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

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the ``First Periodic Review of Scientific and Medical Evidence Related to Cancer for the World Trade Center Health Program.'' The Review can be found at: https://www.cdc.gov/niosh/ topics/wtc/prc/prc-1.html. Background: The James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), Title XXXIII of the Public Health Service Act, 124 Stat. 3623 (codified at 42 U.S.C. 300mm-300mm-61) requires in Section 300mm-22(a)(5)(A) that the Administrator of the World Trade Center (WTC) Health Program ``periodically conduct a review of all available scientific and medical evidence, including findings and recommendations of Clinical Centers of Excellence, published in peer- reviewed journals to determine if, based on such evidence, cancer or a certain type of cancer should be added to the applicable list of WTC- related health conditions.'' The first periodic Review of Cancer provides a summary of the current scientific and medical findings in the peer-reviewed literature about exposures resulting from the September 11, 2001 terrorist attacks in New York City and cancer studies. The review discusses criteria that have been used previously to assist in weighing the scientific evidence to determine if a causal association exists between exposure and cancer. The review summarizes input from the public on three questions regarding conditions relating to cancer for consideration under the WTC Health Program, as requested in the Federal Register on March 8, 2011 (76 FR 12740) and modified on March 29, 2011 (76 FR 17421). See https:// www.cdc.gov/niosh/docket/archive/docket227.html. The review also provides reports from the Mount Sinai School of Medicine, the Bureau of Health Services of the Fire Department of New York City, the WTC Health Registry of the New York City Department of Health and Mental Hygiene and the New York State Department of Health about cancer studies ongoing or planned. Based on the scientific and medical findings in the peer-reviewed literature reported in the first periodic Review of Cancer for the WTC Health Program, insufficient evidence exists at this time to propose a rule to add cancer, or a certain type of cancer, to the List of WTC- Related Health Conditions found at 42 U.S.C. 300mm-22(a)(3) through (4) and 300mm-32(b).

The Food and Drug Administration (FDA) is announcing the availability of a draft report entitled ``Identifying CDER's Science and Research Needs.'' This document identifies current priorities in regulatory science related to the mission of the Center for Drug Evaluation and Research (CDER), and will guide strategic planning of internal research efforts. Through external communication of the science and research needs outlined in the report, CDER hopes to stimulate research and foster collaborations with external partners and stakeholders to address these priorities.

This notice announces an administrative hearing to be held on September 13, 2011, at the CMS Chicago Regional Office, 233 N. Michigan Avenue, Suite 600, Chicago, IL 60601, to reconsider CMS' decision to disapprove Indiana SPA 11-011.

The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an ``Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products.

The National Institute for Occupational Safety and Health

The Office of Biotechnology Activities (OBA) is updating

This notice is to inform the public that the Substance Abuse

This notice is to inform the public that the Substance Abuse

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, September 21, 2011. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding antivascular endothelial growth factor (anti-VEGF) treatment of diabetic macular edema (DME). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).