Department of Health and Human Services November 9, 2007 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-21995
Type: Notice
Date: 2007-11-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-21994
Type: Notice
Date: 2007-11-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-21992
Type: Notice
Date: 2007-11-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-21990
Type: Notice
Date: 2007-11-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E7-21989
Type: Notice
Date: 2007-11-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Emergency Processing Under Office of Management and Budget Review; Orphan Drug Products; Common European Medicines Evaluation Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation
Document Number: E7-21988
Type: Notice
Date: 2007-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information is an amendment to OMB control number 0910-0167 and concerns the joint adoption by FDA and the European Medicines Evaluation Agency (EMEA) of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).
Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
Document Number: E7-21986
Type: Notice
Date: 2007-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.
Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability
Document Number: E7-21985
Type: Notice
Date: 2007-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.'' This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of chronic obstructive pulmonary disease (COPD). The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD.
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E7-21979
Type: Notice
Date: 2007-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
National Advisory Council on Nurse Education and Practice; Notice of Meeting
Document Number: E7-21978
Type: Notice
Date: 2007-11-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
Document Number: E7-21971
Type: Notice
Date: 2007-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the application for participation in the Medical Device Fellowship Program (MDFP).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 07-5480
Type: Notice
Date: 2007-11-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services