Department of Health and Human Services December 23, 2015 – Federal Register Recent Federal Regulation Documents

The Office of the Assistant Secretary for Preparedness and Response (ASPR), located within the U.S. Department of Health and Human Services, announces the launch of the ``My Preparedness Story: Staying Healthy and Resilient'' Video Challenge. Natural disasters and other emergencies can happen anywhere and at any time. Taking action ahead of an emergency can help individuals, families, and communities fully prepare to prevent or minimize potential health impacts. Young people can help their family, friends, and community become stronger by protecting their health during disasters and every day. For example, some can do it by volunteering in a health center or with a local Medical Reserve Corps Unit, learning first aid skills, developing an emergency plan, preparing an emergency kit, or educating their family and friends about actions they can take to be healthy. This contest invites young people between the ages of 14 and 23 to create a short video, 60 seconds or less, that answers the question, ``How are you helping family, friends, and community to protect their health during disasters and every day?''

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual document solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products'' that appeared in the Federal Register of December 15, 2015 (80 FR 77637). The document solicited comments on the bar code label requirements for human drug and biological products. The document was published with an incorrect docket number. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry.'' The guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with revised donor deferral recommendations for individuals at increased risk for transmitting human immunodeficiency virus (HIV) infection. The guidance document recommends corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification, product management, and testing procedures. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2015 and supersedes the memorandum to blood establishments entitled ``Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products'' dated April 23, 1992 (1992 blood memo). While this guidance represents FDA's current thinking on the subject, our recommendations may evolve over time as new scientific evidence becomes available.

The Food and Drug Administration (FDA or the Agency) is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the NIEHS, the National Institutes of Health, 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 September 16, 2015, Pages 55634-55635, 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 Environmental Health Sciences (NIEHS), 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.

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.