August 24, 2016 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 13) granting a joint motion to terminate the investigation based upon a consent order stipulation and proposed consent order. The Commission has issued the consent order. The investigation is terminated.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Louisiana (FEMA-4277-DR), dated 08/16/2016. Incident: Severe Storms and Flooding. Incident Period: 08/11/2016 and continuing. Effective Date: 08/16/2016. Physical Loan Application Deadline Date: 10/17/2016. Economic Injury (EIDL) Loan Application Deadline Date: 05/16/2017.

This is an amendment of the Presidential declaration of a major disaster for the State of West Virginia (FEMA-4273-DR), dated 06/ 25/2016. Incident: Severe Storms, Flooding, Landslides, and Mudslides. Incident Period: 06/22/2016 through 06/29/2016. Effective Date: 07/06/2016. Physical Loan Application Deadline Date: 09/07/2016. EIDL Loan Application Deadline Date: 03/27/2017.

GSA proposes a new system of records subject to the Privacy Act of 1974, as amended, 5 U.S.C. 552a.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The Lyon-Mineral Resource Advisory Committee (RAC) will meet in Yerington, Nevada. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: https:// www.fs.usda.gov/main/pts/specialprojects/racweb.

The SJI Board of Directors will be meeting on Monday, September 12, 2016 at 1:00 p.m. The meeting will be held at the Multnomah County Circuit Court in Portland, Oregon. The purpose of this meeting is to consider grant applications for the 4th quarter of FY 2016, and other business. All portions of this meeting are open to the public.

The designation of the official agency listed below will end on September 30, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agency: Amarillo Grain Exchange, Inc. (Amarillo).

The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.

We are asking for comments on the quality of services provided by this Delegated State: Wisconsin Department of Agriculture, Trade and Consumer Protection (Wisconsin).

GIPSA is announcing the designations of Mid-Iowa Grain Inspection, Inc. (Mid-Iowa); Fremont Grain Inspection Department, Inc. (Fremont); Maryland Department of Agriculture (Maryland); and Titus Grain Inspection, Inc. (Titus) to provide official services under the United States Grain Standards Act (USGSA), as amended.

On July 19, 2016, the National Telecommunications and Information Administration (NTIA) issued a notice and request for public comments on NTIA's preliminary guidance concerning how a qualified state may apply to NTIA for required authority to enter into a spectrum capacity lease with the First Responder Network Authority (FirstNet) and optional grant funds to assist in the construction of its radio access network (RAN) should it opt to do so as allowed under the Middle Class Tax Relief and Job Creation Act of 2012 (Act). In response to requests for additional time in which to comment, NTIA through this notice reopens the comment period. Comments received between the August 18, 2016 due date for comments announced in the July 19, 2016 notice, and publication of this notice in the Federal Register, are deemed to be timely.

The designation of the official agency listed below will end on September 30, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agency: Louisiana Department of Agriculture and Forestry (Louisiana).

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extension of the approved information collection assigned OMB control number OS-0990-0323, which expires on January 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This notice sets forth the schedule and proposed topics of discussion for a public meeting of the Advisory Committee on Supply Chain Competitiveness (Committee).

The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on generic fidaxomicin tablets entitled ``Draft Guidance on Fidaxomicin.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fidaxomicin tablets.

The U.S. Environmental Protection Agency (EPA) proposes to revise its regulations to streamline and clarify processes related to submission and review of title V petitions. This notice covers five key areas, each of which should increase stakeholder access to and understanding of the petition process and aid the EPA's review of petitions. First, the EPA is proposing regulatory provisions that provide direction as to how petitions should be submitted to the agency. Second, the EPA is proposing regulatory provisions that describe the expected format and minimum required content for title V petitions. Third, the proposal clarifies that permitting authorities are required to respond to significant comments received during the public comment period for draft title V permits, and to provide that response with the proposed title V permit to the EPA for the agency's 45-day review period. Fourth, guidance is provided in the form of ``recommended practices'' for various stakeholders to help ensure title V permits have complete administrative records and comport with the requirements of the Clean Air Act (CAA or Act). Fifth, to increase familiarity with the post-petition process, this notice presents information on the agency's interpretation of certain title V provisions of the CAA and its implementing regulations regarding the steps following an EPA objection in response to a title V petition, as previously discussed in specific title V orders.

The U.S. Department of Energy (``DOE'') is granting in part and denying in part a series of petitions to amend a recently published rule that established a procedure through which a party can, within a prescribed period after DOE posts a rule establishing or amending an energy conservation standard, identify a possible error in such a rule and request that DOE correct the error before the rule is published in the Federal Register (``error correction rule''). DOE also provided an opportunity for the public to comment on these petitions. This document responds to both the petitions and related comments that were submitted and received in accordance with the timelines established in a prior Federal Register notice inviting such petitions and comments.

The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.