Department of Health and Human Services October 2015 – Federal Register Recent Federal Regulation Documents

Performance Review Board Members
Document Number: 2015-27749
Type: Notice
Date: 2015-10-30
Agency: Department of Health and Human Services
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; Availability
Document Number: 2015-27744
Type: Notice
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.'' This revised draft guidance document replaces the draft of the same name that published on August 21, 2002. This revised draft guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) reviewed by the Center for Drug Evaluation and Research (CDER).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risks and Benefit Information in Direct-to-Consumer Prescription Drug Ads
Document Number: 2015-27743
Type: Notice
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Impact of Ad Exposure Frequency on Perception and Mental Processing of Risks and Benefit Information in Direct-to-Consumer Prescription Drug Ads'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patient Perceptions
Document Number: 2015-27742
Type: Notice
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patient Perceptions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development
Document Number: 2015-27741
Type: Notice
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Controlled Correspondence Related to Generic Drug Development'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination That TENSILON and TENSILON Preservative Free (Edrophonium Chloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2015-27740
Type: Notice
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance
Document Number: 2015-27729
Type: Notice
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a stay of portions of the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled ``Investigational New Drug ApplicationsDetermining Whether Human Research Studies Can Be Conducted Without an IND.'' We are republishing the guidance with the portions that are being stayed clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to this stay.
Clinical Trials-Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments
Document Number: 2015-27728
Type: Notice
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled ``Clinical TrialsAssessing Safety and Efficacy in Diverse Populations.'' The purpose of the meeting is to discuss approaches in clinical trial design and subgroup analyses for therapeutic product development and life-cycle management.
Proposed Collection; 60-Day Comment Request; A Generic Clearance for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH)
Document Number: 2015-27717
Type: Notice
Date: 2015-10-30
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 NICHD, the 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 to address 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) the quality, utility, and clarity of the information to be collected; and (4) 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 forms, submit comments in writing, or request more information on the proposed project, contact: Rohan Hazra, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, 6100 Executive Blvd., Room 4B11, Bethesda, MD 20892-7510, or call non-toll- free number 301-435-6868 or Email your request, including your address to: hazrar@mail.nih.gov. Formal requests for additional plans and forms 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: Data and Specimen Hub (DASH), 0925NEW, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: The NICHD Data and Specimen Hub (DASH) is being established by NICHD as a data sharing mechanism for biomedical research investigators. It will serve as a centralized resource for investigators to store and access de-identified data from studies funded by NICHD. The potential for public benefit to be achieved through sharing research study data for secondary analysis is significant. NICHD DASH supports NICHD's mission to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation. Data sharing and reuse will promote testing of new hypotheses from data already collected, facilitate trans-disciplinary collaboration, accelerate scientific findings and enable NICHD to maximize the return on its investments in research. Anyone can access NICHD DASH to browse and view descriptive information about the studies and data archived in NICHD DASH without creating an account. Users who wish to submit or request research study data must register for an account. Information will be collected from those wishing to create an account, sufficient to identify them as unique Users. Those submitting or requesting data will be required to provide additional supporting information to ensure proper use and security of NICHD DASH data. The information collected are limited to the essential data required to ensure that the management of Users in NICHD DASH is efficient and the sharing of data among investigators is effective. The primary uses of the information collected from Users by NICHD will be to:
Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period
Document Number: 2015-27707
Type: Proposed Rule
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ``Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry'' announced in the Federal Register of October 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period
Document Number: 2015-27706
Type: Proposed Rule
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' published in the Federal Register of December 24, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
Document Number: 2015-27705
Type: Proposed Rule
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ``Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff,'' published in the Federal Register of December 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-27704
Type: Proposed Rule
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff, with recommendations for applying the criterion of ``homologous use'' as it applies to HCT/Ps. The interpretation and application of the homologous use criterion and related definitions have been of considerable interest to industry stakeholders since they were first proposed during the Agency's rulemaking on HCT/Ps.
Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments
Document Number: 2015-27703
Type: Proposed Rule
Date: 2015-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a 1-day public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). These draft guidances were issued by FDA in response to stakeholders' requests for guidance on FDA's current views about how manufacturers, establishments, and distributors of HCT/Ps and health care professionals can meet the criteria under the Agency's regulations that apply to HCT/Ps. FDA will consider information it obtains from the public hearing in the finalization of these guidances.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2015-27701
Type: Notice
Date: 2015-10-30
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Hooker Electrochemical Corporation in Niagara Falls, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Proposed Collection; 60-Day Comment Request Consumer Health Information in Public Libraries User Needs Survey (NLM)
Document Number: 2015-27678
Type: Notice
Date: 2015-10-30
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 Library of Medicine (NLM), 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: David Sharlip, Office of Administrative and Management Analysis Services,, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 402-9680, or Email your request, including your address to: sharlipd@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: Consumer Health Information in Public Libraries User Needs Survey (NLM)), 0925New, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: In 1994, the NLM was designated a ``Federal Reinvention Laboratory'' with a major objective of improving its methods of delivering information to the public. NLM has become an international leader in health informatics research and development, especially in consumer health informatics. As a result, NLM needs to remain contemporary in consumer health informatics research by utilizing research methods that yield a better understanding of the predictors of consumer satisfaction. Without ongoing insights into the predictors of consumer satisfaction, NLM will lack the research findings to make evidence-based changes in the content, design and editorial management of its consumer Web sites and will not optimally serve the public. Public libraries have been identified as a key resource for public information about the Patient Protection and Affordable Care Act (PPACA), which took full effect on October 1, 2013. A national anonymous survey of library staff will help us better understand the challenges and successes of information provision in this critical area of high information need. Research and funding into the challenges of health information in public libraries is, at present, almost nonexistent. In the present environment of health insurance reform and presumption of informed consumer choice, this is a critical knowledge gap. Information collection from library workers will supply much- needed feedback on the specific areas of challenge for information provision by public libraries. The results of this study will be used by the Principal Investigators' home institutionsthe University of Wisconsin-Madison, an institution of higher education preparing future library workers, and the Specialized Information Services division of the National Library of Medicineto inform preparation of outreach and training materials as well as advising other organizations and institutions providing PPACA information provision assistance to public libraries (e.g., American Library Association). To improve our understanding of the challenges and gaps in information provision and awareness around PPACA, the information we get from this survey will be used to inform and improve NLM's services to public libraries, as well as increase our understanding of the resource and education needs of public library workers. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 390.
Submission for OMB Review; Comment Request
Document Number: 2015-27666
Type: Notice
Date: 2015-10-30
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-27619
Type: Notice
Date: 2015-10-30
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.
NIH Pathways to Prevention Workshop: Total Worker Health®-What's Work Got To Do With It?
Document Number: 2015-27627
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) will host a workshop about Total Worker Health[supreg] on December 9-10, 2015. The workshop is free and open to the public.
Notice of Opportunity for Public Comment on the Dietary Supplement Label Database
Document Number: 2015-27625
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services, National Institutes of Health
The Office of Dietary Supplements (ODS) at the National Institutes of Health, in partnership with the National Library of Medicine (NLM), has developed a Dietary Supplement Label Database (DSLD) that is compiling all information from the labels of dietary supplements marketed in the United States. ODS welcomes comments about features to add and functionality improvements to make so the DSLD may become a more useful tool to users. A federal stakeholder panel for the DSLD will consider all comments received. The ODS requests input from academic researchers, government agencies, the dietary supplement industry, and other interested parties, including consumers. The DSLD can be accessed online at http:/ /dsld.nlm.nih.gov.
Medicare Program; Final Waivers in Connection With the Shared Savings Program
Document Number: 2015-27599
Type: Rule
Date: 2015-10-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of Inspector General
This final rule finalizes waivers of the application of the physician self-referral law, the Federal anti-kickback statute, and the civil monetary penalties (CMP) law provision relating to beneficiary inducements to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the ``Shared Savings Program''), as set forth in the Interim Final Rule with comment period (IFC) dated November 2, 2011. As explained in greater detail below, in light of legislative changes that occurred after publication of the IFC, this final rule does not finalize waivers of the application of the CMP law provision relating to ``gainsharing'' arrangements. Section 1899(f) of the Act, as added by the Affordable Care Act, authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2015-27592
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
Document Number: 2015-27588
Type: Notice
Date: 2015-10-29
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.
Findings of Research Misconduct
Document Number: 2015-27587
Type: Notice
Date: 2015-10-29
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: Dr. Maria C.P. Geraedts, University of Maryland, Baltimore: Based on the report of an investigation conducted by the University of Maryland, Baltimore (UMB) and analysis conducted by ORI in its oversight review, ORI and UMB found that Dr. Maria C.P. Geraedts, former postdoctoral fellow, Department of Anatomy and Neurobiology, UMB, engaged in research misconduct in research supported by National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), grant R01 DC010110. ORI found falsified and/or fabricated data included in the following two (2) publications: Am J Physiol Endocrinol Metab 303:E464-E474, 2012 (hereafter referred to as ``AJP 2012'') Journal of Neuroscience 33(17):7559-7564, 2013 (hereafter referred to as ``JN 2013'') As a result of the UMB investigation, JN 2013 and AJP 2012 have been retracted. ORI found that Respondent falsified and/or fabricated bar graphs in AJP 2012, by changing ELISA-based measurements to produce the desired result for secretion of glucagon-like peptide-1 (GLP-1) from intestinal explants from various mouse strains in: Figure 2 for GLP-1 release from duodenum (2A & D), jejunum (2B & E), and ileum (2C & F). Figure 3 for GLP-1 release from colon (3A & C) and rectum (3D). Figure 4 for GLP-1 release from ileum (4A) and colon (4C) in the presence or absence of an ATP-sensitive K+ channel inhibitor. ORI found that Respondent falsified and/or fabricated bar graphs in Figure 1, JN 2013 by changing ELISA-based measurements to produce the desired result for the secretion of peptides found in taste buds (GLP- 1, glucagon, or neuropeptide Y) from mouse lingual epithelium exposed to various concentrations of stimuli (glucose, sucralose, MSG, polycose). These bar graphs also were included as Figure 7 in grant application R01 DC010110-06. Both the Respondent and the U.S. Department of Health and Human Services (HHS) want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter. Respondent stated that she is not currently involved in U.S. Public Health Service (PHS)- supported research and has no intention of applying for or engaging in PHS-supported research or otherwise working with PHS. Dr. Geraedts has entered into a Voluntary Settlement Agreement with ORI and UMB, in which she voluntarily agreed to the administrative actions set forth below. The administrative actions are required for three (3) years beginning on the date of Dr. Geraedts employment in a position in which she receives or applies for PHS support on or after the effective date of the Agreement (September 22, 2015). If the Respondent has not obtained employment in a research position in which she receives or applies for PHS support within one (1) year of the effective date of the Agreement, the administrative actions set forth below will no longer apply. Dr. Geraedts has voluntarily agreed: (1) To have her research supervised as described below and notify her employer(s)/institution(s) of the terms of this supervision; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is proposed and prior to her 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 her research contribution; Respondent agreed that she will not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that any institution employing her 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 period of three (3) years beginning on September 22, 2015.
Submission for OMB Review; 30-Day Comment Request; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI)
Document Number: 2015-27586
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health, 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 28, 2015, page number 52325 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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.
Center For Scientific Review; Amended Notice of Meeting
Document Number: 2015-27584
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-27583
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2015-27582
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Using Technologies and Innovative Methods To Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket
Document Number: 2015-27581
Type: Notice
Date: 2015-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit input from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations. Specifically, FDA seeks information to understand individual and industry experiences with the use of such technologies to more efficiently conduct clinical research. FDA also seeks stakeholder perspectives on possible barriers to implementing these technologies and methods to conduct clinical investigations.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2015-27563
Type: Notice
Date: 2015-10-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
Document Number: 2015-27562
Type: Notice
Date: 2015-10-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
Document Number: 2015-27559
Type: Notice
Date: 2015-10-29
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants
Document Number: 2015-27558
Type: Notice
Date: 2015-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicant'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities
Document Number: 2015-27557
Type: Notice
Date: 2015-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey on Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
Document Number: 2015-27556
Type: Notice
Date: 2015-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey on Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Small Business Innovation Research Program-Phase II
Document Number: 2015-27512
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services
The Administration for Community Living (ACL), National Institute on Disability, Independent Living, and Rehabilitation Research (NIDLRR) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This notice solicits comments on the information collection requirements relating to the Small Business Innovation Research Program (SBIR)Phase II. Specifically, the information collection is the SBIR Application package, which provides information on requirements for the application including mandatory information provided via government- approved forms.
Proposed Information Collection Activity; Comment Request; State Developmental Disabilities Council-Annual Program Performance Report (PPR)
Document Number: 2015-27511
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services
A Plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State's Governor, and finally submit the plan on a five-year basis. On an annual basis, the Council must submit a Program Performance Report (PPR) to described the extent to which annual progress is being achieved on the 5 year state plan goals. The PPR will be used by (1) the Council as a planning document to track progress made in meeting state plan goals; (2) the citizenry of the State as a mechanism for monitoring progress and activities on the plans of the Council; (4) the Department as a stewardship tool, for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act, as one basis for monitoring and providing technical assistance (e.g., during site visits), and as a support for management decision making.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-27499
Type: Notice
Date: 2015-10-29
Agency: Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 20, 2015 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
Document Number: 2015-27369
Type: Rule
Date: 2015-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of September 22, 2015, for the final rule that appeared in the Federal Register of August 21, 2015, and that amended the color additive regulations to expand the permitted use of spirulina extract as a color additive to include use in coating formulations applied to dietary supplement and drug tablets and capsules.
Prospective Grant of Exclusive License: Development of Therapeutics To Treat Obesity, Type 2 Diabetes, Fatty Liver Disease, and Liver Fibrosis in Humans
Document Number: 2015-27454
Type: Notice
Date: 2015-10-28
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the following inventions embodied in the following patent applications, entitled ``CB1 receptor mediating compounds'':
World Trade Center Health Program; Petition 009-Autoimmune Diseases; Finding of Insufficient Evidence
Document Number: 2015-27435
Type: Proposed Rule
Date: 2015-10-28
Agency: Department of Health and Human Services
On September 14, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 009) to add the autoimmune disease multiple sclerosis to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 009 is not substantially different from Petitions 007 and 008, which also requested the addition of autoimmune diseases. The Administrator recently published responses to both Petition 007 and Petition 008 in the Federal Register and has determined that Petition 009 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases. 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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-27431
Type: Notice
Date: 2015-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-27427
Type: Notice
Date: 2015-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
Document Number: 2015-27420
Type: Notice
Date: 2015-10-28
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 investigational device exemptions reports and records.
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Guidance for Industry and Review Staff; Availability
Document Number: 2015-27418
Type: Notice
Date: 2015-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled ``Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.'' The guidance provides recommendations concerning the evaluation of the nonclinical safety of reformulated drug products or products being used by an alternate route. It is intended for use by interested individuals in industry and reviewers within the Center for Drug Evaluation and Research (CDER). The goals of this guidance are to foster and expedite the development of reformulated drug products or the use of previously approved drugs by alternate routes, communicate to industry current CDER thoughts pertaining to safety data needed to support these drug products, and increase uniformity within CDER on expectations for the nonclinical development of reformulated drug products or products being used by an alternate route. This guidance finalizes the draft guidance of the same name published on March 7, 2008.
Proposed Information Collection Activity; Comment Request
Document Number: 2015-27416
Type: Notice
Date: 2015-10-28
Agency: Department of Health and Human Services, Administration for Children and Families
Product Development Under the Animal Rule; Guidance for Industry; Availability
Document Number: 2015-27361
Type: Notice
Date: 2015-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Product Development Under the Animal Rule.'' When human efficacy studies are not ethical and field trials are not feasible, FDA may rely on adequate and well-controlled animal efficacy studies to support approval of a drug or licensure of a biological product under the Animal Rule. This guidance finalizes the 2014 revised draft guidance for industry ``Product Development Under the Animal Rule.'' It is intended to help potential stakeholders (industry, academia, and government) understand FDA's expectations for product development under the Animal Rule.
Grocery Manufacturers Association; Filing of Food Additive Petition
Document Number: 2015-27277
Type: Proposed Rule
Date: 2015-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Grocery Manufacturers Association, proposing that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in various food applications.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-27327
Type: Notice
Date: 2015-10-27
Agency: Department of Health and Human Services, National Institutes of Health
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