occurs will not be imported. To have such later-appearing citations printed on a patent issued from the continuing application, applicant must submit an IDS with the later-appearing citations.

Examiners will consider all documents corresponding to the imported citations that are compliant with 37 CFR 1.98 in the parent application. As explained previously, the imported citations will be listed on the Notice of Imported Citations, which will be given to the applicant at the time of importation and will be viewable in the electronic file wrapper record of the continuing application via the USPTO's PAIR system. The examiner will consider the information corresponding to the imported citations to the same extent as information submitted by the applicant in an IDS. See MPEP § 609.05(b).

The examiner will indicate consideration of the imported citations in a Notice of Consideration. Examiners will strike through each citation whose document was not considered in the continuing application. This includes any citation that was not compliant with 37 CFR 1.98 in the parent application (e.g., no copy was submitted) or the examiner was unable to consider the relevance of the imported citation for some other reason. However, citations that were not compliant under 37 CFR 1.97 in the parent application will be considered by the examiner in the continuing application, if compliant with 37 CFR 1.98. The examiner should inform the applicant in the first Office action of the reason(s) a citation was not considered. Applicant may then file an IDS to correct the deficiency in the imported citations. Note that the date the IDS is filed to correct the deficiency in the continuing application is the date for determining compliance with the timing requirements of 37 CFR 1.97. See MPEP § 609.05(a).

The examiner's signature on the Notice of Consideration will indicate that the documents corresponding to all citations that have not been lined through have been considered. The Notice of Consideration should be provided with the first Office action on the merits in the continuing application.

All citations that have been imported from the parent application and indicated as considered on the Notice of Consideration will be printed on the patent issuing from the continuing application. These imported citations will be marked with a double-dagger on the patent to distinguish them from the other citations of record. If an item of information is cited more than once on the record (e.g., in a Notice of Consideration and on an IDS), the citation will be listed only once on the patent and will be distinguished as a citation that has been imported from a related application.

As indicated previously, this RPA Initiative seeks to import relevant information for consideration by the examiner at an early time in prosecution while reducing the need for applicants to submit this same information in later-filed applications. The RPA Initiative will begin with the first phase outlined in section III. The USPTO expects to expand this RPA Initiative in subsequent phases to further enhance examination quality and reduce the need for applicants to resubmit citation lists and references.

The USPTO is evaluating how to expand the RPA Initiative in future phases and will use the data acquired in the first phase in making this determination. Currently, the USPTO is considering a first expansion of the RPA Initiative (second phase) to include the importation of U.S. and foreign patent citation information from related PCT and counterpart foreign applications. However, this could change based on the feedback received from examiners and stakeholders in the first phase. Further, the RPA Initiative may be expanded to increase the number of times information is imported from the parent application, as well as encompass more art units within the USPTO so that it will eventually be applicable in all applications regardless of classification.

The timetable for expansion and the chosen sources of expansion will be determined based upon the feedback obtained in the first phase. Applicants are encouraged to provide their feedback on the RPA Initiative to help the USPTO determine how best to expand the RPA Initiative in the next phase and in any future phases. Comments are preferred using the IdeaScale tool which is available at https://uspto-priorart.ideascale.com.

The Office of the Secretary of Defense (OSD) proposes to modify a system of records subject to the Privacy Act of 1974, 5 U.S.C. 552a. This system assists DoD marketing communications programs increase awareness of military service as a career option by compiling names of young adults aged 16 through maximum recruiting age to create a mailing frame from which to conduct surveys. These surveys are conducted multiple times a year and each survey is designed so that appropriate levels of precision can be achieved for inferences to be made at various geographic levels. The system also provides JAMRS with the ability to remove the names of individuals who are current/former members of, or are enlisting in, the Armed Forces and individuals who have asked to be removed from consideration as a participant in any future JAMRS survey. Multiple departments throughout the Federal Government rely on the research conducted by JAMRS, which is frequently reported to Congress. As a result of reviewing this system of records, the modification reformats the system of records notice (SORN), updates the system location, system manager, routine uses, record access procedures, contesting record procedures, and notification procedures.

The OSD 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 at the Defense Privacy, Civil Liberties, and Transparency Division website at https://defense.gov/privacy.

The proposed systems reports, as required by the Privacy Act, as amended, were submitted on July 20, 2018, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to Section 6 to OMB Circular No. A-108, “Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act,” revised December 23, 2016 (December 23, 2016, 81 FR 94424).

Catalog of Federal Domestic Assistance (CFDA) Number: 84.268.

Direct Subsidized Loans, Direct Unsubsidized Loans, Direct PLUS Loans, and Direct Consolidation Loans (collectively referred to as “Direct Loans”) may have either fixed or variable interest rates, depending on when the loan was first disbursed or, in the case of a Direct Consolidation Loan, when the application for the loan was received. Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans first disbursed before July 1, 2006, and Direct Consolidation Loans for which the application was received before February 1, 1999, have variable interest rates. For these loans, a new rate is determined annually and is in effect during the period from July 1 of one year through June 30 of the following year.

Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans first disbursed on or after July 1, 2006, and Direct Consolidation Loans for which the application was received on or after February 1, 1999, have fixed interest rates that apply for the life of the loan.

This notice announces the interest rates for variable-rate Direct Loans that will apply during the period from July 1, 2018, through June 30, 2019. Interest rate information for fixed-rate Direct Loans is announced in a separate notice published in the Federal Register.

Interest rates for variable-rate Direct Loans are determined in accordance with formulas specified in section 455(b) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1087e(b)). The formulas vary depending on loan type and when the loan was first disbursed or, for certain Direct Consolidation Loans, when the application for the loan was received. The HEA specifies a maximum interest rate for these loan types. If the interest rate formula results in a rate that exceeds the statutory maximum rate, the rate is the statutory maximum rate.

For Direct Subsidized Loans and Direct Unsubsidized Loans with first disbursement dates before July 1, 2006, and for Direct PLUS Loans with first disbursement dates on or after July 1, 1998, and before July 1, 2006, the interest rate is equal to the lesser of—

(1) The bond equivalent rate of 91-day Treasury bills auctioned at the final auction held before the June 1 immediately preceding the 12-month period to which the interest rate applies, plus a statutory add-on percentage; or

(2) 8.25 percent (for Direct Subsidized Loans and Direct Unsubsidized Loans) or 9.00 percent (for Direct PLUS Loans).

For Direct Subsidized Loans and Direct Unsubsidized Loans with first disbursement dates on or after July 1, 1995, and before July 1, 2006, the statutory add-on percentage varies depending on whether the loan is in an in-school, grace, or deferment status, or in any other status. For all other loans, the statutory add-on percentage is the same during any status.

The bond equivalent rate of 91-day Treasury bills auctioned on May 29, 2018, is 1.931 percent, rounded to 1.93 percent.

For Direct PLUS Loans with first disbursement dates before July 1, 1998, the interest rate is equal to the lesser of—

(1) The weekly average 1-year constant maturity Treasury yield, as published by the Board of Governors of the Federal Reserve System, for the last calendar week ending on or before the June 26 preceding the 12-month period to which the interest rate applies, plus a statutory add-on percentage; or

(2) 9.00 percent.

The weekly average of the one-year constant maturity Treasury yield published on June 26, 2018, is 2.34 percent.

A Direct Consolidation Loan may have up to three components, depending on the types of loans that were repaid by the consolidation loan and when the application for the consolidation loan was received. The three components are called Direct Subsidized Consolidation Loans, Direct Unsubsidized Consolidation Loans, and (only for Direct Consolidation Loans made based on applications received before July 1, 2006) Direct PLUS Consolidation Loans. In most cases the interest rates for variable-rate Direct Subsidized Consolidation Loans, Direct Unsubsidized Consolidation Loans, and Direct PLUS Consolidation Loans are determined in accordance with the same formulas that apply to Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans, respectively.

Charts 1 and 2 show the interest rate formulas used to determine the interest rates for all variable-rate Direct Loans and the rates that are in effect during the 12-month period from July 1, 2018, through June 30, 2019.

Chart 1 shows the interest rates for loans with rates based on the 91-day Treasury bill rate. Chart 2 shows the interest rates for loans with rates based on the weekly average of the one-year constant maturity Treasury yield.

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

Title of Collection: Survey on the Use of Funds Under Title II, Part A: Supporting Effective Instruction Grants—Subgrants to LEAs.

OMB Control Number: 1810-0618.

Type of Review: A reinstatement of a previously approved information collection.

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

Total Estimated Number of Annual Responses: 4,326.

Total Estimated Number of Annual Burden Hours: 8,577.

Abstract: The Elementary and Secondary Education Act of 1965, as reauthorized by the Every Student Succeeds Act of 2015 (ESSA), provides funds to States to prepare, train, and recruit high-quality teachers, principals, and other school leaders. These funds are provided to districts through Title II, Part A (Supporting Effective Instruction Grants). The purpose of these surveys is to provide the U.S. Department of Education with a better understanding of how local educational agencies (LEAs) utilize these funds. This survey also collects data on teacher salaries funded by Title II, Part A, and professional development provided by LEAs to their teachers.

Similar data have been collected under the Survey on the Use of Funds Under Title II, Part A prior to reauthorization of ESEA. This OMB clearance request is to continue these types of analyses, but using new data collection instruments updated to reflect changes due to the reauthorization of ESEA by the ESSA. The request is to begin data collection and analyses for the 2018-19 school year and subsequent years.

Catalog of Federal Domestic Assistance (CFDA) Number: 84.032.

Section 427A of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1077a), provides formulas for determining the interest rates charged to borrowers on loans made under the FFEL Program, including Federal Subsidized and Unsubsidized Stafford Loans (Stafford Loans), Federal PLUS Loans (PLUS Loans), Federal Consolidation Loans (Consolidation Loans), and Federal Supplemental Loans for Students (SLS Loans). No new loans have been made under the FFEL Program since June 30, 2010.

The FFEL Program includes loans with variable interest rates that change each year and loans with fixed interest rates that remain the same for the life of the loan. For loans with a variable interest rate, the specific interest rate formula that applies to a particular loan depends on the date of the first disbursement of the loan or, in the case of a Consolidation Loan, the date the application for the loan was received. If a loan has a variable interest rate, a new rate is determined annually and is in effect during the period from July 1 of one year through June 30 of the following year.

This notice announces the interest rates for variable-rate FFEL Program loans that will be in effect during the period from July 1, 2018, through June 30, 2019. Interest rates for fixed-rate FFEL Program loans may be found in a Federal Register notice published on September 15, 2015 (80 FR 55342).

For the majority of variable-rate FFEL Program loans, the annual interest rate is equal to the lesser of—

(1) The bond equivalent rate of the 91-day Treasury bills auctioned at the final auction held before June 1 of each year, plus a statutory add-on percentage; or

(2) A statutorily established maximum interest rate.

The bond equivalent rate of the 91-day Treasury bills auctioned on May 29, 2018, is 1.931 percent, rounded to 1.93 percent.

For PLUS Loans first disbursed before July 1, 1998, and for all SLS Loans, the annual interest rate is equal to the lesser of—

(1) The weekly average of the one-year constant maturity Treasury yield, as published by the Board of Governors of the Federal Reserve System for the last day of the calendar week ending on or before June 26 of each year, plus a statutory add-on percentage; or

(2) A statutorily established maximum interest rate.

The weekly average of the one-year constant maturity Treasury yield as published for the week ending on or before June 26, 2018, is 2.34 percent.

For Consolidation Loans that have a variable interest rate, the annual interest rate for the portion of a Consolidation Loan that repaid loans other than loans made under the Health Education Assistance Loans (HEAL) Program is equal to—

(1) The bond equivalent rate of the 91-day Treasury bill auctioned at the final auction held before June 1 of each year, plus a statutory add-on percentage; or

(2) A statutorily established maximum interest rate.

If a Consolidation Loan (whether a variable-rate loan or a fixed-rate loan) repaid loans made under the HEAL Program, the interest rate on the portion of the Consolidation Loan that repaid HEAL loans is a variable rate that is equal to the average of the bond equivalent rates of the 91-day Treasury bills auctioned for the quarter ending June 30, plus a statutory add-on percentage. For the portion of a Consolidation Loan that repaid HEAL loans, there is no maximum interest rate.

The average of the bond equivalent rates of the 91-day Treasury bills auctioned for the quarter ending on June 30, 2018, is 1.88 percent.

The statutory add-on percentages and maximum interest rates vary depending on loan type and when the loan was first disbursed. In addition, the add-on percentage for certain Stafford Loans is different depending on whether the loan is in an in-school, grace, or deferment status, or in any other status. If the interest rate calculated in accordance with the applicable formula exceeds the statutory maximum interest rate, the statutory maximum rate applies.

Charts 1 through 4 show the interest rate formulas that are used to determine the interest rates for all variable-rate FFEL Program loans and the interest rates that are in effect during the 12-month period from July 1, 2018, through June 30, 2019. Unless otherwise indicated, the cohorts shown in each chart include all borrowers, regardless of prior borrowing.

Chart 1 shows the interest rates for loans with rates based on the 91-day Treasury bill, with the exception of “converted” variable-rate Federal Stafford Loans and certain Federal Consolidation Loans.

Chart 2 shows the interest rates for loans with rates based on the weekly average of the one-year constant maturity Treasury yield.

Chart 3 shows the interest rates for “converted” variable-rate Federal Stafford Loans. These are loans that originally had varying fixed interest rates.

Finally, Chart 4 shows the interest rates for variable-rate Federal Consolidation Loans, and for the portion of any Federal Consolidation Loan that repaid loans made under the HEAL Program.

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

Title of Collection: Student Assistance General Provisions—Non-Title IV Revenue Requirements (90/10).

OMB Control Number: 1845-0096.

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

Respondents/Affected Public: Private Sector.

Total Estimated Number of Annual Responses: 1,872.

Total Estimated Number of Annual Burden Hours: 2,808.

Abstract: As enacted by the Higher Education Opportunity Act (Pub. L. 110-315), the regulations in 34 CFR 668.28 provide that a proprietary institution must derive at least 10% of its annual revenue from sources other than Title IV, HEA funds, sanctions for failing to meet this requirement, and otherwise implement the statute by (1) specifying a Net Present Value (NPV) formula used to establish the revenue for institutional loans, (2) providing an administratively easier alternative to the NPV calculation, and (3) describing more fully the non-Title IV eligible programs from which revenue may be counted for 90/10 purposes. The regulations require an institution to disclose in a footnote to its audited financial statements the amounts of Federal and non-Federal revenues, by category, that it used in calculating its 90/10 ratio (see section 487(d) of the HEA). This is a request to extend the information collection that identifies the reporting burden for this regulation.

Catalog of Federal Domestic Assistance (CFDA) Number: 84.268.

Direct Subsidized Loans, Direct Unsubsidized Loans, Direct PLUS Loans, and Direct Consolidation Loans (collectively referred to as “Direct Loans”) may have either fixed or variable interest rates, depending on when the loan was first disbursed or, in the case of a Direct Consolidation Loan, when the application for the loan was received. Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans first disbursed on or after July 1, 2006, and Direct Consolidation Loans for which the application was received on or after February 1, 1999, have fixed interest rates that apply for the life of the loan. Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans first disbursed before July 1, 2006, and Direct Consolidation Loans for which the application was received before February 1, 1999, have variable interest rates that are determined annually and are in effect during the period from July 1 of one year through June 30 of the following year.

This notice announces the fixed interest rates for Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans with first disbursement dates on or after July 1, 2018, and before July 1, 2019, and provides interest rate information for other fixed-rate Direct Loans. Interest rate information for variable-rate Direct Loans is announced in a separate Federal Register Notice.

Section 455(b) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1087e(b)) includes formulas for determining the interest rates for all Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans first disbursed on or after July 1, 2013. The interest rate for these loans is a fixed rate that is determined annually for all loans first disbursed during any 12-month period beginning on July 1 and ending on June 30. The rate is equal to the high yield of the 10-year Treasury notes auctioned at the final auction held before June 1 of that 12-month period, plus a statutory add-on percentage that varies depending on the loan type and, for Direct Unsubsidized Loans, whether the loan was made to an undergraduate or graduate student. The calculated interest rate may not exceed a maximum rate specified in the HEA. If the interest rate formula results in a rate that exceeds the statutory maximum rate, the rate is the statutory maximum rate. Loans first disbursed during different 12-month periods that begin on July 1 and end on June 30 may have different interest rates, but the rate determined for any loan is a fixed interest rate for the life of the loan.

On May 9, 2018, the United States Treasury Department held a 10-year Treasury note auction that resulted in a high yield of 2.995 percent.

Chart 1 shows the fixed interest rates for Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans first disbursed on or after July 1, 2018, and before July 1, 2019.

For reference, Chart 2 compares the fixed interest rates for Direct Subsidized Loans, Direct Unsubsidized Loans, and Direct PLUS Loans first disbursed during the period July 1, 2018, through June 30, 2019, with the fixed interest rates for loans first disbursed during each previous 12-month period from July 1, 2013, through June 30, 2018.

Purpose of Meeting: To develop advice and guidance that promotes research and development leading to the production of biobased fuels and biobased products.

Tentative Agenda: Agenda will include the following:

Public Participation: In keeping with procedures, members of the public are welcome to observe the business of the Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, you must contact Dr. Ian Rowe at (202) 586-7720 or email: [email protected] at least 5 business days prior to the meeting. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Co-chairs of the Committee will make every effort to hear the views of all interested parties. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. The Co-chairs will conduct the meeting to facilitate the orderly conduct of business.

Minutes: The summary of the meeting will be available for public review and copying at http://biomassboard.gov/committee/meetings.html.

Notice is hereby given that the EPA has determined to approve an application by the Nebraska Department of Health and Human Services to incorporate the following EPA National Primary Drinking Water Regulations: Revised Total Coliform Rule (February 13, 2013, 78 FR 10270) and minor corrections (February 26, 2014, 79 FR 10665). This determination to approve the Nebraska program revision is made pursuant to 40 CFR 142.12(d) (3).

The application demonstrates that Nebraska has adopted drinking water regulations which satisfy the National Primary Drinking Water Regulations. EPA has determined that Nebraska's regulations are no less stringent than the corresponding Federal regulations and that Nebraska continues to meet all requirements for primary enforcement responsibility as specified in 40 CFR 142.10.

All documents relating to this determination are available for inspection between the hours of 9:00 a.m. and 3:00 p.m., Monday through Friday at the following offices: Nebraska Department of Health and Human Services, Drinking Water Division, 1200 N Street, Suite 400, Lincoln Nebraska 68509-8922. Environmental Protection Agency, Region 7, Water Wetlands and Pesticides Division, Drinking Water Management Branch, 11201 Renner Blvd. Lenexa, Kansas 66219.

IDEM submitted its final application for the Revised Total Coliform Rule (RTCR) on February 28, 2016. In a letter dated March 23, 2017, EPA issued a determination to them that the State's application for the RTCR was complete and final and the State was awarded interim primacy until final primacy could be awarded. In this same letter EPA indicated that there were certain items that needed to be resolved before EPA could award final primacy. IDEM completed its response to EPA's comments and questions on August 21, 2017.

Any interested party may request a public hearing. A request for a public hearing must be submitted by November 26, 2018, to the Regional Administrator at the EPA Region 5 address shown below. The Regional Administrator may deny frivolous or insubstantial requests for a hearing. However, if a substantial request for a public hearing is made by November 26, 2018, EPA Region 5 will hold a public hearing, and a notice of such hearing will be given in the Federal Register and a newspaper of general circulation. If EPA Region 5 does not receive a timely and appropriate request for a hearing and the Regional Administrator does not elect to hold a hearing on her own motion, this determination shall become final and effective on November 26, 2018. Any request for a public hearing shall include the following information: The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; a brief statement of the requesting person's interest in the Regional Administrator's determination and a brief statement of the information that the requesting person intends to submit at such hearing; and the signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.

This meeting is open to members of the public. The FCC will accommodate as many attendees as possible; however, admittance will be limited to seating availability. The Commission will also provide audio and video coverage of the meeting over the internet at www.fcc.gov/live. Oral statements at the meeting by parties or entities not represented on the ACDDE will be permitted to the extent time permits and at the discretion of the ACDDE Chair and the DFO. Members of the public may submit comments to the ACDDE in the FCC's Electronic Comment Filing System, ECFS, at www.fcc.gov/ecfs. Comments to the ACDDE should be filed in GN Docket No. 17-208.

Open captioning will be provided for this event. Other reasonable accommodations for persons with disabilities are available upon request. Requests for such accommodations should be submitted via email to [email protected] or by calling the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). Such requests should include a detailed description of the accommodation needed. In addition, please include a way for the FCC to contact the requester if more information is needed to fulfill the request. Please allow at least five days' notice. Last minute requests will be accepted but may not be possible to accommodate.

Proposed Agenda: The agenda at this meeting will feature a report from each of the ACDDE Working Groups. The Digital Empowerment and Inclusion Working Group will report on its assessment of access, adoption, and use of broadband and new technologies by under-resourced communities, and its recent workshop on supplier diversity for small, female- and minority-owned entrepreneurs, which included one-on-one networking opportunities. The Diversity in Tech Working Group will report on its examination of issues pertaining to hiring, promotion, and retention of women and minorities in tech industries, and its research to develop a “best practices” guide for employers in the tech sector. The Broadcast Diversity and Development Working Group will report on the status of the broadcast incubator proceeding and the working group's involvement in that effort to increase broadcast ownership opportunities for small business and new entrants, including those owned by women and minorities. In addition, the working group will provide an update on its ongoing initiatives to examine diversity and inclusion in broadcast employment and management.

The Committee's mission is to provide recommendations to the FCC on how to empower disadvantaged communities and accelerate the entry of small businesses, including those owned by women and minorities, into the media, digital news and information, and audio and video programming industries, including as owners, suppliers, and employees. The Committee will provide recommendations on how to ensure that disadvantaged communities are not denied the wide range of opportunities made possible by next-generation networks and develop best practices regarding training and hiring opportunities for women and minorities to encourage diversity in the tech industry.

This agenda may be modified at the discretion of the ACDDE Chair and the DFO.

OMB Control Number: 3060-0807.

Title: Section 51.803, Procedures for Commission Notification of a State Commission's Failure to Act; Supplemental Procedures for Petitions Pursuant to Section 252(e)(5) of the Communications Act of 1934, as amended.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities and State, Local or Tribal government.

Number of Respondents and Responses: 60 respondents; 60 responses.

Estimated Time per Response: 40 hours per requirement.

Frequency of Response: On occasion reporting requirement and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 252(e)(5) as amended by the Communications Act of 1934, as amended.

Total Annual Burden: 1,600 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: The Commission is not requesting petitioners to submit confidential information to the Commission.

Needs and Uses: Any interested party seeking preemption of a state commission's jurisdiction based on the state commission's failure to act shall notify the Commission as follows: (1) File with the Secretary of the Commission a detailed petition, supported by an affidavit, that states with specificity the basis for any claim that it has failed to act; and (2) serve the state commission and other parties to the proceeding on the same day that the party serves the petition on the Commission. Within 15 days of filing the petition, the state commission and parties to the proceeding may file a response to the petition. In an OMB-approved Public Notice, DA 97-2540, released December 4, 1997, the Commission set forth procedures for filing petitions for preemption pursuant to section 252(e)(5). Section 252(e)(5) provides that “if a state commission fails to act to carry out its responsibility under this section in any proceeding or other matter under this section, then the Commission shall issue an order preempting the state commission's jurisdiction of the proceeding or matter within 90 days after being notified (or taking notice) of such failure, and shall assume the responsibility of the state commission under this section with respect to the proceeding or matter and act for the state commission.” All of the requirements are used to ensure that petitioners have complied with their obligations under the Communications Act of 1934, as amended.

A. Purpose

This information collection requirement, OMB Control No. 9000-0079, currently titled “Corporate Aircraft Costs,” is proposed to be retitled “Travel Costs,” due to consolidation with currently approved information collection requirement OMB Control No. 9000-0088, Travel Costs.

This information collection requirement pertains to information that a contractor must submit in response to the requirements in FAR 31.205-46:

1. FAR 31.205-46(a)(3)—In special or unusual situations, costs incurred by a contractor for lodging, meals, and incidental expenses, may exceed on a daily basis the per diem rates in effect as set forth in the Federal Travel Regulation (FTR) for travel in the conterminous 48 United States. The actual costs may be allowed only if the contractor provides the following:

a. FAR 31.205-46(a)(3)(ii)—A written justification for use of the higher amounts approved by an officer of the contractor's organization or designee to ensure that the authority is properly administered and controlled to prevent abuse.

b. FAR 31.205-46(a)(3)(iii)—Advance approval from the contracting officer if it becomes necessary to exercise the authority to use the higher actual expense method repetitively or on a continuing basis in a particular area.

c. FAR 31.205-46(a)(3)(iv)—Documentation to support actual costs incurred including a receipt for each expenditure of $75.00 or more.

2. FAR 31.205-46(c) requires firms to maintain and make available manifest/logs for all flights on company aircraft. As a minimum, the manifest/log must indicate:

a. Date, time, and points of departure;

b. Destination, date, and time of arrival;

c. Name of each passenger and relationship to the contractor;

d. Authorization for trip; and

e. Purpose of trip.

The information required by (a) and (b) and the name of each passenger (required by (c)) are recordkeeping requirements already established by Federal Aviation Administration regulations. This information, plus the additional required information, is needed to ensure that costs of owned, chartered, or leased aircraft are properly charged against Government contracts and that directly associated costs of unallowable activities are not charged to Government contracts.

A 60 day notice was published in the Federal Register at 83 FR 38312, on August 6, 2018. No comments were received.

DoD, GSA and NASA analyzed the FY 2017 data from the Federal Procurement Data System (FPDS) to develop the estimated burden hours for this information collection.

1. FAR 31.205-46(a)(3)—Actual travel costs.

Respondents: 3,247.

Responses per Respondent: 10.

Total Annual Responses: 32,470.

Hours per Response: 0.25.

Total Burden Hours: 8,118.

2. FAR 31.205-46(c)—Manifest/logs for flights on company aircraft.

Number of Recordkeepers: 797.

Records per Recordkeeper per Year: 3.

Total Annual Records: 2,391.

Estimated Hours per Record: 2.0.

Total Recordkeeping Burden Hours: 4,782.

3. Total (counting recordkeepers with respondents).

Recordkeepers and Respondents: 4,044.

Responses: 34,861.

Hours (Reporting and Recordkeeping): 12,900.

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

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

Please cite OMB Control No. 9000-0079, Travel Costs, in all correspondence.

In accordance with FAR 16.4, incentive contracts are normally used when a firm fixed-price contract is not appropriate and the required supplies or services can be acquired at lower costs, and sometimes with improved delivery or technical performance, by relating the amount of profit or fee payable under the contract to the contractor's performance.

The information required periodically from the contractor, such as cost of work already performed, estimated costs of further performance necessary to complete all work, total contract price for supplies or services accepted by the Government for which final prices have been established, and estimated costs allocable to supplies or services accepted by the Government and for which final prices have not been established, is needed to negotiate the final prices of incentive-related items and services. Contractors are required to submit the information in accordance with several incentive fee FAR clauses: FAR 52.216-16, Incentive Price Revision—Firm Target; FAR 52.216-17, Incentive Price Revision—Successive Targets; and FAR 52.216-10, Incentive Fee.

The contracting officer evaluates the information received to determine the contractor's performance in meeting the incentive target and the appropriate price revision, if any, for the items or services.

Respondents: 440.

Responses per Respondent: 2.

Annual Responses: 880.

Hours per Response: 1.5.

Total Burden Hours: 1,320.

A 60-day notice was published in the Federal Register at 83 FR 25457 on June 1, 2018. No comments were received.

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

Please cite OMB Control No. 9000-0067, Incentive Contracts, in all correspondence.

A. Purpose

The policies implemented at FAR 37.115, Uncompensated Overtime, are based on Section 834 of Public Law 101-510 (10 U.S.C. 2331). The policies require insertion of FAR provision 52.237-10, Identification of Uncompensated Overtime, in all solicitations valued at or above the simplified acquisition threshold, for professional or technical services to be acquired on the basis of the number of hours to be provided.

The provision requires that offerors identify uncompensated overtime hours, in excess of 40 hours per week, and the uncompensated overtime rate for direct charge Fair Labor Standards Act—exempt personnel. This permits Government contracting officers to ascertain cost realism of proposed labor rates for professional employees and discourages the use of uncompensated overtime.

The burden placed on offerors is the time required to identify and support any hours in excess of 40 hours per week included in their proposal or subcontractor's proposal. It is estimated that there will be 27,546 service contracts awarded annually at $150,000 or more, of which 65 percent, or 17,905, contracts will be competitively awarded. About seven proposals will be received for each contract award. Of the total 125,335 (17,905 × 7) proposals received, only 25 percent, or 31,334, proposals are expected to include uncompensated overtime hours. It is estimated that offerors will take about 30 minutes to identify and support any hours in excess of 40 hours per week included in their proposal or subcontractor's proposal.

Number of Respondents: 31,334.

Responses per Respondent: 1.

Total Annual Responses: 31,334.

Average Burden Hours per Response: .5.

Total Burden Hours: 15,667.

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

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0152, Service Contracting, in all correspondence.

A. Overview of Information Collection Description of the Information Collection

1. Type of Information Collection: Revision/Renewal of a currently approved collection.

2. Title of the Collection—Labor-related Requirements.

3. Agency form number, if any:—SF 1413, SF 1444.

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

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This information collection requirement, OMB Control No. 9000-0066, currently titled “Professional Employee Compensation Plan,” is proposed to be retitled “Labor-related Requirements,” due to consolidation with currently approved information collection requirements OMB Control Nos. 9000-0175, 9000-0089, 9000-0014, and 9000-0155.

This clearance covers the information that offerors and contractors must submit to comply with the following labor requirements in the Federal Acquisition Regulation (FAR):

1. 52.222-2, Payment for Overtime Premiums. Paragraph (b) of this clause requires a contractor requesting overtime premiums that exceed the amount specified in paragraph (a) of the clause to do the following: (1) Identify the work unit; e.g., department or section in which the requested overtime will be used, together with present workload, staffing, and other data of the affected unit sufficient to permit the Contracting Officer to evaluate the necessity for the overtime; (2) Demonstrate the effect that denial of the request will have on the contract delivery or performance schedule; (3) Identify the extent to which approval of overtime would affect the performance or payments in connection with other Government contracts, together with identification of each affected contract; and (4) Provide reasons why the required work cannot be performed by using multishift operations or by employing additional personnel.

2. 52.222-6, Construction Wage Rate Requirements, paragraph (c) requires the contractor to establish additional classifications, if any laborer or mechanic is to be employed in a classification that is not listed in the wage determination applicable to the contract. The contractor submits to the contracting officer a Standard Form (SF) 1444, Request for Authorization of Additional Classification and Rate, along with other pertinent data, containing the proposed additional classification and minimum wage rate including any fringe benefits payments. OMB control numbers 1235-0023, 1235-0008, and 1235-0018 account for records to be kept by employers under the Fair Labor Standards Act (FLSA), 29 CFR 516, which is the basic recordkeeping regulation for all the laws administered by the Department of Labor (DOL) Wage and Hour Division. 29 CFR 516, prescribes labor standards for federally financed and assisted construction contracts subject to the Davis-Bacon and Related Acts (DBRA), as well as labor standards for non-construction contracts subject to the Contract Work Hours and Safety Standards Act (CWHSSA).

3. 52.222-11, Subcontracts (Labor Standards), requires contractors to submit SF 1413, Statement and Acknowledgment, for each subcontract for construction within the United States, including the subcontractor's signed and dated acknowledgment that the required labor clauses have been included in the subcontract. DOL regulations at 29 CFR Subpart 5.6 require Federal agencies to ascertain compliance with statutes such as the Wage Rate Requirements (Construction) (formerly known as the Davis-Bacon Act) (40 U.S.C. chapter 31), the Copeland Act (Anti-Kickback) (18 U.S.C. 874 and 40 U.S.C. 3145), and the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701 et seq.)

4. 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products, requires offerors to certify they will not supply an end product of a type identified on the DOL List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor, or that the offeror will supply such product, but made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any product furnished under the contract and is unaware of any such use of child labor. For solicitations for commercial items, the Certification Regarding Knowledge of Child Labor for Listed End Products is at paragraph (i) of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Items. This requirement is necessary to comply with Executive Order 13126, Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor, signed by President Clinton on June 12, 1999.

5. 52.222-33, Notice of Requirement for Project Labor Agreement, and 52.222-34, Project Labor Agreement, require offerors (provision) to submit, and contractors (clause) to maintain, a copy of the project labor agreement (PLA). Agencies have discretion on whether or not to use a PLA in connection with large-scale construction contracts, valued at or above $25M. Agencies may require the PLA be submitted: (1) When offers are due, (2) prior to award (by the apparent successful offeror), or (3) after award.

6. 52.222-46, Evaluation of Compensation for Professional Employees. This provision requires offerors to submit for evaluation a total compensation plan setting forth proposed salaries and fringe benefits for professional employees working on the contract. This is required for negotiated service contracts when the contract amount is expected to exceed $700,000 and the service to be provided will require meaningful numbers of professional employees.

Respondents: 2,098.

Responses per Respondent: 1.

Total annual Responses: 2,098.

Hours per Response: 0.25.

Total Burden Hours: 525.

Respondents: 3,831.

Responses per Respondent: 2.

Total Annual Responses: 7,662.

Hours per Response: 0.5.

Total Burden Hours: 3,831.

3. FAR 52.222-11, Subcontracts (Labor Standards), and SF 1413, Statement and Acknowledgment.

Respondents: 36,553.

Responses per Respondent: 2.

Total Annual Responses: 73,106.

Hours per Response: 0.05.

Total Burden Hours: 3,655.

Respondents: 1,104.

Responses per Respondent: 1.

Total Annual Responses: 1,104.

Hours per Response: 0.18.

Total Burden Hours: 198.

Respondents: 45.

Responses per Respondent: 1.

Total Annual Responses: 45.

Hours per Response: 1.

Total Burden Hours: 45.

Respondents: 3,136.

Responses per Respondent: 3.

Total Annual Responses: 9,408.

Hours per Response: 1.3333.

Total Burden Hours: 12,544.

Respondents: 46,767.

Total annual Responses: 93,423.

Total Burden Hours: 20,798.

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

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0066, Labor-related Requirements, in all correspondence.

FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that REVCOVI (elapegademase-lvlr) Injection, manufactured by Leadiant Bioscience Inc., meets the criteria for a priority review voucher. REVCOVI (elapegademase-lvlr) Injection is indicated for the treatment of Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID) in pediatric and adult patients.

For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further information about REVCOVI (elapegademase-lvlr) Injection, go to the “Drugs@FDA” website at https://www.accessdata.fda.gov/scripts/cder/daf/.

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The DSCSA (Title II of Pub. L. 113-54) was signed into law on November 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which established the requirement that trading partners have systems in place to enable them to comply with certain verification obligations.

The draft guidance provides recommendations for robust verification systems for the determination, quarantine, and investigation of suspect products as well as quarantine and disposition of illegitimate products. As explained in the draft guidance, verification systems may include existing standard operating procedures or other processes or procedures provided that the verification systems ensure that the trading partner meets its obligations under section 582 of the FD&C Act. This draft guidance also addresses the manner in which FDA recommends that trading partners submit cleared product notifications (i.e., notifications that a suspect product is not an illegitimate product). Finally, the draft guidance also addresses the statutory requirements for verification, including verification of saleable returns, at the package level for product identifiers on packages and homogenous cases intended to be introduced in a transaction into commerce. While DSCSA also requires trading partners to notify the Agency of illegitimate products or products with high risk of illegitimacy, this requirement was previously discussed in a separate guidance document, and is therefore not addressed in this draft guidance.

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 Agency's current thinking on verification systems for certain human, finished, prescription drugs under section 582 of the FD&C Act. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866.

This draft guidance includes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520) (PRA). In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to those previously approved collections of information found in FDA regulations or guidance.

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

FDA is announcing the availability of a guidance for industry entitled “Testicular Toxicity: Evaluation During Drug Development.” This guidance is intended to help sponsors identify nonclinical signals that raise concern regarding the potential for human testicular toxicity and to evaluate those signals appropriately in human studies.

The guidance describes the standard battery of nonclinical studies that are used to assess the effects of pharmaceuticals on the male reproductive system. The guidance discusses findings in nonclinical studies that may increase the level of concern for drug-related testicular toxicity. The guidance provides a general approach on how to weigh the relevance of nonclinical findings, considering factors that can confound the interpretation of these findings. If a concerning nonclinical signal is identified, the guidance presents suggestions for clinical monitoring when the product is initially administered to humans.

If a reasonable basis for concern of human testicular toxicity exists, a trial with a primary objective of evaluating drug-related testicular toxicity may be warranted. The guidance provides recommendations for the design of such a trial, including study conduct, endpoints, and presentation of results. These are general recommendations for defining the role of drugs in testicular injury; however, the specific details of an individual trial may vary depending on the context of use of the drug product.

This guidance finalizes the draft guidance of the same name issued on July 17, 2015 (80 FR 42501). Changes made to the guidance took into consideration written and verbal comments received. In addition to editorial changes primarily for clarification, the major changes in the guidance include revision of information on nonclinical study design (including species selection, chronic study design, histopathology assessment, sperm quality, and findings that increase concern for impaired fertility) and revision of information that, to the extent possible, subjects enrolled in the dedicated clinical safety trial represent the intended population.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the evaluation of testicular toxicity during drug development. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014. The collections of information in 21 CFR parts 50 and 56 (“Protection of Human Subjects: Informed Consent and Institutional Review Boards”) have been approved under OMB control number 0910-0755.

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

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

Information Collection Request Title: 0990-0279—Extension—Institutional Review Board Registration Form.

Abstract: Assistant Secretary for Health, Office for Human Research Protections is requesting an extension on a currently approved information collection by the Office of Management and Budget, on the Protection of Human Subjects, on the Institutional Review Board (IRB) Form. The purpose of the IRB Registration Form is to provide a simplified procedure for institutions engaged in research conducted or supported by HHS to satisfy the (1) HHS regulations for the protection of human subjects at 45 CFR 46.103((b), 45 CFR 46.107, and 45 CFR 46, subpart E, Registration of Institutional Review Boards; and, the Food and Drug Administration (FDA) regulations for institutional review boards at 21 CFR 56.106.

Likely Respondents: Institutions or organizations operating IRBs that review human subjects research conducted or supported by HHS, or, in the case of FDA's requirements, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products.

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Proposed Collection Title: Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials for the Treatment of Cancer, 0925-0613, Expiration Date 3/31/2019, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH).

Need and Use of Information Collection: The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis/Cancer Therapy Evaluation Program (NCI/DCTD/CTEP) and the Division of Cancer Prevention (DCP) responsible, as a sponsor of investigational drug trials, to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. Data obtained from the Investigational Agent Accountability Record Forms (aka. Drug Accountability Record Forms—DARF) are used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. Requirements for the tracking of investigational agents under an Investigational New Drug Application are outlined in Title 21 Code of Federal Regulations (CRF) part 312. NCI and/or its auditors use this information to ensure compliance with federal regulations and NCI policies. Previously, the investigator registration forms and process were part of this submission. These forms were more appropriately submitted and approved under the CTEP Branch and Support Contracts Forms and Surveys in July 2018 (OMB No. 0925-0753; Expiration Date 7/31/2021). Thus, the investigator registration forms are no longer included in this request.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden are 3,033 hours.

Technology description follows.

RSV is the most important viral agent of severe respiratory tract disease worldwide, especially in infants and young children, and it also causes severe disease in the elderly and in immunocompromised individuals. There are no licensed vaccines or antivirals suitable for routine use.

This invention relates to a reverse genetics system and cDNA-derived virus for a contemporary wild-type clinical isolate of RSV of antigenic subgroup A, termed RSV strain A/Maryland/001/11, that was isolated in 2011 from an adult with respiratory illness. The genomic sequence was determined. A reverse genetics system was created encoding a recombinant, replication competent RSV that contains a codon-optimized G ORF, which was done to stabilize the cDNA for replication in bacteria. Because this virus was generated by reverse genetics, it is a “clean” virus with a well-defined passage history. Clinical study material of this challenge virus has been manufactured and is available for use as an U.S. Food and Drug Administration (FDA) regulated Investigational New Drug (IND) in clinical studies in adult volunteers within and outside of the United States. Preliminary clinical data confirmed that this virus efficiently infects and replicates in 95% of study participants pre-selected for pre-existing RSV antibody titers in the bottom 50% of the range. The challenge virus causes mild upper respiratory illness in the majority of infected participants, typical for RSV illness in otherwise healthy adults. This provides a suitable challenge system for evaluating antivirals, as well as vaccines for older children and adults. This also could be used for developing live-attenuated RSV vaccine candidates based on this contemporary strain, using the stabilized point mutations, stabilized codon-deletions, and gene-deletions that were previously used in RSV strain A2.

This invention relates to a reverse genetics system and the encoded RSV vaccine challenge strain that infects and causes disease in RSV-experienced adults and is available for antiviral and vaccine research.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.

• Vaccine development

• Viral diagnostics

• Vaccine research

• Ease of manufacture

• Clinical trial material

• Low-cost vaccines

• Intranasal administration/needle-free delivery

• In vivo data assessment (human)

Inventors: Ursula Buchholz (NIAID), Peter Collins (NIAID).

Intellectual Property: HHS Reference No. E-235-2018-0.

Licensing Contact: Peter Soukas, J.D., 301-594-8730; [email protected].

Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301-594-8730; [email protected].

Technology description follows.

Description of Technology: Acute respiratory infections during early childhood constitute a major human health burden. Human respiratory syncytial virus (RSV) is the most common and important viral cause of severe acute pediatric respiratory infections worldwide. Mortality due to RSV in the post-neonatal (28 days to 1 year old) population is second only to malaria. It is estimated that RSV causes 34 million lower respiratory tract infections, 4 million hospitalizations, and 66,000-199,000 deaths every year in children less than 5 years of age. Most mortality occurs in the developing world where clinical care is less accessible. Mortality is low in the developed countries, but the morbidity is substantial: In the United States alone, RSV is associated with an estimated 132,000-172,000 hospitalizations annually in children less than 5 years old. There is not yet available a vaccine or an effective antiviral drug suitable for routine use.

This invention relates to a broadly antiviral small chemical molecule, Rostafuroxin, expected to be well tolerated in humans and available for clinical evaluation. In particular, this patent application relates to the novel and unexpected finding that Rostafuroxin substantially inhibits RSV infection.

ATP1A1 is a host protein involved with cellular entry of RSV. RSV entry was found to require activation of a signaling cascade mediated by ATP1A1 which resembles the signaling pathway (also mediated by ATP1A1) triggered by cardiotonic steroids.

Though not evaluated for RSV, ATPA1A was previously implicated as a pro-viral factor in the infection cycles of a number of viruses, but the nature of its involvement and mechanism of action were unknown.

Rostafuroxin, a synthetic digitoxigenin derivative, is a small-molecule that is known to specifically bind ATP1A1. It has not been previously known to have any antiviral activity.

The inventors have evidence that Rostafuroxin inhibits RSV infection in respiratory epithelial cells. Rostafuroxin inhibits RSV induced ATP1A1-mediated signaling pathway required for RSV entry. This was demonstrated in A549 cells, a widely used human respiratory epithelial cell line, and in primary human airway epithelial cells derived from a healthy human.

Rostafuroxin has been previously tested in clinical studies as an anti-hypertensive agent. It has no adverse effects in healthy humans and, importantly, does not lower the normal systolic blood pressure of healthy individuals.

Rostafuroxin is a promising anti-viral drug candidate for RSV and possibly other viruses that use the same pathway for host cell entry.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.

Potential Commercial Applications:

Competitive Advantages:

Development Stage:

Inventors: Shirin Munir (NIAID), Matthias Lingemann (NIAID), Peter Collins (NIAID).

Intellectual Property: HHS Reference No. E-202-2018-0—U.S. Provisional Application No. 62/737,899, filed September 27, 2018 (pending).

Licensing Contact: Peter Soukas, J.D., 301-594-8730; [email protected].

Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301-594-8730; [email protected].

The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.

Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.

The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

Notice is hereby given that the incident period for this disaster is closed effective October 8, 2018.

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

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

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

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