Department of Health and Human Services July 2006 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF) is proposing to add regulations at 45 CFR part 1356 to require States to collect and report data to ACF on youth who are receiving independent living services and the outcomes of certain youth who are in foster care or who age out of foster care. This proposed rule implements the data collection requirements of the Foster Care Independence Act of 1999 (Public Law 106-169) as incorporated into the Social Security Act at section 477.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), 42 U.S.C. 300aa-1 et seq., and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Pacific Proving Grounds, Enewetak Atoll, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 26, 2006, the Secretary of HHS designated the following class of employees as an addition to the SEC:

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 Intervet Inc. The supplemental NADA provides for the revision of a food safety warning on labeling of furosemide injectable solution for use in horses.

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 Pharmacia & Upjohn Co. The supplemental NADA provides for use of ceftiofur crystalline free acid suspension via a new injection site in beef and nonlactating dairy cattle, for use in lactating dairy cattle for the treatment of respiratory disease, and for the establishment of a 13-day pre-slaughter withdrawal period in cattle. FDA is also amending the regulations to revise the tolerance for residues of ceftiofur in bovine kidney to accommodate these new conditions of use.

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 Pharmacia & Upjohn Co. The supplemental NADA provides for revised food safety labeling for mepivacaine injectable solution used in horses for local anesthesia.

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed new collection of information to be submitted to the Office of Management and Budget for review. Proposed Collection: Title: 0917-0002, `` Indian Health Service Contract Health Service Report''. Type of Information Collection Request: Extension, without revision, of currently approved information collection 0917-0002, ``Indian Health Service Contract Health Service Report''. Form Number: IHS 843-1A. Need and Use of Information Collection: The purpose for the collection is to authorize contract health care providers to provide health care services to eligible IHS patients. The IHS form 843-1A ``Order for Health Services'' was developed specifically for this collection of information. Other than revising the title ``Purchase- Delivery Order for Health Services'' to read ``Order for Health Services'', acquisition terms on the front of the form, the contract clauses contained on the back of copy 3 of the form, the form has not been revised and there is no change in the substance or in the use of the form. A copy of the form is at Attachment 2. The majority of the information contained in this form is completed by IHS staff from existing IHS automated patient and vendor data files. Contract health care providers complete and sign the streamlined form and submit it, along with a completed standard Centers for Medicare & Medicaid Services (CMS) health claim form (CMS 1450 (UB 92) and CMS 1500), to the IHS for verification and payment. The CMS forms are used and accepted nation-wide by the health care industry and IHS is an approved user. The information collection is needed to administer and manage the contract health care services provided to eligible American Indian and Alaska Native patients. The form is used to: Authorize contract health care services for eligible patients; certify that the health care services requested and authorized have been performed by the contract provider(s); process payments for health care services performed by such providers; obtain program data; and, serve as a legal document for health and medical care authorized by the IHS and rendered by health care providers under contract with the IHS. The information collected is also used for: Planning for further care of the patient; for keeping an accurate record of the patient's health status and health services received and recommended; for planning future health care programs; for communicating among members of the health care team; for evaluating the health care rendered; for research and continuing education; and, for the provision of program health statistics. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides the estimated burden hours for this information collection:

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Nevada Test Site (NTS), Mercury, Nevada, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 26, 2006, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol, lasalocid, and tylosin to make three-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.

This interim final rule with comment period amends Medicaid regulations to implement the provision of the Deficit Reduction Act that requires States to obtain satisfactory documentary evidence of an applicant's or recipient's citizenship and identity in order to receive Federal financial participation. This regulation provides States with guidance on the types of documentary evidence that may be accepted, including alternative forms of documentary evidence in addition to those described in the statute and the conditions under which this documentary evidence can be accepted to establish the applicant's declaration of citizenship. It also gives States guidance on the processes that may be used to help minimize the administrative burden on both States and applicants and recipients.

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a teleconference meeting of the SACATM on August 3, 2006. The teleconference is scheduled from 1 p.m. to 4 p.m. and is open to the public. At the teleconference, SACATM will discuss the conclusions of a peer review panel that met on May 23, 2006 to evaluate the validation status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral red uptake (NRU) basal cytotoxicity test methods (see ``Background'' for more detail). The public is invited to participate in the teleconference and will be provided with an opportunity to make oral comments during the public comment period. Participation is limited only by the number of phone lines available.

This notice announces the first meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

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 an exclusive license worldwide to practice the invention embodied in: International Patent Application PCT/US2005/031678 filed September 2, 2005 entitled, ``(N)-Methanocarba Adenosine Derivative as A3 Receptor Agonists'', to Can-Fite BioPharma, Ltd. having a place of business in Petach-Tikva, Israel. The contemplated exclusive license may be limited to an FDA approvable human therapeutic for cancer, autoimmune and other inflammatory diseases. The United States of America is the assignee of the patent rights in this invention.

This notice announces the first meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

The Food and Drug Administration (FDA) is announcing the withdrawal of the compliance policy guide (CPG) entitled ``Sec. 616.100 Streptomycin Residues in Cattle Tissues (CPG 7125.22).'' This CPG is obsolete.