Department of Health and Human Services March 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft final guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' (the draft final fresh-cut guidance). This document complements FDA's Current Good Manufacturing Practice (CGMP) requirements for foods by providing specific guidance on the processing of fresh-cut produce. The draft final fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready- to-eat form. FDA also 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 PRA).

The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, or cellular or tissue- based products (HCT/Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction).

This Final Rule sets forth the Secretary's decision to include intestines within the definition of organs covered by the regulations governing the operations of the Organ Procurement and Transplantation Network. The Secretary under the authority granted by section 301 of the National Organ Transplant Act, as amended, further effects a corresponding change to the definition of human organs covered in the statute with this Final Rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two new animal drug applications (NADAs) filed by Bayer HealthCare LLC. The NADAs provide for the topical use by veterinary prescription of topical solutions containing imidacloprid and two strengths of moxidectin, one for use on dogs and the other for use on cats, for the prevention of heartworm disease, the treatment of flea infestations, and the treatment and control of several internal parasites.

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 Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for over-the-counter (OTC) marketing status for oral use of oxfendazole suspension in cattle.

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 National Institute for Occupational Safety and Health (NIOSH) announces the following availability of opportunity for the public to provide input regarding the draft document, ``Explosion Pressure Design Criteria for New Seals in U.S. Mines.'' NIOSH is the Federal agency responsible for conducting research and making recommendations for the prevention of occupational injuries and illnesses, including those occurring in the mining industry. Federal Mine Safety and Health Act, 30 U.S.C. 951. Seals are dam-like structures constructed in underground coal mines throughout the U.S. to isolate abandoned mining panels or groups of panels from the active workings. Historically, mining regulations required seals to withstand a 140 kPa (20 psi) explosion pressure; however, the 2006 MINER Act requires MSHA to increase this design standard by the end of 2007. This report provides a sound scientific and engineering justification to recommend a three-tiered explosion pressure design criteria for new seals in coal mines in response to the MINER Act. Much of the information contained in this report also applies to existing seals. A copy of the draft document can be found at: https://www.cdc.gov/ niosh/review/public/mineseal/. Comments should be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C-34, Cincinnati, OH 45226, telephone 513/533-8450, fax 513/533-8285, nioshdocket@cdc.gov. Comments may also be submitted directly through the Web site https:// www.cdc.gov/niosh/review/public/mineseal/comments.html. The document will remain available for comment until March 12, 2007. Comments should reference docket number NIOSH-100 in the subject heading. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify an existing system titled, ``Medicare Learning Network (MLN) Registration and Product Ordering System (REPOS),'' No. 09-70-0542, most recently modified at 68 FR 35897 (June 17, 2003). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 2 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. Finally, we will delete the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' does not apply because this system does not collect or maintain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' is not applicable to the data maintained in this system. We are modifying the language in the routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system of records is to collect and maintain information on health care providers, and other individuals ordering provider educational materials who voluntarily register for computer/web-based training courses, satellite broadcasts and train- the-trainer sessions. Information in this system will also be used to: (1) support regulatory and policy functions performed within the Agency or by a contractor, consultant, or grantee; and (2) to support litigation involving the Agency related to this system. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is amending its regulations that address food and color additives and generally recognized as safe (GRAS) substances. The purpose of the amendments is to update the name of an FDA office, to correct minor errors in the Code of Federal Regulations (CFR), and to delete obsolete information. The technical amendments made by this final rule are editorial in nature and are intended to provide accuracy and clarity to the agency's regulations.