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

This notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2011. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the final rule that would update the hospital Outpatient Prospective Payment System (OPPS) for CY 2012.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), will hold a public forum from July 11-13, 2011 on processes relating to community health needs assessment (CHNA) and implementation strategy/plan development and execution. HHS/CDC is developing best practices designed to support state and local health departments to meet public health accreditation standards, and by other entities who may wish to utilize them in their community health planning processes. This notice announces the public forum.

HHS gives notice of a determination concerning a petition to add a class of employees from the Bliss & Laughlin Steel Company located at 110 Hopkins Street, Buffalo, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

HHS gives notice of a determination concerning a petition to add a class of employees from the Wah Chang facility in Albany, Oregon, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

HHS gives notice of a determination concerning a petition to add a class of employees from the Linde Ceramics Plant in Tonawanda, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed Consent.'' This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7(R2): Dissolution Test General Chapter'' (Q4B Annex 7(R2)). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Q4B Annex 7(R2) is a revision of the previously published ICH guidance, ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter'' (Q4B Annex 7). The revised guidance specifies additional dissolution apparatuses to which interchangeability applies in the three ICH regions, updates the considerations for implementation, and updates the references used for the Q4B evaluation. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Pharmacogenomic Data Submissions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Timothy J. Rosio, M.D. for 4 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Rosio was convicted of misdemeanors under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Rosio was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Rosio failed to respond. Dr. Rosio's failure to respond constitutes a waiver of his right to a hearing concerning this action.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 18th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) has determined the regulatory review period for DEXILANT (previously KAPIDEX) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for Fusilev (Levoleucovorin) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Department of Health and Human Services released the 12th RoC to the public on June 10, 2011. The report is available on the RoC Web site at: https://ntp.niehs.nih.gov/go/roc12 or in printed text or electronically from the Office of the RoC (see ADDRESSES below).