March 23, 2012 – Federal Register Recent Federal Regulation Documents

This direct final rule makes technical changes that will update a requirement that many of our written agreements and memoranda of understanding (MOUs) with other departments, Agencies, and organizations be published in the Federal Register. Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This direct final rule, accordingly, eliminates it. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents. We are proceeding in accordance with our direct final rule procedures. We are publishing a companion proposed rule under our usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event we receive any significant adverse comments and withdraw this direct final rule. The companion proposed rule and this direct final rule are substantively identical.

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 associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA).

These special conditions are issued for the installation of an inflatable three-point restraint safety belt with an integrated airbag device at the aft position in two-place side-facing divan seats on the Embraer S.A. aircraft model EMB-505. These airplanes, as modified by the installation of these inflatable safety belts, will have novel and unusual design features associated with the upper-torso restraint portions of the three-point safety belts, which contain an integrated airbag device. 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) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements'' (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.

Through this notice, the Department of Labor's Employment and Training Administration (ETA), announces the availability of approximately $12 million in grant funds authorized by the Workforce Investment Act (WIA) to award approximately eight grants to serve adult and youth ex-offenders pre- and post-release. Services to be funded will be targeted to female ex-offenders, but must also be open to eligible male ex-offenders. Applicants may submit only one proposal for up to $1.5 million, with the amount requested depending on the number of participants to be served. These grants will be selected through a competitive process open to any non-profit organization with IRS 501(c)(3) status, unit of state or local government, or any Indian and Native American entity eligible for grants under WIA Section 166. These grants will cover a 30-month period of performance that includes up to six months of planning and a minimum of 24 months of operations. The 24 month period for operations must include time to allow each participant to complete the program and have between 3-4 months of follow-up. Thus, the last cohort of participants must complete program services 3 to 4 months before the end of the grant. Grantees may provide follow-up services to some participants while providing direct services to others. The complete SGA and any subsequent SGA amendments, in connection with this solicitation are described in further detail on ETA's Web site at https://www.doleta.gov/grants/ or on https://www.grants.gov. The Web sites provide application information, eligibility requirements, review and selection procedures and other program requirements governing this solicitation.

EPA issued a notice in the Federal Register of February 1, 2012, concerning a Memorandum of Understanding between the Environmental Protection Agency, Department of Health and Human Services and the Department of Agriculture regarding genetically engineered plants. This document is being issued to clarify and correct the notice announcing the Memorandum of Understanding.

The Environmental Protection Agency (EPA) is proposing to revise one of the use conditions required for use of hydrofluoroolefin (HFO)-1234yf (2,3,3,3-tetrafluoroprop-1-ene), a substitute for ozone- depleting substances (ODSs) in the motor vehicle air conditioning end- use within the refrigeration and air conditioning sector, as acceptable subject to use conditions under the EPA's Significant New Alternatives Policy (SNAP) program. The revised use condition incorporates by reference a revised standard from SAE International. In the ``Rules and Regulations'' section of this Federal Register, we are revising a use condition for use of HFO-1234yf in motor vehicle air conditioning as a direct final rule without a prior proposed rule. If we receive no adverse comment, we will not take further action on this proposed rule.

This proposed notice with comment period acknowledges the receipt of an application from Det Norske Veritas Healthcare (DNVHC) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

We are adopting a new airworthiness directive (AD) for certain Airbus Model A340-211, -212, -311, and -312 airplanes. This AD requires repetitive inspections for cracking at the fastener hole area just above stringer 28, of both left- and right-hand fuselage frame 39.1, and repair if necessary. This AD was prompted by a determination that certain airplanes were not included in a certain airworthiness limitation item (ALI) task (inspections for cracking of the fuselage frame 39.1) and that the inspections must be done to address the identified unsafe condition. We are issuing this AD to detect and correct cracking in the fuselage that could result in reduced structural integrity of the airplane.

This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

This final rule implements standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with title I of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. These programs will mitigate the impact of potential adverse selection and stabilize premiums in the individual and small group markets as insurance reforms and the Affordable Insurance Exchanges (``Exchanges'') are implemented, starting in 2014. The transitional State-based reinsurance program serves to reduce uncertainty by sharing risk in the individual market through making payments for high claims costs for enrollees. The temporary Federally administered risk corridors program serves to protect against uncertainty in rate setting by qualified health plans sharing risk in losses and gains with the Federal government. The permanent State-based risk adjustment program provides payments to health insurance issuers that disproportionately attract high-risk populations (such as individuals with chronic conditions).

The Coast Guard is amending its regulations on ballast water management by establishing a standard for the allowable concentration of living organisms in ships' ballast water discharged in waters of the United States. The Coast Guard is also amending its regulations for engineering equipment by establishing an approval process for ballast water management systems. These new regulations will aid in controlling the introduction and spread of nonindigenous species from ships' ballast water in waters of the United States.

We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model DHC-8-400 series airplanes. This AD was prompted by a report of the inability to open the airstair door while on the ground, because the airstair door seal did not deflate, which prevented the airstair door from opening. This AD requires changing the wiring that controls the pneumatic shut-off valve. We are issuing this AD to prevent the airstair door seal from not deflating, which could result in the airstair door not opening and could impede evacuation in the event of an emergency.

This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition as a national accreditation program for rural health clinics (RHCs) seeking to participate in the Medicare or Medicaid programs.