Department of Health and Human Services March 26, 2013 – Federal Register Recent Federal Regulation Documents

Fiscal Year (FY) 2013 Funding Opportunity
Document Number: 2013-06897
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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.
Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability
Document Number: 2013-06865
Type: Notice
Date: 2013-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility'' dated April 2013. The guidance document provides assistance to blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices. The guidance announced in this document finalizes the draft guidance of the same title dated October 2007.
Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United States; Agent Designation; Change of Address
Document Number: 2013-06864
Type: Rule
Date: 2013-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
Document Number: 2013-06849
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from the Hanford site in Richland, Washington, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On March 6, 2013, 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:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-06846
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services
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:
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
Document Number: 2013-06845
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from General Steel Industries in Granite City, Illinois, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On March 6, 2013, 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:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-06844
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services
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:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-06842
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the Joslyn Manufacturing and Supply Company in Fort Wayne, Indiana, 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:
Prospective Grant of Exclusive License: Papilloma Pseudovirus and Virus-Like Particles as a Delivery System for Human Cancer Therapeutics and Diagnostics
Document Number: 2013-06837
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-06836
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
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.
Prospective Grant of Start-Up Exclusive License: Manual Device for Constructing Tissue Micro Arrays and Methods for Making Cryo Arrays for Use in Association With the Device
Document Number: 2013-06835
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
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.
Medical Devices; Technical Amendment
Document Number: 2013-06826
Type: Rule
Date: 2013-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
Determination That QUESTRAN (Cholestyramine for Oral Suspension, USP), Equivalent to 4 Grams, and QUESTRAN LIGHT (Cholestyramine for Oral Suspension, USP), Equivalent to 4 Grams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2013-06825
Type: Notice
Date: 2013-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability
Document Number: 2013-06824
Type: Proposed Rule
Date: 2013-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning.'' The draft guidance, when finalized, will advise primary seafood processors who purchase reef fish how to minimize the risk of ciguatera fish poisoning (CFP) from fish that they distribute. The draft guidance is intended to help protect the public health by reducing the risk of CFP.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
Document Number: 2013-06823
Type: Notice
Date: 2013-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2013-06812
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-06811
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2013-06810
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2013-06809
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2013-06808
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2013-06807
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-06806
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-06805
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-06804
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-06803
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2013-06801
Type: Notice
Date: 2013-03-26
Agency: Department of Health and Human Services, National Institutes of Health