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

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR). This meeting is open to the public, limited in the room by 60 people and 75 lines over the phone. The public is also welcome to listen to the meeting by 1-888-790-2009, passcode: 7865774, with 75 lines. The deadline for notification of attendance is November 10, 2017. The public comment period is scheduled on Wednesday, November 15, 2017 from 2:00 p.m. until 2:15 p.m.; and from 3:25 p.m. until 3:40 p.m. EST, and on Thursday, November 16, 2017 from 10:10 a.m. until 10:25 a.m. EST. Individuals wishing to make a comment during Public Comment period, please email your name, organization, and phone number by November 6, 2017 to William Cibulas at wic1@cdc.gov.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the October meeting, the Advisory Council will welcome its new members and invite them to share their experiences and where they see the Council going over the length of their terms. The Advisory Council will also spend some time discussing the process of developing recommendations and how those recommendations relate to the National Plan. The Council will then spend much of the meeting discussing the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers, held on October 16-17.

This document withdraws a proposed rule that was published in the Federal Register on January 12, 2017. The proposed rule specified the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom- fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, the proposed rule removed the current exemption from accreditation and quality standards for certain practitioners and suppliers.

This document withdraws a proposed rule that was published in the Federal Register on March 11, 2016. The proposed rule discussed our proposal to implement a new Medicare payment model under section 1115A of the Social Security Act (the Act).

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Azza El-Remessy, Ph.D., University of Georgia, College of Pharmacy: Based on the report of an investigation conducted by the University of Georgia, College of Pharmacy (UGCP) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Azza El-Remessy, former Associate Professor, Department of Clinical and Administrative Pharmacy, UGCP, engaged in research misconduct in research supported by National Eye Institute (NEI), National Institutes of Health (NIH), grants R01 EY011766, R01 EY022408, and R01 EY04618, National Heart, Lung, and Blood Institute (NHLBI), NIH, grant R01 HL056259, and National Cancer Institute (NCI), NIH, grant K01 CA89689. ORI found that false Western blot data were included in: J Cell Sci. 118(Pt. 1):243-52, 2005 (hereafter referred to as ``J Cell Sci. 2005''). Retraction in: J Cell Sci. 129(16):3203, 2016. FASEB J. 21(10):2528-39, 2007 (hereafter referred to as ``FASEB J. 2007''). Retraction in: FASEB J. 31(1):421, 2017. PLoS One 8(8):e71868, 2013 (hereafter referred to as ``PLoS One 2013''). As a result of its investigation, UGCP recommended that PLoS One 2013 be corrected. As a result of the investigation, J Cell Sci. 2005 and FASEB J. 2007 have been retracted. ORI found that Respondent intentionally, knowingly, or recklessly used the same Western blot bands to represent different experimental results. Specifically, Respondent reused and relabeled bands in: 1. Figure 3B, J Cell Sci. 2005, to represent p38 bands from retinal cultured endothelial cells in high glucose in the absence of exogenous VEGF and also cells in peroxynitrite in the presence of exogenous VEGF. 2. Figure 4A, J Cell Sci. 2005, to represent nitrotyrosine immunoprecipitations from retinal endothelial cells cultured in normal glucose in the presence or absence of FeTTP; the Respondent also duplicated controls for p85 immunoprecipitation by using three bands representing 2 normal glucose and 1 high glucose treatments, flipping them horizontally (mirror images) to also represent 2 high glucose and 1 peroxynitrite treatments. 3. Figure 4B, J Cell Sci. 2005, to represent p85 immunoprecipitations from retinal endothelial cells stimulated with VEGF and also cells treated with either high glucose or peroxynitrite. 4. Figure 4A, PLoS One 2013, to represent immunoprecipitations for phosphorylated GSK-3 (p-GSK-3) in cells with normal glucose or high glucose for day 1 and to also represent cells treated with VEGF or VEGF+VEGFI (inhibitor); the Respondent also duplicated GSK-3 controls by using the same bands to represent high glucose treatment for day 1 and day 3 treatments, flipping them horizontally, to also represent for VEGF and VEGFRI treatments. 5. Figure 3, FASEB J. 2007, to represent phosphorylated VEGF2 (P- VEGF2) protein expression in microvascular endothelial cells in: Lanes 1 and 8, lanes 2 and 5, and lanes 6 and 7, where each lane represents different experimental conditions. Dr. El-Remessy entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter without further expenditure of time or other resources. Dr. El-Remessy accepts ORI's findings of research misconduct as set forth above but neither admits nor denies ORI's findings of research misconduct. The settlement is not an admission of liability on the part of the Respondent. Dr. El-Remessy voluntarily agreed, beginning on September 12, 2017: (1) To have her research supervised for a period of three (3) years beginning with the effective date of the Agreement; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (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 agreed that she shall 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 for three (3) years beginning with the effective date of the Agreement, 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 voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years, beginning with the effective date of the Agreement; and (4) that as a condition of the Agreement, Respondent will request that PLoS One 8(8):e71868, 2013 be corrected or retracted.

This document corrects technical and typographical errors in the final rule that appeared in the August 14, 2017, issue of the Federal Register, which will amend the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018.

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 content and format requirements for pregnancy and lactation labeling for human prescription drugs and biological products.

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 the Paperwork Reduction Act of 1995 (the PRA). This 30-day notice requests comments on the information collection requirements related to a proposed Revision of a Currently Approved Information Collection (ICR-Rev). The revision would allow ACL to continue to collect information necessary to determine grantee compliance with Section 4 of the Assistive Technology Act of 1998, as Amended (AT Act).

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 or Agency) is announcing the availability of a guidance for industry (GIF) entitled ``M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance updates the Quality-related sections of the Granularity Document Annex, Module 2.3 Quality Overall Summary, and Module 3 Quality. The guidance is intended to provide recommendations on the organization of the common technical document (CTD)/eCTD and replaces the August 2001 FDA guidance for industry ``M4: Organization of the CTD'' and the October 2005 FDA guidance for industry ``Granularity Document Annex to M4: Organization of the CTD.''

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 the availability of a draft guidance for industry entitled ``Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.'' This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II).

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access.'' The purpose of the public workshop is to provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers that may limit patient access to such drug products, and discuss approaches to overcome/ address any such barriers. FDA is seeking public input from a variety of stakeholders, including industry, academia, patient advocates, and professional associations.

The Food and Drug Administration (FDA) is withdrawing approval of 7 new drug applications (NDAs) and 71 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 ``ANDA SubmissionsAmendments to Abbreviated New Drug Applications Under GDUFA.'' This draft guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The draft guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II review goals.

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.