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

The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-11 Meeting.'' The purpose of the meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR-11 meeting that will be held July 12-14, 2017, in Brasilia, Brazil.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee 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.

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 ``Childhood Blood Lead Surveillance (CBLS) and Adult Blood Lead Epidemiology and Surveillance (ABLES).'' The National Center for Environmental Health (NCEH) is leading a new three-year information collection request (ICR) that covers two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH). CDC requests an annual time burden of 1,120 burden hours for both collections.

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 a revision to the information collection project approved under OMB Control number 0920- 1146 (expiration date 11/30/2019), Survey of Surveillance Records of Aedes aegypti and Aedes albopictus from 1960 to Present.

The Food and Drug Administration (FDA, Agency, or we) is publishing three waivers from the requirements of the Sanitary Transportation of Human and Animal Food (the Sanitary Transportation rule). The Agency is taking this action in accord with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C 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) has determined that CEDAX (ceftibuten dihydrate) for oral suspension, 90 milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ceftibuten dihydrate for oral suspension, 90 mg/5 mL and 180 mg/5 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Medical Device Conference (MedCon).'' This 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge. Million Hearts[supreg] is a national initiative to prevent one million heart attacks and strokes by 2022. Achieving this goal means 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to health care, and community approaches, such as strengthening tobacco control and promoting physical activity. For more information about the initiative, visit https://millionhearts.hhs.gov/. To support improved blood pressure control, HHS/CDC is announcing the 2017 Million Hearts[supreg] Hypertension Control Challenge. The challenge will improve understanding of successful implementation strategies at the health system level by motivating clinical practices and health systems to strengthen their hypertension control efforts. It will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, strategies, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke, proposing that FDA repeal the color additive regulation providing for the use of lead acetate in cosmetics intended for coloring hair on the scalp.

The National Heart, Lung, and Blood Institute (NHLBI), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to Corvidia Therapeutics Inc. (Corvidia) located in Waltham, MA and incorporated under the laws of Delaware.

This proposed rule would delay the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017. The current effective date for the final rule is July 13, 2017, and this rule proposes to delay the effective date for an additional 6 months until January 13, 2018. This proposed rule would also make two conforming changes to dates that are included in the regulations text.