November 20, 2013 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 144
Proposed Information Collection (Designation of Certifying Official(s)); Comment Request
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection and allow 60 days for public comment in response to the notice. This notice solicits comments for information needed to identify individuals authorized to certify reports on behalf of an educational institution or job training establishment.
Notice of Permits Issued Under the Antarctic Conservation Act of 1978
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.
Notice of Permits Issued Under the Antarctic Conservation Act of 1978
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.
Notice of Permits Issued Under the Antarctic Conservation Act of 1978
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.
Environmental Impact Statement: Caddo Parish, Louisiana
The FHWA is issuing this revised notice of intent to advise the public of modifications to the I-49 Inner City Connector Environmental Impact Statement (EIS). The previous notice of intent described the I-49 Inner City Connector as an approximate 3.8 mile new freeway designed to connect existing I-49 to future I-49 North at its proposed junction with I-220 in Shreveport, Louisiana. During the public involvement process undertaken as part of the EIS, a build alternative utilizing an existing roadway was proposed and will be studied in the EIS. This alternative represents an approximate 12 mile connector to link existing I-49 at its junction with Louisiana Highway 3132 to future I-49 North at its proposed junction with I-220. This NOI revises the NOI issued on February 8, 2012.
Safety and Security Plans for Class 3 Hazardous Materials Transported by Rail
PHMSA and FRA are issuing this safety advisory as a follow-up to the agencies' joint safety advisory published on August 7, 2013 and FRA's Emergency Order No. 28 published that same day, both of which relate to the July 6, 2013, catastrophic accident in Lac- M[eacute]gantic, Quebec. In this safety advisory, PHMSA and FRA are reinforcing the importance of proper characterization, classification, and selection of a packing group for Class 3 materials, and the corresponding requirements in the Federal hazardous materials regulations for safety and security planning. In addition, we are reinforcing that we expect offerors by rail and rail carriers to revise their safety and security plans required by the Federal hazardous materials regulations, including the required risk assessments, to address the safety and security issues identified in FRA's Emergency Order No. 28 and the August 7, 2013, joint Safety Advisory.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Periods
The Food and Drug Administration (FDA) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of January 16, 2013 (78 FR 3504), entitled ``Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption'' and for its information collection provisions.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
The Food and Drug Administration (FDA) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of January 16, 2013 (78 FR 3646), entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food'' and its information collection provisions.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions in the guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables.''
Meeting of the Defense Advisory Committee on Women in the Services (DACOWITS)
The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Women in the Services (DACOWITS) will take place. The purpose of the meeting is to vote on the Committee's Annual Report and to receive briefings and updates relating to the Committee's current work.
Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Halibut and Crab Prohibited Species Catch Allowances in the Bering Sea and Aleutian Islands Management Area
NMFS is reallocating the projected unused amounts of the 2013 halibut and crab prohibited species catch (PSC) allowances from the Bering Sea and Aleutian Islands trawl (BSAI) limited access sector to the Amendment 80 cooperatives in the BSAI management area. This action is necessary to allow the Amendment 80 cooperatives to fully harvest their 2013 groundfish allocations.
Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area
NMFS is reallocating the projected unused amounts of Pacific cod from catcher vessels using jig gear, catcher vessels greater than 60 feet (18.3 meters) length overall (LOA) using pot gear, and catcher vessels using trawl gear to catcher vessels less than 60 feet (18.3 meters) LOA using hook- and-line or pot gear, American Fisheries Act (AFA) catcher/processors (C/P), Amendment 80 (A80) C/Ps, C/P vessels using pot gear, and C/P vessels using hook-and-line gear in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2013 total allowable catch of Pacific cod to be harvested.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation'' dated November 2013. The draft guidance document provides recommendations to submitters and FDA reviewers in preparing and reviewing 510(k) submissions for nucleic acid-based HLA test kits used for matching of donors and recipients in transfusion and transplantation. The guidance provides detailed information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s.
Amendments to General Regulations of the Food and Drug Administration; Technical Amendments
The Food and Drug Administration (FDA or we) published a final rule in the Federal Register on November 30, 2010, amending certain regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule inadvertently deleted an authority citation and language related to the definition of ``package.'' We are restoring the inadvertent deletions and making a corresponding technical change.
Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate and Reward True Patient-Centric Value in Innovation; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation.'' FDA is cosponsoring the workshop with the American Gastroenterological Association (AGA). The purpose of the workshop is to facilitate discussion between FDA, AGA, and other interested parties of the development of medical devices for the treatment of morbid obesity and other metabolic diseases and evolving approaches for the regulation and reimbursement of minimally invasive procedures. The public workshop is being rescheduled due to the government shutdown. The title of the workshop has also been changed.
Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.'' When finalized, the draft guidance will replace the guidance of the same title issued January 25, 2012. The draft guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human drugs, including biological drug products, and prescription animal drugs and articulates the circumstances under which FDA intends to exercise enforcement discretion.
Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The draft guidance document provides sponsors of Investigational New Drug Applications for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products. In the notice, we requested comments on the draft guidance. We are taking this action to allow interested persons additional time to submit comments and to allow for public discussion at the February 25-26, 2014, Cellular, Tissue, and Gene Therapies Advisory Committee meeting, where FDA will present the draft guidance document for review.
Change in Postal Rates
The Commission is noticing a recently Postal Service filing concerning the Postal Service's intention to change rates of general applicability for competitive products. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Agency Information Collection (
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.
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