March 28, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for PARAPLATIN (carboplatin), TRUSOPT (dorzolamide), CAMPTOSAR (irinotecan), PREVACID (lansoprazole), TAMIFLU (oseltamivir), VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate), IMITREX (sumatriptan), DETROL and DETROL LA (tolterodine). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement. In addition, the agency is also announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies for the following antidepressants: CELAXA (citalopram), REMERON (mirtazapine), SERZONE (nefazodone), PAXIL (paroxetine), and ZOLOFT (sertraline). Studies for these drugs were submitted before the BPCA was implemented. Therefore, they are not subject to its requirements. However, due to the public's interest in these pediatric studies, FDA asked the sponsors to consent to the public disclosure of a summary of the medical and clinical pharmacology reviews for these studies. Based on sponsors' consent, FDA is making the summaries publicly available.

The Coast Guard is correcting the preamble to a final rule that appeared in the Federal Register of March 18, 2005 (70 FR 13102). The final rule expands the number of conditions that a State may require in order for owners to obtain vessel numbering certificates in that State. The preamble to the final rule contains an error in the regulatory evaluation.

This document confirms the effective date of the direct final rule which revises Class E airspace at Ozark, MO.

The FAA proposes to rule and invites public comment on the application to impose and use PFC revenue at Eugene Airport, Mahlon Sweet Field under the provisions of 49 U.S.C. 40117 and part 158 of the Federal Aviation Regulations (14 part CFR 158).

This document responds to petitions for reconsideration of a June 24, 2003 final rule that incorporated improved test dummies and updated procedures into Federal Motor Vehicle Safety Standard No. 213 and extended the standard to child restraints recommended for use by children weighing up to 30 kilograms (65 pounds). That final rule responded to Section 14 of the Transportation Recall Enhancement, Accountability and Documentation Act of 2000. NHTSA received petitions for reconsideration of different aspects of the final rule from Ford and from Denton ATD. This document denies Ford's petition and grants Denton's.

Rural Development announces the availability of up to $22.8 million in competitive grant funds for fiscal year (FY) 2005 to purchase renewable energy systems and make energy improvements for agricultural producers and rural small businesses. Of the $22.8 million, $11.4 million will be set aside through August 31, 2005, for guaranteed loans. These funds will be administered under a final rule to be published in the Federal Register later this fiscal year. Any guaranteed loan funds not obligated by August 31, 2005, will be made available for competitive grants under this notice. In order to be eligible for grant funds, the agricultural producer or rural small business must demonstrate financial need. The grant request must not exceed 25 percent of the eligible project costs.

Pursuant to section 2(b) of the Mineral Leasing Act of 1920, as amended by Section 4 of the Federal Coal Leasing Amendments Act of 1976, 90 Stat. 1083, 30 U.S.C. 201(b), and to the regulations adopted as 43 CFR 3410, all interested parties are hereby invited to participate with Powder River Coal Company on a pro rata cost sharing basis in its program for the exploration of coal deposits owned by the United States of America in the following-described lands in Campbell County, WY: