Department of Health and Human Services August 31, 2016 – Federal Register Recent Federal Regulation Documents

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-21000
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-20997
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-20996
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-20994
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2016-20936
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry; Availability
Document Number: 2016-20914
Type: Notice
Date: 2016-08-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' The guidance document is notifying blood establishments that collect Whole Blood and blood components, that FDA has determined Zika virus (ZIKV) to be a relevant transfusion- transmitted infection (RTTI) and provides FDA's assessment. The guidance also provides recommendations to reduce the risk of transmission of ZIKV by Whole Blood and blood components. The guidance applies to the collection of Whole Blood and blood components. The guidance does not apply to the collection of Source Plasma. The guidance supersedes the February 2016 document entitled, ``Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry'' (February 2016 guidance), and the March 2016 document entitled, ``Questions and Answers Regarding `Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry' '' no later than 12 weeks after the date of the issuance of this guidance. Implementation of the guidance will be immediate for blood establishments that collect Whole Blood and blood components in States and territories with local transmission of ZIKV by mosquitos, and will be phased in over 4 to 12 weeks in other States and territories using a tiered, risk-based approach. Blood establishments should follow the recommendations in the February 2016 guidance until the recommendations in the guidance document have been fully implemented.
Submission of Warning Plans for Cigars; Draft Guidance for Industry; Availability
Document Number: 2016-20913
Type: Notice
Date: 2016-08-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Warning Plans for Cigars.'' The draft guidance, when finalized, will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan requirements under FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance reiterates the required health warning statements and the requirements for random display and distribution that should be provided in cigar warning plans, and, when finalized, will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan.
Patient Safety Organizations: Voluntary Relinquishment From QAISys, Inc.
Document Number: 2016-20912
Type: Notice
Date: 2016-08-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from QAISys, Inc. of its status as a PSO, and has delisted the PSO accordingly. QAISys, Inc. submitted this request for voluntary relinquishment after receiving a Notice of Preliminary Finding of Deficiency.
National Advisory Committee on Rural Health and Human Services; Notice of Meeting
Document Number: 2016-20911
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017; Correction
Document Number: 2016-20897
Type: Rule
Date: 2016-08-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects typographical errors in the final rule that appeared in the August 5, 2016 Federal Register entitled, ``Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017''.
National Institute of Mental Health; Notice of Meeting
Document Number: 2016-20878
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Center For Complementary & Integrative Health; Notice of Meeting
Document Number: 2016-20877
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-20876
Type: Notice
Date: 2016-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs
Document Number: 2016-20471
Type: Rule
Date: 2016-08-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.