Department of Health and Human Services April 15, 2016 – Federal Register Recent Federal Regulation Documents
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National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
The NIH OSP is amending portions of the NIH Guidelines in order to provide investigators with biosafety guidance regarding the standards for containment of non-human primates (NHPs) in biosafety level (BL) 4 laboratories and to make such guidance consistent with the expectations articulated in the Centers for Disease Control and Prevention (CDC)/NIH Biosafety in Microbiological and Biomedical Laboratories 5th edition (BMBL). Specifically, the NIH Guidelines will allow for housing of NHPs in open caging in a dedicated animal holding room provided there are two physical barriers between that animal holding room and non-containment space within the laboratory, the animal holding room has negative air pressure with respect to any adjacent non-containment corridors, and there are specific decontamination protocols in place before the door to the animal holding room is opened to allow for the periodic transfer of new animals into the room. These amendments do not change the current containment requirements in the NIH Guidelines but rather offer an alternative for achieving primary containment without compromising safety. In addition, the recertification requirement for biosafety cabinets in BL4 laboratories is updated in recognition of the technological standards for modern biosafety cabinets. The NIH OSP also is updating the validation requirements for equipment responsible for centralized heat decontamination of liquid effluents in laboratories working with large animals. These amendments to the NIH Guidelines will be implemented immediately upon publication in the Federal Register. These changes were developed after extensive consultation with biosafety experts, directors of and principal investigators in BL4 facilities working with NHPs, and CDC's Division of Select Agent and Toxins (DSAT) leadership at a public workshop and discussion at a public Recombinant DNA Advisory Committee (RAC) meeting. Publication in the Federal Register will inform the scientific and biosafety communities.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. We are taking this action in response to a food additive petition filed jointly by Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 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.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices 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.
Announcing the Award of a Single-Source Program Expansion Supplement Grant to the National Resources Center on Domestic Violence, Inc. (NRCDV) in Harrisburg, PA
ACF/ACYF/FYSB/DFVPS, in collaboration with CDC/NIPC/DVP announce the award of $686,000 to NRCDV in Harrisburg, Pennsylvania. The grantee is a technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs, continuums of care, homeless service providers, and housing service providers.
Determination of Regulatory Review Period for Purposes of Patent Extension; CYRAMZA
The Food and Drug Administration (FDA) has determined the regulatory review period for CYRAMZA 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 human biological product.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children
The Health Resources and Services Administration (HRSA) is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of Health and Human Services. HRSA is seeking nominations of qualified candidates to fill three positions on the Committee.
Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 10, 2014 (79 FR 13308). The document withdrew approval of 8 new drug applications (NDAs) and 46 abbreviated new drug applications (ANDAs) for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of NDA 017507, held by Xanodyne Pharmaceuticals, Inc. (Xanodyne). Xanodyne wrote to FDA asking the Agency to withdraw approval of NDA 017507 and waiving its opportunity for a hearing. FDA confirms the withdrawal of approval of NDA 017507.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes
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.
Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to non-exempt infant formulas.
Data Integrity and Compliance With Current Good Manufacturing Practice; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Data Integrity and Compliance With CGMP.'' The purpose of the draft guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The draft guidance is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide the Agency's current thinking on the creation and handling of data in accordance with CGMP requirements.
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Pharmaceutical Distribution Supply Chain Pilot Projects; Request for Information
The Food and Drug Administration (FDA) is soliciting information regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.
Proposed Collection; 60-Day Comment Request; NLM PEOPLE LOCATOR® System
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, NLM Project Clearance Liaison, Office of Administrative and Management Analysis Services, OAMAS, NLM, NIH, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 496-5441, or Email your request, including your address to: sharlipd@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: NLM People Locator System 0925-0612, Expiration Date: 07/31/2016, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: This collection of data is intended to assist in the reunification of family members and friends who are separated during a disaster. Experience in operational drills and during real-world disasters such as the January 2010 earthquakes in Haiti demonstrates that family members and loved ones are often separated during disasters and have significant difficulty determining each other's safety, condition, and location. Reunification can not only improve their emotional well-being during the recovery period, but also improve the chances that injured victims will be cared for once they are released from urgent medical care. Family and friends are also a valuable source of medical information that may be important to the care of injured victims (e.g., by providing family or personal medical history, information about allergies). The National Library of Medicine (NLM) aims to assist Federal, State and Local agencies in disaster relief efforts and to serve its mission of supporting national efforts to the response to disasters via the PEOPLE LOCATOR[supreg] system and related mobile app (ReUniteTM) developed as part of the intramural Lost Person Finder (LPF) R&D project. The information collection would support efforts to reunite family and friends who are separated during a disaster. Information about missing (``lost'') people would be collected from family members or loved ones who are searching for them. Information about recovered (``found'') people could be provided by medical personnel, volunteers and other relief workers assisting in the disaster recovery effort. Information collected about missing and recovered persons would vary including any one of the following and possibly all: A photograph, name (if available for a found person), age group (child, adult) and/or range, gender, status (alive and well, injured, deceased, unknown), and location. The information collection would be voluntary. It would be activated only during times of declared emergencies, training and demonstration support activities, and would operate in declared emergencies until relief efforts have ceased in response to a particular disaster. This data collection is authorized pursuant to sections 301, 307, 465 and 478A of the Public Health Service Act [42 U.S.C. 241, 242l, 286 and 286d]. NLM has in its mission the development and coordination of communication technology to improve the delivery of health services. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 7,500.
Proposed Collection; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-Wave 4 of Data Collection (NIDA)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing or request more information on the proposed project, contact: Kevin P. Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 5185; or call non-toll-free number (301) 443-8755; or Email your request, including your address to: PATHprojectofficer@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Population Assessment of Tobacco and Health (PATH) StudyWave 4 of Data Collection (NIDA)0925-0664, expiration date 8/31/2018REVISIONNIDA, NIH, in partnership with the Food and Drug Administration (FDA). Need and Use of Information Collection: This is a revision request (OMB number 0925-0664, expiration date 8/31/2018) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the fourth wave of data collection. The PATH Study is a large national longitudinal cohort study on tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17. On an annual basis, the PATH Study conducts interviews with and collects biospecimens from adults and youth to help inform the development, implementation, and evaluation of tobacco-product regulations by FDA in meeting its mission under the Family Smoking Prevention and Tobacco Control Act (TCA) to regulate tobacco products, including tobacco-product advertising, labeling, marketing, constituents, ingredients, and additives. The longitudinal design of the PATH Study provides it with the capacity to measure and report within-person changes and between-person differences in tobacco product use behaviors and health effects within the cohort over time. These data will help to inform regulatory decisions and actions by FDA and FDA's evaluations of associations between its regulations and tobacco use behaviors and health indicators in the population. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 105,079.
Announcement of the Award of a Single-Source Expansion Supplement Grant to National Safe Place Network in Louisville, KY
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS), announces the award of a single-source expansion supplement grant of $852,000 to the National Safe Place Network located in Louisville, KY, to support costs associated with the expansion of the scope of approved activities under its award for the Runaway and Homeless Youth Training and Technical Assistance Center (RHYTTAC).
Announcement of the Award of a Single-Source Expansion Supplement Grant to the Washington State Department of Social and Health Services in Lacey, WA
The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), Division of Program Innovation, announces the award of a single-source program expansion supplement grant in the amount of $34,568 to the Washington State Department of Social and Health Services in Lacey, WA, to support the development of additional dissemination tools such as reports and web-based trainings on the lessons learned and early findings from the Evaluation of the Behavioral Interventions for Child Support Services of the Behavioral Interventions for Child Support Services (BICS) Demonstration. In FY 2014, OCSE competitively awarded a cooperative agreement to the Washington State Department of Social and Health Services to conduct a 5-year evaluation of OCSE's national demonstration called Behavioral Interventions for Child Support Services (BICS) under Funding Opportunity Announcement (FOA) number HHS-2014-ACF-OCSE-FD- 0822. Under this FOA, a total of $1.7 million of 1115 funds are made available over the five year project period to conduct this evaluation. The Washington State Department of Social and Health Services was the only grantee that received funding under this FOA.
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