April 4, 2014 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2014-04-04-ReaderAids
Type: Reader Aids
Date: 2014-04-04
National Sexual Assault Awareness and Prevention Month, 2014
Document Number: 2014-07782
Type: Proclamation
Date: 2014-04-04
Agency: Executive Office of the President
National Financial Capability Month, 2014
Document Number: 2014-07781
Type: Proclamation
Date: 2014-04-04
Agency: Executive Office of the President
National Donate Life Month, 2014
Document Number: 2014-07780
Type: Proclamation
Date: 2014-04-04
Agency: Executive Office of the President
National Child Abuse Prevention Month, 2014
Document Number: 2014-07778
Type: Proclamation
Date: 2014-04-04
Agency: Executive Office of the President
National Cancer Control Month, 2014
Document Number: 2014-07777
Type: Proclamation
Date: 2014-04-04
Agency: Executive Office of the President
Sunshine Act Meeting
Document Number: 2014-07686
Type: Notice
Date: 2014-04-04
Agency: Securities and Exchange Commission, Agencies and Commissions
Sunshine Act Meeting
Document Number: 2014-07653
Type: Notice
Date: 2014-04-04
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Phase 1 Reopening for the Directed Butterfish Fishery
Document Number: 2014-07612
Type: Rule
Date: 2014-04-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces that phase 1 of the directed butterfish fishery will be reopened to provide the opportunity for vessels targeting butterfish to fish with a higher possession limit. Vessels issued a longfin squid/butterfish moratorium permit may fish for, catch, possess, or land unlimited amounts of butterfish when using greater than or equal to 3-inch (76-mm) mesh. The possession limit remains 2,500-lb (1.13 mt) per trip or calendar day for vessels fishing less than 3-inch (76-mm) mesh. The incidental possession limit also remains unchanged at 600 lb (0.27 mt).
Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Specifications and Management Measures
Document Number: 2014-07610
Type: Rule
Date: 2014-04-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is implementing the specifications for fishing year (FY) 2014 for butterfish, as well as other management measures for the species managed under the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan. NMFS previously set specifications for longfin squid and Illex squid for 3 years in 2012 (FYs 2012-2014) and, therefore, new specifications for these species are not included in this year's specification rulemaking. Likewise, NMFS set specifications for mackerel for 3 years in 2013 (2013-2015), so new mackerel specifications are not included in this action. This action increases the butterfish acceptable biological catch by 8 percent and the butterfish landings limit by 24 percent compared to FY 2013. This action also increases the butterfish Phase 3 trip limit from 500 lb (0.23 mt) to 600 lb (0.27 mt) for longfin squid/butterfish moratorium permit holders; establishes a 236-mt cap on river herring (blueback and alewife) and shad (American and hickory) catch in the mackerel fishery; and raises the post-closure possession limit for longfin squid to 15,000 lb (6.80 mt) for vessels targeting Illex squid.
United States Rail Service Issues
Document Number: 2014-07605
Type: Notice
Date: 2014-04-04
Agency: Surface Transportation Board, Department of Transportation
The Surface Transportation Board (Board) will hold a public hearing on April 10, 2014, at its offices in Washington, DC, to provide interested persons the opportunity to report on recent service problems in the United States rail network, to hear from rail industry executives on plans to address their service problems, and to discuss additional options to improve service.
Agency Information Collection Activities: Consideration of Deferred Action for Childhood Arrivals, Form I-821D; Revision of a Currently Approved Collection
Document Number: 2014-07597
Type: Notice
Date: 2014-04-04
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on December 18, 2013, at 78 FR 76636, allowing for a 60-day public comment period. USCIS did receive multiple comments in connection with the 60-day notice. The comments, and USCIS' responses, are discussed within the Supporting Statement that can be found with the documents submitted to OMB in support of this proposed collection of information.
Washington; Amendment No. 1 to Notice of an Emergency Declaration
Document Number: 2014-07592
Type: Notice
Date: 2014-04-04
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of an emergency declaration for the State of Washington (FEMA-3370-EM), dated March 24, 2014, and related determinations.
Application To Export Electric Energy; CP Energy Marketing (US) Inc.
Document Number: 2014-07591
Type: Notice
Date: 2014-04-04
Agency: Department of Energy
CP Energy Marketing (US) Inc. (CP Energy Marketing) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.
Notification of Citizens Coinage Advisory Committee April 8, 2014, Public Meeting.
Document Number: 2014-07588
Type: Notice
Date: 2014-04-04
Agency: United States Mint, Department of Treasury, Department of the Treasury
Pursuant to United States Code, Title 31, section 5135(b)(8)(C), the United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for April 8, 2014. Date: April 8, 2014. Time: 2:00 p.m. to 4:00 p.m. Location: This meeting will occur via teleconference. Interested members of the public may attend the meeting at the United States Mint; 801 9th Street NW., Washington, DC, Conference Room A. Subject: Discussion of potential recommendation to change the reverse design of the American Eagle Silver $1 Bullion Coin, and discussion and potential recommendation to recommend designs for national medals. Interested persons should call the CCAC HOTLINE at (202) 354-7502 for the latest update on meeting time and room location. In accordance with 31 U.S.C. 5135, the CCAC: [ssquf] Advises the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals. [ssquf] Advises the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made. [ssquf] Makes recommendations with respect to the mintage level for any commemorative coin recommended.
Suspension of Community Eligibility
Document Number: 2014-07587
Type: Rule
Date: 2014-04-04
Agency: Federal Emergency Management Agency, Department of Homeland Security
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at http:// www.fema.gov/fema/csb.shtm.
Imazapic; Pesticide Tolerances
Document Number: 2014-07585
Type: Rule
Date: 2014-04-04
Agency: Environmental Protection Agency
This regulation establishes a tolerance for residues of imazapic in or on soybean, seed. BASF Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Environmental Impact Statements; Notice of Availability
Document Number: 2014-07584
Type: Notice
Date: 2014-04-04
Agency: Environmental Protection Agency
New York; Amendment No. 4 to Notice of a Major Disaster Declaration
Document Number: 2014-07583
Type: Notice
Date: 2014-04-04
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for State of New York (FEMA-4129-DR), dated July 12, 2013, and related determinations.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-07582
Type: Notice
Date: 2014-04-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
South Carolina; Major Disaster and Related Determinations
Document Number: 2014-07581
Type: Notice
Date: 2014-04-04
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of South Carolina (FEMA-4166-DR), dated March 12, 2014, and related determinations.
Nine Mile Point 3 Nuclear Project, LLC and UniStar Nuclear Operating Services, LLC
Document Number: 2014-07580
Type: Notice
Date: 2014-04-04
Agency: Nuclear Regulatory Commission, Agencies and Commissions
License Amendment Application for Department of the Army, U.S. Armament Research, Development and Engineering Center
Document Number: 2014-07579
Type: Notice
Date: 2014-04-04
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) has received an application by the Department of the Army, U.S. Armament Research, Development and Engineering Center (ARDEC) for amendment of Materials License No. SUB-348, which authorizes use of radioactive byproduct material for research and development. The amendment would allow ARDEC to begin remediation activities in Area 1222 of the Picatinny Arsenal site to confirm that Area 1222 would meet the requirements for release for unrestricted use. The area would remain a portion of the Picatinny Arsenal site.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Trawl Catcher Vessels in the Central Regulatory Area of the Gulf of Alaska
Document Number: 2014-07578
Type: Rule
Date: 2014-04-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2014 Pacific cod total allowable catch apportioned to trawl catcher vessels in the Central Regulatory Area of the GOA.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2014-07577
Type: Notice
Date: 2014-04-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Tornado Missile Protection
Document Number: 2014-07576
Type: Notice
Date: 2014-04-04
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is seeking public comment on a draft regulatory issue summary (RIS) that restates regulatory requirements and staff positions on protection from tornado missiles.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-07575
Type: Notice
Date: 2014-04-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Notice of Solicitation of Nominations for Members of the Foundation for Food and Agriculture Research
Document Number: 2014-07574
Type: Notice
Date: 2014-04-04
Agency: Department of Agriculture, Office of the Secretary
In accordance with Sec. 7601 of Pub. L. 113-79, the United States Department of Agriculture announces solicitation for nominations to fill 15 vacancies on the Foundation for Food and Agricultural Research. Seven (7) representatives are to be selected from lists of candidates provided by industry, and eight (8) representatives are to be selected from a list of candidates provided by the National Academy of Sciences. The National Academy of Sciences will be soliciting nominations through a separate process. The Agricultural Act of 2014 can be found at: http://www.gpo.gov/fdsys/pkg/BILLS-113hr2642enr/pdf/ BILLS-113hr2642enr.pdf.
Georgia; Major Disaster and Related Determinations
Document Number: 2014-07573
Type: Notice
Date: 2014-04-04
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of Georgia (FEMA-4165-DR), dated March 6, 2014, and related determinations.
Update on Reimbursement for Costs of Remedial Action at Uranium and Thorium Processing Sites
Document Number: 2014-07571
Type: Notice
Date: 2014-04-04
Agency: Department of Energy
In light of the passage of the Consolidated Appropriations Act, 2014 (Pub. L. 113-76), funds were not made available in FY 2014 to the Department of Energy (DOE) for reimbursement for cleanup work performed by licensees at eligible uranium and thorium processing sites in accordance with Title X of the Energy Policy Act of 1992 (Pub. L. 102-486). However, licensees may submit their claims for cleanup work with the understanding that DOE may be able to perform audits/financial review on the claims but cannot provide licensees with reimbursements. If licensees do not submit claims in FY 2014, they can do so the following year. In order to keep an accurate account of claims, DOE will continue to provide an annual status report or report letter on reimbursements to licensees of eligible uranium and thorium processing sites. If licensees submit claims in FY 2014, those licensees are not required to resubmit those same claims in later years.
Certain Standard Cell Libraries, Products Containing or Made Using the Same, Integrated Circuits Made Using the Same, and Products Containing Such Integrated Circuits: Commission Decision Not To Review Granting Complainant's Motion To Amend the Complaint and Notice of Investigation
Document Number: 2014-07570
Type: Notice
Date: 2014-04-04
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 10) of the presiding administrative law judge (``ALJ'') granting complainant's motion to amend the complaint and notice of investigation in the above-captioned investigation.
Announcement of Grant Application Deadlines
Document Number: 2014-07567
Type: Notice
Date: 2014-04-04
Agency: Department of Agriculture, Rural Utilities Service
The Rural Utilities Service (RUS) is announcing a special Fiscal Year (FY) 2014 application window for a Colonias Needs Assessment to be completed through the Technical Assistance and Training Grant Program (TAT). In 2013, RUS partnered with EPA to launch a USDA/EPA Mexico Border Needs Assessment and Support Project. The five-phased project intends to identify small communities' gaps in water and wastewater infrastructure development and in technical capacity in the Mexico Border region. Once the gaps are identified, the project intends to support appropriate water and wastewater infrastructure projects that meet the specific needs of small communities. The ultimate goal would be to reduce health risks and increase economic development in Colonias regions. Phase 1 is completed and consisted of RUS/EPA research and collection of data related to socio-economic factors, public health and Federal and State investments in infrastructure in Colonias regions. Phase 2 of the project is to conduct a detailed assessment of water and wastewater infrastructure needs in select Colonias areas in four states, including California, New Mexico, Arizona and Texas. The areas of focus for the study are further defined in the application guide and are those where Phase I data showed highest health, environmental and economic challenges. Through this announcement RUS seeks applications to conduct the needs assessment and provide a detailed accounting of results that will enable RUS and EPA to advance to Phase 3 of the project. The grant will have a start date of July 1, 2014 and end on December 31, 2014. The study will be done only in the colonias areas. For RUS programs, Colonia is defined as a community that (1) is in the state of Arizona, California, New Mexico, or Texas; (2) is within 150 miles of the U.S.-Mexico border, except for any metropolitan area exceeding one million people; (3) on the basis of objective criteria, lacks adequate sewage systems and lacks decent, safe, and sanitary housing; and (4) existed as a colonia before October 1, 1989. However, the needs assessment may include other rural areas classified as Colonias by other state and Federal agencies. RUS intends to award one grant to an eligible entity for up to $500,000. The grantee will be expected to commence work July 1, 2014 and submit all deliverables by December 31, 2014
Washington; Emergency and Related Determinations
Document Number: 2014-07566
Type: Notice
Date: 2014-04-04
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of an emergency for the State of Washington (FEMA-3370-EM), dated March 24, 2014, and related determinations.
Proquinazid; Pesticide Tolerances
Document Number: 2014-07563
Type: Rule
Date: 2014-04-04
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of proquinazid in or on grape and raisin. DuPont Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Opportunity To Co-sponsor an AHRQ Research Conference
Document Number: 2014-07562
Type: Notice
Date: 2014-04-04
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
AHRQ announces the opportunity for non-Federal public and private sector entities to co-sponsor an AHRQ conference in the Washington, DC area in early March, 2015. Potential co-sponsors must have a demonstrated interest and experience in health services research, implementation, and evaluation. Potential co-sponsors must also be capable of sponsoring and managing various discrete sessions or events associated with the conference and be willing to participate substantively in the co-sponsored activity.
Metaflumizone; Pesticide Tolerances
Document Number: 2014-07559
Type: Rule
Date: 2014-04-04
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of metaflumizone in or on eggplant, pepper, tomato, and tomato, paste. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
First Responder Network Authority Board Special Meeting
Document Number: 2014-07558
Type: Notice
Date: 2014-04-04
Agency: Department of Commerce, National Telecommunications and Information Administration
The Board of the First Responder Network Authority (FirstNet) will hold a Special Meeting via telephone conference (teleconference) on April 8, 2014.
Final Enforceable Consent Agreement and Testing Consent Order for Octamethylcyclotetrasiloxane (D4); Export Notification
Document Number: 2014-07557
Type: Rule
Date: 2014-04-04
Agency: Environmental Protection Agency
Under the Toxic Substances Control Act (TSCA), EPA has issued a testing consent order (Order) that incorporates an enforceable consent agreement (ECA) with Dow Corning Corporation, Evonik Corporation, Momentive Performance Materials USA Inc., Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation (the Companies). The Companies have agreed to certain environmental testing that will be used by EPA to characterize sources and pathways of release of octamethylcyclotetrasiloxane (D4) to the environment and resulting exposures of aquatic and sediment dwelling organisms to D4, contributing to the Agency's efforts to understand potential environmental effects of D4. This document revises the listing for D4 in the table of testing consent orders for substances and mixtures with Chemical Abstract Service (CAS) Registry Numbers. This document announces the ECA and the Order that incorporates the ECA for this testing, and summarizes the terms of the ECA. As a result of this action, exporters of D4, CAS No. 556-67-2, including persons who do not sign the ECA, are subject to TSCA export notification requirements.
Thiram; Time-Limited Pesticide Tolerances
Document Number: 2014-07556
Type: Rule
Date: 2014-04-04
Agency: Environmental Protection Agency
This regulation establishes time-limited tolerances for residues of thiram in or on banana. Taminco US, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). The tolerances expire on March 31, 2015.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2014-07555
Type: Notice
Date: 2014-04-04
Agency: Federal Reserve System, Agencies and Commissions
Formations of, Acquisitions by, and Mergers of Bank Holding Companies; Correction
Document Number: 2014-07554
Type: Notice
Date: 2014-04-04
Agency: Federal Reserve System, Agencies and Commissions
Notice of Intent To Grant Exclusive License
Document Number: 2014-07553
Type: Notice
Date: 2014-04-04
Agency: Agricultural Research Service, Department of Agriculture
Notice is hereby given that the U.S. Department of Agriculture, Agricultural Research Service, intends to grant to Eureka Genomics Corporation of Hercules, California, an exclusive license to the Federal Government's rights in U.S. Patent Application Serial No. 13/824,348, ``SCALABLE CHARACTERIZATION OF NUCLEIC ACIDS BY PARALLEL SEQUENCING'', filed on March 15, 2013.
Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2014-07551
Type: Proposed Rule
Date: 2014-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act.'' The guidance provides updated information pertaining to FDA's authority to access and copy records relating to food. It is a revision of FDA's November 2005 guidance entitled ``Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.''
Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements
Document Number: 2014-07550
Type: Rule
Date: 2014-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.'' This final rule affirms the IFR's change to FDA's records access as required by the FDA Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the Secretary (by delegation FDA) with access to records relating to food that FDA reasonably believes to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.
Atlantic Highly Migratory Species; 2014 Atlantic Bluefin Tuna Quota Specifications
Document Number: 2014-07549
Type: Proposed Rule
Date: 2014-04-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes 2014 quota specifications for the Atlantic bluefin tuna (BFT) fisheries and seeks comments from the public on the allocation of available underharvest among the fishing categories under certain circumstances. This action is necessary to implement binding recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT), as required by the Atlantic Tunas Convention Act (ATCA), and to achieve domestic management objectives under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson- Stevens Act).
Guidance for Industry on What You Need To Know About Establishment, Maintenance, and Availability of Records-Small Entity Compliance Guide; Availability
Document Number: 2014-07548
Type: Proposed Rule
Date: 2014-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need To Know About Establishment, Maintenance, and Availability of Records Small Entity Compliance Guide'' (SECG), which updates an earlier guidance of the same title. Previously, this guidance restated the legal requirements of FDA's maintenance and establishment of records regulation and served as that regulation's SECG. Because the FDA Food Safety Modernization Act (FSMA) amended FDA's maintenance and establishment of records regulation, FDA issued an interim final rule (IFR) amending certain regulations to be consistent with the changes. Accordingly, FDA is revising this guidance to help any entity comply with FDA's maintenance and establishment of records requirements, including the amendments to these requirements made by the IFR as finalized. This guidance continues to serve as FDA's SECG.
Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-07546
Type: Notice
Date: 2014-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review and other additional types of communication, to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed to in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III). These new Agency communication commitments are to increase the efficiency of the review process.
Procurement List; Proposed Additions and Deletions
Document Number: 2014-07545
Type: Notice
Date: 2014-04-04
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
The Committee is proposing to add products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and delete products and a service previously furnished by such agencies. Comments Must Be Received On Or Before: 5/5/2014.
Procurement List; Additions and Deletions
Document Number: 2014-07544
Type: Notice
Date: 2014-04-04
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
This action adds products to the Procurement List that will be furnished by the nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products and services from the Procurement List previously furnished by such agencies.
Regulations Issued Under the Export Apple Act; Exempting Bulk Shipments to Canada From Minimum Requirements and Inspection
Document Number: 2014-07543
Type: Rule
Date: 2014-04-04
Agency: Agricultural Marketing Service, Department of Agriculture
This interim rule revises the regulations issued under the Export Apple Act to exempt bulk shipments of apples to Canada from the minimum requirements and inspection provisions of the Export Apple Act, and to add a definition for bulk containers. The rule is necessary because section 10009 of the Agricultural Act of 2014 amended the Export Apple Act to exempt apples shipped to Canada in bulk containers weighing more than 100 pounds from inspection requirements.