2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability of the draft guidance entitled ``Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,'' published in the Federal Register of June 18, 2014. FDA is reopening the comment period in response to a request for additional time and to allow interested persons more time to submit comments.

Through the CDFI Program, the CDFI Fund provides (i) FA awards of up to $1 million to Certified Community Development Financial Institutions (CDFIs) serving Native American, Alaska Native, or Native Hawaiian populations or Native American areas defined as Federally-designated reservations, Hawaiian homelands, Alaska Native Villages and U.S. Census Bureau-designated Tribal Statistical Areas (collectively, ``Native Communities'') to build their financial capacity to lend to their Target Markets, and (ii) TA grants of up to $150,000 to build Certified, Certifiable, and Emerging CDFIs' organizational capacity to serve their Target Markets and Sponsoring Entities ability to create Certified CDFIs that serve Native Communities. All awards provided through this NOFA are subject to funding availability.

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 solicits comments on adverse event reporting by FDA on new animal drugs and product/manufacturing defects collected on paper forms.

This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction.

The National Park Service announces the availability of the Final Environmental Impact Statement for the general management plan for Big Thicket National Preserve. Consistent with NPS laws, regulations, and policies and the purpose of the parkway, the general management plan will guide the management of the park over the next 15- 20 years.

The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. Chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the Federal Register notifying the public that the agency has made such a submission. This notice also allows an additional 30 days for public comments.

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.

The Secretary of Homeland Security announces that the annual fiscal year numerical limitation for the Commonwealth of the Northern Mariana Islands (CNMI)-only Transitional Worker (CW-1) nonimmigrant classification for fiscal year (FY) 2015 is set at 13,999. In accordance with Title VII of the Consolidated Natural Resources Act of 2008 (CNRA) (codified, in relevant part, at 48 U.S.C. 1806(d)) and 8 CFR 214.2(w)(1)(viii)(C), this document announces the mandated annual reduction of the CW-1 numerical limit and provides the public with additional information regarding the new CW-1 numerical limit. This document is intended to ensure that CNMI employers and employees have sufficient notice regarding the maximum number of CW-1 transitional workers who may be granted status during FY 2015.

The Indian Health Service (IHS or ``the Agency'') is issuing this Notice to implement the final Policy for conferring with Urban Indian Organizations (UIOs). In March 2010, the Indian Health Care Improvement Act (IHCIA) was reauthorized and amended as part of the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act (together, the Affordable Care Act), Public Law 111-152. One of the changes made to the IHCIA was to create a new requirement that the IHS ``confer'' with UIOs, to the maximum extent practicable, in carrying out the IHCIA.

The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Placer County Air Pollution Control District (PCAPCD) portion of the California State Implementation Plan (SIP). This revision concerns a permitting rule that regulates construction and modification of major stationary sources of air pollution. These revisions correct deficiencies in PCAPCD Rule 502, New Source Review, previously identified by EPA in a final rule dated September 24, 2013. We are approving revisions that correct the identified deficiencies.

The Commission is noticing a recent Postal Service filing concerning an addition of Priority Mail Contract 93 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 18th, 2014 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is revising certain provisions of the proposed rule, issued in July 2013, on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. We are primarily revising the proposed requirements concerning compliance status review of food and foreign suppliers, hazard analysis, and supplier verification activities. We are taking this action in response to the extensive public input we have received regarding these provisions and in coordination with revisions we are concurrently making to the proposed rule on current good manufacturing practice (CGMP) and hazard analysis and risk-based preventive controls for human food. We are seeking public comment on the revised proposed FSVP regulations. We are reopening the comment period on the proposed rule only with respect to the specific provisions identified in this Federal Register document.

The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food. In that 2013 proposed rule, we proposed to amend the CGMP requirements to modernize them and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also proposed to revise certain definitions in our current regulation for Registration of Food Facilities to clarify the scope of an exemption from registration requirements for ``farms'' and, in so doing, to clarify which domestic and foreign facilities would be subject to the proposed requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action because the extensive input we have received from public comments has led to significant changes in our current thinking on certain key provisions of these proposed rules. We are reopening the comment period only with respect to specific issues identified in this proposed rule.