Department of Health and Human Services July 28, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 20 of 20
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Animal Generic Drug User Fee Cover Sheet
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Animal Generic Drug User Fee Cover Sheet'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Exploring the Possibility of Proprietary Name Reservation for Drug Products; Establishment of a Public Docket
The Food and Drug Administration (FDA or Agency) is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication error. Among those goals, FDA and industry expressed an interest in exploring the possibility of ``reserving'' proprietary names for companies once the names have been tentatively accepted by the Agency. Accordingly, FDA is initiating a public process to discuss issues around reserving proprietary names.
Notice of Kidney Interagency Coordinating Committee Meeting
The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on September 12, 2014 about assessing public health interventions in chronic kidney disease (CKD). The meeting is open to the public.
Proposed Collection; 60-Day Comment Request; Progress Reports for Center for Global Health's Low and Mid-Income Countries; (LMICs) Global Health Collaborations
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Teri Brown, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W530, Rockville, MD 20850 or call non-toll-free number 240-276-5810 or Email your request, including your address to: brownte@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Progress Reports for Center for Global Health's Low and Mid-Income Countries (LMICs) Global Health Collaborations, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Global Health's (CGH) Low and Mid-Income Countries (LMICs) Global Health Collaborations is proposing new program specific progress report guidelines. The CGH LMIC Global Health Collaborations are part of a pilot initiative and partnership, between the NCI CGH and the Office of Cancer Centers (OCC), to promote collaborations between the NCI designated Cancer Centers and foreign institutions from Low and Middle Income Countries (LMICs). This collaboration is designed to develop and implement mutually beneficial global cancer research programs by increasing the capability of these countries to participate and partner in cancer research. The proposed guidelines request information about award performance related to objectives, accomplishments, barriers and challenges, collaborators, and findings. The information is gathered six months into the award and 12 months after the award (upon expiry). This information is needed to monitor the performance of this special program within NCI, funded through three Request for Proposals (RFPs); the first was released April 18, 2013 and CGH expects to release another in 2014 and the final one in 2015. The respondents are the Principal Investigators of the awards. The information will be used to monitor individual award performance and the effectiveness of the program as a whole. Since these projects are funded through the contract mechanism, the PIs will not be required to submit interim and final progress reports like other National Institutes of Health grantees must. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 83.
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].'' This guidance document describes FDA's current review practices for premarket notification (510(k)) submissions by describing in greater detail the regulatory framework, policies, and practices underlying FDA's review of traditional 510(k) submissions. This guidance document does not address the special and abbreviated 510(k) programs. FDA intends to finalize those sections separately.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Reports of Corrections and Removals
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Reports of Corrections and Removals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program; Evaluation Criteria and Standards for Beneficiary and Family Centered Care Quality Improvement Organization Contract
This notice with comment period describes the general criteria we intend to use to evaluate the effectiveness and efficiency of Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs) that will enter into contracts with CMS under the 11th Statement of Work (SOW) in May 2014 titled, ``Beneficiary and Family Centered Care (BFCC) Quality Improvement Organization (QIO) Contract'' (HHSM-500-2014-RFP-BFCC-QIO). This contract allows for a transition period from the incumbent QIOs to the successor QIOs. The activities for the BFCC-QIO SOW begin August 1, 2014. The evaluation of a BFCC-QIO's performance related to the SOW will be based on evaluation criteria specified for the tasks set forth in Attachment J-10 of the BFCC-QIOs' SOW contract.
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