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

Results 251 - 300 of 347
Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide; Availability
Document Number: 2013-05470
Type: Notice
Date: 2013-03-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide'' (SECG) which updates an earlier guidance of similar title. Previously, this guidance restated the legal requirements of FDA's administrative detention regulation. This document also at one time served as FDA's guidance for administrative detention. In October 2011, FDA revised an earlier version of this guidance document to be consistent with the changes made by an interim final rule (IFR) issued in the Federal Register of May 5, 2011, and to serve as guidance for industry on administrative detention. FDA has since issued a final rule adopting the IFR as final without changes which was published in the Federal Register of February 5, 2013. Accordingly, FDA is further revising the existing guidance document to provide guidance intended to help any entity comply with the requirements in FDA's administrative detention regulation, including the amendments to these requirements made by the final rule. This notice also clarifies that this document continues to serve as FDA's guidance for administrative detention.
Office of Health Assessment and Translation Webinar on the Assessment of Data Quality in Animal Studies; Notice of Public Webinar and Registration Information
Document Number: 2013-05406
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces a public, web- based meeting on the assessment of data quality in animal studies. The Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS) will host the web-based meeting using Adobe[supreg] Connect TM and the public can register to attend.
Report on Carcinogens Webinar on Pentachlorophenol; Notice of Public Webinar and Registration Information
Document Number: 2013-05405
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces a public webinar, ``Human cancer studies on exposure to pentachlorophenol (PCP): Differentiating potential cancer effects of PCP exposure from effects due to occupational co-exposures or PCP contaminants.'' The Office of the Report on Carcinogens (ORoC), Division of the NTP (DNTP), National Institute of Environmental Health Sciences (NIEHS) will hold the webinar using Adobe[supreg] ConnectTM, and the public can register to attend.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Initial Review
Document Number: 2013-05393
Type: Notice
Date: 2013-03-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-05389
Type: Notice
Date: 2013-03-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-05388
Type: Notice
Date: 2013-03-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2013-05378
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, Administration for Children and Families
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-05370
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2013-05369
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2013-05368
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-05367
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-05366
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-05365
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-05364
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-05350
Type: Notice
Date: 2013-03-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Veterinary Oversight of Antimicrobial Use in Livestock: Impact on Stakeholders; Public Meetings; Request for Comments
Document Number: 2013-05339
Type: Notice
Date: 2013-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing plans for five meetings to provide an opportunity for public dialogue and feedback on challenges faced by the animal agriculture industry and practicing veterinarians as FDA implements its initiative for the judicious use of medically important antimicrobials in medicated feed or drinking water of food-producing animals. Particular emphasis will be placed on challenges faced by animal producers in areas that may lack access to adequate veterinary services. The meetings are jointly sponsored by FDA and the U.S. Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS).
Submission for OMB Review; Comment Request
Document Number: 2013-05331
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services, Administration for Children and Families
Health Resources and Services Administration
Document Number: 2013-05304
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services
HRSA published a document in the Federal Register of January 7, 2013 (FR Doc. 2013-00032), regarding organizational changes that update the functional statements for the Office of Management. The administrative code for the Division of Information Technology (IT) Security and Records Management was incorrectly written as RBR at four occasions, on pages 956 and 957.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-05303
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-05302
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA specifically requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Findings of Research Misconduct
Document Number: 2013-05301
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Adam C. Savine, Washington University in St. Louis: Based on the report from Washington University in St. Louis (WUSTL) and Respondent's admission, ORI found that Mr. Adam C. Savine, former doctoral student, Department of Psychology, WUSTL, engaged in research misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant R56 MH066078, National Institute on Drug Abuse (NIDA), NIH, grants F31 DA032152 and R21 DA027821, and National Institute on Aging (NIA), NIH, grant T32 AG00030. ORI found that the Respondent engaged in research misconduct by falsifying data that were included in the following three publications and six conference abstracts:
Advancing Interoperability and Health Information Exchange
Document Number: 2013-05266
Type: Notice
Date: 2013-03-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
HHS seeks input on a series of potential policy and programmatic changes to accelerate electronic health information exchange across providers, as well as new ideas that would be both effective and feasible to implement. To further accelerate and advance interoperability and health information exchange beyond what is currently being done through ONC programs and the EHR Incentive Program, HHS is considering a number of policy levers using existing authorities and programs.
Medicare Program; Extension of the Payment Adjustment for Low-volume Hospitals and the Medicare-dependent Hospital (MDH) Program Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Year 2013
Document Number: 2013-05263
Type: Rule
Date: 2013-03-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital (MDH) program under the hospital inpatient prospective payment systems (IPPS) for FY 2013 in accordance with sections 605 and 606, respectively, of the American Taxpayer Relief Act of 2012.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2013-05240
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-05239
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation of Nominations to the Presidential Advisory Council on HIV/AIDS
Document Number: 2013-05218
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of the Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four-year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention of HIV disease and AIDS. The functions of the Council are solely advisory in nature.
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
Document Number: 2013-05212
Type: Notice
Date: 2013-03-07
Agency: Department of Health and Human Services
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: http:// www.surgeongeneral.gov/initiatives/prevention/advisorygrp/ind ex.html
New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N
Document Number: 2013-04999
Type: Rule
Date: 2013-03-07
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 the withdrawal approval of 19 new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA). The applications are being withdrawn for lack of compliance with the reporting requirements in an FDA regulation.
Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications
Document Number: 2013-04998
Type: Notice
Date: 2013-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 19 new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.
Food and Color Additives; Technical Amendments
Document Number: 2013-04701
Type: Rule
Date: 2013-03-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending certain regulations regarding food and color additives to correct minor errors (such as misspelled chemical names) and to update office names and addresses. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
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