August 27, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Self- Identification of Generic Drug Facilities, Sites, and Organizations.'' On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) (Pub. L. 112-144, Title III) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry as it prepares to meet the self- identification requirement. It explains who is required to self- identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA also requires that generic drug facilities, sites, and organizations located around the world provide identification information annually to FDA. This guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA.

This notice announces a fee of $170 to be charged for the 2013 tariff- rate quota (TRQ) year for each license issued to a person or firm by the Department of Agriculture authorizing the importation of certain dairy articles, which are subject to tariff-rate quotas set forth in the Harmonized Tariff Schedule (HTS) of the United States.

In accordance with the Paperwork Reduction Act of 1995, PHMSA invites comments on two information collections that we will be submitting to the Office of Management and Budget (OMB) for renewal. The information collections relate to the program for Control Room Management/Human Factors and the Integrity Management Program for Gas Distribution Pipelines.

The Department of Justice is amending its regulations to allow the Director of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to exercise, for a one-year period following the effective date of this rule, the authority to seize and administratively forfeit property involved in controlled substance offenses. Many years of experience have demonstrated that forfeiting the assets of criminals is an essential tool in combating criminal activity and provides law enforcement with the capacity to dismantle criminal organizations that would continue to function after the conviction and incarceration of individual offenders. Moreover, administrative forfeiture permits the expedient and effective use of this crucial law enforcement tool.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C., 3501-3521), this notice announces that the Department of Veterans Affairs (VA), will submit to the Office of Management and Budget (OMB) the following emergency proposal for the collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. 3507(j)(1)). An emergency clearance is being requested for information needed to assess the effectiveness of pain care management provided to veterans.

We are revising an earlier proposed airworthiness directive (AD) for certain The Boeing Company Model 737-600, -700, -700C, -800, - 900, and -900ER series airplanes. That NPRM proposed to require, for certain airplanes, installing two warning level indicator lights on each of the P1-3 and P3-1 instrument panels in the flight compartment. That NPRM also proposed to require revising the airplane flight manual to remove certain requirements of previous AD actions, and to advise the flightcrew of the following changes: revised non-normal procedures to use when a cabin altitude warning or rapid depressurization occurs, and revised cabin pressurization procedures for normal operations. That NPRM was prompted by a design change in the cabin altitude warning system that would address the identified unsafe condition. This action revises that NPRM by adding airplanes to the applicability; adding airplanes to the installation requirement, including, for certain airplanes, replacing the existing P5-16 and P5-10 panels; and, for certain airplanes, replacing the basic P5-16 panel with a high altitude landing P5-16 panel. We are proposing this supplemental NPRM to prevent failure of the flightcrew to recognize and react to a valid cabin altitude warning horn, which could result in incapacitation of the flightcrew due to hypoxia (lack of oxygen in the body), and consequent loss of control of the airplane. Since these actions impose an additional burden over that proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these proposed changes.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning change order accounting. Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.