Department of Health and Human Services February 26, 2010 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' The draft guidance provides sponsors and the review staff in FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) with information regarding adaptive design clinical trials when used in drug development programs. The draft guidance gives advice on various topics, such as what aspects of adaptive design clinical trials (i.e., clinical, statistical, regulatory) call for special consideration, when to interact with FDA while planning and conducting adaptive design studies, what information to include in the adaptive design for FDA review, and issues to consider in the evaluation of a completed adaptive design study. The draft guidance is intended to assist sponsors in planning and conducting adaptive design clinical studies, and to facilitate an efficient FDA review.

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 recordkeeping requirements for this collection of information concerning substances prohibited from use in animal food or feed and animal proteins prohibited in ruminant feed.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application 60/010,737, entitled ``Dihydropyridine, pyridine-, benzopyran one-, and triazoloquinazoline derivatives, their preparation and use as adenosine receptor antagonists,'' filed January 29, 1996 [HHS Ref. No. E-225-1995/0-US-1], U.S. Provisional Patent Application 60/021,191, entitled ``Dihydropyridine, pyridine-, benzopyran one-, and triazoloquinazoline derivatives, their preparation and use as adenosine receptor antagonists,'' filed July 3, 1996 [HHS Ref. No. E-225-1995/1-US-1], PCT Application PCT/US97/01252, entitled ``Dihydropyridine, pyridine-, benzopyran one-, and triazoloquinazoline derivatives, their preparation and use as adenosine receptor antagonists,'' filed January 29, 1997 [HHS Ref. No. E-225-1995/2-PCT- 1], U.S. Patent 6,066,642, entitled ``Dihydropyridine, pyridine-, benzopyran one-, and triazoloquinazoline derivatives, their preparation and use as adenosine receptor antagonists,'' issued May 23, 2000 [HHS Ref. No. E-225-1995/2-US-08], Australian Patent 709190, issued December 9, 1999 [HHS Ref. No. E-225-1995/2-AU-04], European Patent Application No. 97905627.2, filed January 29, 1997 [HHS Ref. No. E-225-1995/2-EP- 05], Hong Kong Application No. 99102653.6, filed January 29, 1997 [HHS Ref. No. E-225-1995/2-HK-06], Japanese Patent Application No. 527065/ 1997, filed January 29, 1997 [HHS Ref. No. E-225-1995/2-JP-07], Australian Patent 755525, issued March 27, 2003 [HHS Ref. No. E-225- 1995/2-AU-02], and Canadian Patent 2244774, issued October 17, 2006 [HHS Ref. No. E-225-1995/2-CA-03], U.S. Provisional Patent Application 60/092,292, entitled ``A3 Adenosine Receptor Antagonists,'' filed July 10, 1998 [HHS Ref. No. E-096-1998/0-US-1], PCT Application PCT/US99/ 15562, entitled''A3 Adenosine Receptor Antagonists,'' filed July 2, 1999 [HHS Ref. No. E-096-1998/0-PCT-2], U.S. Patent 6,376,521, entitled ``A3 Adenosine Receptor Antagonists,'' issued April 23, 2003, [HHS Ref. No. E-096-1998/0-US-04], and Canadian Patent Application No. 2336967, filed July 2, 1999 [HHS Ref. No. E-096-1998/0-CA-03], U.S. Provisional Patent Application 61/085,588, entitled ``Truncated Methanacarba Adenosine Derivatives as A3 Antagonists,'' filed August 1, 2008 [HHS Ref. No. E-285-2008/0-US-1], PCT Application PCT/US2009/52439, entitled ``Truncated Methanacarba Adenosine Derivatives as A3 Antagonists,'' filed July 31, 2009 [HHS Ref. No. E-285-2008/0-PCT-2], and Korean International Application No. PCT/KR2007/001131, entitled ``Adenosine derivatives, method of synthesis thereof, and the pharmaceutical compositions for the prevention and treatment of the inflammatory diseases containing the same as an active ingredient,'' filed March 7, 2007, [HHS Ref. No. E-109-2006/0-PCT-01] to Acorn Biomedical, Inc., having an office in at 612 SE. 5th Avenue, Suite 3, Fort Lauderdale, FL 33301 U.S.A. The patent rights in these inventions have been assigned to the United States of America.

HRSA will be providing extensions with funds ranging from 5 to 10 months to program grantees for the following programs in order to bring these programs into alignment with changes resulting from HRSA's Maternal and Child Health Bureau's developing strategic plan and the Early Learning and Development Initiative of the HHS and Department of Education. The programs are:

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, April 21, 2010. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services should be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding the risks, benefits, and outcomes of radiation therapy, inclusive of external beam radiotherapy (EBRT) and brachytherapy, for the treatment of localized prostate cancer. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).