Protection of human subjects; informed consent--FDA. Final rule

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.     

Protection of human research subjects. Department of Health and Human Services (DHHS). Final rule

The Department of Health and Human Services (DHHS) is amending its human subjects protection regulations. These regulations provide additional protections for pregnant women and human fetuses involved in research and pertains to human in vitro fertilization. The rule continues the special protections for pregnant women and human fetuses that have existed since 1975. The rule enhances the opportunity for participation of pregnant women in research by promoting a policy of presumed inclusion, by permitting the pregnant woman to be the sole decision maker with regard to her participation in research, and by exempting from the regulations six categories of research. The rule also provides a mechanism for the Secretary of HHS to conduct or fund research not otherwise approvable after consultation with an expert panel and public review and comment.     

Federal policy for the protection of human subjects. Final rule

This document sets forth a common Federal Policy for the Protection of Human Subjects (Model Policy) accepted by the Office of Science and Technology Policy and promulgated in regulation by each of the listed Departments and Agencies. A Proposed Federal Policy for the Protection of Human Subjects published November 10, 1988 (53 FR 45661) has been revised in response to public comments. The Policy as revised is now set forth as a common final rule. For related documents, see other sections of this Federal Register part.     

Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on institutional review boards (IRB's) and on informed consent to conform them to the "Federal Policy for the Protection of Human Research Subjects" (Federal Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing the protection of human subjects share a common core with the Federal Policy and implement the fundamental principles embodied in that policy.     

Protection of human subjects; prisoners used as subjects in research; stay of effective date--Food and Drug Administration. Final rule; stay of effective date

The Food and Drug Administration (FDA) is staying the effective date of its regulations establishing conditions under which biomedical research o prisoners will be accepted in satisfaction of FDA's regulatory requirements. All provisions of Subpart C of Part 50 of the final regulations are stayed pending reproposal of the subpart, including 50.44 (21 CFR 50.44). The stay will remain in effect until final action taken on the reproposal in effective.     

Health and Human Services policy for protection of human subjects research--HHS. Final rule

The Department of Health and Human Services (HHS) is amending its Human Subjects Protection regulations to rescind the provision requiring prior review and advice from an Ethical Advisory Board for research applications and proposals involving in vitro fertilization (IVF) of human ova as a prerequisite to funding by HHS and its components. The provision was nullified by the National Institutes of Health Revitalization Act of 1993. The regulations are being amended to reflect this statutory nullification. Institutional Review Board (IRB) review and approval of applications and proposals involving in vitro fertilization (IVF) of human ova continues to be required in accordance with other provisions of the Human Subjects Protection regulations. Furthermore, the Secretary may still exercise the option of seeking advice from an Ethical Advisory Board on ethical issues, including IVF, raised by research applications and proposals.     

Two kinds of rule regulating human subjects research

Alan Wertheimer argues that before we promulgate some rule regarding the conduct of research on human subjects we ethically ought to consider the consequences of the rule being followed. This ethical requirement has an exception, though, Wertheimer maintains: it doesn''t apply to rules that are not motivated by considerations of outcome. I agree that there is an exception to be made to Wertheimer''s proposed ethical requirement, but not Wertheimer''s exception. The important distinction is not that between rules motivated by considerations of outcome and rules motivated otherwise, but between rules designed to enforce ethics and rules not so designed. Before we promulgate the latter kind of rule, we are ethically required to consider the consequences of doing so. This is not so for the former kind of rule. My exception, unlike Wertheimer''s, yields the conclusion that we should promulgate, regardless of the consequences of doing so, a rule requiring that the potential benefit to the subject of participation in a study outweigh the risks. This rule is motivated by considerations of outcome, so it would land on the wrong side of Wertheimer''s divide. But it''s also designed to enforce ethics, so it lands on the correct side of my divide.     

Anorectal drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing that any over-the-counter (OTC) drug product containing a combination of hydrocortisone and pramoxine hydrochloride (HCl) for anorectal use is not generally recognized as safe and effective and is misbranded. This combination product is not currently marketed OTC. This final rule discusses data on the combination of hydrocortisone and pramoxine HCl that were still under review when an earlier final rule on OTC anorectal drug products was issued. This rule is part of FDA's ongoing review of OTC drug products.     

Hazardous waste management; Environmental Protection Agency. Final rule

The Resource Conservation and Recovery Act, as amended, provides for the development and implementation of a comprehensive program to protect human health and the environment from the improper management of hazardous waste. A fundamental premise of the statute is that human health and the environment will best be protected by careful management of the transportation, treatment, storage, and disposal of hazardous waste, in accordance with standards developed under the Act. In today's Federal Register, the Environmental Protection Agency is publishing several documents setting in motion a series of events which will culminate in full implementation of the hazardous waste control program. This document sets forth definitions of words and phrases which appear in the subsequent Parts as well as general guidance for the use of these regulations and provisions which are generally applicable to all Parts.     

Tamper-evident packaging requirements for over-the-counter human drug products--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on tamper-resistant packaging to require that all over-the-counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed using a tamper-evident technology; to change the term "tamper-resistant" in the labeling of all OTC drug products to "tamper-evident;" and to specify that the required OTC drug product labeling statement must refer to all packaging features used to comply with the tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure, and any capsule sealing technologies used. FDA is taking this action as a result of its continuing review of the potential public health threat posed by product tampering and to improve consumer protection by addressing specific vulnerabilities in the OTC drug market.     

Public Health Service policies on research misconduct. Final rule

This final rule removes 42 CFR part 50, subpart A, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science," and replaces it with a new, more comprehensive part 93, "Public Health Service Policies on Research Misconduct." The proposed part 93 was published for public comment on April 16, 2004. The final rule reflects both substantive and non-substantive amendments in response to public comments and to correct errors and improve clarity, but the general approach of the NPRM is retained. The purpose of the final rule is to implement legislative and policy changes applicable to research misconduct that occurred over the last several years, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy on December 6, 2000.     

Labeling of diphenhydramine-containing drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing a final rule amending the final monographs for over-the-counter (OTC) antiemetic, antihistamine, antitussive, and nighttime sleep-aid drug products to add a warning statement for oral products containing diphenhydramine citrate or diphenhydramine hydrochloride. The warning advises consumers not to use oral OTC diphenhydramine products with any other product containing diphenhydramine, including products used topically. This final rule also includes the agency's conclusions on additional warning statements and a direction statement for OTC external analgesic drug products containing diphenhydramine hydrochloride. These conclusions will be incorporated into the final monograph for OTC external analgesic drug products in a future issue of the Federal Register. FDA is issuing this final rule after considering public comments on the agency's proposed regulation and all new data and information on drug products containing diphenhydramine that have come to the agency's attention     

Ingrown toenail relief drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing conditions under which over-the-counter (OTC) ingrown toenail relief drug products containing sodium sulfide 1 percent in a gel vehicle are generally recognized as safe and effective and not misbranded. This rule also amends the regulation that lists nonmonograph active ingredients in OTC drug products for ingrown toenail relief by removing sodium sulfide from that list. This final rule is part of FDA's ongoing review of OTC drug products.