Department of Health and Human Services September 14, 2012 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; Comment Request: Process Evaluation of the Early Independence Award (EIA) Program
Document Number: 2012-22741
Type: Notice
Date: 2012-09-14
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 Office of Strategic Coordination (OSC), Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), 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 June 13, 2012 (Vol. 77, No 114, Page 35408), 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 NIH 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: Process Evaluation of the Early Independence Award (EIA) Program. Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will assess the EIA program operations. The primary objectives of the study are to: (1) Assess if the Requests for Applications (RFAs) are meeting the needs of applicants; (2) document the selection process; (3) document EIA program operations; (4) assess the progress being made by the Early Independence Principal Investigators; and (5) assess the support provided by the Host Institutions to the Early Independence Principal Investigators. The findings will provide valuable information concerning: (1) Aspects of the program that could be revised or improved; (2) progress made by the Early Independence Principal Investigators; and (3) implementation of the program at Host Institutions. Frequency of Response: On occasion. Affected Public: None. Type of Respondents: Applicants, reviewers, and awardees. The annual reporting burden is as follows: Estimated Number of Respondents: 390; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .4; and Estimated Total Annual Burden Hours Requested: 158. The annualized cost to respondents is estimated at $9,774. There are no Capital Costs to report.
Submission for OMB Review; Comment Request: A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI)
Document Number: 2012-22740
Type: Notice
Date: 2012-09-14
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 February 24, 2012 (77 FR 11136) and allowed 60 days for public comment. There was one public comment that was not relevant to the scope, methodology, or burden of the study. The program staff submitted a response to the public comment. 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: A Multi-Center International Hospital- Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) (OMB No. 0925-0654). Type of Information Collection Request: Extension. Need and Use of Information Collection: Incidence rates of certain lymphomas have increased in the United States and in many other parts of the world. The contribution of environmental, occupational, and genetic factors to the cause of lymphoma has generated a series of new findings from epidemiological studies conducted in the United States that have attempted to explain this increase. This study focuses on collecting critically needed information to understand and reduce the cancer burden from lymphoid malignancies in the Asian population, the incidence of which has risen in recent decades. Specifically, environmental exposures to industrial emissions, genetic susceptibility, viral exposures, early life exposures, ultraviolet (UV) radiation exposures, and other risk factors for lymphoma overall and specifically for populations in Asia will be examined. Patients from 19 participating hospitals will continue to be screened and enrolled. There will be a one-time computer-administered interview, and patients will also be asked to provide a one-time blood and buccal cell mouth wash sample and lymphoma cases will be asked to make available a portion of their pathology sample. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Newly diagnosed patients with lymphoma or patients undergoing surgery or other treatment for non-cancer related medical issues who live in Taiwan and in Hong Kong, Chengdu and Tianjin, China will be enrolled at treating hospitals. The annual reporting burden is estimated at 5,302 hours (see Table below). There are $77,000 in Capital Costs, Operating Costs, and/ or Maintenance Costs to report.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2012-22707
Type: Notice
Date: 2012-09-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
Document Number: 2012-22660
Type: Notice
Date: 2012-09-14
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 collections of information associated with Clinical Laboratory Improvement Amendments of 1988 waiver applications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal
Document Number: 2012-22659
Type: Notice
Date: 2012-09-14
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 use of the FDA Electronic Submission Gateway (ESG) and the Safety Reporting Portal (the SRP) to collect adverse event reports and other safety information for FDA-regulated products.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
Document Number: 2012-22658
Type: Notice
Date: 2012-09-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Meeting of the Community Preventive Services Task Force (Task Force)
Document Number: 2012-22654
Type: Notice
Date: 2012-09-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is independent and nonfederal. Its members are nationally known leaders in public health practice, policy, and research, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting, the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast
Document Number: 2012-22653
Type: Notice
Date: 2012-09-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the notice of a public webcast concerning compliance with the Federal Select Agent Program. The purpose of this notice is to notify all interested parties, including individuals and entities possessing, using, or transferring biological agents and toxins listed in 7 CFR 331.3, 9 CFR 121.3 and 121.4, or 42 CFR 73.3 and 73.4, of the webcast. The webcast is organized by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA/APHIS), the Department of Health and Human Services Centers for Disease Control and Prevention (HHS/CDC), and the Department of Justice's Federal Bureau of Investigation (FBI). Issues to be discussed include changes to the select agent regulations; occupational health, information and physical security; personnel suitability; Bioterrorism Security Risk Assessment Form (FD-961 form); and changes to the Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1).
New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin
Document Number: 2012-22646
Type: Rule
Date: 2012-09-14
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 a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
National Institute on Aging; Notice of Closed Meetings
Document Number: 2012-22617
Type: Notice
Date: 2012-09-14
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2012-22616
Type: Notice
Date: 2012-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2012-22615
Type: Notice
Date: 2012-09-14
Agency: Department of Health and Human Services, National Institutes of Health
Secretarial Review and Publication of the Annual Report to Congress Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement
Document Number: 2012-22379
Type: Notice
Date: 2012-09-14
Agency: Department of Health and Human Services
This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the annual report submitted to the Secretary and Congress by the contracted consensus-based entity as mandated by section 1890(b)(5) of the Social Security Act, as added by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and section 3014 of the Affordable Care Act of 2010. The statute requires the Secretary to publish the report in the Federal Register together with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills those requirements. FOR FURTHER INFORMATION CONTACT: Stephanie Mika (202) 260-6366.