Bar code label requirement for human drug products and biological products. Final rule

The Food and Drug Administration (FDA) is issuing a new rule to require certain human drug and biological product labels to have bar codes. The bar code for human drug products and biological products (other than blood, blood components, and devices regulated by the Center for Biologics Evaluation and Research) must contain the National Drug Code (NDC) number in a linear bar code. The rule will help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. The rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors.     

Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim final rule to except human dura mater and human heart valve allografts, currently subject to application or notification requirements under the Federal Food, Drug, and Cosmetic Act (the act), from the scope of the definition of "human cells, tissues, or cellular or tissue-based products (HCT/P's)" subject to the registration and listing requirements contained in 21 CFR part 1271. That definition became effective on January 21, 2004. FDA is taking this action to assure that these products, which are currently subject to the act and therefore regulated under the current good manufacturing practice regulations set out in the quality system regulations in 21 CFR part 820 are not released from the scope of those regulations before a more comprehensive regulatory framework applicable to HCT/P's, including donor suitability requirements, good tissue practice regulations, and appropriate enforcement provisions, is fully in place. When that comprehensive framework is in place, FDA intends that human dura mater and human heart valves will be subject to it. FDA intends to revoke this interim final rule at that time.     

Battered women's perceptions of risk versus risk factors and instruments in predicting repeat reassault

This study partially replicates and expands on a previous study that showed women's perceptions of risk to be a strong predictor of reassault among batterers. The current study employed a larger and multisite sample, a longer follow-up period of 15 months, and multiple outcomes including "repeated reassault" (n = 499). According to the multinomial logistic regressions, women's perceptions of risk improved prediction with risk factors (ROC area under the curve improved by.04 and sensitivity of repeated reassault increased 12 percentage points). In comparison to simulated risk instruments, women's perceptions by themselves were better predictors than the K-SID, similar in predictive ability to the SARA, and almost as strong as the DAS. The best prediction of repeated reassault was obtained using risk markers, including women's perceptions (ROC AUC =.83; 70% sensitivity) or by using the DAS and women's perceptions together (ROC AUC =.73; 64% sensitivity).     

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Participation in a national,means‐tested school voucher program

We use data from a sample of applicants to a national means‐tested school voucher program and a national sample of the population eligible for the program to evaluate the factors leading families to use school vouchers. Our analysis divides the process of voucher usage into two distinct stages: initial application and subsequent take‐up. Using a nested logit model, we find that some factors, like religious affiliation and religious service attendance, affect both stages. Others, like mother's education, affect only one (application). Still others, like ethnicity, have opposite effects at the two stages. Compared to Whites, minorities are more likely to apply for vouchers, but less likely to take them when given the opportunity. © 2005 by the Association for Public Policy Analysis and Management     

Cognitive and Normative Determinants of State Policymaking Behavior: Lessons from the Sociological Institutionalism

Although comparative state policy frameworks consider the roleof societal norms, few account for cognitive and normative imperativesthat originate outside a state's boundaries and are specificto promoting or impeding the adoption of particular policies.One approach that does so is the new institutionalism in sociology,which emphasizes legitimacy-seeking actors who face pressuresto conform to cultural rules, norms, and expectations, regardlessof outcomes. This article introduces comparative state policyresearchers to the sociological institutionalism, emphasizingbasic concepts and arguments and suggesting how reliance onthis framework can enable researchers to better integrate rational-actorand cultural-based views for understanding why states chooseparticular public policies. Interviews with national and stateexperts in Medicaid nursing-facility reimbursement illustratethe utility of the sociological institutionalism for comparativestate policy research.     

PUBLIC OPINION REACTION TO REPEATED EVENTS: Citizen Response to Multiple Supreme Court Abortion Decisions

While numerous works explores how single events or political actions affect public opinion, almost no research explores how this effect evolves with repeated actions. The Conditional Response Model holds that while elite actors can influence and polarize the public when they first act on an issue, subsequent action will not have this same effect. We challenge this model based on its depiction of psychological models of attitude formation and change. Instead of focusing on the number of times an actor has addressed an issue, we argue that the state of public opinion is the key to determining how the public will react to multiple elite actions over a long timeframe. We examine how the public reacted to multiple Supreme Court decisions on abortion. Our results suggest that the Conditional Response Model does a poor job of depicting public opinion and that actors are not limited in their influence by the number of previous actions on an issue.     

Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) ophthalmic drug products are generally recognized as safe and effective and not misbranded. This amendment clarifies the active ingredient in OTC eyewash drug products and the labeling of the active ingredient and its purpose. This final rule is part of FDA's ongoing review of OTC drug products.     

International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3A(R) Impurities in New Drug Substances." The revised guidance, which updates a guidance on the same topic published in the Federal Register of January 4, 1996 (the 1996 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance clarifies the 1996 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a country, region, or member State.