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

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Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled ``Guidance on IRB Approval of Research with Conditions,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic.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Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``Guidance on IRB Continuing Review of Research,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, will represent OHRP's current thinking on this topic and will supersede OHRP's January 15, 2007 guidance document entitled ``Guidance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.