Department of Health and Human Services March 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.
Meeting of the National Vaccine Program Office on Vaccine Financing
The Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Program Office (NVPO) will convene a meeting of the Vaccine Finance Working Group and is inviting input from stakeholders on this issue. The meeting will be open to the public.
Public Comments and Revised Final Criteria for Removing Chemicals From Future Editions of CDC's National Report on Human Exposure to Environmental Chemicals
On Tuesday, May 16, 2006, CDC published draft criteria for removing chemicals from future releases of CDC's National Report on Human Exposure to Environmental Chemicals (the ``Report'') (See FR, Vol. 71, No. 94, p. 28346-7). This and previous notices related to the ``Report'' are at https://www.cdc.gov/exposurereport/chemical_ nominations.htm. The proposed criteria provided that a chemical may be removed from the ``Report'' if (1) a new replacement chemical (i.e., a metabolite) is more representative of exposure than is the chemical currently measured; or (2) after three survey periods (or not less than 6 years), detection rates for all chemicals within a methodological and chemically related group are less than 5 percent for all population subgroups (i.e., two sexes, three race/ethnicity groups, and three age groups); or (3) after three survey periods (or not less than 6 years), levels of chemicals within a methodological and chemically related group are unchanged or declining in all the specific subgroups as documented in the ``Report.'' Using these criteria, CDC would have continued to measure the chemical and not remove it from the ``Report'' if it met either of two proposed exceptions to these criteria: (a) It is a chemical for which there is an established biomonitoring threshold (e.g., CDC's level of concern for blood lead levels in children) or any chemical for which there is widespread public health concern (e.g., mercury) or (b) three survey periods (or not less than 6 years) have passed, constituting the minimum time before a chemical could be removed; a longer period may be necessary to account for the half-life of a particular chemical or to account for a recent change (e.g., the removal of a chemical from commerce) that would necessitate monitoring of the population. In that notice, CDC pointed out that the criteria for removing a chemical from the ``Report'' are not corollaries of the criteria for adding chemicals to the ``Report.''
Government-Owned Inventions; Availability for Licensing
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.
Medicare and Medicaid Programs; Approval of the Joint Commission for Continued Deeming Authority for Home Health Agencies
This final notice announces our decision to approve The Joint Commission for recognition as a national accreditation program for home health agencies (HHAs) seeking to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Approval of the Community Health Accreditation Program for Continued Deeming Authority for Home Health Agencies
This final notice announces our decision to approve the Community Health Accreditation Program (CHAP) for recognition as a national accreditation program for home health agencies (HHAs) seeking to participate in the Medicare or Medicaid programs.
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of Preparedness and Emergency Operations (OPEO), Revised National Disaster Medical System (NDMS) Patient Treatment and Tracking Records System
In accordance with the Privacy Act of 1974, we are proposing to revise the new Privacy Act System of Records (SOR) entitled, ``The National Disaster Medical System (NDMS) Patient Treatment and Tracking Records System,'' System Number 09-90-0040, in response to public comments received. The primary purpose of the NDMS Patient Treatment and Tracking Records System is to collect and store data about individuals who are served by the medical care response capabilities provided by the Department of Health and Human Services (HHS) through the NDMS, and through other HHS medical personnel. The proposed system will cover the collection, storage and sharing of personally identifiable data in accordance with the Privacy Act.
Draft Guidance for Industry on Coronary Drug Eluting Stents-Nonclinical and Clinical Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Coronary Drug Eluting StentsNonclinical and Clinical Studies.'' This draft guidance is intended to provide recommendations to sponsors or applicants planning to develop, or to submit to FDA, a marketing application for a coronary drug eluting stent (DES). The draft guidance discusses the clinical studies that should be performed and the data that should be submitted to support such an application. The draft guidance is being issued in two parts. The companion document provides additional and more detailed guidance on some of the recommendations included in this document. The companion document is intended to be used together with this draft guidance.
Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007
The Food and Drug Administration (FDA) is issuing this notice to notify holders of certain prescription new drug and biological license applications that they will be deemed to have in effect an approved risk evaluation and mitigation strategy (REMS) under the Food and Drug Administration Amendments Act of 2007 (FDAAA). Holders of applications deemed to have in effect an approved REMS are required to submit a proposed REMS to FDA.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (0MB) approve the proposed information collection project: ``Health Care Systems for Tracking Colorectal Cancer Screening Tests.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
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