Department of Health and Human Services December 2014 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 233
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-28847
Type: Notice
Date: 2014-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2014-28843
Type: Notice
Date: 2014-12-10
Agency: Department of Health and Human Services, Administration for Children and Families
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability
Document Number: 2014-28830
Type: Notice
Date: 2014-12-10
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 (GFI #214) entitled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data'' (VICH GL35). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommended standards to construct a single Adverse Event Report (AER) electronic message to transmit VICH GL42 contents to all member regions and Product Problem Reports (PPR) to FDA for veterinary medicinal products. Please note that VICH GL42 has been harmonized in GFI #188, ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.''
Uniform Compliance Date for Food Labeling Regulations
Document Number: 2014-28829
Type: Rule
Date: 2014-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is establishing January 1, 2018, as the uniform compliance date for food labeling regulations that are issued between January 1, 2015, and December 31, 2016. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On November 28, 2012, we established January 1, 2016, as the uniform compliance date for food labeling regulations issued between January 1, 2013, and December 31, 2014.
Patient-Focused Drug Development Public Meeting on Chagas Disease
Document Number: 2014-28828
Type: Notice
Date: 2014-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Chagas disease. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The meeting is intended to allow FDA to obtain patients' perspectives on the impact that Chagas disease has on their daily lives, as well as their perspectives on the available therapies for Chagas disease. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat Chagas disease. In the afternoon, FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat Chagas disease. The input from this public meeting will help in developing topics for further discussion.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
Document Number: 2014-28825
Type: Notice
Date: 2014-12-10
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 reporting requirements contained in current FDA regulations: Administrative Practices and Procedures; Formal Evidentiary Public Hearing.
Findings of Misconduct in Science
Document Number: 2014-28859
Type: Notice
Date: 2014-12-09
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: Kaushik Deb, Ph.D., University of Missouri-Columbia: Based upon the evidence and findings of an investigation report by the University of Missouri-Columbia (UM) transmitted to the United States Department of Health and Human Services (HHS), Office of Research Integrity (ORI) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Kaushik Deb, former Postdoctoral Fellow, Life Sciences Center, UM, engaged in misconduct in science in research that was supported by National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), grants 2 R01 HD021896 and 5 R01 HD042201-05 and National Center for Research Resources (NCRR), NIH, grant 5 R01 RR013438-07. ORI found that the Respondent intentionally, knowingly, and recklessly fabricated and falsified data reported in the following published paper: Deb, K., Sivarguru, M., Yong, H., & Roberts, R.M. ``Cdx2 gene expression and trophectoderm lineage specification in mouse embryos.'' Science 311:992-996, 2006 (hereafter referred to as ``Science 311''); this paper was retracted on July 27, 2007 An earlier version of Science 311 had been previously submitted to Nature on or about June 24, 2005 (hereafter referred to as ``Nature #1''). It was revised and resubmitted to Nature on or about August 24, 2005, and ultimately was rejected by Nature on September 14, 2005 (hereafter referred to as ``Nature #2''). Specifically, ORI finds by a preponderance of the evidence that the Respondent engaged in misconduct in science by intentionally, knowingly, and recklessly: 1. Falsifying and/or fabricating three panels of data in Figure 1 (Figures 1C, 1D, and 1E) in Science 311 and in Nature #1 and Nature #2, by photo-manipulating confocal fluorescent images to falsely represent three-, four-, and six-cell embryos, thereby supporting the paper's central premise that cells derived from a late-dividing blastomere would be positive for a transcription factor, Cdx2, while the cells derived from a leading blastomere would be Cdx2 negative 2. using photo-manipulation to falsify and fabricate at least 13 panels of confocal image data in Figures 2, 3, and S2, including Figures 2K, 2L, 2Q, 2R, 2V, 2X, 3G, 3H, 3I, S2s, S2t, S2u, and 2W, in Science 311 and in corresponding figures in Nature #1 and Nature #2 so that these images falsely supported the central premise in Science 311 that Cdx2-expressing cells were peripherally located in the embryo 3. falsifying Figures 2G, 3J, 3L, S2V, S2X, S6I, S6J, and S6K in Science 311, Figures 2A, 2C, S4v, and S4x in Nature #1, and Figures 2G, 3I, 3J, and 3K in Nature #2 by reusing and re-labelling the same image to represent different embryos and different experimental conditions 4. falsifying Figure 4 in Science 311 and corresponding figures submitted in Nature #1 and Nature #2 to falsely illustrate that the first dividing cell of a two-cell mouse embryo will ultimately differentiate into the trophoblast; specifically, Respondent: Falsely colored and photomanipulated a single bright-phase image of a three-cell embryo to make it appear as four separate embryos that had been differentially injected with TRD falsely colored and photomanipulated a four-cell embryo to make TRD appear distinctly located in the lagging cell and in its descendent cell, when the actual embryo contained diffuse staining within the sub-zonal, extracellular space photomanipulated a damaged, non-viable two-cell embryo to make it appear viable re-used, falsely colored, and relabeled seven images from an unrelated experiment to falsely represent a time lapse course of eight different images 5. falsifying Figures 5K, 5L, 5N, and 5O in Science 311 by photo- manipulating a single confocal image to falsely represent four different images at two different stages of embryonic development. The images also were presented as Figures 4k, 4l, 4n, and 4o in Nature #1. The Respondent failed to take responsibility for the fabrication and falsification described in ORI's findings. The following administrative actions have been implemented for a period of three (3) years, beginning on November 17, 2014: (1) Respondent is debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq) of Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) Respondent is prohibited 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.
Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability
Document Number: 2014-28809
Type: Notice
Date: 2014-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion'' dated December 2014. The draft guidance document provides blood collection establishments and transfusion services with recommendations for initial testing (primary testing) for bacterial contamination of platelets intended for transfusion, and provides additional considerations for blood collection establishments and transfusion services for subsequent retesting (secondary testing) of platelets prior to transfusion. The recommendations for primary testing of platelets and the additional considerations for secondary testing of platelets described in this guidance are expected to enhance the detection of bacteria in platelet products and thus enhance transfusion safety. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods'' dated December 2007.
Submission for OMB Review; Comment Request
Document Number: 2014-28776
Type: Notice
Date: 2014-12-09
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2014-28753
Type: Notice
Date: 2014-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-28752
Type: Notice
Date: 2014-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-28751
Type: Notice
Date: 2014-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director Notice of Charter Renewal
Document Number: 2014-28750
Type: Notice
Date: 2014-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: A3 Adenosine Receptor (A3AR) Agonists as an Orally-Administered Analgesic for Treatment of Chronic Neuropathic Pain
Document Number: 2014-28749
Type: Notice
Date: 2014-12-09
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 part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to BioIntervene, Inc., a company having a place of business in Saint Louis, Missouri to practice the inventions embodied in the following patent applications and patents: 1. U.S. Patent 8,735,407, issued May 27, 2014, titled ``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. E-140-2008/0-US-06]; 2. European Patent Application 09728154.7, filed March 24, 2009, titled ``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. E-140-2008/0-EP-05]; 3. Canadian Patent Application 2720037, filed March 24, 2009, titled ``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. E-140-2008/0-CA-04]; 4. Australian Patent 2009231978, issued February 20, 2014, titled ``Purine Derivatives As A3 Adenosine Receptor-Selective Agonists'' [HHS Ref. No. E-140-2008/0-AU-03]; 5. U.S. Patent Application 13/371,081, filed February 10, 2012, titled ``A3 Adenosine Receptor Agonists And Antagonists'' [HHS Ref. No. E-140-2008/1-US-01]; 6. U.S. Provisional Application 61/909,742, filed November 27, 2013, titled ``A3 Adenosine Receptor Agonists'' [HHS Ref. No. E-742- 2013/0-US-01]; and 7. U.S. Provisional Application 62/033,723, filed August 6, 2014, titled ``A3 Adenosine Receptor Agonists'' [HHS Ref. No. E-210-2014/0- US-01]. The patent rights in these inventions either have been assigned to the Government of the United States of America, or have been granted exclusive rights to the Government of the United States of America. The territory of the prospective Start-up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to: ``The use of an A3 Adenosine Receptor (A3AR) agonist as an orally- administered analgesic, either as monotherapy or as an add-on analgesic, for treatment of chronic neuropathic pain conditions''. Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, BioIntervene will have the exclusive right to execute a Start-up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-28748
Type: Notice
Date: 2014-12-09
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.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-28747
Type: Notice
Date: 2014-12-09
Agency: Department of Health and Human Services, National Institutes of Health
General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability
Document Number: 2014-28716
Type: Notice
Date: 2014-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.'' The draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who are planning to conduct clinical studies in pediatric populations. Effectiveness, safety, or dose finding studies in pediatric patients involve gathering clinical pharmacology information, such as information regarding a product's pharmacokinetics and pharmacodynamics pertaining to dose selection and individualization. This draft guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs and biologic products can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications; Correction
Document Number: 2014-28714
Type: Notice
Date: 2014-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document entitled ``Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications'' that appeared in the Federal Register of August 1, 2014. The document announced the generic clearance for the collection of qualitative data on tobacco products and communications. The document was published with the incorrect docket number. This document corrects that error.
Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Extension of Comment Period
Document Number: 2014-28713
Type: Notice
Date: 2014-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for a notice of availability of draft guidance for industry (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and Controls Technical Sections'' that appeared in the Federal Register of October 20, 2014. In that notice, FDA made available for comment the draft guidance, which provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers; Availability
Document Number: 2014-28711
Type: Notice
Date: 2014-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.'' This draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance describes FDA's expectations for prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) about reporting to FDA under the DSCSA.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2014-28705
Type: Notice
Date: 2014-12-09
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), 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 for revision of the approved information collection assigned OMB control number 0990- 0390 which expires on February 28, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-28702
Type: Notice
Date: 2014-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
Meeting of the National Preparedness and Response Science Board
Document Number: 2014-28722
Type: Proposed Rule
Date: 2014-12-08
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB), also known as the National Biodefense Science Board will be holding a public meeting on January 30, 2015.
Expert Panel Meeting on Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid; Notice of Public Meeting and Registration Information
Document Number: 2014-28681
Type: Proposed Rule
Date: 2014-12-08
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) and the Office of Dietary Supplements (ODS) announce a public expert panel meeting on May 11-12, 2015, to identify research needs based on the state of the science related to the safe use of high intakes of folic acid. The expert panel meeting is open to the public. Registration is requested for public attendance, in-person or via the webcast, and for oral comment. Information about the meeting and registration are available at http:// ntp.niehs.nih.gov/go/730864.
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2014-28661
Type: Proposed Rule
Date: 2014-12-08
Agency: Department of Health and Human Services, National Institutes of Health
Request for Nominations on the Food Advisory Committee
Document Number: 2014-28652
Type: Proposed Rule
Date: 2014-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Food Advisory Committee for the Center for Food Safety and Applied Nutrition (CFSAN) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Food Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2014-28650
Type: Proposed Rule
Date: 2014-12-08
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.
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2014-28636
Type: Proposed Rule
Date: 2014-12-08
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Document Number: 2014-28635
Type: Proposed Rule
Date: 2014-12-08
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.
Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials
Document Number: 2014-28634
Type: Proposed Rule
Date: 2014-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974 (the Privacy Act) and the Food and Drug Administration's (FDA or the Agency) regulations for the protection of privacy, FDA is publishing notice of a Privacy Act system of records entitled, ``FDA Commissioning of State and Local Officials, HHS/FDA/ORA'' System No. 09-10-0022. FDA is deleting the System of Records Notice (SORN) for ``FDA Credential Holder File, HHS/FDA/OC'' System No. 09-10-0003, because the records covered by that SORN are now covered by this new SORN and by existing personnel records SORNs. The new system of records will contain information about State and local officials who have applied for an FDA commission that would allow them to assist FDA with its regulatory compliance and enforcement efforts. FDA will use the records in this system to assess qualifications of commissioning candidates, initiate background investigations, record the status of applications, and track the status of commissioned officials.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-28632
Type: Proposed Rule
Date: 2014-12-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (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.
Request for Comments on Ethical Considerations and Implications of Public Health Emergency Response With a Focus on the Current Ebola Virus Disease Epidemic
Document Number: 2014-28617
Type: Proposed Rule
Date: 2014-12-08
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues is requesting public comment on ethical considerations and implications of public health emergency response with a focus on the current Ebola virus disease epidemic.
Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations
Document Number: 2014-28388
Type: Proposed Rule
Date: 2014-12-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule addresses changes to the Medicare Shared Savings Program (Shared Savings Program), including provisions relating to the payment of Accountable Care Organizations (ACOs) participating in the Shared Savings Program. Under the Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-28555
Type: Notice
Date: 2014-12-05
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.
Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug Applications and 68 Abbreviated New Drug Applications
Document Number: 2014-28541
Type: Notice
Date: 2014-12-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 23 new drug applications (NDAs) and 68 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
How To Obtain a Letter From the Food and Drug Administration Stating That Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable Risk Evaluation and Mitigation Strategies for Reference Listed Drugs; Draft Guidance for Industry; Availability
Document Number: 2014-28540
Type: Notice
Date: 2014-12-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD.'' This draft guidance describes how a prospective abbreviated new drug application (ANDA) applicant may request a letter stating that FDA has determined the following: The potential applicant's bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable to the reference listed drug (RLD) and FDA will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its ANDA.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-28530
Type: Notice
Date: 2014-12-05
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Meeting
Document Number: 2014-28529
Type: Notice
Date: 2014-12-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-28528
Type: Notice
Date: 2014-12-05
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Center; Notice of Closed Meeting
Document Number: 2014-28527
Type: Notice
Date: 2014-12-05
Agency: Department of Health and Human Services, National Institutes of Health
Payment for Physician and Other Health Care Professional Services Purchased by Indian Health Programs and Medical Charges Associated With Non-Hospital-Based Care
Document Number: 2014-28508
Type: Proposed Rule
Date: 2014-12-05
Agency: Department of Health and Human Services, Indian Health Service
This proposed rule would amend Indian Health Service (IHS) Purchased and Referred Care (PRC), formally known as the Contract Health Services (CHS), regulations to apply Medicare payment methodologies to all physician and other health care professional services and non-hospital-based services that are either authorized under such regulations or purchased by urban Indian organizations. Specifically, it proposes that the health programs operated by IHS, Tribe, Tribal organization, or urban Indian organization (collectively, I/T/U programs) will pay the lowest of the amount provided for under the applicable Medicare fee schedule, prospective payment system, or Medicare waiver; the amount negotiated by a repricing agent, if available; or the usual and customary billing rate. Repricing agents may be used to determine whether IHS may benefit from savings by utilizing negotiated rates offered through commercial health care networks. This proposed rule seeks comment on how to establish reimbursement that is consistent across Federal health care programs, aligns payment with inpatient services, and enables the IHS to expand beneficiary access to medical care.
Medicare Program; Requirements for the Medicare Incentive Reward Program and Provider Enrollment
Document Number: 2014-28505
Type: Rule
Date: 2014-12-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements various provider enrollment requirements. These include: Expanding the instances in which a felony conviction can serve as a basis for denial or revocation of a provider or supplier's enrollment; if certain criteria are met, enabling us to deny enrollment if the enrolling provider, supplier, or owner thereof had an ownership relationship with a previously enrolled provider or supplier that had a Medicare debt; enabling us to revoke Medicare billing privileges if we determine that the provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements; and limiting the ability of ambulance suppliers to ``backbill'' for services performed prior to enrollment.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2015
Document Number: 2014-28503
Type: Notice
Date: 2014-12-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a $553.00 calendar year (CY) 2015 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2015 and on or before December 31, 2015.
Proposed Collection; 60-Day Comment Request; Health Information National Trends Survey (HINTS)
Document Number: 2014-28513
Type: Notice
Date: 2014-12-04
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project contact: Bradford W. Hesse, Ph.D., Health Communication and Informatics Research Branch, 9609 Medical Center Drive, MSC 9761, Room 3E610, Rockville, MD 20850 or call non-toll free number 240-276-6721 or Email your request, including your address, to hesseb@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Health Information National Trends Survey (HINTS) 0925-0538, Reinstatement with Change, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This partnership between NCI and FDA will include assessing the public's knowledge of medical devices, communications related to product recalls, nutritional supplement labeling, and topics to inform FDA's regulatory authority over tobacco, such as risk perceptions about new tobacco products, product pack color gradations, perceptions of product harm, and tobacco product claims and labels. This HINTS survey will couple knowledge- related questions with inquiries into the communication channels through which understanding is being obtained, and assessment of FDA- regulated material. This survey will extend the information collected and priorities from HINTS which have been to provide a comprehensive assessment of the American public's current access to, and use of, information about cancer across the cancer care continuum from cancer prevention, early detection, diagnosis, treatment, and survivorship. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,159.
Proposed Collection; 60-Day Comment Request; Surveys and Interviews To Support an Evaluation of the Innovative Molecular Analysis Technologies (IMAT) Program (NCI)
Document Number: 2014-28498
Type: Notice
Date: 2014-12-04
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Anthony Dickherber, NCI Center for Strategic Scientific Initiatives, 31 Center Drive, Rm10A33, Bethesda, MD 20892 or call non-toll-free number 301- 547-9980 or Email your request, including your address to: dickherberaj@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Surveys and Interviews to Support an Evaluation of the Innovative Molecular Analysis Technologies (IMAT) Program (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the proposed evaluation is to pursue a comprehensive process and outcome assessment of the 15-year old Innovative Molecular Analysis Technologies (IMAT) program. While the program consistently offers promising indicators of success, the full program has not been evaluated since 2008, and never in as comprehensive a manner as has been formulated in the current evaluation plan. An outcome evaluation of the long-standing National Cancer Institute's (NCI) IMAT program presents a rich and unique opportunity likely to serve institutes across the National Institutes of Health (NIH), and perhaps other federal agencies, considering the costs and benefits of directing resources towards supporting technology development. An award through the NIH Evaluation Set-Aside program to support this evaluation, for which NIH-wide relevance is a principle element of determining merit for support, is testament to this. The evaluation serves as an opportunity to gauge the impact of investments in technology development and also to assess the strengths and weaknesses of phased innovation award mechanisms. Like all institutes and centers (ICs) of the NIH, NCI seeks opportunities for improving their programs' utility for the broad continuum of researchers, clinicians and ultimately patients. NCI Director Harold Varmus and other leadership across NCI, as well as the NCI Board of Scientific Advisors, will be the primary users of the evaluation results. Findings are primarily intended for considering the long-term strategy to support innovative technology development and how to more efficiently translate emerging capabilities through such technologies into the promised benefits for cancer research and clinical care. Interviews with grantees, program officers, review officers, and other NIH awardees make up a crucial component of the evaluation plan and will largely follow set survey protocols. Specific near-term aims include the use of this information to consider the utility of continued investment through existing solicitations and in strategic planning generally for institute support for innovative technology development. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 575.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2014-28493
Type: Notice
Date: 2014-12-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// beta.samhsa.gov/workplace.
Administration for Native Americans; Statement of Organization, Functions, and Delegations of Authority
Document Number: 2014-28486
Type: Notice
Date: 2014-12-04
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) has reorganized the Administration for Native Americans (ANA). This reorganization creates the Division of Policy and makes other technical changes to reflect the current functions within ANA. The realignment of functions better reflects the current work environment and priorities within ANA, manifests ANA's commitment to Federal/Tribal government-to- government relationships, and promotes self-determination for all Native Americans. The statement of mission, organization, functions, and delegations of authority conforms to and carries out the statutory requirements of the Native American Programs Act (NAPA).
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability
Document Number: 2014-28242
Type: Notice
Date: 2014-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This draft guidance is intended to assist applicants in complying with the new content and format requirements in the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products, as described in the final rule, Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. The rule, which is being published concurrently with this draft guidance, is referred to as the ``Pregnancy and Lactation Labeling Rule'' (PLLR). The draft guidance will assist applicants in developing labeling for new products, revising existing labeling, and implementing the content and format requirements of the PLLR for human prescription drug and biological products.
Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
Document Number: 2014-28241
Type: Rule
Date: 2014-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the ``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the ``Labor and delivery'' subsection because information about labor and delivery is included in the ``Pregnancy'' subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.
Notice of Hearing: Reconsideration of Disapproval Ohio Medicaid State Plan Amendment (SPA) 14-002
Document Number: 2014-28427
Type: Notice
Date: 2014-12-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on January 7, 2015, at the Department of Health and Human Services, Centers for Medicare and Medicaid Services, Division of Medicaid & Children's Health, Chicago Regional Office, 233 N. Michigan, Avenue Suite 600 Chicago, Illinois 60601-5519, to reconsider CMS' decision to disapprove Ohio's Medicaid SPA 14-002.