Department of Health and Human Services April 20, 2018 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Advisory Committee on Children and Disasters Public Teleconference
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will hold a public teleconference on May 1, 2018.
National Advisory Council on Nurse Education and Practice
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) will hold a public meeting.
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question and answer (Q&A) guidance addresses questions about implementation of FDA's guidance ``Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients'' (ICH Q7). The Q&A guidance is intended to clarify uncertainties due to the interpretation of certain sections of ICH Q7 and to help ensure that all active pharmaceutical ingredients (APIs) meet the standards for quality and purity they purport or are represented to possess.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing.
Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, National Institute of Mental Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period
In a final rule published on January 19, 2017, federal departments and agencies made revisions to the Federal Policy for the Protection of Human Subjects (hereafter the ``2018 Requirements''). The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). The departments and agencies listed in this document have also published an interim final rule delaying the effective date and general compliance date for the 2018 Requirements for six months, to cover the time period of January 19, 2018 until July 19, 2018. As per the interim final rule, the effective date of the 2018 Requirements is now July 19, 2018. The departments and agencies listed in this document propose delaying the general compliance date for the 2018 Requirements for an additional six months, for the time period of July 19, 2018 until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements. This proposed rule, if finalized, would require regulated entities to continue to comply with the requirements of the current Federal Policy for the Protection of Human Subjects (hereafter the ``pre-2018 Requirements'') until January 21, 2019. This proposal also takes comment on whether to permit institutions to implement, for certain research studies, the following provisions in the 2018 Requirements during the period from July 19, 2018, until January 21, 2019, that the general compliance date is delayed. Those three provisions, intended to reduce burdens on regulated entities, are the 2018 Requirements' definition of ``research,'' which deems certain activities not to be research, the allowance for no annual continuing review of certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications related to the research. The way that this option is proposed, regulated entities would be required to comply with all pre- 2018 Requirements during the period that the general compliance date is delayed, except for provisions substituted by the three burden-reducing provisions of the 2018 Requirements. As described in section III, below, this flexibility is proposed only for studies for which an institution makes a choice to transition to comply with the 2018 Requirements, beginning on July 19, 2018. In order to clearly describe this proposed flexibility, including how it would impact institutions choosing to transition research to comply with the 2018 Requirements, this document proposes a redrafted transition provision.
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