Department of Health and Human Services June 2008 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 304
National Institute on Aging; Amended Notice of Meeting
Document Number: E8-13240
Type: Notice
Date: 2008-06-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-13239
Type: Notice
Date: 2008-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-13238
Type: Notice
Date: 2008-06-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
Document Number: E8-13522
Type: Notice
Date: 2008-06-16
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 review and clearance under the Paperwork Reduction Act of 1995.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-13485
Type: Notice
Date: 2008-06-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Recruitment of Sites for Assignment of Corps Personnel
Document Number: E8-13454
Type: Notice
Date: 2008-06-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) personnel (Corps Personnel, Corps members) for the period July 1, 2008, through June 30, 2009, is posted on the NHSC Web site at http://nhsc.bhpr.hrsa.gov/jobs/ index.asp. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option.
Proposed Collection; Comment Request; National Institutes of Health Construction Grants-42 CFR Part 52b (Final Rule)
Document Number: E8-13388
Type: Notice
Date: 2008-06-16
Agency: Department of Health and Human Services, National Institutes of Health
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 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. Proposed Collection: Title: National Institutes of Health Construction Grants42 CFR Part 52b (Final Rule). Type of Information Collection Request: EXTENSION of No. 0925-0424, expiration date 8/31/ 2008. Need and Use of the Information Collection: This request is for OMB review and approval of an extension for the information collection and recordkeeping requirements contained in the regulation codified at 42 CFR Part 52b. The purpose of the regulation is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the buildings (or applicable part of the buildings) suitable for the purpose for which it was constructed. In terms of reporting requirements: Section 52b.9(b) of the regulation requires the transferor of a facility which is sold or transferred, or owner of a facility, the use of which has changed, to provide written notice of the sale, transfer or change within 30 days. Section 52b.10(f) requires a grantee to submit an approved copy of the construction schedule prior to the start of construction. Section 52b.10(g) requires a grantee to provide daily construction logs and monthly status reports upon request at the job site. Section 52b.11(b) requires applicants for a project involving the acquisition of existing facilities to provide the estimated cost of the project, cost of the acquisition of existing facilities, and cost of remodeling, renovating, or altering facilities to serve the purposes for which they are acquired. In terms of recordkeeping requirements: Section 52b.10(g) requires grantees to maintain daily construction logs and monthly status reports at the job site. Frequency of Response: On occasion. Affected Public: Non-profit organizations and Federal agencies. Type of respondents: Grantees. The estimated respondent burden is as follows:
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-13168
Type: Notice
Date: 2008-06-16
Agency: Department of Health and Human Services, National Institutes of Health
Oral Dosage Form New Animal Drugs; Ivermectin, Fenbendazole, and Praziquantel Tablets
Document Number: E8-13354
Type: Rule
Date: 2008-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of chewable tablets containing ivermectin, fenbendazole, and praziquantel for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs.
Oral Dosage Form New Animal Drugs; Deracoxib
Document Number: E8-13353
Type: Rule
Date: 2008-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 50-milligram size deracoxib tablet which is used for the control of pain and inflammation in dogs.
Medical Devices; Medical Device Reporting; Baseline Reports
Document Number: E8-13350
Type: Rule
Date: 2008-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden. FDA is amending the regulation in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.
Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule
Document Number: E8-13349
Type: Proposed Rule
Date: 2008-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is proposing to remove the requirement for baseline reports. The removal of this requirement would eliminate unnecessary duplication and reduce the manufacturer's reporting burden. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry: Notice of Charter Renewal
Document Number: E8-13318
Type: Notice
Date: 2008-06-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-13317
Type: Notice
Date: 2008-06-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-13169
Type: Notice
Date: 2008-06-13
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meeting
Document Number: E8-13167
Type: Notice
Date: 2008-06-13
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Public Meeting in Calendar Year 2008 for New Clinical Laboratory Tests Payment Determinations
Document Number: E8-13097
Type: Notice
Date: 2008-06-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2009, which will be effective on January 1, 2009. The meeting will address technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the CMS meeting.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-13095
Type: Notice
Date: 2008-06-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Pediatric Medical Device Stakeholders Workshop
Document Number: E8-13278
Type: Notice
Date: 2008-06-12
Agency: Department of Health and Human Services
The Interagency (AHRQ-FDA-NIH) Pediatric Devices Working Group is holding a workshop to gather information about the development of pediatric devices.
Hospira, Inc., et al.; Withdrawal of Approval of One New Drug Application and Two Abbreviated New Drug Applications
Document Number: E8-13273
Type: Notice
Date: 2008-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of one new drug application (NDA) and two abbreviated new drug applications (ANDAs) for edetate disodium injection. The holders of these applications have agreed in writing to permit FDA to withdraw approval of the applications and have waived their opportunity for a hearing.
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Individual Case Safety Reports; Availability
Document Number: E8-13269
Type: Notice
Date: 2008-06-12
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 ``Providing Regulatory Submissions in Electronic FormatPostmarketing Individual Case Safety Reports.'' This draft guidance consolidates and revises information in two existing draft guidances pertaining to electronic submission of postmarketing individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments). The submission of ICSRs and ICSR attachments in an electronic format significantly improves the agency's efficiency in processing, archiving, and reviewing the reports.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-13194
Type: Notice
Date: 2008-06-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-13189
Type: Notice
Date: 2008-06-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-13181
Type: Notice
Date: 2008-06-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E8-13150
Type: Notice
Date: 2008-06-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E8-13149
Type: Notice
Date: 2008-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: E8-13089
Type: Notice
Date: 2008-06-12
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: E8-13021
Type: Notice
Date: 2008-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-13020
Type: Notice
Date: 2008-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-13017
Type: Notice
Date: 2008-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices; Availability
Document Number: 08-1350
Type: Notice
Date: 2008-06-12
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 ``Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This draft guidance informs industry of how FDA intends to comply with the FDAAA requirement. Specifically, the draft guidance describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use. This draft guidance also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing (AST) devices.
Salt and Sodium; Petition to Revise the Regulatory Status of Salt and Establish Food Labeling Requirements Regarding Salt and Sodium; Public Hearing; Reopening of the Comment Period
Document Number: E8-13122
Type: Proposed Rule
Date: 2008-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening until August 11, 2008, the comment period for the notice of public hearing, published in the Federal Register of October 23, 2007 (72 FR 59973), requesting comments regarding FDA's current framework of policies regarding salt and sodium and potential future approaches, including approaches described in a citizen petition. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. FDA is also reopening the comment period to update comments and to receive any new information.
Task Force on Community Preventive Services
Document Number: E8-13114
Type: Notice
Date: 2008-06-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; ROTATEQ
Document Number: E8-13109
Type: Notice
Date: 2008-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ROTATEQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.