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

On March 15, 2017 the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [82 FR 13809] announcing the availability of a draft Current Intelligence Bulletin entitled The Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards for public comment. NIOSH convened a public meeting in Cincinnati, Ohio on Tuesday, May 23, 2017 to discuss the document. The draft document can be found at www.regulations.gov. by entering CDC-2017-0028 in the search field and clicking ``Search.'' Written comments were to be received by June 13, 2017. In response to a request from an interested party, NIOSH is announcing the reopening of the comment period.

The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulationsQuestions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled ``Part 11, Electronic Records; Electronic SignaturesScope and Application'' issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations.

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 in the guidance on registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

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 reporting and recordkeeping requirements for firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers.

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 ``Application for Participation in FDA Fellowship Programs.''

In 2014, ACL announced a funding opportunity known as ``the Native American Elder Justice Initiative'' that awarded funds to the University of North Dakota (UND) National Indigenous Elder Justice Initiative (NIEJI), to address the need for more culturally appropriate information and community education materials on elder abuse, neglect, and exploitation in Indian Country. The one year extension will enable NIEJI to (1) continue to develop culturally appropriate para- professional training to tribal aging networks, including work with community health representatives, Senior Companions and Foster Grandparents; (2) develop additional training modules around aspects of elder neglect, exploitation and abuse; (3) continue to work with individual tribes and tribal organizations seeking direction on developing prevention and awareness programs, and to (4) provide on- going training to tribal aging and health programs.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to a new collection (ICR New).

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Brandi M. Baughman, Ph.D., National Institutes of Health (NIH): Based on Respondent's admission and analysis conducted by ORI, ORI found that Dr. Brandi M. Baughman, former Intramural Research Training Awardee, National Institute of Environmental and Health Sciences (NIEHS), NIH, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant R01 DK101645 and the NIEHS, NIH, Postdoctoral Intramural Research Training Award (IRTA). ORI found that falsified and/or fabricated data were included in eleven (11) figures in PLoS One 11(10):e0164378, 2016 (hereafter referred to as ``PLoS One 2016''). ORI found that Respondent falsified and/or fabricated data and text published in PLoS One 2016, in Figures 2, 3, 4, 5, 6, 8, S1, S2, S3, S4, and S5, by claiming that a screening strategy of the kinase focused libraries, PKIS and 5K, was performed, when original data do not exist to support the claims. Respondent also claimed that three (3) inhibitory compounds for the inositol phosphate kinase, PPIP5K, were identified from the 5K library, when these compounds, UNC10112646, UNC10225354, and UNC10225498, were not part of the data set for the 5K library. Specifically, Respondent falsified and/or fabricated the characterization of the inhibitor compounds in: Figures 2 and 3 results for Z'-factor, %CV, signal:background ratio, and a 10-point dose response titration experiment for inhibitor UNC10225354 claims in the text of PLoS One 2016 that eight molecules from the PKIS library and fifteen molecules from the 5K library inhibited PPIP5K activity by >50% Figure 4D results for the inhibition by UNC10112646, UNC10225354, and UNC10225498, in dose response assays against the kinase domain of PPIP5K Figures 5A and 5B results for isothermal titration calorimetry (ITC) assays for quantifying intermolecular interactions between PPIP5K and the inhibitors, UNC1011264 and UNC10225498, and Figure S5 for UNC10225354 Figure 6 results for the analysis of the mechanisms of inhibition of PPIP5K by UNC10112646 and UNC10225498 Figures 8A and 8B results for high performance liquid chromatography (HPLC) analysis for the effects of UNC10112646 or UNC10225498 on PPIP5K activity and IP6K activity Figures S1-S4 for experimental results further characterizing UNC10112646, UNC10225498, and other inhibitors, when the results were not supported by the experimental records. As a result of Respondent's admission, NIH recommended that the PLoS One 2016 paper be retracted. Dr. Baughman has entered into a Voluntary Settlement Agreement with ORI, in which she voluntarily agreed: (1) To have her research supervised for a period of three (3) years beginning on May 17, 2017; Respondent agreed to ensure that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which 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 agreed that she will not participate in any PHS-supported research until a plan for supervision is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that for a period of three (3) years beginning on May 17, 2017, 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; (3) to exclude herself from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years, beginning on May 17, 2017; and (4) as a condition of the Agreement, to the retraction or correction of PLoS One 11(10):e0164378d, 2016 (PMID: 27736936).

The Administration for Children and Families, Office of Refugee Resettlement (ORR), announces the award of six single-source program expansion supplement grants for a total of $14,821,314 under the UC Program.

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 (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 requirements governing the acceptance of electronic records and electronic signatures.

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 a generic clearance to collect information to support communications used by FDA about drug products.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion.''

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces changes in the application process to import a dog inadequately immunized against rabies. As a result of these changes, at least 10 business days before arriving into the United States with an inadequately immunized dog, an importer must apply online at https://www.cdc.gov/importation/ for a Permit to Import a Dog Inadequately Immunized against Rabies. Permit applications to import an inadequately immunized dog will not be available at the port of entry and no permits will be issued at the port of entry. Inadequately immunized dogs arriving at a port of entry without an approved permit will be denied entry into the United States and exported to its country of origin at the owner's expense.

This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2018. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests. The Clinical Diagnostic Laboratory Test (CDLT) Advisory Panel will participate in this meeting by gathering information and asking questions to presenters on July 31, 2017, and will hold a public meeting on August 1, 2017 to discuss matters of the Panel and make recommendations regarding the test codes presented at the CLFS public meeting. In the event the CLFS public meeting needs to extend to August 1, 2017, the CDLT Advisory Panel will convene its public meeting immediately following the CLFS public meeting, rather than starting at 9:00 a.m. Eastern Daylight Savings Time (E.D.T.) as currently planned.