February 8, 2013 – Federal Register Recent Federal Regulation Documents

The Pacific Fishery Management Council's (Council) will hold a workshop on electronic monitoring in the rationalized groundfish trawl fishery.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA's current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that occur before the onset of overt dementia.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.'' This draft guidance provides responses to questions FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) relating to tobacco products in retail outlets. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/ or public meeting will be considered in preparing the U.S. position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2013. This notice is issued under the Controlled Substances Act (the CSA).

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB). Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collection of information to determine (1) The practical utility of the collection; (2) the accuracy of the estimated burden of the collection; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of the publication date. Section 2 of the Railroad Retirement Act (RRA) provides for payment of disability annuities to qualified employees and widow(ers). The establishment of permanent disability for work in the applicants ``regular occupation'' or for work in any regular employment is prescribed in 20 CFR 220.12 and 220.13 respectively. The RRB utilizes Form G-251, Vocational Report, to obtain an applicant's work history. This information is used by the RRB to determine the effect of a disability on an applicant's ability to work. Form G-251 is designed for use with the RRB's disability benefit application forms and is provided to all applicants for employee disability annuities and to those applicants for a widow(er)'s disability annuity who indicate that they have been employed at some time. Completion is required to obtain or retain a benefit. One response is requested of each respondent. Previous Requests for Comments: The RRB has already published the initial 60-day notice (77 FR 63358 on October 16, 2012) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 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.

The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 14117, HCTC Registration for Medicare Family Members, and REG- 128841-07, Public Approval Guidance for Tax-Exempt Bonds (NPRM).

With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the re-opening of a public comment period for a request for information and comment published on October 17, 2012. The request for information sought information and comments from the public regarding whether highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. The comment period closed on December 17, 2012. We are reopening the comment period to allow interested persons additional time to prepare and submit comments.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Ohio (FEMA- 4098-DR), dated 01/03/2013. Incident: Severe storms and flooding due to the remnants of Hurricane Sandy. Incident Period: 10/29/2012 through 10/30/2012. Effective Date: 01/29/2013. Physical Loan Application Deadline Date: 03/04/2013. Economic Injury (EIDL) Loan Application Deadline Date: 10/03/2013.

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. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. Currently, the OCC is soliciting comment concerning its renewal of an information collection titled, ``Municipal Securities Dealers and Government Securities Brokers and DealersRegistration and Withdrawal.''

EPA is taking direct final action to approve a State Implementation Plan (SIP) revision submitted by the Maryland Department of the Environment (MDE) pertaining to the F. Keeler Company Boiler at Mount Saint Mary's College. This revision removes the Mount Saint Mary's College 1979 Consent Order (1979 Consent Order) from the Maryland SIP because the coal-fired F. Keeler Boiler has been modified by removing the coal-firing capability and converting the boiler to fire natural gas with No. 2 fuel oil as backup. EPA is approving this SIP revision because the 1979 Consent Order is no longer required as the modified gas-fired unit can comply with all visible emission and particulate requirements in the Maryland SIP, and this 1979 Consent Order is no longer required to satisfy any applicable Federal regulations or the Clean Air Act (CAA). This action is being taken under the CAA.

Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.

The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. The information collected through HUD's Integrated Disbursement and Information System (IDIS) (Sec. 92.502) is used by HUD Field Offices, HUD Headquarters and HOME Program Participating Jurisdictions (PJs). The information on program funds committed and disbursed is used by HUD to track PJ performance and to determine compliance with the statutory 24-month commitment deadline and the regulatory 5-year expenditure deadline (Sec. 92.500(d)). The project-specific property, tenant, owner and financial data is used to compile annual reports to Congress required at Section 284(b) of the Act, as well as to make program management decisions about how well program participants are achieving the statutory objectives of the HOME Program. Program management reports are generated by IDIS to provide data on the status of program participants' commitment and disbursement of HOME funds. These reports are provided to HUD staff as well as to HOME PJs. Management reports required in conjunction with the Annual Performance Report (Sec. 92.509) are used by HUD Field Offices to assess the effectiveness of locally designed programs in meeting specific statutory requirements and by Headquarters in preparing the Annual Report to Congress. Specifically, these reports permit HUD to determine compliance with the requirement that PJs provide a 25% match for HOME funds expended during the Federal fiscal year (Section 220 of the Act) and that program income be used for HOME eligible activities (Section 219 of the Act), as well as the Women and Minority Business Enterprise requirements (Sec. 92.351(b)). Financial, project, tenant and owner documentation is used to determine compliance with HOME Program cost limits (Section 212(e) of the Act), eligible activities (Sec. 92.205), and eligible costs (Sec. 92.206), as well as to determine whether program participants are lenders on their overall program performance. The information collected is used to determine insurance eligibility and claim eligibility.