Department of Health and Human Services March 31, 2008 – Federal Register Recent Federal Regulation Documents
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Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine Suspension
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 IVX Animal Health, Inc. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for penicillin G benzathine and penicillin G procaine injectable suspension.
New Animal Drugs For Use in Animal Feed; Zilpaterol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride and melengestrol acetate in two-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.
Request for Information: NIH Public Access Policy
With this notice, the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) requests input from the community regarding the NIH Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research (NIH Public Access Policy). Complete and detailed information about the law at Division G, Title II, section 218 of Public Law 110-161 (Consolidated Appropriations Act, 2008), the NIH Public Access Policy, and implementation procedures issued to date are available at https:// publicaccess.nih.gov/index.htm. This request for information (RFI) seeks input on the Public Access Policy as described on the above Web site. This RFI will be active from March 31, 2008 to May 31, 2008 on https://publicaccess.nih.gov/comments.htm. The NIH will post analysis and results from this RFI for public view onto https:// publicaccess.nih.gov by September 30, 2008. Background: The National Institutes of Health (NIH)The Nation's Medical Research Agencyis comprised of 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov. PubMed Central is an archive of full-text biomedical journal articles available online without a fee. Articles on PubMed Central contain links to other scientific databases such as GenBank (https:// www.ncbi.nlm.nih.gov/ Genbank/) and PubChem (https:// pubchem.ncbi.nlm.nih.gov/). Articles collected under the Public Access Policy are archived on PubMed Central. More information about PubMed Central is available at https://www.pubmedcentral.nih.gov/about/ faq.html. Prior to the Consolidated Appropriations Act of 2008, NIH's voluntary Public Access Policy (NOT-OD-05-022 available at https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html and in the section on SUPPLEMENTARY INFORMATION) encouraged but did not require those receiving NIH funding to deposit their peer reviewed manuscripts into PubMed Central. Division G, Title II, section 218 of Public Law 110-161 (Consolidated Appropriations Act of 2008) states:
Compliance Policy Guide Sec. 500.500 Guidance Levels for 3-MCPD (3-chloro-1, 2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces; Availability
The Food and Drug Administration (FDA) is announcing the availability of compliance policy guide (CPG) Sec. 500.500 Guidance Levels for 3-MCPD (3-chloro-1, 2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces. The CPG provides regulatory action guidance for FDA staff regarding 3-MCPD in acid-hydrolyzed protein (acid-HP) and Asian-style sauces.
Reimbursement Rates for Calendar Year 2008
Notice is given that the Director of Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001 (a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2008 for Medicare and Medicaid beneficiaries and beneficiaries of other Federal programs. The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment may be available to the extent that those services meet applicable requirements. Public Law 106-554, section 432, dated December 21, 2000, authorized IHS facilities to file Medicare Part B claims with the carrier for payment for physician and certain other practitioner services provided on or after July 1, 2001.
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