Revised diphtheria, tetanus, and pertussis (DTP/DTaP/DT) vaccine information materials--CDC. Notice

Under the National Childhood Vaccine Injury Act (42 U.S.C section 300aa-26), the CDC must develop vaccine information materials that health care providers, either public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 13, 1996, CDC published a notice in the Federal Register (61 FR 48597) seeking public comment on proposed revision of the diphtheria, tetanus, and pertussis vaccine information materials to reflect Food and Drug Administration (FDA) licensure of acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP) for administration to infants as young as two months of age. The 60-day comment period ended on November 12, 1996. Following review of the comments submitted and consultation as required under the law, CDC has finalized the revised diphtheria, tetanus, and pertussis vaccine information materials. Those final materials are contained in this notice.     

Proposed vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), Varicella (chickenpox), and measles, mumps, rubella (MMR) vaccines--CDC. Notice with comment period

Under the National Childhood Vaccine Injury Act (42 U.S.C. section 300aa-26), CDC must develop vaccine information materials that health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for hepatitis B, Haemophilus influenzae type b, and Varicella vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines.     

New vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), and varicella (chickenpox) vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

Under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers, whether public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 3, 1998, CDC published a notice in the Federal Register (63 FR 47026) seeking public comment on proposed vaccine information materials for the newly covered vaccines hepatitis B, Haemophilus influenzae type b, and varicella vaccines, and also seeking comment on proposed revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. The 60 day comment period ended on November 2, 1998. Following review of the comments submitted and consultation as required under the law, CDC has finalized these vaccine information materials. The final materials are contained in this notice.     

Establishment of vaccination clinics; user fees for investigational new drug (IND) influenza vaccine services and vaccines. Interim final rule and request for comments

We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.     

Report on the 2003 revision of the U.S. Standard Certificate of Death.

The National Center for Health Statistics (NCHS) is responsible for publishing Standard Certificates of Birth and Death for the United States of America. The standard certificates are revised roughly every 10 years. The revision process is designed to ensure that the standard certificates meet, as nearly as possible, the use for which they are intended at all levels: individual, local, state, and federal. The authors report on the most recent revision of the U.S. Standard Certificate of Death, recording the process and the role of the National Association of Medical Examiners in the process. Changes recommended during revision include requesting known aliases of a decedent and rearrangement of the certificate to provide more room for those items requesting dates and for describing how the injury occurred. New items have been added asking for information regarding traffic fatalities, the role of tobacco use in causing death, and whether female decedents were pregnant. Once approved by the Department of Health and Human Services, the new standard certificate will be made available to the states. Each state will have 2 years to adapt the U.S. Standard Certificate of Death to its use and to implement new state death certificates on January 1, 2003.     

论刑法修正的协调性

刑法修正的协调性是保障刑法公正性的基础性条件。《刑法修正案(十一)》新增罪(含修正罪)充分注意到了《刑法》与相关法律之间的协调(衔接)。但是,刑法修正还要考虑新增罪(修正罪)与既有罪之间、新增罪(修正罪)之间以及修正的刑法条文与相关刑法解释(含解释性文件)之间的协调。刑法修正需要在罪状的设置、法定刑的设置以及量刑情节的设置方面保持协调。面对协调性的瑕疵,可以通过补正解释的方法确保司法适用的公正,在解释论无法解决的情况下,则只能通过进一步修正刑法加以完善。     

Grants and cooperative agreements to state and local governments, universities, hospitals, and other non-profit organizations--USDA. Interim final rule

This interim final rule amendment is issued to implement the Single Audit Act Amendments of 1996 (Public Law 104-156, 110 Stat. 1396) and the June 24, 1997, revision of OMB Circular A-133, "Audits of States, Local Governments, and Non-Profit Organizations" and to replace the existing audit requirements that are superseded by Public Law 104-156 and the revised A-133.     

Food labeling: safe handling statements: labeling of shell eggs. Final rule

The Food and Drug Administration (FDA) is amending its food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement "Keep Refrigerated" appears on the principal display panel (PDP) or information panel. This final rule will provide the industry greater flexibility in the placement of safe handling instructions on egg cartons, while continuing to provide consumers with this important information. This action is in response to numerous requests from the egg industry.     

Food labeling: health claims; garlic, reduction of serum cholesterol, and the risk of cardiovascular disease in adults--FDA. Interim final rule

The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a claim relating to the relationship between garlic, decreased serum cholesterol, and the risk in adults of cardiovascular disease. This interim final rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed the statement that the petitioner submitted in that notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim because the statement submitted as the basis of the claim is not an "authoritative statement" of a scientific body, as required by FDAMA; therefore, section 303 of FDAMA, does not authorize use of this claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.     

Food and Drug Administration--infant formulas; interim guidelines for nutrient composition; notice to manufacturers, packers, and distributors. Notice

The Food and Drug Administration (FDA) is announcing in this notice a statement of policy concerning interim guidelines for the nutrient composition and nutrient levels in infant formulas. The recommendations on standards for nutrient levels in infant formulas made by the Committee on Nutrition of the American Academy of Pediatrics in 1976 should be followed by infant formula manufacturers as interim guidelines until revision in the existing infant formula nutrient composition regulation (21 CFR 105,65) is completed.     

International Conference on Harmonisation; final recommendation for the revision of the permitted daily exposure for the solvent cumene according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.' The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).     

Medical use of byproduct material; proposed revision--NRC. Proposal rule

The Nuclear Regulatory Commission (NRC) is proposing a revision of its regulations governing the medical use of byproduct material. The proposed rule is one component of the Commission's overall program for revising its regulatory framework for medical use. The overall goals of this program are to focus NRC's regulations on those medical procedures that pose the highest risk to workers, patients, and the public, and to structure its regulations to be risk-informed and more performance-based, consistent with the NRC's "Strategic Plan for Fiscal Year 1997-Fiscal Year 2002". A notice in this issue of the Federal Register announcing the Commission's proposed revision of its 1979 "Medical use Policy Statement" for public comment is published elsewhere.     

《史记》整理平议

对古籍新整理本特别是公认的典范之作进行平议，将有助于进一步提高古籍整理出版的质量。中华书局校点本《史记》是人们学习和开展《史记》研究工作最常用的权威本，并被认为是古籍整理方面成绩优异的代表作之一。实际上，校点本仅正部分就新生字差错80余处，径自改移增删、脱漏校改符号等古籍整理失范之处不少，吸收学术成果不足，漏校、误校问题亦多。随着当代学术研究的深入，对《史记》有重加整理的必要。     

International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first is a guidance entitled "Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV' (the Q1F guidance). The second is a revised guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products' (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations.     

Terror and triage: prioritizing access to mass smallpox vaccination

In response to the threat of a smallpox attack on the United States, the Centers for Disease Control and Prevention ("CDC") recommended the establishment of smallpox clinics designed to distribute a vaccine to the entire U.S. population in a ten day period. However, a number of potential obstacles raise questions about the feasibility of this plan. What is needed is a plan that applies principles of triage to smallpox vaccine distribution following a bioterrorism attack. Only in this way can those most vulnerable--the previously unvaccinated--be protected from a significantly increased risk due to delays that might arise in executing the CDC plan.     

Draft guideline for the prevention of surgical site infection, 1998--CDC. Notice

This notice is a request for review of and comment on the Draft Guideline for the Prevention of Surgical Site Infection, 1998. The guideline consists of two parts: Part 1. "Surgical Site Infection, an Overview" and Part 2. "Recommendations for the Prevention of Surgical Site Infections", and was prepared by the Hospital Infection Control Practices Advisory Committee (HICPAC), the Hospital Infection Program (HIP), the National Center for Infectious Diseases (NCID), CDC.     

Revision of Department of Justice Freedom of Information Act and Privacy Act Regulations and Implementation of Electronic Freedom of Information Act Amendments of 1996--DoJ. Proposed Rule

This document sets forth proposed revision of the Department's regulations under both the Freedom of Information Act (FOIA) and the Privacy Act of 1974. The FOIA and Privacy Act regulations have been streamlined and condensed, in accordance with the principles of the National Performance Reviews. With more "user-friendly" language wherever possible. These revisions also reflect the principles established by President Clinton and Attorney General Reno in their FOIA Policy Memoranda of October 4, 1993. The new statement of discretionary disclosure policy will supercede the existing regulation regarding discretionary access to records of historical interest. Additionally, the regulations have been updated to reflect developments in the case law and to include updated cost figures to be used in calculating and charging fees. These proposed revisions also contain new provisions implementing the Electronic Freedom of Information Act Amendments of 1996.     

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a process for the evaluation and recommendation by the ICH Q4B Expert Working Group (EWG) of selected pharmacopeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favorable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry in favor of a common testing strategy in each ICH regulatory region.