2016 – Federal Register Recent Federal Regulation Documents

Results 9,251 - 9,300 of 31,152
New England Fishery Management Council; Public Meeting
Document Number: 2016-21907
Type: Notice
Date: 2016-09-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The New England Fishery Management Council (Council) is scheduling a public joint meeting of its Whiting Advisory Panel and Whiting Plan Development Team on October 6, 2016 to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-21906
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-21905
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-21904
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
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.
Certain Quartz Slabs and Portions Thereof (II); Commission Decision Not To Review an Initial Determination Terminating the Investigation Based Upon Withdrawal of the Complaint; Termination of Investigation
Document Number: 2016-21903
Type: Notice
Date: 2016-09-13
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 2), which terminated the investigation on the basis of withdrawal of the complaint.
ON Semiconductor Corporation; Analysis To Aid Public Comment
Document Number: 2016-21902
Type: Notice
Date: 2016-09-13
Agency: Federal Trade Commission, Agencies and Commissions
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order embodied in the consent agreementthat would settle these allegations.
World War One Centennial Commission; Notification of Upcoming Public Advisory Meeting
Document Number: 2016-21901
Type: Notice
Date: 2016-09-13
Agency: General Services Administration, Agencies and Commissions
Notice of this meeting is being provided according to the requirements of the Federal Advisory Committee Act, 5 U.S.C. App. 10(a)(2). This notice provides the schedule and agenda for the September 30, 2016 meeting of the World War One Centennial Commission (the Commission). The meeting is open to the public.
Notice of Public Meeting of the Minnesota Advisory Committee To Discuss Project Concepts in Preparation To Select the Committee's Next Topic of Civil Rights Study
Document Number: 2016-21900
Type: Notice
Date: 2016-09-13
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Minnesota Advisory Committee (Committee) will hold a meeting on Monday, September 26, 2016, at 11 a.m. CDT. for the purpose of discussing project concepts regarding future study of civil rights concerns in the state.
Office of the Director Notice of Charter Renewal
Document Number: 2016-21899
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Document Number: 2016-21898
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2016-21897
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2016-21896
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-21895
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-21894
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-21893
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comments Request
Document Number: 2016-21892
Type: Notice
Date: 2016-09-13
Agency: Equal Employment Opportunity Commission, Agencies and Commissions
In accordance with the Paperwork Reduction Act, the Equal Employment Opportunity Commission (EEOC or Commission) announces that it intends to submit to the Office of Management and Budget (OMB) a request for a three-year extension without change of the Local Union Report (EEO-3) (Form 274). Pending OMB approval of an emergency extension request, to be effective after the current September 30, 2016 expiration date, a regular clearance request for OMB review and approval of a three-year extension of the EEO-3 Report is beginning.
Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance
Document Number: 2016-21891
Type: Notice
Date: 2016-09-13
Agency: Department of Commerce, Economic Development Administration
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement
Document Number: 2016-21889
Type: Notice
Date: 2016-09-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Removing Outmoded Regulations Regarding the Smallpox Vaccine Injury Compensation Program
Document Number: 2016-21888
Type: Rule
Date: 2016-09-13
Agency: Department of Health and Human Services
This action removes the outmoded regulations for the Smallpox Vaccine Injury Compensation Program. The program and its implementing regulation have been rendered obsolete by the expiration of the Declaration Regarding Administration of Smallpox Countermeasures under the Smallpox Emergency Personnel Protection Act of 2003 and incorporation of the smallpox countermeasure injury coverage under the Public Readiness and Emergency Preparedness Act of 2005 and its authorization of the Countermeasures Injury Compensation Program.
Approval of California Air Plan Revisions, Great Basin Unified Air Pollution Control District
Document Number: 2016-21872
Type: Proposed Rule
Date: 2016-09-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Great Basin Unified Air Pollution Control District (GBUAPCD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of particulate matter (PM) at Owens Lake, CA. We are proposing to approve a local rule to regulate this emission source under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.
Receiverships for Uninsured National Banks
Document Number: 2016-21846
Type: Proposed Rule
Date: 2016-09-13
Agency: Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
The Office of the Comptroller of the Currency (OCC) is proposing a rule addressing the conduct of receiverships for national banks that are not insured by the Federal Deposit Insurance Corporation (FDIC) (uninsured banks) and for which the FDIC would not be appointed as receiver. The proposed rule would implement the provisions of the National Bank Act (NBA) that provide the legal framework for receiverships of such institutions.
National Dairy Promotion and Research Program
Document Number: 2016-21841
Type: Rule
Date: 2016-09-13
Agency: Agricultural Marketing Service, Department of Agriculture
The Agricultural Marketing Service (AMS) hereby gives notice that no changes will be made to the current distribution of domestic National Dairy Promotion and Research Board (Dairy Board) members in 12 regions as outlined in Section 1150.131(b) of the Dairy Research and Promotion Order (Dairy Order). The Dairy Order provides that the Dairy Board shall review the geographic distribution of milk production throughout the United States (U.S.) and, if warranted, shall recommend to the Secretary a reapportionment of the regions and/or modification of the number of domestic members from the regions in order to better reflect the geographic distribution of milk production volumes in the U.S. The number of domestic Dairy Board members was last modified in 2011 based on 2010 U.S. milk production.
Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Crab Rationalization Program
Document Number: 2016-21824
Type: Proposed Rule
Date: 2016-09-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The North Pacific Fishery Management Council submitted Amendment 47 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (Crab FMP) to NMFS for review. If approved, Amendment 47 would exempt eastern Chionoecetes bairdi Tanner (EBT) and western C. bairdi Tanner (WBT) crab that is custom processed at a facility through contractual arrangements with the processing facility owners from being applied against the individual processing quota (IPQ) use cap of the processing facility owners. Amendment 47 would modify the Crab FMP to allow all of the EBT and WBT Class A individual fishing quota crab to be processed at the facilities currently processing EBT and WBT crab and would have significant, positive economic effects on the fishermen, processors, and communities that participate in the EBT and WBT fisheries. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Crab FMP, and other applicable laws.
2016 National Nanotechnology Initiative Strategic Plan; Notice of Availability and Request for Public Comment
Document Number: 2016-21796
Type: Notice
Date: 2016-09-13
Agency: Office of Science and Technology Policy
The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology; National Science and Technology Council (NSTC); announces the availability of the draft 2016 National Nanotechnology Initiative (NNI) Strategic Plan for public comment. The draft plan is posted at www.nano.gov/2016strategy. Comments of approximately one page or less in length are requested.
Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Real Estate Lending and Appraisals
Document Number: 2016-21741
Type: Notice
Date: 2016-09-13
Agency: Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning renewal of its information collection titled, ``Real Estate Lending and Appraisals.'' The OCC also is giving notice that it has sent the collection to OMB for review.
Modification of Class D Airspace; Peru, IN
Document Number: 2016-21709
Type: Rule
Date: 2016-09-13
Agency: Federal Aviation Administration, Department of Transportation
This action modifies Class D airspace at Grissom Army Reserve Base (ARB), IN, to allow for a lower Circling Minimum Descent Altitude, where Instrument Flight Rules Category E circling procedures are being used. This action increases the area of the existing controlled airspace for Grissom ARB, IN. Additionally, this action will add Peru, Grissom ARB, IN to the subtitle of the airspace designation.
Airworthiness Directives; M7 Aerospace LLC
Document Number: 2016-21704
Type: Proposed Rule
Date: 2016-09-13
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for all M7 Aerospace LLC Models SA226-AT, SA226-T, SA226-T(B), SA226-TC, SA227- AC (C-26A), SA227-AT, SA227-BC (C-26A), SA227-CC, SA227-DC (C-26B), and SA227-TT airplanes. This proposed AD was prompted by corrosion and stress corrosion cracking of the pitch trim actuator upper attach fittings of the horizontal stabilizer front spar. This proposed AD would require repetitive inspections of the pitch trim actuator upper attach fittings for corrosion and/or cracking in the bolt holes and the web/flange radius with replacement of fittings as necessary. We are proposing this AD to prevent jamming and/or loss of control of the horizontal stabilizer, which could result in partial or complete loss of airplane pitch control.
Rates for Interstate Inmate Calling Services
Document Number: 2016-21637
Type: Rule
Date: 2016-09-13
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Commission continues its reform of the inmate calling services (ICS) marketplace by responding to points raised in a petition filed by Michael S. Hamden, seeking reconsideration of certain aspects of the Commission's 2015 ICS Order. Specifically, the Commission amends its rate caps to better allow ICS providers to recover costs incurred as a result of providing inmate calling services, including the costs of reimbursing facilities for any costs they may incur that are reasonably and directly related to the provision of service. The Order also clarifies the definition of ``mandatory taxes and fees'' and addresses other arguments raised by Mr. Hamden.
Energy Conservation Program: Energy Conservation Standards for Walk-In Cooler and Freezer Refrigeration Systems
Document Number: 2016-21583
Type: Proposed Rule
Date: 2016-09-13
Agency: Department of Energy
The Energy Policy and Conservation Act of 1975 (``EPCA''), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including walk-in coolers and freezers. EPCA also requires the U.S. Department of Energy (``DOE'') to periodically determine whether more-stringent, amended standards would be technologically feasible and economically justified, and would save a significant amount of energy. DOE proposes prescribing energy conservation standards for certain categories of walk-in cooler and freezer refrigeration systems and plans to hold a public meeting to receive comment on these proposed standards along with their accompanying analyses.
Notice of Final Federal Agency Action on I-35 Improvements From Rundberg Lane to US 290 East in Austin, Travis County, Texas
Document Number: 2016-21406
Type: Notice
Date: 2016-09-13
Agency: Federal Highway Administration, Department of Transportation
This notice announces actions taken by TxDOT and Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The environmental review, consultation, and other actions required by applicable Federal environmental laws for this project are being, or have been, carried-out by TxDOT pursuant to 23 U.S.C. 327 and a Memorandum of Understanding dated December 16, 2014 and executed by FHWA and TxDOT. The actions relate to a proposed highway project, I-35 Improvements from Rundberg Lane to US 290 East in Austin, Travis County, in the State of Texas. Those actions grant licenses, permits, and approvals for the project. Under MAP-21 section 1319, TxDOT has issued a Finding of No Significant Impact for this action.
Approval of Air Quality Implementation Plans; Puerto Rico; Infrastructure Requirements for the 1997 and 2008 Ozone, 1997 and 2006 Fine Particulate Matter and 2008 Lead NAAQS
Document Number: 2016-21326
Type: Rule
Date: 2016-09-13
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving most elements of the five State Implementation Plan (SIP) revision submittals from the Commonwealth of Puerto Rico to demonstrate that the State meets the requirements of section 110(a)(1) and (2) of the Clean Air Act (CAA) for the 1997 and 2008 ozone, 1997 and 2006 fine particulate matter (PM2.5) and 2008 lead National Ambient Air Quality Standards (NAAQS). The SIP is required to address basic program elements, including, but not limited to: Regulatory structure, monitoring, modeling, legal authority, and adequate resources necessary to assure attainment and maintenance of the standards. These elements are referred to as infrastructure requirements. In this rulemaking action, EPA is approving, in accordance with the requirements of the CAA, the infrastructure SIP submissions with the exception of some portions of the submittals addressing Prevention of Significant Deterioration (PSD).
Adjustment of Cable Statutory License Royalty Rates
Document Number: 2016-20529
Type: Rule
Date: 2016-09-13
Agency: Copyright Royalty Board, Library of Congress, Library of Congress, Agencies and Commissions
On April 26, 2016, the Copyright Royalty Judges (Judges) published for comment proposed regulations governing royalty rates and terms for the distant retransmission of over-the-air television and radio broadcast stations by cable television systems to their subscribers. The participants in the proceeding concluded their negotiations and asked for readoption of the cable rate regulations without change. The Judges accepted the negotiated settlement and did not propose any substantive changes to the participants' proposed rates and terms. However, the Judges' proposed regulations updated terms, moved the rules to the chapter of the CFR that includes other applicable rules of the Copyright Royalty Board, and proposed certain other non-substantive changes to make the rules easier to read. The Judges received comments from the Phase I parties on the proposed changes and finding the suggested revisions therein clarified the rule, accepted all of the proposed changes.
Reader Aids
Document Number: FR-2016-09-12-ReaderAids
Type: Reader Aids
Date: 2016-09-12
Sunshine Act: Notice of Agency Meeting
Document Number: 2016-21973
Type: Notice
Date: 2016-09-12
Agency: National Credit Union Administration, Agencies and Commissions
Sunshine Act Meeting Notice
Document Number: 2016-21957
Type: Notice
Date: 2016-09-12
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Government in the Sunshine Act Meeting Notice
Document Number: 2016-21921
Type: Notice
Date: 2016-09-12
Agency: International Trade Commission, Agencies and Commissions
Government in the Sunshine Act Meeting Notice
Document Number: 2016-21918
Type: Notice
Date: 2016-09-12
Agency: International Trade Commission, Agencies and Commissions
Codex Alimentarius Commission: Meeting of the Codex Committee on Food Hygiene
Document Number: 2016-21890
Type: Notice
Date: 2016-09-12
Agency: Department of Agriculture, Food Safety and Inspection Service
The Office of the Deputy Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS), are sponsoring a public meeting on October 11, 2016. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 48th Session of the Codex Committee on Food Hygiene (CCFH) of the Codex Alimentarius Commission (Codex), taking place in Los Angeles, CA, November 7-11, 2016. The Deputy Under Secretary for Food Safety and the FDA recognize the importance of providing interested parties the opportunity to obtain background information on the 48th Session of the CCFH and to address items on the agenda.
Meeting of the Hispanic Council on Federal Employment
Document Number: 2016-21887
Type: Notice
Date: 2016-09-12
Agency: Office of Personnel Management
The Hispanic Council on Federal Employment (Council) meeting will be held on Thursday, October 13, 2016 at the following time and location shown below: Time: 10:00 a.m. to 11:30 a.m. Location: U.S. Office of Personnel Management, 1900 E Street NW., Executive Conference Room, 5th Floor, Washington, DC 20415 The Council is an advisory committee composed of representatives from Hispanic organizations and senior government officials. Along with its other responsibilities, the Council must advise the Director of the Office of Personnel Management on matters involving the recruitment, hiring, and advancement of Hispanics in the Federal workforce. The Council is co-chaired by the Director of the Office of Personnel Management and the Chair of the National Hispanic Leadership Agenda (NHLA). The meeting is open to the public. Please contact the Office of Personnel Management at the address shown below if you wish to present material to the Council at any of the meetings. The manner and time prescribed for presentations may be limited, depending upon the number of parties that express interest in presenting information.
Access to Employee Exposure and Medical Records; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
Document Number: 2016-21886
Type: Notice
Date: 2016-09-12
Agency: Department of Labor, Occupational Safety and Health Administration
OSHA solicits public comments concerning its proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements contained in the Access to Employee Exposure and Medical Records Standard (29 CFR 1910.1020).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-21885
Type: Notice
Date: 2016-09-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-21884
Type: Notice
Date: 2016-09-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on August 25, 2016 for public comment.
Certain Steel Nails From the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2014-2015
Document Number: 2016-21883
Type: Notice
Date: 2016-09-12
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (``Department'') is conducting the sixth administrative review of the antidumping duty order on certain steel nails (``nails'') from the People's Republic of China (``PRC''). The Department preliminarily determines that Stanley Works (Langfang) Fastening Systems Co., Ltd. and Stanley Black & Decker, Inc. (collectively ``Stanley'') sold subject merchandise in the United States at prices below normal value (``NV'') during the period of review (``POR''), August 1, 2014, through July 31, 2015. The Department also preliminarily determines that Tianjin Lianda Group Co., Ltd. (``Tianjin Lianda'') failed to demonstrate that it is entitled to a separate rate and has been treated as part of the PRC-wide entity. If these preliminary results are adopted in the final results, the Department will instruct U.S. Customs and Border Protection (``CBP'') to assess antidumping duties on all appropriate entries of subject merchandise during the POR. Interested parties are invited to comment on these preliminary results.
Certain Frozen Warmwater Shrimp From the Socialist Republic of Vietnam: Final Results of Antidumping Duty Administrative Review, 2014-2015
Document Number: 2016-21882
Type: Notice
Date: 2016-09-12
Agency: Department of Commerce, International Trade Administration
On March 10, 2016, the Department of Commerce (``Department'') published in the Federal Register the preliminary results of the tenth administrative review of the antidumping duty order on certain warmwater shrimp from the Socialist Republic of Vietnam (``Vietnam''). Based upon our analysis of the comments and information received, we determine that Stapimex sold subject merchandise at less than normal value (``NV'') during the period of review (``POR''), February 1, 2014, through January 31, 2015.
Agency Information Collection Activities: Comment Request
Document Number: 2016-21879
Type: Notice
Date: 2016-09-12
Agency: Export-Import Bank of the United States
The Export-Import Bank of the United States (Ex-Im Bank), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the paperwork Reduction Act of 1995. By neutralizing the effect of export credit insurance and guarantees offered by foreign governments and by absorbing credit risks that the private section will not accept, Ex-Im Bank enables U.S. exporters to compete fairly in foreign markets on the basis of price and product. This collection of information is necessary, pursuant to 12 U.S.C. 635(a)(1), to determine eligibility of the applicant for Ex- Im Bank support. This form is used by a financial institution (or broker acting on its behalf) in order to obtain approval for non-honoring coverage of short-term letters of credit. The information received provides Ex-Im Bank staff with the information necessary to make a determination of the eligibility of the applicant and transaction for Ex-Im Bank assistance under its programs. The application can be viewed at https://www.exim.gov/sites/default/ files/pub/pending/eib92-34.pdf.
Civil Monetary Penalty Inflation Adjustment
Document Number: 2016-21878
Type: Rule
Date: 2016-09-12
Agency: Department of Defense, Office of the Secretary
On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990. The 2015 Act updates the process by which agencies adjust applicable civil monetary penalties (CMP) for inflation to retain the deterrent effect of those penalties. The 2015 Act requires that not later than July 1, 2016, and not later than January 15 of every year thereafter, the head of each agency must, by regulation published in the Federal Register, adjust each CMP within its jurisdiction by the inflation adjustment described in the 2015 Act. Accordingly, the Department of Defense must adjust the level of all civil monetary penalties under its jurisdiction through a final rule and make subsequent annual adjustments for inflation.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2016-21877
Type: Notice
Date: 2016-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
Document Number: 2016-21876
Type: Notice
Date: 2016-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Third Party Review Program.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (TP) Review Program authorized under section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In an effort to encourage harmonization, this guidance proposes to refer to, for the purpose of the TP Review Program, where appropriate and consistent with the FD&C Act and other applicable laws and regulations, the elements from the International Medical Device Regulators Forum's regulatory assessment program called the Medical Device Single Audit Program. In addition, the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to establish and publish in the Federal Register criteria to reaccredit and deny reaccreditation of TP Review Organizations. Those criteria, including others, are described in this draft guidance. This draft guidance is not final nor is it in effect at this time.
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