Department of Health and Human Services May 30, 2008 – Federal Register Recent Federal Regulation Documents

Board of Scientific Counselors, National Center for Health Marketing, (BSC, NCHM)
Document Number: E8-12125
Type: Notice
Date: 2008-05-30
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System
Document Number: E8-12120
Type: Proposed Rule
Date: 2008-05-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to reclassify the full field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce full field digital x-ray images of the breast. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document entitled ``Class II Special Controls Guidance Document: Full Field Digital Mammography System'' that would serve as the special control for the device, if FDA reclassifies this device type.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability
Document Number: E8-12119
Type: Notice
Date: 2008-05-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Full Field Digital Mammography System.'' This draft guidance document describes a means by which the full field digital mammography (FFDM) system may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the FFDM system device type from class III (premarket approval) into class II (special controls). This draft guidance is neither final nor is it in effect at this time.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area
Document Number: E8-12117
Type: Notice
Date: 2008-05-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a hospital's request for a waiver from entering into an agreement with its designated Organ Procurement Organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Availability
Document Number: E8-12116
Type: Notice
Date: 2008-05-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The draft guidance was developed as the special controls to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls). This draft guidance describes a means by which PTCA catheters, other than cutting/scoring PTCA catheters, may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify PTCA catheters, other than cutting/scoring PTCA catheters, from class III to class II. This draft guidance is not final nor is it in effect at this time.
Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters
Document Number: E8-12079
Type: Notice
Date: 2008-05-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) to class II (special controls). The Panel made this recommendation after reviewing the reclassification petition submitted by Cook Group Inc. (COOK) and other publicly available information. FDA is also announcing for public comment its tentative findings based on the Panel's recommendation and other publicly available information. After considering any public comments on the Panel's recommendation and FDA's tentative findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document that FDA intends will serve as the special control for this device type, if it is reclassified.
General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device
Document Number: E8-12078
Type: Rule
Date: 2008-05-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reclassifying the device type, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses remain in class III and continue to require premarket approval applications (PMAs). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin'' that will serve as the special control for the reclassified device type.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability
Document Number: E8-12072
Type: Notice
Date: 2008-05-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.'' This guidance document describes a means by which tissue adhesive for the topical approximation of skin may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify these device types from class III into class II (special controls).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-12070
Type: Notice
Date: 2008-05-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-12069
Type: Notice
Date: 2008-05-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: E8-12046
Type: Notice
Date: 2008-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Alternative Medicine; Notice of Closed Meetings
Document Number: E8-12044
Type: Notice
Date: 2008-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: E8-12042
Type: Notice
Date: 2008-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-11929
Type: Notice
Date: 2008-05-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-11928
Type: Notice
Date: 2008-05-30
Agency: Department of Health and Human Services, National Institutes of Health