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

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by May 29, 2015. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the Web site for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH Web site under the heading About OMH.

The notice announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Cobalt and Certain Cobalt Compounds. This document was prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at https:// ntp.niehs.nih.gov/go/38853.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 February 13, 2015, page 8723 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), 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. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Vaccines and Related Biological Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0331 (which expires on August 21, 2015) through December 31, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In summarizing the challenge that will be issued by your agency, please answer the following four questions:

This final rule amends the regulations implementing the National Organ Transplant Act of 1984, as amended, (NOTA) pursuant to statutory requirements of the HIV Organ Policy Equity Act (HOPE Act), enacted in 2013. In accordance with the mandates of the HOPE Act, this regulation removes the current regulatory provision that requires the Organ Procurement Transplantation Network (OPTN) to adopt and use standards for preventing the acquisition of organs from individuals known to be infected with human immunodeficiency virus (HIV). In its place, this regulation includes new requirements that organs from individuals infected with HIV may be transplanted only into individuals who are infected with HIV before receiving such organs and who are participating in clinical research approved by an institutional review board, as provided by regulation. The only exception to this requirement of participation in such clinical research is if the Secretary publishes a determination in the future that participation in such clinical research, as a requirement for transplants of organs from individuals infected with HIV, is no longer warranted. In addition, this regulatory change establishes that OPTN standards must ensure that any HIV-infected transplant recipients are participating in clinical research in accordance with the research criteria to be published by the Secretary. Alternately, if and when the Secretary determines that participation in such clinical research should no longer be a requirement for transplants with organs from donors infected with HIV to individuals infected with HIV, the regulation mandates that the OPTN adopt and use standards of quality, as directed by the Secretary, consistent with the law and in a way that ensures the changes will not reduce the safety of organ transplantation.

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) 2016. 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 Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry on the implementation of the mandatory food recall provisions of the FDA Food Safety Modernization Act (FSMA). The guidance is in the form of Questions and Answers and provides answers to common questions that might arise about the mandatory recall provisions and FDA's plans for their implementation.

The Food and Drug Administration (FDA) has determined the regulatory review period for OVUGEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of U.S. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for HVAD ROTARY BLOOD PUMP and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.