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

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.

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.

Due to an information collection request oversight, the Centers for Disease Control and Prevention (CDC) requests immediate publication withdrawal of the 30-Day Federal Register Notice (FRN) entitled ``Agency Forms Undergoing Paperwork Reduction Act Review'' concerning the Public Health Associate Program (PHAP) Alumni Assessment.

The Food and Drug Administration (FDA or we) is proposing to amend its regulation for registration of food facilities that requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This proposed rule would amend and update FDA's registration regulations and is part of our implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. Moreover, a number of provisions in FSMA apply only to facilities required to register, including hazard analysis and risk-based preventive controls and mandatory recall authority. The proposed amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.

A notice was published in the Federal Register on Monday, February 23, 2015, Vol. 80, No. 35, pages 9465-9466 to announce the availability of the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (Advisory Report) and to solicit written comments on the Advisory Report (among other things). In the notice dated February 23, 2015, it was announced that the due date for providing comments was April 8, 2015. This notice is to announce the extension of the solicitation period to allow for additional time for written comments to be submitted for consideration.

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 procedures to conduct interviews with Age Friendly Initiative, Senior Village, and local health department staff, as well as surveys of older adults.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several non-substantive changes. These technical amendments are being made to improve the accuracy of the regulations.

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH or Center) is announcing the 2015 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to apply to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the ELP.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that CHOLBAM (cholic acid), manufactured by Asklepion Pharmaceuticals, LLC, meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that UNITUXIN (dinutuximab), manufactured by United Therapeutics Corporation, meets the criteria for a priority review voucher.

ACF and HRSA announce the renewal of the Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation to provide advice to the Secretary of Health and Human Services (``the Secretary'') on the design, plan, progress, and findings of the evaluation required under the Act.

In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), the Health Resources and Services Administration (HRSA) is publishing notice of a proposed alteration of the system of records entitled and numbered ``Public Health and National Health Service Corps Scholarship Program (NHSC SP), National Health Service Corps Loan Repayment Program (NHSC LRP), Students to Service, (S2S), NHSC Student/Resident Experiences and Rotations in Community Health (SEARCH), NURSE Corps Loan Repayment Program (NURSE Corps LRP) formerly the Nursing Education Loan Repayment Program (NELRP), NURSE Corps Scholarship Program (NURSE Corps SP) formerly the Nursing Scholarship Program (NSP), Native Hawaiian Health Scholarship Program (NHHSP), and Faculty Loan Repayment Program (FLRP), Applicants and/or Participants Records System, HHS/HRSA/BHW,'' No. 09-15-0037. The proposed alterations affect the system name, system location, categories of records, purposes, routine uses, safeguards, records retention and disposal, system manager title and address, as well as minor editorial corrections and clarifications.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Teresita L. Briones, Ph.D., Wayne State University: Based on the report of an inquiry conducted by Wayne State University (WSU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Teresita L. Briones, former Associate Professor, College of Nursing, WSU, engaged in research misconduct in research supported by National Institute of Nursing Research (NINR), National Institutes of Health (NIH), grants P30 NR009014, R01 NR005260, and R01 NR007666. ORI found that Respondent intentionally, knowingly, and recklessly engaged in research misconduct by falsifying and/or fabricating data that were included in five (5) publications and three (3) grant applications submitted to NINR, NIH:

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.

Notice is given that the Director of the Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2015 for Medicare and Medicaid beneficiaries, and beneficiaries of other Federal programs, and for recoveries under the Federal Medical Care Recovery Act (42 U.S.C. Sec. Sec. 2651-2653). The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment shall be available to the extent that those services are provided.

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 classifying the urethral insert with pump for bladder drainage into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the urethral insert with pump for bladder drainage's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The Food and Drug Administration (FDA) is announcing an educational conference cosponsored with the Society of Clinical Research Associates (SOCRA). The public conference regarding FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process including informed consent documents, regulations relating to drugs, devices, and biologics, as well as inspections of clinical investigators, IRBs, and research sponsors. Date and Time: The public conference will be held on May 13 and 14, 2015, from 8 a.m. to 5 p.m. Location: The conference will be held at The Westin Cincinnati, 21 East Fifth Street, Cincinnati, OH 45202; 513-621-7700. Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $169 plus applicable taxes (available until April 15, 2015, or until the SOCRA room block is filled). Contact: John Fraser, Cincinnati District Office, Food and Drug Administration, 6751 Steger Dr., Cincinnati OH 45237, 513-679-2700, FAX: 513-679-2771 or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292 or 215-822-8644, FAX: 215-822-8633, email: Office@socra.org, Web site: https://www.socra.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Registration: The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. The cost of the registration is as follows: SOCRA member, $575; SOCRA nonmember (includes membership), $650; Federal Government member, $450; Federal Government nonmember, $525; FDA employee, free (fee waived). If you need special accommodations due to a disability, please contact SOCRA (see Contact) at least 21 days in advance. Extended periods of question and answer and discussion have been included in the program schedule. SOCRA designates this education activity for a maximum of 13.3 Continuing Education (CE) Credits for SOCRA CE and Continuing Nurse Education (CNE). SOCRA designates this live activity for a maximum of 13.3 American Medical Association Physicians Recognition Award Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation. Continuing Medical Education for physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for nurses: SOCRA is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation(ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09. Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to ``SOCRA''. Mail to: SOCRA (see Contact for address). To register via the Internet, go to https://www.socra.org/html/ FDA_Conference.htm. Payment by major credit card is accepted (Visa/ MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SOCRA (see Contact).

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name of the Anti-Infective Drugs Advisory Committee. This action is being taken to change the name of this committee on the Agency's list of standing advisory committees.

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). NVPO provides leadership and fosters collaboration among the various federal agencies involved in vaccine and immunization activities. The NVPO also supports the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the ASH in her capacity as the Director of National Vaccine Program on matters related to vaccine program responsibilities. Recognizing that immunizations are given across the lifespan and there are likely to be important differences in vaccine acceptance at different stages of life, in February of 2013 the National Vaccine Advisory Committee accepted an initial charge from the Assistant Secretary for Health (ASH) to report on how confidence in vaccines impacts the optimal use of recommended childhood vaccines in the United States, including reaching Healthy People 2020 immunization coverage targets. Focus of such a report may include understanding the determinants of vaccination acceptance among parents, what HHS should be doing to improve parental confidence in vaccine recommendations and how to best measure confidence in vaccine and vaccination to inform and evaluate interventions in the future. Through a series of teleconferences, electronic communications, presentations and public discussions during the NVAC meetings, a working group identified a number of draft recommendations to further understand and address issues of vaccine confidence in the United States. On behalf of NVAC, NVPO is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in June 2015 at the quarterly NVAC meeting.

In accordance with section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/initiatives/prevention/advisorygrp/ind ex.html.

The Food and Drug Administration (FDA) is extending the comment period for the notice entitled ``Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development; Request for Comments'' that appeared in the Federal Register of February 13, 2015 (80 FR 8089). In the notice, FDA requested comments on identifying potential biomarkers for qualification and describing contexts of use to address areas important to drug development. The Agency is taking this action for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through September 30, 2015.

The National Institute of Neurological Disorders and Stroke (NINDS) Office of Pain Policy is soliciting public comment on the draft National Pain Strategy.

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.

This notice announces the availability of test tools and test procedures approved by the National Coordinator for Health Information Technology (the National Coordinator) for the testing of EHR technology to two 2014 Edition Release 2 EHR certification criteria under the ONC HIT Certification Program. The approved test tools and test procedures for the ``optionaltransitions of care'' certification criterion (Sec. 170.314(b)(8)) and the revised ``view, download, and transmit to 3rd party'' certification criterion (Sec. 170.314(e)(1)) are identified on the ONC Web site at: https://healthit.gov/policy- researchers-implementers/testing-and-test-methods. The test tools and test procedures for all the other 2014 Edition Release 2 EHR certification criteria were previously approved by the National Coordinator.

This document corrects a notice that was published in the Federal Register on March 25, 2015 Volume 80, Number 57, page 15798. The time and date should read as follows: Time and Date: 11:00 a.m.-6:00 p.m., April 15, 2015 (Closed).

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 the reporting and recordkeeping requirements for ``New Animal Drugs for Investigational Uses''.

In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), the Administration for Children and Families is publishing notice of a republication multiple systems of records, including amendments to existing systems, establishment of new systems, and deletion of obsolete systems.

The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jun Yang for a period of 4 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Yang was convicted, as defined in the FD&C Act, of one felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Yang was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 7, 2014 (30 days after receipt of the notice), Mr. Yang had not responded. Mr. Yang's failure to respond constitutes a waiver of his right to a hearing concerning this action.

ATSDR is initiating the development of its 29th set of toxicological profiles (CERCLA Set 29). This notice announces the list of proposed substances that will be evaluated for CERCLA Set 29 toxicological profile development. ATSDR's Division of Toxicology and Human Health Sciences is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the nomination of any additional, non-CERCLA substances that may have public health implications, on the basis of ATSDR's authority to prepare toxicological profiles for substances not found at sites on the National Priorities List. The agency will do so in order to ``. . . establish and maintain inventory of literature, research, and studies on the health effects of toxic substances'' under CERCLA Section 104(i)(1)(B), to respond to requests for consultation under section 104(i)(4), and to support the site- specific response actions conducted by ATSDR, as otherwise necessary.

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 burden hours associated with the animal food industry declaring the presence of certified and noncertified color additives in their animal food products on the animal food label.