February 2014 – Federal Register Recent Federal Regulation Documents

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communication 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 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.

The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management, Oregon State Office, Portland, Oregon, 30 days from the date of this publication.

We, the Department of the Interior (Department) and the U.S. Fish and Wildlife Service (Service), announce the availability of the record of decision (ROD) for the final environmental impact statement (EIS) for a proposed land exchange/road corridor on the Izembek National Wildlife Refuge (Refuge), Alaska. We prepared this ROD pursuant to the National Environmental Policy Act of 1969 (NEPA) and its implementing regulations. We provide this notice to advise the public and other agencies of our decision and of availability of the ROD.

We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (Act) prohibits activities with endangered and threatened species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing these permits.

The plats of survey of lands described below are scheduled to be officially filed in the Bureau of Land Management California State Office, Sacramento, California, thirty (30) calendar days from the date of this publication.

The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) and 7 abbreviated new drug applications (ANDAs) for products containing phenylpropanolamine. The basis for the withdrawals is that the products are no longer considered safe due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke. The holders of these NDAs and ANDAs have waived their opportunity for a hearing.

The Food and Drug Administration (FDA) is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device ``nonthermal shortwave therapy (SWT).'' FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing a technical correction in the regulation for the carrier frequency for SWD and nonthermal SWT devices. This proposed action would implement certain regulatory requirements.

The Food and Drug Administration (FDA) is establishing a public docket to receive information and comments on standards for the interoperable exchange of information associated with transactions involving human prescription drugs in a finished dosage form (prescription drugs) to comply with new requirements in the Drug Supply Chain Security Act (DSCSA). We are seeking information from drug manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and other drug supply chain stakeholders and interested parties, including standards organizations, State and Federal Agencies, and solution providers. In particular, stakeholders and other interested parties are requested to comment about the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs. This action is related to FDA's implementation of the DSCSA.

The National Endowment for the Arts (NEA), the National Endowment for the Humanities (NEH), and the Institute of Museum and Library Services (IMLS) are amending their joint Freedom of Information Act (FOIA) regulations, to remove any reference to the NEH, the Federal Council on the Arts and the Humanities (FCAH), an agency for which the NEH provides legal counsel, and the IMLS. The NEA, the NEH and the IMLS are amending these joint regulations because each agency has adopted or plans to adopt its own separate FOIA regulations.

The U.S. Department of Energy (DOE) is initiating a rulemaking and data collection process to consider amendments to DOE's test procedure for commercial packaged boilers. This rulemaking is intended to fulfill DOE's statutory obligation to review its test procedures for covered products at least once every seven years. As part of this process, DOE is considering the potential for adoption of part-load efficiency measurement as part of this test procedure rulemaking for commercial packaged boilers. To help inform the test procedure rulemaking, DOE has identified a variety of issues on which it is seeking comment, as outlined in this document; these issues mainly concern part-load operation and efficiency, appropriate operating conditions for both part-load and full-load operation, and the integration of part-load measurements into the applicable energy efficiency metric. Although DOE welcomes comment on all aspects of its test procedure, DOE is particularly interested in receiving comments and data from stakeholders and the public on these topics.

The Board of Governors of the Federal Reserve System (Board) is proposing to amend its Identity Theft Red Flags rule, which implements section 615(e) of the Fair Credit Reporting Act (FCRA). The Red Flag Program Clarification Act of 2010 (Clarification Act) added a definition of ``creditor'' in FCRA section 615(e) that is specific to section 615(e). Accordingly, the proposed rule would amend the definition of ``creditor'' in the Identity Theft Red Flags rule to reflect the definition of that term as added by the statute. The proposed rule would also update a cross-reference in the Identity Theft Red Flags rule to reflect a statutory change in rulemaking authority.

FMCSA proposes to establish the Commercial Driver's License Drug and Alcohol Clearinghouse (Clearinghouse), a database under the Agency's administration that will contain controlled substances (drug) and alcohol test result information for the holders of commercial driver's licenses (CDLs). The proposed rule would require FMCSA- regulated motor carrier employers, Medical Review Officers (MROs), Substance Abuse Professionals (SAPs), and consortia/third party administrators (C/TPAs) supporting U.S. Department of Transportation (DOT) testing programs to report verified positive, adulterated, and substituted drug test results, positive alcohol test results, test refusals, negative return-to-duty test results, and information on follow-up testing. The proposed rule would also require employers to report actual knowledge of traffic citations for driving a commercial motor vehicle (CMV) while under the influence (DUI) of alcohol or drugs. The proposed rule would establish the terms of access to the database, including the conditions under which information would be submitted, accessed, maintained, updated, removed, and released to prospective employers, current employers, and other authorized entities. Finally, it would require laboratories that provide FMCSA- regulated motor carrier employers with DOT drug testing services to report, annual, summary information about their testing activities. This rule is mandated by Section 32402 of the Moving Ahead for Progress in the 21st Century Act.

The Farm Credit Administration (FCA, we, or our) proposes to amend its regulations governing standards of conduct of directors, employees, and agents of Farm Credit System (System) institutions, excluding the Federal Agricultural Mortgage Corporation. The amendments would clarify and strengthen reporting requirements and prohibitions, require institutions to establish a Code of Ethics, and enhance the role of the Standards of Conduct Official.

NHTSA is proposing to require badges, labels and owner's manual information for new passenger cars, low speed vehicles (LSVs) and light-duty trucks rated at not more than 8,500 pounds gross vehicle weight in order to increase consumer awareness regarding the use and benefits of alternative fuels. In the Energy Independence and Security Act of 2007 (EISA), Congress directed the Secretary of Transportation to develop and implement varied and wide-ranging consumer information and education initiatives related to fuel economy, greenhouse gas, alternative fuels and thermal management technologies. NHTSA is implementing these new information and education initiatives through several different rulemakings. This proposed rule would implement specific statutory mandates that manufacturers be required to: Identify each vehicle capable of running on an alternative fuel by means of a permanent and prominent display affixed to the exterior of the vehicle; add proposed text describing the capabilities and benefits of using alternative fuels to the owners' manuals provided for alternative fuel vehicles; and identify each vehicle that is capable of running on an alternative fuel by means of a label in the fuel filler compartment.

Notice is hereby given, pursuant to the Government in the Sunshine Act (5 U.S.C. 552b(e)(3)), that the February 13, 2014 regular meeting of the Farm Credit Administration Board (Board) has been rescheduled. The regular meeting of the Board will be held Tuesday, February 18, 2014 starting at 2 p.m. An agenda for this meeting was published on February 6, 2014 at 79 FR 7189.

In this document, the Federal Communications Commission (Commission) proposed to modify its rules for operation of the Ancillary Terrestrial Component (ATC) of the single Mobile-Satellite Service (MSS) system operating in the 2483.5-2495 MHz band. The proposed rule changes would allow the MSS operator to deploy a low- power terrestrial broadband network that would operate in both Globalstar's licensed spectrum at 2483.5-2495 GHz, and, with the same equipment, spectrum in the adjacent 2473-2483.5 MHz band used by unlicensed devices. This action could potentially increase the amount of spectrum available for broadband access in the United States. The Commission seeks comment on the potential impacts this proposal could have on unlicensed devices, which operate in the 2400-2483.5 MHz band, licensed Broadcast Auxiliary Service (BAS) stations, which operate in the 2483.5-2500 MHz band, and licensed Broadband Radio Service/ Educational Broadband Service (BRS/EBS) stations, which operate in the 2496-2690 MHz band, along with the costs and benefits of the proposed approach.

The National Aeronautics and Space Administration, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of February 10, 2014. The document revised our infant formula regulations to establish requirements for current good manufacturing practices, including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA took the action to improve the protection of infants who consume infant formula products. The document was published with an incorrect docket number. This document corrects that error.

These special conditions are issued for the Bombardier Inc. Models BD-500-1A10 and BD-500-1A11 series airplanes. These airplanes will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These features are associated with the materials used to fabricate the fuselage, which may affect fire propagation during an in-flight fire. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Food and Drug Administration (FDA) published a document in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The document established administrative detention procedures for devices intended for human use believed to be adulterated or misbranded. The document was published with a citation in the first column on page 13240 that subsequently was changed by the Nutrition Labeling and Education Act Amendments of 1993. In addition, the document was published with one typographical error in the first column on page 13241. This document corrects these errors.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Analytical Procedures and Methods Validation for Drugs and Biologics.'' This revised draft guidance supersedes the 2000 draft guidance for industry on ``Analytical Procedures and Methods Validation'' and, when finalized, will also replace the 1987 FDA guidance for industry on ``Submitting Samples and Analytical Data for Methods Validation.'' This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.