February 15, 2012 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2012-02-15-ReaderAids
Type: Reader Aids
Date: 2012-02-15
Sunshine Act Meeting Notice
Document Number: 2012-3656
Type: Notice
Date: 2012-02-15
Agency: Department of Energy, Federal Energy Regulatory Commission
Revising Underground Storage Tank Regulations-Revisions to Existing Requirements and New Requirements for Secondary Containment and Operator Training
Document Number: 2012-3589
Type: Proposed Rule
Date: 2012-02-15
Agency: Environmental Protection Agency
EPA is extending the public comment period for the proposed changes to the 1988 underground storage tank (UST) technical, financial responsibility, and state program approval regulations published in the Federal Register on November 18, 2011 (76 FR 71708) (FRL-9485-5). These changes establish federal requirements that are similar to key portions of the Energy Policy Act of 2005; they also update certain 1988 UST regulations. Proposed changes include: Adding secondary containment requirements for new and replaced tanks and piping; adding operator training requirements; adding periodic operation and maintenance requirements for UST systems; removing certain deferrals; adding new release prevention and detection technologies; updating codes of practice; making editorial and technical corrections; and updating state program approval requirements to incorporate these new changes. These changes will likely protect human health and the environment by increasing the number of prevented UST releases and quickly detecting them, if they occur. This document extends the comment period for 60 days, from February 16, 2012 until April 16, 2012.
Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval
Document Number: 2012-3588
Type: Notice
Date: 2012-02-15
Agency: Environmental Protection Agency
Notice is hereby given that the State of Illinois submitted a primacy application for its approved Public Water System Supervision Program. Illinois is applying its Long Term 2 Enhanced Surface Water Treatment Regulations to all Illinois water systems that use surface water and ground water under the influence of surface water as a source, thereby satisfying the requirements of the Long-Term 2 Enhanced Surface Water Treatment Rule. Illinois is also applying its Stage 2 Disinfectants and Disinfection By-products Regulations to all Illinois community and noncommunity water systems that add and/or deliver water that is treated with a primary or residual disinfectant other than ultraviolet light, thereby satisfying the requirements of the Stage 2 Disinfectants and Disinfection Byproducts Rule. EPA has determined that the state regulations and procedures submitted by the State to EPA for review are no less stringent than the corresponding federal regulations. Therefore, EPA intends to award primacy to Illinois for Long-Term 2 Enhanced Surface Water Treatment and Stage 2 Disinfectants and Disinfection By-product Rules implementation. Any interested party may request a public hearing. A request for a public hearing must be submitted by March 16, 2012, to the Regional Administrator at the EPA Region 5 address shown below. The Regional Administrator may deny frivolous or insubstantial requests for a hearing. However, if a substantial request for a public hearing is made by March 16, 2012; EPA Region 5 will hold a public hearing. If EPA Region 5 does not receive a timely and appropriate request for a hearing and the Regional Administrator does not elect to hold a hearing on her own motion, this determination shall become final and effective on March 16, 2012. Any request for a public hearing shall include the following information: The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; a brief statement of the requesting person's interest in the Regional Administrator's determination and a brief statement of the information that the requesting person intends to submit at such hearing; and the signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.
Pasteuria nishizawae
Document Number: 2012-3586
Type: Rule
Date: 2012-02-15
Agency: Environmental Protection Agency
This regulation establishes an exemption from the requirement of a tolerance for residues of Pasteuria nishizawaePn1 in or on all food commodities when applied as a nematicide and used in accordance with good agricultural practices. Pasteuria Bioscience, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Pasteuria nishizawaePn1 under the FFDCA.
Aureobasidium pullulans
Document Number: 2012-3585
Type: Rule
Date: 2012-02-15
Agency: Environmental Protection Agency
This regulation establishes an exemption from the requirement of a tolerance for residues of the Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on all food commodities when applied pre- harvest and used in accordance with good agricultural practices. Bio- ferm GmbH submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941.
Final Reissuance of the NPDES General Permit for Facilities Related to Oil and Gas Extraction in the Territorial Seas of Texas
Document Number: 2012-3584
Type: Notice
Date: 2012-02-15
Agency: Environmental Protection Agency
The Director of the Water Quality Protection Division, EPA Region 6 today announces issuance of the final National Pollutant Discharge Elimination System (NPDES) general permit for the Territorial Seas of Texas (No. TXG260000) for discharges from existing and new dischargers and New Sources in the Offshore Subcategory of the Oil and Gas Extraction Point Source Category as authorized by section 402 of the Clean Water Act, 33 U.S.C. 1342 (CWA). The permit supersedes the previous general permit (TXG260000) which expired on November 4, 2010. This permit renewal authorizes discharges from exploration, development, and production facilities located in and discharging to the territorial seas off Texas. EPA proposed the draft permit in the Federal Register on October 24, 2011. EPA Region 6 has considered all comments received and makes one significant change to the proposed permit. A copy of the Region's responses to comments and the final permit may be obtained from the EPA Region 6 Internet site: https://www.epa.gov/region6/water/npdes/ genpermit/index.htm.
President's Export Council, Subcommittee on Export Administration; Notice of Open Meeting
Document Number: 2012-3582
Type: Notice
Date: 2012-02-15
Agency: Department of Commerce, Bureau of Industry and Security
Recent Postings of Broadly Applicable Alternative Test Methods
Document Number: 2012-3581
Type: Notice
Date: 2012-02-15
Agency: Environmental Protection Agency
This notice announces the broadly applicable alternative test method approval decisions the EPA has made under and in support of New Source Performance Standards (NSPS) and the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act (CAA) in 2011.
Notice of Submission for OMB Review
Document Number: 2012-3580
Type: Notice
Date: 2012-02-15
Agency: Department of Education
The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13).
Transportation and Related Equipment; Technical Advisory Committee; Notice of Partially Closed Meeting
Document Number: 2012-3579
Type: Notice
Date: 2012-02-15
Agency: Department of Commerce, Bureau of Industry and Security
Notice of Proposed Information Collection Requests
Document Number: 2012-3578
Type: Notice
Date: 2012-02-15
Agency: Department of Education
The Department of Education (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995 (Pub. L.104-13).
Federal Prevailing Rate Advisory Committee; Open Committee Meetings
Document Number: 2012-3577
Type: Notice
Date: 2012-02-15
Agency: Office of Personnel Management
According to the provisions of section 10 of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given that an additional meeting of the Federal Prevailing Rate Advisory Committee will be held on Thursday, March 8, 2012. The meeting will start at 10 a.m. and will be held in Room 5A06A, U.S. Office of Personnel Management Building, 1900 E Street NW., Washington, DC. The Federal Prevailing Rate Advisory Committee is composed of a Chair, five representatives from labor unions holding exclusive bargaining rights for Federal blue-collar employees, and five representatives from Federal agencies. Entitlement to membership on the Committee is provided for in 5 U.S.C. 5347. The Committee's primary responsibility is to review the Prevailing Rate System and other matters pertinent to establishing prevailing rates under subchapter IV, chapter 53, 5 U.S.C., as amended, and from time to time advise the U.S. Office of Personnel Management. This scheduled meeting is open to the public with both labor and management representatives attending. During the meeting either the labor members or the management members may caucus separately to devise strategy and formulate positions. Premature disclosure of the matters discussed in these caucuses would unacceptably impair the ability of the Committee to reach a consensus on the matters being considered and would disrupt substantially the disposition of its business. Therefore, these caucuses will be closed to the public because of a determination made by the Director of the U.S. Office of Personnel Management under the provisions of section 10(d) of the Federal Advisory Committee Act (Pub. L. 92-463) and 5 U.S.C. 552b(c)(9)(B). These caucuses may, depending on the issues involved, constitute a substantial portion of a meeting. Annually, the Chair compiles a report of pay issues discussed and concluded recommendations. These reports are available to the public, upon written request to the Committee. The public is invited to submit material in writing to the Chair on Federal Wage System pay matters felt to be deserving of the Committee's attention. Additional information on these meetings may be obtained by contacting the Committee at U.S. Office of Personnel Management, Federal Prevailing Rate Advisory Committee, Room 5H27, 1900 E Street NW., Washington, DC 20415, (202) 606-9400.
Furnishing Identifying Number of Tax Return Preparer
Document Number: 2012-3576
Type: Proposed Rule
Date: 2012-02-15
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains proposed regulations that provide guidance on the eligibility of tax return preparers to obtain a preparer tax identification number (PTIN). These proposed regulations expand the list of tax return preparers who may obtain and renew a PTIN. The proposed regulations additionally provide guidance concerning those tax forms submitted to the Internal Revenue Service that are considered returns of tax or claims for refund of tax for purposes of the requirement to obtain a PTIN and related provisions. This document also invites comments from the public regarding these proposed regulations.
Materials Processing Equipment Technical Advisory Committee; Notice of Partially Closed Meeting
Document Number: 2012-3575
Type: Notice
Date: 2012-02-15
Agency: Department of Commerce, Bureau of Industry and Security
Office of the Director Notice of Establishment
Document Number: 2012-3572
Type: Notice
Date: 2012-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Foreign-Trade Zone 183-Austin, TX; Application for Reorganization Under the Alternative Site Framework
Document Number: 2012-3570
Type: Notice
Date: 2012-02-15
Agency: Department of Commerce, Foreign-Trade Zones Board
National Institute on Deafness and Other Communication Disorders Notice of Closed Meetings
Document Number: 2012-3569
Type: Notice
Date: 2012-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Receipt of an Amended Complaint; Solicitation of Comments Relating to the Public Interest
Document Number: 2012-3567
Type: Notice
Date: 2012-02-15
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has received an amended complaint entitled Certain Consumer Electronics and Display Devices and Products Containing Same, DN 2858; the Commission is soliciting comments on any public interest issues raised by the amended complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(b)).
Dairy Product Mandatory Reporting
Document Number: 2012-3566
Type: Rule
Date: 2012-02-15
Agency: Agricultural Marketing Service, Department of Agriculture
This final rule adopts changes to Agricultural Marketing Service (AMS) regulations as required by section 273(d) of the Agricultural Marketing Act of 1946 (the Act) as amended by the Mandatory Price Reporting Act of 2010. The amendment to the Act requires the Secretary of Agriculture (Secretary) to establish an electronic reporting system for certain manufacturers of dairy products to report sales information for a mandatory dairy product reporting program. The amendment further states that the Secretary shall publish the information obtained for the preceding week not later than 3 p.m. Eastern Time on Wednesday of each week.
Magnuson-Stevens Act Provisions; Fisheries of the Northeastern United States; Northeast Multispecies Fishery; 2012 Sector Operations Plans and Contracts, and Allocation of Northeast Multispecies Annual Catch Entitlements
Document Number: 2012-3565
Type: Proposed Rule
Date: 2012-02-15
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This rule proposes 19 Northeast (NE) multispecies (groundfish) sector operations plans and contracts for fishing year (FY) 2012, and would allocate quotas of NE multispecies to the sectors. The NE Multispecies Fishery Management Plan (FMP) requires sectors to submit their operations plans and contracts to NMFS for approval or disapproval. Approval of a sector operations plan and contract is necessary for that sector to be allocated fish, and allows the sector members to be exempted from certain effort control regulations. If a sector operations plan and contract is not approved, the members of that sector must fish in the common pool and comply with all existing regulations. This rule also notifies the public that NMFS is extending the deadline to join a sector for FY 2012 through April 30, 2012. NMFS is soliciting comment on the proposed operations plans and contracts, and our proposal to grant 25 of the 49 exemptions requested, and deny the rest.
United States Travel and Tourism Advisory Board; Teleconference Meeting
Document Number: 2012-3564
Type: Notice
Date: 2012-02-15
Agency: Department of Commerce, International Trade Administration
The United States Travel and Tourism Advisory Board (Board) will hold a teleconference meeting to deliberate upon industry input and priorities to provide the Secretary of Commerce in his role as co- chair of the Task Force on Travel and Competitiveness (Task Force), established by Executive Order 13597 Establishing Visa and Foreign Visitor Processing Goals and the Task Force on Travel and Competitiveness, as the Task Force works to develop a National Travel and Tourism Strategy (Strategy). The Executive Order was issued by President Barack Obama on January 19, 2012.
Fisheries of the Northeastern United States; Atlantic Bluefish Fishery; 2012 Atlantic Bluefish Specifications
Document Number: 2012-3563
Type: Proposed Rule
Date: 2012-02-15
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes specifications for the 2012 Atlantic bluefish fishery, including an annual catch limit, total allowable landings, a commercial quota and recreational harvest limit, and a recreational possession limit. The intent of this action is to establish the allowable 2012 harvest levels and other management measures to achieve the target fishing mortality rate, consistent with the Atlantic Bluefish Fishery Management Plan.
Chrysler Group, LLC, Receipt of Petition for Decision of Inconsequential Noncompliance
Document Number: 2012-3562
Type: Notice
Date: 2012-02-15
Agency: National Highway Traffic Safety Administration, Department of Transportation
Chrysler Group, LLC, (Chrysler),\1\ has determined that certain model year 2011 Chrysler Town & Country and Dodge Grand Caravan multipurpose passenger vehicles manufactured between March 16, 2011 through March 22, 2011, do not fully comply with paragraph S4.3(d) of Federal Motor Vehicle Safety Standard (FMVSS) No. 110, Tire selection and rims and motor home/recreation vehicle trailer load carrying capacity information for motor vehicles with a GVWR of 4,536 kilograms (10,000 pounds) or less. Chrysler has filed an appropriate report dated May 3, 2011, pursuant to 49 CFR Part 573, Defect and Noncompliance Responsibility and Reports.
Radio Broadcasting Services; AM or FM Proposals To Change the Community of License
Document Number: 2012-3561
Type: Notice
Date: 2012-02-15
Agency: Federal Communications Commission, Agencies and Commissions
The following applicants filed AM or FM proposals to change the community of license: BBC BROADCASTING, INC, Station KPRI, Facility ID 21416, BP-20090226AAF, From FERNDALE, WA, To POINT ROBERTS, WA; CUMULUS LICENSING LLC, Station WYOK, Facility ID 8680, BPH-20120131AJS, From ATMORE, AL, To SARALAND, FL; GRACE BAPTIST CHURCH OF ORANGE BURG, Station NEW, Facility ID 171479, BMPED-20120131ALI, From RIDGEVILLE, SC, To ST. GEORGE, SC; RADIO LICENSE HOLDING II, LLC, Station WYAY, Facility ID 48727, BPH-20120131AHR, From GAINESVILLE, GA, To SANDING SPRINGS, GA.
Gulf of Mexico Fishery Management Council; Public Meetings
Document Number: 2012-3558
Type: Notice
Date: 2012-02-15
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Gulf of Mexico Fishery Management Council (Council) will convene its Law Enforcement Advisory Panel (LEAP) in conjunction with the Gulf States Marine Fisheries Commission's Law Enforcement Committee (LEC).
New England Fishery Management Council; Public Hearings
Document Number: 2012-3557
Type: Notice
Date: 2012-02-15
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The New England Fishery Management Council (Council) will hold eight public hearings to solicit comment on Draft Amendment 5 to the Atlantic Herring Fishery Management Plan (FMP).
Culturally Significant Objects Imported for Exhibition Determinations: “The Dawn of Egyptian Art”
Document Number: 2012-3555
Type: Notice
Date: 2012-02-15
Agency: Department of State
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``The Dawn of Egyptian Art,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art, New York, NY from on or about April 2, 2012, until on or about August 5, 2012, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Culturally Significant Objects Imported for Exhibition Determinations: “Rembrandt's Self-Portrait”
Document Number: 2012-3554
Type: Notice
Date: 2012-02-15
Agency: Department of State
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the object to be included in the exhibition ``Rembrandt's Self-Portrait,'' imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit object at the Metropolitan Museum of Art, New York, NY from on or about April 5, 2012 until on or about May 28, 2012; and, as part of an exhibition called ``Gainsborough, Rembrandt, Van Dyck: The Treasures of Kenwood House, London,'' the further display of the object at the Museum of Fine Arts, Houston from on or about June 3, 2012 until on or about September 4, 2012; the Milwaukee Art Museum from on or about October 4, 2012 until on or about January 6, 2013; the Seattle Art Museum from on or about February 14, 2013 until on or about May 19, 2013; and the Arkansas Art Center from on or about June 6, 2013 until on or about September 9, 2013; and at possible additional exhibitions or venues yet to be determined; is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice
Document Number: 2012-3553
Type: Notice
Date: 2012-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Detroit District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. Date and Time: The public workshop will be held on May 9 and 10, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Marriott Ann Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197, 800-606-7044. Contact: Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 1-800-762-7292 or 215-822- 8644, FAX: 215-822-8633, email: SoCRAmail@aol.com, Web site: https:// www.SoCRA.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.); or Nancy Bellamy, Food and Drug Administration, Detroit District Office, 300 River Pl., Suite 5900, Detroit, MI 48207, 313-393-8143, Fax: 313- 393-8139, email: nancy.bellamy@fda.hhs.gov. Accommodations: Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $119 plus applicable taxes (available until April 17, 2012 or until the SoCRA room block is filled).
Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Availability
Document Number: 2012-3552
Type: Notice
Date: 2012-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.'' This draft guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This draft guidance gives an overview of FDA's approach to determining biosimilarity.
Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Document Number: 2012-3551
Type: Notice
Date: 2012-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
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 the collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle.
Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; Availability
Document Number: 2012-3550
Type: Notice
Date: 2012-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product.'' This draft guidance is intended to provide sponsors with an overview of analytical factors to consider when assessing biosimilarity between a proposed protein product and a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This draft guidance provides an overview of FDA's approach to quality considerations in determining biosimilarity.
Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability
Document Number: 2012-3549
Type: Notice
Date: 2012-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' This draft guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications
Document Number: 2012-3548
Type: Notice
Date: 2012-02-15
Agency: Food and Drug Administration, Department of Health and Human Services
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 concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for the requirements for an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product.
RIN 1545-BJ60
Document Number: 2012-3547
Type: Rule
Date: 2012-02-15
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
These regulations finalize, without change, interim final regulations authorizing the exemption of group health plans and group health insurance coverage sponsored by certain religious employers from having to cover certain preventive health services under provisions of the Patient Protection and Affordable Care Act.
International Fisheries; Western and Central Pacific Fisheries for Highly Migratory Species; Transshipping, Bunkering, Reporting, and Purse Seine Discard Requirements
Document Number: 2012-3546
Type: Proposed Rule
Date: 2012-02-15
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes regulations under the authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFC Implementation Act) to implement requirements for U.S. fishing vessels used for commercial fishing that offload or receive transshipments of highly migratory species (HMS), U.S. fishing vessels used for commercial fishing that provide bunkering or other support services to fishing vessels, and U.S. fishing vessels used for commercial fishing that receive bunkering or engage in other support services, in the area of application of the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention). Some of the requirements would also apply to transshipments of fish caught in the area of application of the Convention (Convention Area) and transshipped elsewhere. NMFS also proposes requirements regarding notification of entry into and exit from the ``Eastern High Seas Special Management Area'' (Eastern SMA) and requirements relating to discards from purse seine fishing vessels. This action is necessary for the United States to implement decisions of the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Commission or WCPFC) and to satisfy its obligations under the Convention, to which it is a Contracting Party.
International Fisheries; Western and Central Pacific Fisheries for Highly Migratory Species; High Seas Transshipment Prohibitions
Document Number: 2012-3545
Type: Proposed Rule
Date: 2012-02-15
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is considering promulgating regulations under the authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFC Implementation Act) to prohibit the transshipment of highly migratory species (HMS) on the high seas to or from certain types of U.S. vessels that operate in the area of application of the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention). These regulations would implement certain decisions of the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Commission or WCPFC) in order to meet the obligations of the United States under the Convention. NMFS issues this advance notice of proposed rulemaking to solicit information and comments about HMS transshipment activities by U.S. vessels, and the potential effects of a prohibition on high seas transshipments in the Convention Area.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2012-3544
Type: Notice
Date: 2012-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery of the South Atlantic; Closure
Document Number: 2012-3543
Type: Rule
Date: 2012-02-15
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS closes the commercial sector for golden tilefish in the exclusive economic zone (EEZ) of the South Atlantic. This closure is necessary to protect the golden tilefish resource.
Takes of Marine Mammals Incidental to Specified Activities; St. George Reef Light Station Restoration and Maintenance at Northwest Seal Rock, Del Norte County, CA
Document Number: 2012-3542
Type: Notice
Date: 2012-02-15
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to the St. George Reef Lighthouse Preservation Society (SGRLPS) to take marine mammals, by Level B harassment only, incidental to conducting aircraft operations, and lighthouse renovation and light maintenance activities on the St. George Reef Light Station on Northwest Seal Rock (NWSR) in the northeast Pacific Ocean, from the period of February 10, 2012, through April 30, 2012, or during the period of November 1, 2012, through December 31, 2012.
Notice of Rail Energy Transportation Advisory Committee Meeting
Document Number: 2012-3541
Type: Notice
Date: 2012-02-15
Agency: Surface Transportation Board, Department of Transportation
Notice is hereby given of a meeting of the Rail Energy Transportation Advisory Committee (RETAC), pursuant to section 10(a)(2) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C., App. 2).
Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits
Document Number: 2012-3540
Type: Rule
Date: 2012-02-15
Agency: Pension Benefit Guaranty Corporation, Agencies and Commissions
This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single- Employer Plans to prescribe interest assumptions under the regulation for valuation dates in March 2012. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.
Reporting and Recordkeeping Requirements Under OMB Review
Document Number: 2012-3539
Type: Notice
Date: 2012-02-15
Agency: Small Business Administration, Agencies and Commissions
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required 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.
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