Department of Health and Human Services February 5, 2008 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing
Document Number: E8-2079
Type: Notice
Date: 2008-02-05
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 public comments on the reporting and recordkeeping burden associated with the paperwork requirements under Sec. 807.31 (21 CFR 807.31), which requires device establishments to retain and, upon FDA's specific request, submit certain additional listing information.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
Document Number: E8-2078
Type: Notice
Date: 2008-02-05
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 information collection requirements for the tracking of medical devices.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Document Number: E8-2076
Type: Notice
Date: 2008-02-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program
Document Number: E8-2068
Type: Notice
Date: 2008-02-05
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.
Oral Dosage Form New Animal Drugs; Spectinomycin
Document Number: E8-2065
Type: Rule
Date: 2008-02-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to correct an error in the indications for use for spectinomycin oral solution in swine. FDA is also amending the regulations for other oral dosage forms of spectinomycin to reflect a current format. These actions are being taken to improve the accuracy and readability of the animal drug regulations.
Submission for OMB Review: Comment Request Questionnaire Cognitive Interview and Pretesting (ARP/DCCPS/NCI)
Document Number: E8-2029
Type: Notice
Date: 2008-02-05
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 26, 2007 (Vol. 72, No. 226, p. 65969) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Questionnaire Cognitive Interview and Pretesting. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of the data collection is to conduct cognitive interviews, focus groups, Pilot household interviews, and experimental research in laboratory and field settings, both for applied questionnaire evaluation and more basic research on response errors in surveys. The most common evaluation method is the cognitive interview, in which a questionnaire design specialist interviews a volunteer participant. The interviewer administers the draft survey questions as written, but also probes the participant in depth about interpretations of questions, recall processes used to answer them, and adequacy of response categories to express answers, while noting points of confusion and errors in responding. Interviews are generally conducted in small rounds of 10-15 interviews. When possible, cognitive interviews are conducted in the survey's intended mode of administration. Cognitive interviewing provides useful information on questionnaire performance at minimal cost and respondent burden. Similar methodology has been adopted by other federal agencies, as well as by academic and commercial survey organizations. There are no costs to respondents other than their time. Frequency of Response: Once. Affected Public: Individuals or households.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-1993
Type: Notice
Date: 2008-02-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 08-486
Type: Notice
Date: 2008-02-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 08-481
Type: Notice
Date: 2008-02-05
Agency: Department of Health and Human Services, National Institutes of Health
National Committee on Vital and Health Statistics: Meeting
Document Number: 08-479
Type: Notice
Date: 2008-02-05
Agency: Department of Health and Human Services
National Committee on Vital and Health Statistics: Meeting
Document Number: 08-478
Type: Notice
Date: 2008-02-05
Agency: Department of Health and Human Services
Reauthorization of the Temporary Assistance for Needy Families (TANF) Program
Document Number: 08-455
Type: Rule
Date: 2008-02-05
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This final rule implements changes to the Temporary Assistance for Needy Families (TANF) program required by the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171). The DRA reauthorized the TANF program through fiscal year (FY) 2010 with a renewed focus on work, program integrity, and strengthening families through healthy marriage promotion and responsible fatherhood. On June 29, 2006, ACF published an interim final rule implementing the required statutory changes with a 60-day comment period that ended on August 28, 2006. We have considered all comments received during this period and made necessary changes as reflected in this final rule.
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