Department of Health and Human Services March 2013 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) proposes to revise the fee structure currently used by the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC) to charge respirator manufacturers for the examination, inspection, and testing of respirators which are submitted to NIOSH for the purpose of creating or modifying a certificate of approval. Existing regulations reflect prices for respirator testing and approval that were promulgated in 1972, and have not kept pace with the actual costs of providing these services that benefit respirator manufacturers. This proposed rule is designed to update the regulations.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $1.5 million (total costs) for up to five years to the state of Idaho for a Strategic Prevention Framework State Incentive Grant. This is not a formal request for applications. Assistance will be provided only to the state of Idaho based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP-13-005. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 516 of the Public Health Service Act, as amended . Justification: Eligibility for this SPF SIG award is limited to the state of Idaho, the only state receiving a Substance Abuse Prevention and Treatment Block Grant (SABG) that has never been awarded a SPF SIG grant from SAMHSA. The SPF SIG grant has already allowed 49 states to strengthen and consolidate their prevention systems and build greater capacity in their communities. SAMHSA/CSAP believes that every state must build prevention capacity and infrastructure to prevent the onset and reduce the progression of substance abuse, including childhood and underage drinking, and to reduce substance abuse-related problems across the nation. Following the SPF five-step process, the state of Idaho will have the opportunity to use SPF SIG funds to develop a comprehensive prevention plan at the state level and support a broad range of sub-recipient communities to implement effective programs, policies and practices to reduce substance abuse and its related problems. By giving a SPF SIG to every state, including Idaho, SAMHSA will have effected nationwide, systemic change in preventing the onset and reducing the progression of substance abuse and substance abuse- related problems nationwide. Contact: Cathy Friedman, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1097, Rockville, MD 20857; telephone: (240) 276-2316; email: cathy.friedman@samhsa.hhs.gov.

The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of April 9, 2007 (72 FR 17397 at 17401) to reflect changes to the Center for Devices and Radiological Health's address. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

HHS gives notice of a decision to designate a class of employees from the Battelle Laboratories King Avenue facility in Columbus, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Baker Brothers site in Toledo, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:

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 license to Aura BioSciences to practice the inventions embodied in U.S. Provisional Patent Application No. 60/928,495 entitled, ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 8, 2007 [HHS Ref. No. E-186-2007/0-US-01], U.S. Provisional Patent Application No. 61/065,897 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed February 14, 2008 [HHS Ref. No. E-186-2007/1-US-01], PCT Application No. PCT/US2008/ 062296 ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-PCT-01], Australian Patent Application No. 2008251615 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-AU-02], Canadian Patent Application No. 2,686,990 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-CA- 03], European Patent Application No. 08747407.8 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-EP-04], U.S. Patent Application No. 12/598,684 entitled, ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed February 8, 2010 [HHS Ref. No. E-186-2007/2-US-05], and US Patent Application No. 13/763,365 entitled, ``Papilloma Pseudovirus for Detection and Therapy of Tumors'' filed February 8, 2013 [HHS Ref. No. E-186-2007/2-US-06] and all continuing applications and foreign counterparts. 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 development and use of the Licensed Patent Rights in combination with Licensee's proprietary nanosphere encapsulation technology for the treatment, diagnosis and imaging of cancer tumors and metastases as well as their respective pre-cursor dysplasia states. Licensee's proprietary nanosphere encapsulation technology is understood to consist of: (1) Methods for manipulating the outer proteins of human papillomavirus-derived nanoparticles to create particles targeted to solid tumors and distant metastases; and (2) enhancements for the delivery of particles created by Licensee's proprietary technology.

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, is contemplating the grant of a start-up exclusive license to practice the inventions embodied in U.S. Patent No. 7,854,899, (E-098-2004/0) filed 08/26/2004 and issued 12/20/2010 entitled ``Template Methods and Device for Preparing Sample Arrays''; by Hewitt et al. (NCI); and U.S. Patent No. 6,951,761 9 (E- 064-2001/0) filed 08/30/2002 and issued 11/04/2005 ``Measurements of Multiple Molecules Using a Cryoarray'' by Star et al. (NIDDK) to Micatu, Inc. having a place of business at 231 West Water Street, Elmira, NY 14901. The patent rights in this invention have been assigned to the United States of America.

The Food and Drug Administration (FDA) has determined that QUESTRAN (cholestyramine for oral suspension, USP), equivalent to (EQ) 4 grams (g), and QUESTRAN LIGHT (cholestyramine for oral suspension, USP), EQ 4 g, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug applications (ANDAs) that refer to these drugs, and it will allow FDA to approve ANDAs that refer to these drugs as long as they meet relevant legal and regulatory requirements.

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.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Intramural Training & Education/OIR/OD, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 extending the comment period for the notice that appeared in the Federal Register of January 7, 2013 (78 FR 951). In the notice, FDA requested comments on the public workshop entitled ``Accessible Standardized Medical Device Labeling.'' The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The National Institutes of Health (NIH) is providing guidance to Public Health Service (PHS) awardee institutions on implementation of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals: 2013 Edition (Guidelines). The NIH is seeking input from the public on any concerns they may have regarding the updated Guidelines.