Department of Health and Human Services August 23, 2011 – Federal Register Recent Federal Regulation Documents
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2011 Technology Transfer Summit North America Conference
The NIH Office of Technology Transfer extends invitations to attend the 2011 Technology Transfer Summit North America Conference.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice of availability that appeared in the Federal Register of August 4, 2011 (76 FR 47211). The Agency is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. The August 4, 2011, notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. The document was published with an error. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Nutrition Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E2F Development Safety Update Report.'' 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 the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR will serve as a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The DSUR can be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.
Request for Information: Announcement of Carcinogen and Recommended Exposure Limit (REL) Policy Assessment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. As part of this effort, NIOSH is requesting initial input on these issues (including answers to the 5 questions in the following section), to be submitted to the NIOSH Docket number 240, for a comment period lasting through September 22, 2011. This information will be taken under consideration and used to inform NIOSH efforts to assess and document its carcinogen policy and REL policy regarding occupational hazards associated with cancer. NIOSH has also created a new NIOSH Cancer and REL Policy Web Topic Page [see https://www.cdc.gov/niosh/topics/cancer/policy.html] to provide additional details about this effort and progress updates. Public Comment Period: Comments must be received by September 22, 2011.
Notice of Intent To Award Affordable Care Act Funding, DP-09-001
This notice provides public announcement of CDC's intent to fund Approved cooperative agreement applications previously received and competed in response to CDC Funding Opportunity, RFA-DP-09-001, ``Health Promotion and Disease Prevention Research Centers (U48).'' It is the intent of CDC to fund the applications with Patient Protection Affordable Care Act (ACA), Section 4002, appropriations. CFDA Number 93.542 is the ACA-specific CFDA number for this initiative.
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