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

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Document Number: 2014-29649
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
As authorized by the 2014 Omnibus Act, ACF is requesting public comment on a voluntary set of minimum health and safety standards for early care and education settings titled, ``Caring for Our Children Basics.''
Document Number: 2014-29647
Type: Proposed Rule
Date: 2014-12-18
Agency: Department of Health and Human Services
On October 20, 2014, the Administrator of the World Trade Center (WTC) Health Program received a petition to add primary biliary cirrhosis (Petition 006) to the List of WTC-Related Health Conditions (List). The Administrator has not found sufficient scientific evidence to conduct an analysis of whether to add primary biliary cirrhosis to the List. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Document Number: 2014-29641
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-29627
Type: Notice
Date: 2014-12-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29612
Type: Notice
Date: 2014-12-18
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.
Document Number: 2014-29611
Type: Notice
Date: 2014-12-18
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.
Document Number: 2014-29609
Type: Notice
Date: 2014-12-18
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 ``Providing Regulatory Submissions in Electronic FormatSubmissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.'' The guidance announced in this notice sets forth FDA's interpretation of the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act be submitted in electronic format, beginning no earlier than 24 months after issuance of a final version of a guidance document specifying the format for such electronic submissions. This guidance describes how FDA interprets and plans to implement the electronic submission requirements and finalizes the draft guidance that was issued on February 6, 2014.
Document Number: 2014-29608
Type: Notice
Date: 2014-12-18
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 ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data.'' The guidance announced in this document is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). This finalizes the revised draft guidance that was issued on February 6, 2014.
Document Number: 2014-29607
Type: Notice
Date: 2014-12-18
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.
Document Number: 2014-29573
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-29572
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: E-032-2011/0, Blaney et al., ``Multivalent Vaccines for Rabies Virus and Filoviruses'', U.S. Patent Application Number 61/439,046, filed on February 3, 2011, PCT Application Number PCT/US2012/23575, filed on February 2, 2012, U.S. Patent Application Number 13/983,545, filed on August 2, 2013, European Patent Application Number 12702953.6, filed on February 2, 2012, and Canadian Patent Application Number 2826594, filed on February 2, 2012, to Exxell BIO, Inc., having a place of business in Shoreview, Minnesota, United States of America. The patent rights in these inventions have been assigned to the United States of America and Thomas Jefferson University.
Document Number: 2014-29571
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-29570
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-29522
Type: Proposed Rule
Date: 2014-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.
Document Number: 2014-29576
Type: Notice
Date: 2014-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2014-29520
Type: Notice
Date: 2014-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Document Number: 2014-29505
Type: Notice
Date: 2014-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Document Number: 2014-29504
Type: Notice
Date: 2014-12-17
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 the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Document Number: 2014-29503
Type: Notice
Date: 2014-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29489
Type: Notice
Date: 2014-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29488
Type: Notice
Date: 2014-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29487
Type: Notice
Date: 2014-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29478
Type: Notice
Date: 2014-12-17
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey entitled ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015-2025).''
Document Number: 2014-29460
Type: Notice
Date: 2014-12-16
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 August 21, 2014, page 49523 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to request an additional 30 days for public comment and reinstatement without change. The Center for Scientific Review (CSR), 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 31, 2014, 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.
Document Number: 2014-29439
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-29426
Type: Notice
Date: 2014-12-16
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.
Document Number: 2014-29425
Type: Notice
Date: 2014-12-16
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.
Document Number: 2014-29424
Type: Notice
Date: 2014-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 8, 2014. The document misstated the effective date of the new system of records. This notice corrects that error.
Document Number: 2014-29423
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-29421
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-29417
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services
Document Number: 2014-29322
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-29321
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-29320
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-29319
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Document Number: 2014-29314
Type: Notice
Date: 2014-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for FDA staff entitled ``Compliance Policy Guide CrabmeatFresh and FrozenAdulteration with Filth, Involving the Presence of Escherichia coli.'' The draft Compliance Policy Guide (CPG), when finalized, will update the previously issued ``CPG CrabmeatFresh and FrozenAdulteration with Filth, Involving the Presence of the Organism Escherichia coli.'' This revised draft provides guidance for FDA staff on the level of Escherichia coli (E. coli) in crabmeat at which we may consider the crabmeat to be adulterated with filth.
Document Number: 2014-29291
Type: Notice
Date: 2014-12-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29337
Type: Notice
Date: 2014-12-15
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: James P. Warne, Ph.D., University of California San Francisco: Based on an assessment conducted by the University of California San Francisco (UCSF), the Respondent's admission, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. James P. Warne, former Senior Scientist, Diabetes Center, UCSF School of Medicine, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants DK080427, DK007161, and DK063720. ORI found that Respondent engaged in research misconduct by falsifying data that were included in the following two (2) publications and two (2) grant applications:
Document Number: 2014-29323
Type: Notice
Date: 2014-12-15
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services (HHS)(Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.
Document Number: 2014-29295
Type: Notice
Date: 2014-12-15
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: H. Rosie Xing, Ph.D., University of Chicago: Based on the report of an investigation conducted by the University of Chicago (UC) and additional analysis by ORI in its oversight review, ORI found that Dr. H. Rosie Xing, former Assistant Professor, UC, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA098022. ORI found that Respondent engaged in research misconduct (42 CFR 93.103-104) by using images that had been among a set of manipulated images produced while at another institution, which had been found to be false by that institution. ORI found that Respondent falsely reported these images in Figures 1D, 2A, and Supplementary Figures 1B and 1C in Molecular Cancer Therapeutics 9:2724-36, 2010. The Respondent does not agree with ORI's finding of research misconduct and asserts that there are extenuating circumstances for her actions. Specifically, ORI found that Respondent: 1. included falsely labeled immunoblots in Figures 1D and 2A as follows: a. Figure 1D (lower panel), representing the total ERK levels in extracts from cells exposed to 15 Gy of gamma radiation for 0-120 minutes, by using results from an unrelated experiment for MAPK levels in extracts from cells exposed to 2, 12, or 20 Gy of gamma irradiation for 1, 5, 20, or 60 minutes b. Figure 2A (KSR1 panel), representing a control Flag-KSR1 immunoblot for extracts of cells transfected with control (TRE), wild- type KSR (KSR-S), or dominant negative inactive KSR (DN-KSR) exposed to no radiation or 5 minutes gamma irradiation, by using results form an unrelated experiment for KSR-transfected cells (KSR-S) irradiated with 0, 2, 5, 20, 15, 20 Gy irradiation c. Figure 2A (ERK panel), representing a control ERK immunoblot for extracts of cells transfected with control (TRE), wild-type KSR (KSR- S), or dominant negative inactive KSR (DN-KSR) exposed to no radiation or 5 minutes gamma irradiation, by using results from an unrelated experiment for KSR-transfected cells (KSR-S) irradiated with 0, 2, 5, 10, 15, 20 Gy irradiation 2. included falsified images in Figures 1D, 2A, and Supplementary Figures 1B and 1C by duplicating bands within the figures as follows: a. Figure 1D (top panel) for an immunoblot for p-ERK in A431 cells, by using the same bands to represent cells treated with ionizing radiation for 5 and 10 minutes with the bands for 60 and 90 minutes b. Figure 2A (top) for an in vitro kinase assay for p-GST-Elk-1, by duplicating lanes 2 and 5 to represent the control plasmid (TRE) at 5 minutes post radiation (lane 2) and the dominant negative inactive KSR (DN-KSR) NT lane (lane 5) c. Supplementary Figure 1B (middle panel) for an in vitro kinase assay for p-GST-MEK, by using the same bands to represent cells exposed to 5 and 20 Gy ionizing radiation d. Supplementary Figure 1C (top panel) for an immunoblot for p- MEK1/2, by using the same bands to represent cells exposed to 2 and 20 Gy ionizing radiation Dr. Xing has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed: (1) that if within three (3) years from the effective date of the Agreement, Respondent receives or applies for U.S. Public Health Service (PHS) support, Respondent agrees to have her PHS-supported research supervised for a period of three (3) years beginning on the date of her employment in which she receives or applies for PHS support, and to notify her employer(s)/institution(s) of the terms of this supervision; Respondent agrees that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research; Respondent agrees that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that if within three (3) years from the effective date of this Agreement, Respondent receives or applies for PHS support, for a period of three (3) years beginning on the date of her employment in which she receives or applies for PHS support, any institution employing her to work on PHS-supported projects shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) to exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years beginning on November 13, 2014.
Document Number: 2014-29294
Type: Notice
Date: 2014-12-15
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 July 9, 2014, Vol. 79, page 38921, and allowed 60-days for public comment. No public comments were received during the 60-day period. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director (OD), 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.
Document Number: 2014-29289
Type: Notice
Date: 2014-12-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29258
Type: Notice
Date: 2014-12-15
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the availability of Set 26 Toxicological Profiles for review and comment. Comments can include additional information or reports on studies about the health effects of Set 26 substances. Although ATSDR considered key studies for each of these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Set 26 Toxicological Profiles are available online at http:// www.atsdr.cdc.gov/toxprofiles/index.asp and http://www.regulations.gov/ #!home, docket ATSDR-2014-0001. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3),[42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare Toxicological Profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.
Document Number: 2014-29252
Type: Notice
Date: 2014-12-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29249
Type: Unknown
Date: 2014-12-15
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 actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.
Document Number: 2014-29248
Type: Unknown
Date: 2014-12-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) for an oxytetracycline soluble powder used to make medicated drinking water for livestock and poultry. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed.
Document Number: 2014-29235
Type: Notice
Date: 2014-12-15
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-29220
Type: Notice
Date: 2014-12-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29219
Type: Notice
Date: 2014-12-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-29218
Type: Notice
Date: 2014-12-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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