Department of Health and Human Services July 2017 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Alec Mirchandani, Florida Atlantic University: Based on the report of the inquiry conducted by Florida Atlantic University (FAU), the Respondent's admission, and analysis conducted by ORI, ORI found that Mr. Alec Mirchandani, former post-baccalaureate research volunteer in the Center for Complex Systems and Brain Sciences, Florida Atlantic University (FAU), engaged in research misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant 1 R15 MH099590-01A1. ORI found that Respondent engaged in research misconduct by knowingly and intentionally: (1) Fabricating the results of the T-maze behavioral experiment for control mice, (2) falsifying the laboratory and vivarium entry logs in an effort to cover up his actions, and (3) reporting the fabricated and falsified data to his laboratory supervisors. Specifically, ORI found that Respondent knowingly and intentionally: Fabricated the results that he recorded for the T-maze behavioral experiment in three of the five TMZ control mice on the laboratory data sheets and white board on fourteen (14) of the sixteen (16) eligible days in June 2016, to make it appear as though he had conducted the experiments; Falsified the animal transfer logs on twelve (12) of the sixteen (16) eligible days in June 2016, to make it appear as though he had conducted the experiments; Fabricated the times he recorded on the laboratory data sheets on fourteen (14) of the sixteen (16) eligible days in June 2016, to make it appear as though he had conducted the experiments; incorporated and recorded the fabricated and falsified data with his previous data in his laboratory notebook and reported the results to his laboratory supervisor and principal investigator, such that the experimental control data (five animals) for experiments conducted from January 2016-June 30, 2016, were not accurately represented. Mr. Mirchandani has entered into a Voluntary Settlement Agreement with ORI, in which he voluntarily agreed, beginning on June 29, 2017: (1) That if within two (2) years from the effective date of the Agreement, Respondent receives or applies for U.S. Public Health Service (PHS) support, Respondent agrees to have his research supervised for a period of one (1) year, beginning on the date of his employment in a position in which he receives or applies for PHS support, and agrees to notify his employer(s)/institution(s) of the terms of this supervision. Respondent agrees that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval. The supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution. Respondent agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI. Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan. (2) To exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of one (1) year, beginning with the effective date of the Agreement.

ACF, ORR, announces the award of five single-source low-cost extension supplement grants for a total of $20,954,962 under the Unaccompanied Alien Children's (UAC) Program.

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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 4, 2016 (81 FR 68427). The document announced the withdrawal of approval of 44 new drug applications and 158 abbreviated new drug applications (ANDAs) from multiple applicants, effective November 3, 2016. The document inadvertently announced withdrawal of approval for the following two ANDAs: ANDA 074123 for Pindolol Tablets, held by G&W Laboratories, Inc., 111 Coolidge St., South Plainfield, NJ 07080; and ANDA 080828 for Hydrocortisone Acetate Ophthalmic Ointment USP, held by Fera Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley, NY 11560. FDA confirms that the approval of ANDAs 074123 and 080828 is still in effect.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Health and Diet Survey as used by FDA to gauge and to track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling.

The Food and Drug Administration (FDA, the Agency, or we) 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.

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.

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.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's existing reporting and recordkeeping requirements for animal drug adverse events and product/manufacturing defects.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information necessary to determine grantee compliance with Section 4 of the Assistive Technology Act of 1998, as amended (AT Act). Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 proposed action. This notice solicits comments on a proposed revision to an existing data collection related to the State Grants for Assistive Technology Program Annual Progress Report (AT APR), formerly the 572 Report (0985-0042).

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Evaluation of the SAMHSA Naloxone Education and Distribution Program.'' CDC will use the information collected to evaluate the program ``Substance Abuse and Mental Health Services Agency (SAMHSA) Grants to Prevent Prescription Drug/Opioid Overdose-Related Deaths.'' The program was recently funded to improve access to treatment for opioid use disorders, reduce opioid related deaths, and strengthen drug misuse prevention efforts.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the CDC information collection project titled ``CDC Diabetes Prevention Recognition Program (DPRP).'' This revision of DPRP Standards and Operating Procedures (i.e., DPRP Standards)will allow continued collection of nationwide, de-identified data against the implementation of the National Diabetes Prevention Programs (National DPPs) using a set of evidence-based standards. CDC uses this data to effectively manage the DPRP.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances, when finalized, provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's Web site. The guidances identified in this notice were developed using the process described in that guidance.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces its intent to prepare an Environmental Impact Statement (EIS) to analyze and assess the environmental impacts of the proposed acquisition of a site in Cincinnati, Ohio, and the development of this site into a new consolidated CDC/National Institute for Occupational Safety and Health (NIOSH) campus (Proposed Action). The site being considered for acquisition and development is bounded by Martin Luther King Drive East to the south, Harvey Avenue to the west, Ridgeway Avenue to the north, and Reading Road to the east. This notice is pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). CDC, in cooperation with GSA, also intends to initiate consultation, as required by Section 106 of the National Historic Preservation Act (NHPA), to evaluate the potential effects, if any, of the Proposed Action on historic properties.