Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents

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 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 Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' The guidance document is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA, U.S. Department of Health and Human Services and the National Oceanic and Atmospheric Administration, U.S. Department of Commerce. The purpose of the MOU is for cooperation and information sharing in the inspection of fish and fishery products and establishments.

The National Institutes of Health is amending the current regulations governing grants for research projects by revising the definition of Principal Investigator to mean one or more individuals designated by the grantee in the grant application and approved by the Secretary, who is or are responsible for the scientific and technical direction of the project, rather than limiting the role of Principal Investigator to one single individual; and the conditions for multiple or concurrent awards pursuant to one or more applications.

The Department of Health and Human Services (HHS) is reorganizing a portion of two offices, the Office of the Assistant Secretary for Resources and Technology (ASRT) and the Office of the Assistant Secretary for Administration and Management (ASAM), both of which are located within the Office of the Secretary (OS). The reorganization is designed to increase the efficiency and effectiveness of these two offices by consolidating the resource-related functions, including budget, grants, acquisition, finance, and the American Recovery and Reinvestment Act (Recovery Act) coordination, under ASRT and the administrative functions under ASAM. The titles of the Assistant Secretary for Resources and Technology (ASRT) and the Assistant Secretary for Administration and Management (ASAM) will also be changed to the Assistant Secretary for Financial Resources (ASFR) and Assistant Secretary for Administration (ASA), respectively. This reorganization also will transfer support for the Office of Small & Disadvantaged Business Utilization (OSDBU) from ASAM to ASRT, while maintaining the Office's same direct-line reporting structure to the Deputy Secretary. Finally, this reorganization will transfer direct- line reporting of the Office of the Chief Information Office from ASRT to the Deputy Secretary while moving day-to-day support for OCIO from ASRT to ASA.

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 National Cancer Institute (NCI), 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 an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the bar code label requirements for human drug and biological products.

HHS gives notice of the release of an update to The Report on Residual Radioactive and Beryllium Contamination at Atomic Weapons Employer Facilities and Beryllium Vendor Facilities under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7484-7385.

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled ``Guidance on IRB Approval of Research with Conditions,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``Guidance on IRB Continuing Review of Research,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, will represent OHRP's current thinking on this topic and will supersede OHRP's January 15, 2007 guidance document entitled ``Guidance on Continuing Review,'' available at https://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.ht m. The draft document, which is available on the OHRP Web site at https:// www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements contained in the requirements for submission of labeling for human prescription drugs and biologics in electronic format.

This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at the Lake Ontario Ordnance Works, Niagara, Falls, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 29, 2009, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled ``Dosage Delivery Devices for OTC Liquid Drug Products.'' FDA is issuing this guidance because of ongoing concerns about potentially serious accidental drug overdoses that can result from the use of dosage delivery devices with markings inconsistent or incompatible with the labeled dosage directions for over-the-counter (OTC) liquid drug products.

The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh. This action is in response to a petition filed by DSM Nutritional Products, Inc.

The Food and Drug Administration (FDA) is extending to January 4, 2010, the comment period for the draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons'' that appeared in the Federal Register of August 3, 2009 (74 FR 38437), as corrected on August 21, 2009 (74 FR 42311). In the notice of availability, FDA requested comments by November 2, 2009. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is extending to January 4, 2010, the comment period for the draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes'' that appeared in the Federal Register of August 3, 2009 (74 FR 38438), as corrected on August 21, 2009 (74 FR 42311). In the notice of availability, FDA requested comments by November 2, 2009. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is deleting an existing system of records titled ``Ricky Ray Hemophilia Relief Fund Act of 1998,'' HRSA System No. 09-15-0061, established at Volume 64, Number 237 Federal Register pages 69274-69277 on December 10, 1999.

In accordance with the requirements of the Privacy Act of 1974, HRSA is deleting an existing system of records titled the ``Minority/Disadvantaged Health Professions Programs'' HRSA System No. 09-15-0060, established at 63 Federal Register 14121 (March 24, 1998).

The Food and Drug Administration (FDA), in collaboration with the United States Department of Agriculture, Food Safety and Inspection Service (FSIS), is announcing a public meeting regarding product tracing systems for food intended for humans and animals. The purpose of the meeting is to stimulate and focus a discussion about mechanisms to enhance product tracing systems for food. This discussion will help FDA and FSIS determine what short and long term steps the two agencies should take to enhance the current tracing system.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``ICH S2 Genetic Toxicology Issues.'' The 1-day public workshop is intended to seek constructive input from experts in the field of genetic toxicology on proposed changes to the International Conference on Harmonisation (ICH) guidance ``S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use'' that was published in March 2008.

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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 12/281,589 and PCT Application No. PCT/US07/ 05555 entitled ``Materials and Methods Directed to Asparagine Synthetase and Asparaginase Therapies'' (HHS Ref. No. E-132-2006/2), to the French-based ERYtech Pharma LLC which is located in Lyon, France (with an additional office in Philadelphia, Pennsylvania). The patent rights in this invention have been assigned to the United States of America.

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 announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for peramivir 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients. Peramivir is a drug that is not approved by FDA. FDA is issuing the Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of peramivir. The Authorization follows the determination by then Acting Secretary of the U.S. Department of Health and Human Services Charles E. Johnson (then Acting Secretary) that a public health emergency exists involving Swine Influenza A (now known as ``2009-H1N1 Influenza'') that affects, or has the significant potential to affect, national security. The determination has been renewed. On the basis of such determination, the Secretary declared an emergency justifying the authorization of the emergency use of the antiviral peramivir, accompanied by emergency use information, subject to the terms of any authorization issued under the act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. The notice of the declaration of the Secretary is announced elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is postponing the meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee scheduled for November 20, 2009. This meeting was announced in the Federal Register of October 16, 2009 (74 FR 53274). The postponement is due to a scheduling conflict. A future meeting date will be announced in the Federal Register.

This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services. This meeting is open to the public.

HHS gives notice of a decision to designate a class of employees at the Norton Company, Worcester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 29, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of workers of North American Aviation who worked at the Canoga Avenue Facility, Los Angeles, California, 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:

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

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 announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the medicated feed mill licensing applications.

We (Food and Drug Administration (FDA)) are withdrawing a notice of eligibility and call-for-data for safety and effectiveness information. The original notice published in the Federal Register of August 23, 2004 (69 FR 51852). In that notice, we announced that Saccharomyces boulardii (S. boulardii) was eligible for consideration to be added to the over-the-counter (OTC) monograph for antidiarrheal drug products.

This notice announces the final priority data needs for six priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). This notice also serves as a continuous call for voluntary research proposals.

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is proposing to: change the security classification of the system from low to moderate; add an additional system location, to reflect the creation of a system contingency site; delete language from authorized users of the system; add information on physical safeguards pertaining to system security; delete the use of a receptionist controlled area from the physical safeguards for the system; change the room number for the system manager; change the legal authority cited for maintenance of system information; add a new routine use to Information Center (IC) Integrated Clearinghouse System (ICS), 09-15-0067, last published at 72 Federal Register 44846-44847 (August 9, 2007). The HRSA Office of Communications is responsible for the HRSA IC/ICS System of Records (SOR), which is an existing Agency SOR.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of an existing collection of information pertaining to the tobacco product standard for flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a Federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.