December 18, 2017 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2017-12-18-ReaderAids
Type: Reader Aids
Date: 2017-12-18
National Organic Program (NOP); Organic Livestock and Poultry Practices-Withdrawal
Document Number: 2017-27316
Type: Proposed Rule
Date: 2017-12-18
Agency: Agricultural Marketing Service, Department of Agriculture
This proposed rule sets forth the U.S. Department of Agriculture's (USDA or Department) intention to withdraw the Organic Livestock and Poultry Practices (OLPP) final rule published in the Federal Register on January 19, 2017, by USDA's Agricultural Marketing Service (AMS). The OLPP final rule amends the organic livestock and poultry production requirements in the USDA organic regulations by adding new provisions for livestock handling and transport for slaughter and avian living conditions; and expands and clarifies existing requirements covering livestock care and production practices and mammalian living conditions. The OLPP final rule was originally set to take effect on March 20, 2017. The effective date has been extended to May 14, 2018 under separate actions.
Air Plan Approval; VT; Nonattainment New Source Review and Prevention of Significant Deterioration Permit Program Revisions; Infrastructure Requirements for National Ambient Air Quality Standards
Document Number: 2017-27215
Type: Proposed Rule
Date: 2017-12-18
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve several different revisions to the State Implementation Plan (SIP) submitted to EPA by the Vermont Department of Environmental Conservation (VT DEC). On May 23, 2017, Vermont submitted revisions to EPA satisfying the VT DEC's earlier commitment to adopt and submit revisions that meet certain requirements of the federal Prevention of Significant Deterioration (PSD) air permit program. Vermont's submission also included revisions relating to the federal nonattainment new source review (NNSR) permit program. This action proposes to approve those revisions and also proposes to fully approve certain of Vermont's infrastructure SIPs (ISIPs), which were conditionally approved by EPA on June 27, 2017. Additionally, EPA is proposing to approve several other minor regulatory changes to the SIP submitted by VT DEC on May 23, 2017. This action is being taken in accordance with the Clean Air Act.
Air Plan Approval; Vermont; Regional Haze Five-Year Progress Report
Document Number: 2017-27214
Type: Rule
Date: 2017-12-18
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving Vermont's Regional Haze Five-Year Progress Report (Progress Report), submitted on February 29, 2016 as a revision to its State Implementation Plan (SIP). Vermont's SIP revision addresses requirements of the Clean Air Act (CAA) and EPA's rules that require states to submit periodic reports describing the progress toward reasonable progress goals (RPGs) established for regional haze and a determination of adequacy of the State's existing regional haze SIP. EPA is approving Vermont's Progress Report on the basis that it addresses the progress report and adequacy determination requirements for the first implementation period covering through 2018.
Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) Request for Ad Hoc Expert Nominations; Notice of Public Meeting
Document Number: 2017-27213
Type: Notice
Date: 2017-12-18
Agency: Environmental Protection Agency
The Agency is issuing this notice to announce the opportunity to provide additional nominations for experts to serve as ad hoc members for the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) reviewing physiologically-based pharmacokinetic (PBPK) modeling to address pharmacokinetic differences between and within species on six selected pesticidal active ingredients. This meeting of the FIFRA SAP, originally scheduled for October 24-27, 2017, has been postponed until 2018. New dates for this meeting will be announced in a separate notice.
Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 217, Special Contracting Methods
Document Number: 2017-27212
Type: Notice
Date: 2017-12-18
Agency: Defense Acquisition Regulations System, Department of Defense
In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection requirement for use through February 28, 2018. DoD proposes that OMB extend its approval for three additional years.
NASA Federal Advisory Committees; Public Nominations
Document Number: 2017-27211
Type: Notice
Date: 2017-12-18
Agency: National Aeronautics and Space Administration, Agencies and Commissions
Further to the NASA Federal Register notice of December 12, 2017 (see citation above), NASA announces an invitation for public nominations of U.S. citizens to serve as potential members of the National Space Council Users' Advisory Group (UAG). The UAG is a new Federal advisory committee under the Federal Advisory Committee Act (FACA) being established pursuant to the National Aeronautics and Space Administration Authorization Act, Fiscal Year 1991 (Pub. L. 101-611, Section 121) and Executive Order 13803, Section 6 (``Reviving the National Space Council'') signed by the President on June 30, 2017. The UAG is purely advisory and will ensure that the interests of industry and other non-Federal entities are adequately represented in the deliberations of the National Space Council. NASA is sponsoring the UAG on behalf of the National Space Council, an Executive Branch interagency coordinating committee chaired by the Vice President, which is tasked with advising and assisting the President on national space policy and strategy. Members of the UAG will serve either as ``Representatives'' (representing industry, other non-Federal entities, and other recognizable groups of persons involved in aeronautical and space activities), or as ``Special Government Employees'' (individual subject matter experts or consultants). Deadline: The deadline for NASA to receive all public nominations is January 10, 2018. Instructions for Public Nominations: U.S. citizens or organizations may nominate individuals for consideration as potential members of the UAG. Interested candidates may also self-nominate. The candidate must be a U.S. citizen, may not be a regular government employee, and must not be registered by the Department of Justice under the Foreign Agents Registration Act (FARA), 22 U.S.C. 611 et seq. Additionally, a candidate for a Special Government Employee appointment must not be federally registered as a lobbyist under the Lobbying Disclosure Act of 1995, 2 U.S.C. 1602, as amended. Nominations must be contained in an email to NASA attaching the required documents. All nominations should include a cover letter, a resume (including contact information for the individual) and a professional biography demonstrating professional stature, knowledge and experience commensurate with achieving the UAG's purpose as set forth in Public Law 101-611, Section 121. Each document must not exceed one page. The cover letter must be a signed letter saved as a PDF file, indicate the category of membership for which the individual is being nominated (``Representative'' or ``Special Government Employee''), and contain an affirmative statement that the individual meets all aforesaid requirements. Cover letters for Representative nominations must also indicate why the individual should be considered for membership relative to the UAG's representational objectives, and be on the supporting organization's letterhead. Cover letters for Special Government Employee nominations must also identify the subject area(s) where the individual's expertise and/or consultative stature is nationally recognized relative to the UAG's advisory objectives. Nominations must be submitted in a single email attaching the cover letter, resume, and professional biography to HQ-UAGnoms@nasa.gov. Hard copies such as paper documents sent through postal mail will not be accepted. Privacy Act Notification: The information provided in response to this announcement will support membership selection of the National Space Council Users' Advisory Group (UAG). Its collection is authorized by the Federal Advisory Committee Act (FACA), Public Law 92-463, 5 U.S.C. App., as amended; 5 U.S.C. 3109; Title V of Public Law 100-685; Public Law 101-611, Section 121; Executive Order 13803 of June 30, 2017, Section 6; and 44 U.S.C. 3101. Providing this information is voluntary, but not providing it or not providing it as requested may result in information or an individual not being considered in the UAG membership selection process. NASA may share this information for authorized purposes consistent with the purpose for which it is collected. Elaboration and conditions of information disclosure may be found under ``Routine Uses'' of the full System of Records Notice for System 10SPER, ``Special Personnel Records'' (15-118, 81 FR 10, pp. 2244-2247) at https://www.gpo.gov/fdsys/pkg/FR-2016-01-15/pdf/2016- 00689.pdf and in Appendix B (11-091, 76 FR 200, pp. 64112-64114) at https://www.gpo.gov/fdsys/pkg/FR-2011-10-17/pdf/2011-26731.pd f.
Notice of Permit Modification Issued Under the Antarctic Conservation Act of 1978
Document Number: 2017-27210
Type: Notice
Date: 2017-12-18
Agency: National Science Foundation, Agencies and Commissions
The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.
Agency Information Collection Activities; Submission for OMB Review; Comment Request
Document Number: 2017-27207
Type: Notice
Date: 2017-12-18
Agency: Federal Trade Commission, Agencies and Commissions
The information collection requirements described below will be submitted to the Office of Management and Budget (``OMB'') for review, as required by the Paperwork Reduction Act (``PRA''). The FTC is seeking public comments on its proposal to extend for an additional three years its OMB clearance for the information collection requirements contained in the Commission's Business Opportunity Rule (``Rule''). That clearance expires on January 31, 2018.
Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Suspensions Pending Appeal and Bonding
Document Number: 2017-27204
Type: Notice
Date: 2017-12-18
Agency: Department of the Interior, Office of Natural Resources Revenue
To comply with the Paperwork Reduction Act of 1995 (PRA), we, the Office of Natural Resources Revenue (ONRR), are proposing to renew an information collection.
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2017-27201
Type: Notice
Date: 2017-12-18
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2017-27200
Type: Notice
Date: 2017-12-18
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elimination of Main Studio Rule
Document Number: 2017-27197
Type: Rule
Date: 2017-12-18
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved the non-substantive change request for the information collection requirements contained in FCC 17-137. This document is consistent with the Report and Order, which stated that the Commission would publish a document in the Federal Register announcing OMB approval and the effective date of these rules.
Information Collection Being Reviewed by the Federal Communications Commission
Document Number: 2017-27196
Type: Notice
Date: 2017-12-18
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
30-Day Notice of Proposed Information Collection: Performing Loan Servicing for the Home Equity Conversion Mortgage (HECM)
Document Number: 2017-27195
Type: Notice
Date: 2017-12-18
Agency: Department of Housing and Urban Development
HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.
Notice of Intent To Prepare a Draft Environmental Impact Statement (EIS) for the NDRC Ohio Creek Watershed Project in Norfolk, Virginia
Document Number: 2017-27194
Type: Notice
Date: 2017-12-18
Agency: Department of Housing and Urban Development
The Commonwealth of Virginia, through the Virginia Department of Housing and Community Development (DHCD), is providing notice of its intent to prepare an Environmental Impact Statement (EIS) for the Ohio Creek Watershed Project located in the City of Norfolk, Virginia. The proposed project was developed as part of Virginia's application for assistance through the U.S. Department of Housing and Urban Development (HUD) under the National Disaster Resilience Competition (NDRC). NDRC's objectives through the competition are to support innovative resilience projects at a local level. This Notice of Intent to prepare an EIS represents the beginning of the public scoping process. Following the scoping meeting referenced below, a Draft EIS will be prepared and ultimately circulated for public comment.
30-Day Notice of Proposed Information Collection: Housing Counseling Program-Biennial Agency Performance Review
Document Number: 2017-27193
Type: Notice
Date: 2017-12-18
Agency: Department of Housing and Urban Development
HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.
New Postal Product
Document Number: 2017-27192
Type: Notice
Date: 2017-12-18
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
30-Day Notice of Proposed Information Collection: Continuation of Interest Reduction Payments After Refinancing Section 236 Projects
Document Number: 2017-27191
Type: Notice
Date: 2017-12-18
Agency: Department of Housing and Urban Development
HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.
Worker Safety and Health Program
Document Number: 2017-27190
Type: Rule
Date: 2017-12-18
Agency: Department of Energy
The Department of Energy (DOE) is amending the worker safety and health program regulations to update the safety and health standards and delete the obsolete directives currently incorporated by reference in the code of federal regulations. The regulatory amendments do not alter substantive rights or obligations under current law.
Invitation to Manufacturers of Pertussis Serological Kits
Document Number: 2017-27189
Type: Notice
Date: 2017-12-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces an opportunity for commercial manufacturers to work with CDC's National Center for Immunization and Respiratory Diseases (NCIRD) on the validation of pertussis serological kits prior to submission to the Food and Drug Administration (FDA) for marketing authorization. CDC is interested in the development of an assay that is an Immunoglobulin G (IgG) anti-pertussis toxin (PT) enzyme-linked immunosorbent assay (ELISA), calibrated to an international reference standard (such as FDA Reference Standard Lot #3, World Health Organization (WHO) International Standard 06/140, or equivalents). The ELISA will be used for in vitro serological diagnosis of pertussis in clinical cases of selected age groups. CDC will be able to provide guidance, materials, and evaluation support for the manufacturer; however, the manufacturer will be responsible for submitting a premarket submission to FDA with adequate information, including any analytical or clinical data needed to support the submission, to demonstrate to FDA that FDA can grant marketing authorization to the product.
Notice of Request for Information (RFI) on Identifying Opportunities To Address Barriers for Lowering the Cost and Risk of Geothermal Drilling
Document Number: 2017-27188
Type: Notice
Date: 2017-12-18
Agency: Department of Energy, Office of Energy Efficiency and Renewable Energy
The U.S. Department of Energy (DOE) invites public comment on its Request for Information (RFI) on Identifying Opportunities to Address Barriers for Lowering the Cost and Risk of Geothermal Drilling. The Office of Energy Efficiency and Renewable Energy is specifically interested in information on defining major challenges in geothermal drilling and identifying opportunities in research and development and process improvement, including opportunities to collaborate on best practices with other drilling industries.
Michel P. Toret, M.D.; Decision and Order
Document Number: 2017-27186
Type: Notice
Date: 2017-12-18
Agency: Drug Enforcement Administration, Department of Justice
Science Advisory Board (SAB); Notice of a Meeting
Document Number: 2017-27185
Type: Notice
Date: 2017-12-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This notice sets forth the schedule and proposed agenda of a meeting of the NOAA Science Advisory Board (SAB). The members will discuss issues outlined in the section on Matters to be considered. Time and Date: The meeting will be held Tuesday, February 20, 2018 from 2:00 to 4:00 p.m. Eastern Standard Time (EST). These times and the agenda topic described below are subject to change. For the latest agenda please refer to the SAB website: http://sab.noaa.gov/ SABMeetings.aspx.
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2017-27184
Type: Notice
Date: 2017-12-18
Agency: Federal Reserve System, Agencies and Commissions
Agency Information Collection Activities; Proposed eCollection, eComments Requested; Crime Data Explorer Feedback Survey
Document Number: 2017-27183
Type: Notice
Date: 2017-12-18
Agency: Department of Justice
Department of Justice (DOJ), Federal Bureau of Investigation, Criminal Justice Information Services Division will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Postponement of Meeting of the Labor Advisory Committee for Trade Negotiation and Trade Policy
Document Number: 2017-27182
Type: Notice
Date: 2017-12-18
Agency: Department of Labor, Office of the Secretary
Notice is hereby given that a meeting of the Labor Advisory Committee for Trade Negotiation and Trade Policy has been postponed until further notice. This meeting, which was closed to the public, was scheduled for December 15, 2017, from 2 p.m. to 4 p.m., at the U.S. Department of Labor, Secretary's Conference Room, 200 Constitution Ave. NW, Washington, DC.
Fisheries of the Northeastern United States; Summer Flounder Fishery; Quota Transfer
Document Number: 2017-27179
Type: Rule
Date: 2017-12-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces that the Commonwealth of Virginia is transferring a portion of its 2017 commercial summer flounder quota to the Commonwealth of Massachusetts. This quota adjustment is necessary to comply with the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan quota transfer provisions. This announcement informs the public of the revised commercial quotas for Virginia and Massachusetts.
Agency Information Collection Activities: Request for Comments for a New Information Collection
Document Number: 2017-27178
Type: Notice
Date: 2017-12-18
Agency: Federal Highway Administration, Department of Transportation
The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for a new information collection, which is summarized below under Supplementary Information. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.
Notice of Intent To Request Approval To Revise and Extend an Information Collection
Document Number: 2017-27177
Type: Notice
Date: 2017-12-18
Agency: Department of Agriculture, National Agricultural Statistics Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request approval to revise and extend a currently approved information collection, the Milk and Milk Products Surveys. Revision to burden hours may be needed due to changes in the size of the target population, sample design, and/or questionnaire length.
Combined Notice of Filings #1
Document Number: 2017-27175
Type: Notice
Date: 2017-12-18
Agency: Department of Energy, Federal Energy Regulatory Commission
Alabama Municipal Electric Authority; Notice of Petition for Partial Waiver
Document Number: 2017-27174
Type: Notice
Date: 2017-12-18
Agency: Department of Energy, Federal Energy Regulatory Commission
Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization
Document Number: 2017-27172
Type: Notice
Date: 2017-12-18
Agency: Department of Energy, Federal Energy Regulatory Commission
WBI Energy Transmission, Inc.; Notice of Request Under Blanket Authorization
Document Number: 2017-27171
Type: Notice
Date: 2017-12-18
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2017-27170
Type: Notice
Date: 2017-12-18
Agency: Department of Energy, Federal Energy Regulatory Commission
Certain Magnetic Data Storage Tapes and Cartridges Containing the Same; Commission Determination To Review-in-Part a Final Initial Determination Finding a Violation of Section 337; Request for Written Submissions; Extension of Target Date for Completion of the Investigation
Document Number: 2017-27168
Type: Notice
Date: 2017-12-18
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined to review in part the presiding administrative law judge's (``ALJ'') final initial determination (``Final ID'') issued on September 1, 2017, finding a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (``section 337'') in the above-captioned investigation. The Commission has also determined to extend the target date for completion of the above-captioned investigation to February 20, 2018.
Notice of Closed Meeting
Document Number: 2017-27165
Type: Notice
Date: 2017-12-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC); Notice of Charter Renewal; Correction
Document Number: 2017-27164
Type: Notice
Date: 2017-12-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2019.
Notice of Public Information Collections Being Reviewed by the U.S. Agency for International Development; Comments Requested
Document Number: 2017-27163
Type: Notice
Date: 2017-12-18
Agency: U.s. Agency for International Development
U.S. Agency for International Development (USAID) is making efforts to reduce the paperwork burden. USAID invites the general public and other Federal agencies to take this opportunity to comment on the following proposed and/or continuing information collections, as required by the Paperwork Reduction Act for 1995. Comments are requested concerning: (a) The accuracy of the burden estimates; (b) ways to enhance the quality, utility, and clarity of the information collected; and (c) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques, or other forms of information technology.
Loan Guaranty: Assistance to Eligible Individuals in Acquiring Specially Adapted Housing; Cost-of-Construction Index
Document Number: 2017-27162
Type: Notice
Date: 2017-12-18
Agency: Department of Veterans Affairs
The Department of Veterans Affairs (VA) announces that the aggregate amounts of assistance available under the Specially Adapted Housing (SAH) grant program will increase by 4.88 percent for Fiscal Year (FY) 2018.
Regulation Q; Regulatory Capital Rules: Risk-Based Capital Surcharges for Global Systemically Important Bank Holding Companies
Document Number: 2017-27161
Type: Notice
Date: 2017-12-18
Agency: Federal Reserve System, Agencies and Commissions
The Board is providing notice of the aggregate global indicator amounts for purposes of a calculation for 2017, which is required under the Board's rule regarding risk-based capital surcharges for global systemically important bank holding companies (GSIB surcharge rule).
Notice to All Interested Parties of Intent To Terminate the Receivership of 4632, BestBank, Boulder, Colorado
Document Number: 2017-27158
Type: Notice
Date: 2017-12-18
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Draft Guidance for Industry; Availability
Document Number: 2017-27156
Type: Notice
Date: 2017-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.'' The purpose of this guidance is to describe the FDA's current recommendations on how to group patients with different molecular alterations for eligibility in clinical trials; and general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies.
Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards; Availability
Document Number: 2017-27155
Type: Notice
Date: 2017-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Investigational IVDs Used in Clinical Investigations of Therapeutic Products.'' This draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational in vitro diagnostics (IVDs) and institutional review boards (IRBs) that review such investigations in complying with the Investigational Device Exemption (IDE) regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance is not final nor is it in effect at this time.
Petition for Exemption; Summary of Petition Received
Document Number: 2017-27154
Type: Notice
Date: 2017-12-18
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.