March 13, 2012 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) is seeking to identify interest and obtain information relevant to the design of a pilot operational study (or studies) on alternative donor deferral criteria that would permit blood and plasma donations (subsequently termed ``blood donations'') by men who have had sex with other men (MSM). Based upon documented higher levels of certain transfusion- transmissible infections (e.g. Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV)) in some groups of men who have had sex with men, all men with a history of this behavior since 1977 are currently deferred from donating blood. However, the increased effectiveness of donor testing for HIV, HBV, syphilis and other infectious agents has greatly enhanced blood safety. As a result, questions have been raised about the need to continue an indefinite deferral of all MSM and whether there could be blood donation by MSM who may not be at increased risk. In June 2010, HHS sought advice from its Advisory Committee for Blood Safety and Availability (ACBSA) on the issue of the current MSM deferral policy. The Advisory Committee noted that the existing policy is suboptimal, but recommended that the policy should be retained pending the completion of targeted research studies that might support a safe alternative policy. HHS and the agencies responsible for blood safety are committed to efforts to maintain and enhance the safety of the nation's blood supply, taking into account all new and emerging scientific information. Consistent with the June 2010 recommendations of the ACBSA, HHS seeks to determine through appropriate studies whether blood safety can be maintained or enhanced under revised blood donor screening criteria that would permit donation by some MSM. This request for information (RFI) is being issued in recognition of the challenges of designing such studies. This RFI seeks information from interested parties regarding the design, logistics and feasibility of a pilot operational study (or studies) to assess alternative blood donor eligibility criteria for MSM. Responses to this RFI will inform HHS on the design, logistics and feasibility of such a study, which, if feasible, could result in identifying potential pathways toward future alternate policies that will maintain or enhance the current very high levels of blood safety. The concept is to conduct a pilot operational study, in which MSM who meet specified criteria would be permitted to donate blood, with additional safeguards in place to protect blood recipients during the course of the study. Data would be gathered to assess the effectiveness of the specified criteria to select low risk donors among MSM. Upon completing all data collection activities, there will be a transparent and evidence-based evaluation of current and possible future MSM blood donation policies. This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of HHS. HHS does not intend to award a grant or contract to pay for the preparation of any information submitted or for the use of such information by HHS. Whereas all responses to this notice will be carefully considered, acknowledgment of receipt of responses will not be made, nor will respondents be notified of the evaluation by HHS of the information received. No basis for claims against HHS shall arise as a result of a response to this request for information or to the use of such information by HHS as either part of our evaluation process or in developing specifications for any subsequent announcement.

On October 7, 2011, the Department of Commerce (the Department) published in the Federal Register the preliminary results of the antidumping duty administrative review for certain lined paper products from India (CLPP).\1\ This review covers 35 manufacturers and exporters of the subject merchandise,\2\ including Navneet Publications (India) Limited (Navneet) and Riddhi Enterprises (Riddhi), for the period September 1, 2009, through August 31, 2010. As a result of our analysis of the comments received, these final results differ from the Preliminary Results. On February 3, 2012, the Department extended the final results of this review from February 6, 2012, to March 5, 2012.\3\

This notice announces the availability of the Final Environmental Assessment (EA) on the application from PacifiCorp Energy (PacifiCorp or applicant) for an Incidental Take Permit (ITP) and Habitat Conservation Plan (HCP) for take of a threatened species in accordance with the Endangered Species Act of 1973, as amended (ESA). NMFS and PacifiCorp have also developed an implementing agreement (IA) which details how NMFS and PacifiCorp will work together to implement the HCP. This notice also announces that NMFS has made a decision to issue an ITP to PacifiCorp for the covered activities described in their HCP, and has authorized the incidental take of Southern Oregon/ Northern California Coast (SONCC) Evolutionarily Significant Unit (ESU) coho salmon (Oncorhynchus kisutch) as a result of operation and maintenance of its Klamath Hydroelectric Project (Project) in and near the Klamath River in Southern Oregon and Northern California, and implementation of the HCP during a ten-year period. This notice is provided under National Environmental Policy Act (NEPA) regulations and NMFS ESA permit regulations to inform the public that the Final EA HCP, responses to public comments, and associated documents are available for review; and NMFS has made a decision to issue the ITP.

NMFS has received an application from AMEC Environment & Infrastructure, on behalf of Fishermen's Atlantic City Windfarm, LLC (Fishermen's) for an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to pile driving off the New Jersey coast. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is proposing to issue an IHA to take, by Level B harassment, bottlenose dolphins, harbor porpoises, and harbor seals during the specified activity within a specific geographic region and is requesting comments on its proposal.

The Department of State has submitted the following information collection request to the Office of Management and Budget (OMB) for approval in accordance with the Paperwork Reduction Act of 1995. Title of Information Collection: Department of State Acquisition Regulation (DOSAR). OMB Control Number: 1405-0050. Type of Request: Extension of a Currently Approved Collection. Originating Office: Bureau of Administration, Office of the Procurement Executive (A/OPE). Form Number: N/A. Respondents: Any business, other for-profit, individual, not-for-profit, or household organization wishing to receive Department of State contracts. Estimated Number of Respondents: 3,466. Estimated Number of Responses: 9,316. Average Hours Per Response: Varies. Total Estimated Burden: 275,970 hours. Frequency: On occasion. Obligation to Respond: Voluntary.

NMFS increases the possession limits for Georges Bank (GB) cod and Southern New England (SNE)/Mid-Atlantic (MA) yellowtail flounder for Northeast (NE) multispecies common pool vessels for the remainder of the 2011 fishing year (FY), through April 30, 2012. This is intended to facilitate the harvest of GB cod and SNE/MA yellowtail flounder to allow the total catch of these stocks to approach their pertinent common pool sub-annual catch limits (sub-ACLs).

NMFS is prohibiting directed fishing for pollock in Statistical Area 630 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the B season allowance of the 2012 total allowable catch of pollock for Statistical Area 630 in the GOA.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

The Food and Drug Administration (FDA) has determined that the DURANEST (etidocaine hydrochloride) drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these drug products if all other legal and regulatory requirements are met.

The Environmental Protection Agency (EPA) Region 8 is issuing a Notice of Intent to Delete Operable Unit (OU) 1 the former Fire Protection Training Area (FPTA), along with two other Areas of Concern (AOC): The Gateway Lake Ash Study Area and the Pride Hangar Study Area of the Ellsworth Air Force Base (AFB) Superfund Site located in Meade and Pennington Counties, South Dakota, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of South Dakota, through the Department of Environment and Natural Resources, have determined that all appropriate response actions at these identified parcels under CERCLA other than five year reviews have been completed. However, this deletion does not preclude future actions under Superfund. This partial deletion pertains to the surface soil, unsaturated subsurface soil, surface water and sediments of Operable Unit (OU) 1, the Gateway Lake Ash Study Area, and the Pride Hangar Study Area. The groundwater medium associated with OU-11, Basewide Groundwater, will remain on the NPL and is not being considered for deletion as part of this action. The other OUs associated with Ellsworth AFB were deleted in 2006.

The EPA Science Advisory Board (SAB) Staff Office announces a public meeting and a public teleconference of the Clean Air Scientific Advisory Committee (CASAC) Lead Review Panel to conduct a peer review of EPA's Integrated Science Assessment for Lead (Second External Review DraftFebruary 2012), and a public teleconference of the Chartered CASAC to conduct a quality review of the Panel's draft report.

In accordance with section 113(g) of the Clean Air Act, as amended (``CAA''), 42 U.S.C. 7413(g), notice is hereby given of a proposed consent decree to resolve a lawsuit filed by Midwest Environmental Defense Center, Inc., and Clean Water Action Council of Northeast Wisconsin (``Plaintiffs''), in the United States District Court for the District of Columbia: Midwest Environmental Defense Center, Inc., et al. v. Jackson, No. 11-cv-02137-BAH (D. D.C.). On July 23, 2011, Plaintiffs filed a deadline suit to compel the Administrator to respond to an administrative petition seeking EPA's objection to a CAA Title V operating permit issued by the Wisconsin Department of Natural Resources, for the Georgia Pacific Consumer Products Plant in Green Bay, Wisconsin. Under the proposed consent decree, EPA would agree to respond to the petition by July 23, 2012, or within 14 days after entry of the consent decree by the Court, whichever is later.

This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, the Gaston East-West Connector, from I-85 west of Gastonia in Gaston County, North Carolina, to I-485 near the Charlotte-Douglas International Airport in Mecklenburg County, North Carolina. The Gaston East-West Connector is also known as State Transportation Improvement Program Project U-3321. Those actions grant licenses, permits, and approvals for the project.

This notice sets forth the schedule and proposed agenda of a meeting of the Environmental Technologies Trade Advisory Committee (ETTAC).