Department of Health and Human Services December 2011 – Federal Register Recent Federal Regulation Documents

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 176,373, filed January 14, 2000 and currently abandoned [HHS Ref. No. E-176-1999/0-US-01]; PCT Application PCT/US01/00981, filed January 12, 2001 and currently expired [HHS Ref. No. E-176-1999/0-PCT-02]; U.S. Patent Application No. 10/169,975, filed July 12, 2002 and issued as U.S. Patent No. 7,087,589 on August 8, 2006 [HHS Ref. No. E-176-1999/0- US-06]; U.S. Patent Application No. 11/500,860, filed August 8, 2006 and issued as U.S. Patent No. 7,790,735 on September 14, 2006 [HHS Ref. No. E-176-1999/0-US-07]; Australian Patent Application No. 2001230913, filed January 12, 2001 and issued as Australian Patent No. 2001230913 on October 13, 2005 [HHS Ref. No. E-176-1999/0-AU-03]; Canadian Patent Application No. 2,397,366, filed January 12, 2001 and issued as Canadian Patent No. 2,397,366 on March 15, 2011 [HHS Ref. No. E-176- 1999/0-CA-04]; European Patent Application No. 01903043.6, filed January 12, 2001 and issued as European Patent No. 1252160 on August 6, 2006 and currently abandoned [HHS Ref. No. E-176-1999/0-EP-05]; and UK Patent Application No. 01903043.6, filed January 12, 2001 and issued as UK Patent No. 1252160 on August 16, 2006 [HHS Ref. No. E-176-1999/0-GB- 08], entitled ``Methanocarba Cycloalkyl Nucleoside Analogues'' to Cornovus Pharmaceuticals, Inc., a company incorporated under the laws of the State of Delaware having its headquarters in Farmington, Connecticut. The United States of America is the assignee of the rights of the above inventions. The prospective exclusive evaluation option license territory may be ``worldwide'', and the field of use may be limited to ``The use of (1'S,2R,3S,4'R,5'S)-4- (6-amino-2-chloro-9H-purin-9-yl)-1-[phosphoryloxymethyl] bicycle[3.1.0]hexane-2,3-diol) (MRS2339) to treat and/or prevent cardiac diseases in humans.'' Upon the expiration or termination of the exclusive evaluation option license, Cornovus Pharmaceuticals, Inc. will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the evaluation license.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, NIMH has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 8, 2011 (76 FR 33310). The document announced the withdrawal of approval of 70 new drug applications (NDAs) and 97 abbreviated new drug applications (ANDAs) from multiple applicants, effective July 8, 2011. The document indicated that FDA was withdrawing approval of the following three ANDAs after receiving a request from the ANDA holder, A.H. Robins Co., c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101- 8299: ANDA 086661, DONNATAL (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) Elixir; ANDA 086676, DONNATAL (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) Tablets; and ANDA 086677, DONNATAL (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) Capsules. Before withdrawal of these ANDAs became effective, PBM Pharmaceuticals, Inc., acquired the rights to the ANDAs and informed FDA that it did not want them withdrawn. Because the basis for withdrawal would have been a request from the ANDA holder and the request was timely withdrawn, the approval of ANDAs 086661, 086676, and 086677 is still in effect.

In accordance with the requirements of the Privacy Act of 1974, HHS/OS/ONC is establishing a new system of records, ``ONC Health IT Dashboard,'' to create datasets that will be used by ONC and its partners (including grantees in the Health IT Extension Center program and ONC program evaluation contractors) to assess, improve, and publicize the effectiveness of ONC health IT grants to States and State-designated entities. The datasets will enable ONC to (1) Evaluate the state of health IT implementation by parties registered to receive (i.e., who have received or could receive) electronic health record implementation assistance from ONC grantees, (2) compare the evaluations to grantees' progress reports in order to validate claims submitted for grant payments, (3) share the evaluations with the grantees to help improve grant performance, and (4) make aggregate data (e.g., national and State-level implementation estimates) publicly available on ONC's Web site at https://www.healthit.hhs.gov. The parties receiving grants and health IT implementation assistance from ONC grantees include health care providers (not only provider-entities such as hospitals, but individual providers such as individual physicians), community colleges, State-designated entities, and other entities. Information about an individual provider (e.g., an individual physician as opposed to a hospital, corporation or other organization) is protected by the Privacy Act. Privacy Act-protected information about each individual provider will consist of the provider's health IT implementation information, demographic information, and contact information, retrieved by his or her National Provider Identifier (NPI). The system will not contain information about patients. The system of records is more thoroughly described in the Supplementary Information section and System of Records Notice (SORN), below.

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 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 concerning the establishment and operation of clinical trial data monitoring committees.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of cyclosporine oral solution, USP (MODIFIED) for the control of feline allergic dermatitis.

This notice with comment period announces a waiver request from Pioneer Community Hospital to participate in an Organ Procurement Organization (OPO) outside of its designated OPO. The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act) which provides that a hospital may obtain a waiver from the Secretary under certain conditions. This notice solicits comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2012. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the Agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.'' This document describes FDA's intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations.

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 information collection provisions of FDA's requirements on content and format of labeling for human prescription drug and biological products.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific focus on addressing potential differences in study design, conduct, outcomes, and interpretation that should be considered to ensure sex-specific issues are adequately addressed in clinical trials. This draft guidance is not final nor is it in effect at this time.

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 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.