Department of Health and Human Services February 2007 – 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 invention listed below is owned by an agency of the U.S. Government and is 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.

This notice announces the 13th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the seventh meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the University of Arkansas (UA) Institute of Food Science and Engineering (IFSE), is announcing a public workshop entitled ``Food Defense Workshop.'' This public workshop is intended to provide information about food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to FDA- regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants). Date and Time: This public workshop will be held on May 23 through 24, 2007, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Continuing Education Center, 2 East Center St., Fayetteville, AR (located downtown). Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or e-mail: david.arvelo@fda.hhs.gov. For information on accommodation options, contact Steven C. Seideman, 2650 North Young Ave., Institute of Food Science and Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575- 4221, FAX: 479-575-2165, or email: seideman@uark.edu. Registration: You are encouraged to register by May 9, 2007. The University of Arkansas has a $150 registration fee to cover the cost of facilities, materials, speakers, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $200 payable to: ``The University of Arkansas.'' If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact section of this document) at least 7 days in advance. Registration Form Instructions: To register, please complete the following form and submit along with a check or money order for $150 payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science and Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704.

The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart disease (CHD). The amendment proposes to exempt certain foods from the nutrient content requirement of ``low fat.'' The exemption would apply if the food exceeds this requirement due to fat content derived from whole oat sources. FDA is taking this action in response to a petition submitted by the Quaker Oats Company (the petitioner). The amendment would expand the use of this health claim to some whole oat products that are currently ineligible for the health claim.

In accordance with the requirements of the Privacy Act of 1974, the Indian Health Service (IHS) is proposing to modify or alter a SOR, ``Indian Health Service Scholarship and Loan Repayment Programs,'' System No. 09-17-0002. We propose to modify the SOR to reflect current program changes, technology changes, statutory and implementation changes. Under the system name, we propose no change to the title but the office acronyms have been changed as a result of an organizational change. We are proposing to change the system location to reflect the current organizational and office location changes. We are proposing to update the categories of individuals covered by the system with minor edits to include Tribal medical/health care and Title V Urban healthcare entity; and to update the categories of records in the system with edits to include additional program requirements ``(e.g. from W-4, direct deposit form for scholarship recipients and loan repayment participants).'' We are proposing to update the Authority for maintenance of the system to correct statutory authorities and to include additional statutory authorities (e.g., Privacy Act, Federal Records Act, and Department Regulations). We are proposing to update the Purposes by categorizing the two programs and modifying/altering by listing the applicable purposes into each of the two programs (Scholarship and Loan Repayment). We are proposing to modify/alter/ delete several published routine uses, as explained, to accommodate program and statutory changes as indicated: Numbers 1 through 3 remain unchanged; number 4 is modified/altered to reflect program language revisions and is renumbered as 5; number 5 is modified to include legal proceedings related to administrative claims and the inclusive provision of the Department of Health and Human Services (DHHS)/Office of General Counsel (OGC) representation in litigation matters and is renumbered as 4; number 6 is deleted as no longer applicable; number 7 is renumbered as 6 with no changes in the wording; number 8 is renumbered as 7 with no changes in the wording; number 9 is renumbered as 8 with no changes in the wording; number 10 is renumbered as 9 with minor editorial changes; number 11 is renumbered as 10 with minor editorial changes to include the IHCIA acronym citation (i.e., Indian Health Care Improvement Act, as amended); number 12 is renumbered as 11 with no changes in the wording with the exception of the removal of the statement on ``Disclosure to Consumer Reporting Agencies.'' We are proposing to add 7 new routine uses to provide disclosures of records when all requirements are met: number 12, to provide disclosure to consumer reporting agency for commercial credit report and to National Student Clearinghouse using the Loan Location Internet System for verification of applicant's loan data. The statement on ``Disclosure to Consumer Reporting Agencies'' is now incorporated in this new routine use; number 13, to provide disclosure to any Federal agency on delinquent debtors or defaulting participants to effect salary offset, court-ordered administrative offset, and to the Treasury Department, Internal Revenue Service (IRS) for verification of current mailing address for collection purposes; number 14, to allow disclosure to debt collection agents and those authorized federal or non-federal entities to collect a Federal debt from delinquent debtors or defaulting participants; number 15, to provide disclosure of applicant's information to IRS for verification of any delinquent tax account and to determine credit worthiness; number 16, to provide disclosure of applicant's information to IRS any debt that becomes partly or wholly uncollectible as taxable income; number 17, to allow disclosure to IRS of any IHS debtors or defaulting participants' information for IRS offset on tax refund; number 18, to allow the disclosure of lenders or educational institutions' information to Federal or non-Federal entities authorized to collect Federal debt and for identification of an individual and the nature of the debt. We are proposing to modify/alter the section on storage by including computerized and electronic formats; the section on safeguards for authorized users by redefining the staff functions; the section on physical safeguards to identify specific safeguards for electronic records; and the section on retention and disposal to reflect separate program changes to the IHS Records Schedule for the scholarship program records and to the loan repayment program records. We are proposing to modify/alter the section on the system managers and addresses to reflect the organization and function changes. Under the notification procedures, we are proposing to modify/alter the sections on requests in person and requests by mail to reflect minor edits and a policy change on Social Security numbers; and the section on requests by telephone by revising the wording in a clear and concise program change. In addition, we are proposing two new notification procedures that address requests by facsimile and requests by electronic mail by including a confidentiality statement on facsimile requests and clarification for electronic requests and its security safeguard risks. Under the records source categories section, we are proposing to modify/alter by including the Indian health program human resources department. This system exemption previously listed as ``None'' will remain.

The Food and Drug Administration (FDA) has determined that SUSTIVA (efavirenz) 300-milligram (mg) tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for efavirenz 300-mg tablets, if all other legal and regulatory requirements are met.

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 ADM Alliance Nutrition, Inc. The supplemental NADA provides for the use of a lasalocid Type A medicated article containing 20-percent lasalocid activity per pound to make free-choice Type C medicated feeds used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA, Duke University (DU) and Duke University Health System, Inc. (DUHS). The purpose of the MOU is to establish the terms of collaboration between FDA, DU and DUHS to support shared interests and will begin with an initiative entitled: The FDA, DU and DUMC Elective Program.

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic countermeasures based on a credible risk that an avian influenza virus spreads and evolves into a strain capable of causing a pandemic of human influenza.

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this notice is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.'' The guidance document describes a means by which a cord blood processing system and storage container may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying a cord blood processing system and storage container into class II (special controls). This guidance document is immediately in effect as the special control for this device, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infectious Disease in Xenotransplantation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This proposed rule would update the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed payment amounts and factors used to determine the updated Federal rates that are described in this proposed rule were determined based on the LTCH PPS rate year July 1, 2007 through June 30, 2008. The annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and would continue to be effective each October 1. The proposed outlier threshold for July 1, 2007, through June 30, 2008, would also be derived from the LTCH PPS rate year calculations. We are also proposing to make policy changes which include proposed revisions to the GME and IME policies. In addition, we are adding a technical amendment correcting the regulations text at Sec. 412.22.