2011 – Federal Register Recent Federal Regulation Documents

On December 12, 2011 the Agency for Toxic Substance and Disease Register published a 30-day public comment period notice in the Federal Register (76 FR 77234) for the Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data From the Island of Vieques, Puerto Rico.'' This comment period was published as closing on January 11, 2012 in error. The comment period will be open for 90 days and will close March 11, 2012.

Between 1975 and 1977, the Occupational Safety and Health Administration (``OSHA'' or ``the Agency'') granted permanent variances to 24 companies engaged in the construction of cylindrical steel tanks. The variances specified several conditions that served as an alternative means of compliance to the falling-object-protection and fall-protection requirements of the standard on general requirements for scaffolds in effect during this period. In 1996, OSHA revised Sec. 1926.451 to include provisions that duplicated the conditions specified by these variances. Therefore, OSHA believes the alternative means of compliance granted by the variances is no longer necessary, and is proposing to revoke the variances.

The Food and Drug Administration (FDA) has determined that Bretylium Tosylate injection, 50 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Bretylium Tosylate injection, 50 mg/mL, if all other legal and regulatory requirements are met.

The Energy and Mineral Development Program (EMDP) provides funding to Indian tribes with the mission goal of assessing, evaluating, and promoting energy and mineral resources on Indian trust lands for the economic benefit of Indian mineral owners. To achieve these goals, the Department of the Interior's Office of Indian Energy and Economic Development (IEED), through its Division of Energy and Mineral Development (DEMD) office, is soliciting proposals from tribes. The Department will use a competitive evaluation process to select several proposed projects to receive an award.

The Architectural and Transportation Barriers Compliance Board (Access Board) plans to hold its regular committee and Board meetings in Washington, DC, Monday through Wednesday, January 9-11, 2012 on the times and location listed below.

The Food and Drug Administration (FDA or the Agency) is issuing an interim final rule amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act. The provisions of the Federal Food, Drug and Cosmetic Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. This interim final rule modifies the term ``discontinuance'' and clarifies the term ``sole manufacturer'' with respect to notification of discontinuance requirements. The broader reporting resulting from these changes will enable FDA to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers and other stakeholders to respond to potential drug shortages.

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).

This notice announces the intention of the National Agricultural Statistics Service (NASS) to reduce the currently approved information collections for rice and potato stocks that are currently approved under OMB 0535-0007. Under the current OMB approval the Potato Stocks Survey is conducted on a monthly basis from December through June of each year. Under this reduction NASS plans to discontinue the collecting and publishing of potato stock data for the months of January, March and May. In the four remaining months (December, February, April and June) there will be no changes to the surveys or the publications. The Rice Stocks Survey is currently conducted in January, March, June, August, September, and October (only California for October). Under this reduction, NASS plans to discontinue the collection of data in September, along with the related publication.

The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill four positions on the Committee membership that will be vacated during the 2012 calendar year.

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services as the Director of the National Vaccine Program. The ASH has charged the NVAC with developing recommended strategies for annually achieving 90% influenza vaccination coverage among healthcare personnel, as stated in the Healthy People 2020 goals. The Healthcare Personnel Influenza Vaccination Subgroup (HCPIVS), a subgroup of the NVAC Adult Immunization Working Group (AWIG), was established to address this charge on behalf of the NVAC. A draft report and draft recommendations have been developed by the HCPIVS for consideration by the NVAC and will be deliberated on by the NVAC when developing NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the Healthcare Personnel Influenza Vaccination Subgroup draft report and draft recommendations for increasing vaccination of healthcare personnel to meet the Healthy People 2020 goals. Individuals and organizations are encouraged to submit their comments on the draft report and draft recommendations. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented in February 2012 to the NVAC for deliberation and decision on their final recommendations.

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 21 July 1996.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-21), this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-21), this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.

The Department of Veterans Affairs (VA) is amending its regulation concerning the medical benefits package offered to veterans enrolled in the VA health care system. This rulemaking updates the regulation to conform to amendments made by the enactment of the Caregivers and Veteran Omnibus Health Services Act of 2010, which authorized VA to provide certain health care services to a newborn child of a woman veteran who is receiving maternity care furnished by VA. Health services for newborn care will be authorized for no more than seven days after the birth of the child if the veteran delivered the child in a VA facility or in another facility pursuant to a VA contract for maternity services.

In the Rules and Regulations section of this issue of the Federal Register, the Internal Revenue Service is issuing temporary regulations relating to the requirement that individuals attach a statement to their income tax return to provide required information regarding foreign financial assets in which they have an interest. The text of the temporary regulations also serves as the text of these proposed regulations. This notice of proposed rulemaking also includes a proposed regulation setting forth requirements for certain domestic entities to report foreign financial assets in the same manner as an individual.

This proposed rule would require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (``covered recipients''). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public Web site.

This document contains proposed regulations concerning the continuity of interest requirement for corporate reorganizations. The guidance is necessary to clarify the manner in which the continuity of interest requirement is measured in particular circumstances. The proposed regulations affect corporations and their shareholders.

This action establishes Class D and E airspace and amends existing Class E airspace at Brooksville, FL, to accommodate a new air traffic control tower at Hernando County Airport This action enhances the safety and management of Instrument Flight Rules (IFR) operations for standard instrument approach procedures at the airport. This action also makes a minor adjustment to the geographic coordinates of the airport.

We are superseding an existing airworthiness directive (AD) that applies to certain Bombardier, Inc. Model DHC-8-300 series airplanes. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

We are revising an existing airworthiness directive (AD) that applies to all Eclipse Aerospace, Inc. Model EA500 airplanes equipped with Pratt & Whitney Canada, Corp. (P&WC) Model PW610F-A engines. The existing AD currently requires incorporating an operating limitation of a maximum operating altitude of 30,000 feet into Section 2, Limitations, of the airplane flight manual (AFM). Since we issued that AD, P&WC has developed a design change for the combustion chamber liner assembly. This new AD retains the requirements of the current AD, clarifies the engine applicability, and allows the option of incorporating the design change to terminate the current operating limitation and restore the original certificated maximum operating altitude of 41,000 feet. We are issuing this AD to correct the unsafe condition on these products.