Department of Health and Human Services March 6, 2013 – Federal Register Recent Federal Regulation Documents

Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-05236
Type: Notice
Date: 2013-03-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-05233
Type: Notice
Date: 2013-03-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-05176
Type: Notice
Date: 2013-03-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Submission for OMB Review; 30-Day Comment Request: A Generic Submission for Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Document Number: 2013-05164
Type: Notice
Date: 2013-03-06
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 Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 2, 2013 (Volume 78, Page 105) and allowed 60-days for public comment. Two public comments were received and responded to. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2013-05163
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on March 28, 2013, focusing on ``Federal Initiatives to Address Gestational Diabetes Mellitus.'' The meeting is open to the public.
Cheng Yi Liang: Debarment Order
Document Number: 2013-05160
Type: Notice
Date: 2013-03-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Cheng Yi Liang, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Mr. Liang was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for the development or approval, of a drug product. Mr. Liang was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Liang failed to respond. Mr. Liang's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-05158
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is to reinstate the use of the previously approved information collection assigned OMB control number 4040-0003, which expired on 11/30/2011. The 4040-0003 previously included the Project Abstract and Key Contacts Form. Those forms are no longer included in 4040-0003 and shall be moved to OMB control number 4040-0010. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-05156
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is to reinstate the use of the previously approved information collection assigned OMB control number 4040-0004, which expired on 03/31/2012. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-05155
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is to reinstate the use of the previously approved information collection assigned OMB control number 4040-0010, which expired on 08/31/2011. The 4040-0010 includes the following forms: SF-424 Project Abstract form, SF-424 Key Contacts form, and SF-424 Performance/Site Location form. The SF-424 Project Abstract form and the SF-424 Key Contacts form were previously assigned to OMB control number 4040-0003. EGOV seeks to move these two instruments to the OMB control number 4040-0010. The ICR also requests categorizing the forms as common forms, meaning HHS will only request approval for its own use of the forms rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-05148
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, Administration for Children and Families
Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability
Document Number: 2013-05125
Type: Notice
Date: 2013-03-06
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 ``Investigational Device Exemption (IDE) Guidance for Retinal Prostheses.'' This guidance document describes FDA's recommendations for clinical investigations of medical devices indicated for the treatment of visual impairments resulting from retinal diseases.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-05111
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-05110
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-05109
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-05108
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-05107
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-05105
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-05104
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-05103
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2013-05102
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-05101
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2013-05100
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-05098
Type: Notice
Date: 2013-03-06
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration