Department of Health and Human Services June 2008 – Federal Register Recent Federal Regulation Documents

The U.S. Department of Health and Human Services (HHS) (a) announces the availability of the Physical Activity Guidelines Advisory Committee Report, 2008; and (b) solicits written comments on the Report. The Physical Activity Guidelines Advisory Committee was charged with reviewing existing scientific literature to identify where there was sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The report to the Secretary of HHS documents the scientific background and rationale for the issuance of physical activity guidelines. The report also identifies areas where further scientific research is needed. The Committee's evaluation of the science will be utilized by the Department to prepare the Physical Activity Guidelines for Americans. The intent is to issue physical activity guidelines for all Americans that will be tailored as necessary for specific subgroups of the population.

The Food and Drug Administration (FDA) is amending certain medical device regulations to correct typographical errors and to ensure accuracy and clarity in the agency's regulations.

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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the opportunity for manufacturers and stakeholders to provide NIOSH with input on the potential modification of the NIOSH Statement of Standard for a Chemical, Biological, Radiological, and Nuclear (CBRN) Full Facepiece Air-Purifying Respirator (APR), which would permit an alternative to the single standard 40-mm screw mounted canister for the Department of Defense. Authority: Occupational Safety and Health Act, 29 U.S.C. 651 et seq. Public Comment Period: Submit input to the NIOSH Docket Office within 120 days from June 18, 2008. Status: Written comments may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C 34, CBRN APR Mechanical Connector Design, Cincinnati, Ohio 45226, telephone (513) 533-8303, Facsimile (513) 533-8285. All material submitted should reference NIOSH Docket number 139. Comments may be e-mailed to nioshdocket@cdc.gov. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copies available at the NIOSH Docket Office, Room 111, 4674 Colombia Parkway, Cincinnati, Ohio 45226. Background: The National Personal Protective Technology Laboratory (NPPTL) is currently seeking stakeholder input regarding a request from the Department of Defense (DoD). The request is for a proposed modification to the CBRN APR Statement of Standard to allow for mechanical connectors other than the specified single 40-mm thread connector. The DoD is seeking modification of the standard to allow DoD first responders to use a newly developed respirator, the Joint Service General Protective Mask (JSGPM), for respiratory protection on military installations in the United States, or when called upon to support civil authorities. The JSGPM uses a bayonet mounted, dual filter design instead of the single standard 40-mm screw mounted canister. DoD's request is to supplement the existing NIOSH standard with an alternate design for DoD application. The DoD request to NIOSH for modification of the NIOSH Statement of Standard may be obtained from the NIOSH Docket Office using the contact information available above. Because of their experiences in responding to the terrorist events of 2001, emergency responders identified the need for the interoperability of canisters and facepieces as a respirator user issue that NIOSH needed to address. During the evolution of the CBRN Statement of Standard, NIOSH identified a single mechanical connector design requirement to support interchangeability of CBRN certified canisters and masks. The user community strongly encouraged requiring interoperable capability at all three public meetings held that discussed the requirements for the CBRN APR, and interoperability was strongly recommended in the 2002 Rand Report entitled, ``Protecting Emergency Responders Lessons Learned from Terrorist Attacks.'' Through a collaborative approach with multiple partnerships, applicable military and industrial technologies were integrated by NIOSH in the CBRN APR standard to provide the full range of protection needed by emergency responders. Working with the partnerships from Federal government agencies, the private sector, and user groups, NIOSH expedited development and publication of new testing and certification standards for voluntary use by emergency responders in CBRN terrorist attacks. Information about the public meetings that discussed the conceptual requirements for the CBRN APR is available through this link: https://www.cdc.gov/niosh/npptl/ standardsdev/cbrn/meetings.html. The NIOSH Statement of Standard and supporting concept papers for the CBRN APR are available through this link: https://www.cdc.gov/niosh/ npptl/standardsdev/cbrn/apr/. Since the Standard was established in 2003, multiple models of CBRN APRs from multiple manufacturers have been certified to the Statement of Standard. The DoD's request is to supplement the existing NIOSH standard with an alternate permissible design for DoD applications. DoD requirements for the JSGPM require availability of replacement filters in the mask carrier worn on the individual and field level logistic support for additional filters. Neither of these are requirements for commercial mask applications. For the DoD user, the advantages of the bayonet attachment on the JSGPM does not compromise the interoperability considerations for emergency responders outside of the DoD. DoD Instruction 6055.1 indicates that in non-military unique workplaces where OSHA standards or other Federal safety standards apply but do not cover, or only partially cover, existing conditions, the DoD Components shall use appropriate national safety and occupational health consensus standards under Public Law 104-113. When there is no relevant OSHA or national consensus standard, the DoD Components may develop other protective measures to ensure the safety and health of DoD personnel. Also, the DoD Components may prescribe more stringent exposure limits or monitoring frequencies than those in the basic OSHA standards. Requesting NIOSH to include another mechanical connector design for DoD applications that may allow for NIOSH certification of the JSGPM meets this intent. Through this announcement, NIOSH/NPPTL is seeking input from stakeholders and manufacturers to determine the following: 1. Opinions on the current design requirement for the single 40-mm thread canister mechanical connector. 2. Rationale and data to maintain the current design requirement. 3. Rationale and data to support adding an alternative design for DoD applications for canister mechanical connectors. 4. Identification of alternative approaches to implement the alternative design concept for the canister mechanical connector. 5. Other comments on the subject. Contact Person for Technical Information: Jonathan V. Szalajda, General Engineer, National Personal Protective Technology Laboratory (NPPTL), NIOSH, CDC, telephone (412) 386-6627, E-mail zfx1@cdc.gov.

The National Center for Complementary and Alternative Medicine (NCCAM) will convene a workshop on Meditation for Health Purposes. The goals of the workshop are to assess current knowledge and identify opportunities for future research on the mechanisms and efficacy of meditation practices for a variety of health concerns. This workshop will bring together experts in the fields of meditation practices, research design and methodology, physiological mechanisms, and affective and cognitive processes and outcomes. The meeting will draw on this expertise to elucidate relevant aspects that would best move the field of meditation research forward. The meeting will utilize a combination of short presentations, discussions, and breakout groups. The Workshop will take place on July 8-9, 2008 in Bethesda, Maryland. Seating will be limited, and researchers in the relevant scientific fields are particularly encouraged to attend. Attendees should register by July 1, 2008 by visiting https://nccam.nih.gov/news/ upcomingmeetings/. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. NCCAM funds research grants that explore the science of CAM. For more information, see https://nccam.nih.gov/research/nccamfunds.htm.

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 invention embodied in U.S. Patent No. 6,890,917, issued May 10, 2005, entitled ``Geldanamycin Derivative and Method of Treating Cancer Using Same'' [E-050-2000/0-US- 15] and foreign equivalents, to Avira Therapeutics, LLC, having a place of business in Menlo Park, California. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the manufacture, use, distribution and sale of 17-DMAG, an analog of geldanamycin, as a therapeutic to inhibit the influenza virus, respiratory syncytial virus (RSV) and dengue virus. This replaces a notice published in 73 FR 31702 on Tuesday, June 3, 2008, which omitted the name of the potential licensee.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for Los Alamos National Laboratory, Los Alamos, New Mexico, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Los Alamos National Laboratory. Location: Los Alamos, New Mexico. Job Titles and/or Job Duties: All service support workers (which includes, but is not limited to, security guards, firefighters, laborers, custodians, carpenters, plumbers, electricians, pipefitters, sheet metal workers, ironworkers, welders, maintenance workers, truck drivers, delivery persons, radiation technicians, and area work coordinators) who worked in any operational Technical Areas with a history of radioactive material use. Period of Employment: January 1, 1976 through December 31, 2005.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for revision of an effectiveness claim and pathogen nomenclature for a tylosin phosphate and sulfamethazine Type A medicated article used to manufacture medicated swine feeds.