Department of Health and Human Services November 24, 2014 – Federal Register Recent Federal Regulation Documents

Proposed Collection; 60-Day Comment Request Electronic Prior Approval Submission System (ePASS) (NHLBI)
Document Number: 2014-27762
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
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 Heart, Lung and Blood Institute (NHLBI), 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: Ms. Suzanne White, 6701 Rockledge, Office of Grants Management, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr., MSC 7926, Bethesda, MD 20892-7926, or call non-toll-free number 301-435-0166, or Email your request, including your address to whitesa@nhlbi.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: Electronic Prior Approval Submission System (ePASS), 0925New, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose and use of the information collection for this project is to collect and track certain requests (such as budget modifications or undertaking particular activities) from NIH grantees in an electronic format. This new electronic system, ePASS (electronic Prior Approval Submission System), will enable grantees to have a standard way to submit requests for their projects per NIH policy. The grantee will initiate a request for a certain action as required by NIH policy: Use of unobligated balances/carryover, change of PI, change of effort, Training Grant (NRSA) waivers, significant rebudgeting, 2nd and 3rd no cost extensions, and change of scope. These are all prior approvals as required by the NIH Grants Policy, and need to be reviewed and approved by the NHLBI. ePASS will provide a template to ensure that all specific points are addressed and documented in the official grant file. All information is submitted via the internet, tracked in ePASS, and the documentation will automatically be forwarded to the official grant file. The system will ensure that individuals authorized by the grantee are submitting requests and that the appropriate NIH staff is receiving the requests. The requests will be template driven so that the grantee is including the minimally required information, thus eliminating the usual back and forth to obtain missing information. Forms will have automatic fill-in capability that will reduce typos in grant numbers and PI names, further reducing approval time. Reminders will be sent to NIH staff within ePASS based on roles to ensure timely responses to the grantee. The system will facilitate email communication with applicants by automatic notifications when applications are received and when NIH has made a determination regarding a request (approval issued or request denied with explanation for denial). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 470.
Proposed Collection; 60-Day Comment Request; Assessing an Online Process To Study the Prevalence of Drugged Driving in the U.S.: Development of the Drugged Driving Reporting System
Document Number: 2014-27760
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
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), the 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Harold Perl, Ph.D., Chief, Prevention Research Branch, Division of Epidemiology, Services & Prevention Research, NIDA, 6001 Executive Blvd., Rockville, MD 20852 or call this non-toll-free number (301) 443-6504, or email your request, including your address to: hperl@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: Assessing an Online Process to Study the Prevalence of Drugged Driving in the U.S: Development of the Drugged Driving Reporting System. Type of Information Collection Request: 0925- NEW. National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: The study seeks to provide an improved understanding of the prevalence of drugged driving among adult drivers in the U.S and will assess the effectiveness of the online survey implementation process. The primary objectives of the study are to: (a) To provide comprehensive data on drugged driving; (b) determine if the Drugged Driving Survey Instrument (DDS) is an effective and accurate measure of drugged driving among licensed U.S. Drivers aged 18 and older; and, (c) to assess the effectiveness of the survey implementation process, including various levels of incentives for participation to determine the appropriate/optimal incentive amount needed to obtain the desired number of total survey respondents within the timeframe within which survey data will be collected. The findings will provide valuable information concerning various aspects of substance use and driving behavior, including: (1) Demographic information about drivers who do and do not drive while impaired by medication and/or drugs (e.g. age, zip code, type of driver's license); (2) which drugs/medications are most likely to be used while driving; (3) drivers' beliefs and attitudes toward drugged driving. OMB approval is requested for 2 years. There are no direct costs to respondents other than their time. The total annualized estimated burden hours are 750.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-27756
Type: Notice
Date: 2014-11-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Announcement of the Award of a Single-Source Expansion Supplement Grant to National Safe Place in Louisville, KY
Document Number: 2014-27738
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, Administration for Children and Families
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 $610,000 to Safe Place in Louisville, KY, to support costs associated with the expansion of the scope of approved activities under their award for the Runaway and Homeless Youth Training and Technical Assistance Center (RHYTTAC).
Medicare Program; Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Technical Amendment
Document Number: 2014-27737
Type: Rule
Date: 2014-11-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This technical amendment corrects codification, terminology, and technical errors in the requirements for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) at 42 CFR 424.57.
New Clinical Trials Demographic Data; Availability for Comment
Document Number: 2014-27732
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of Demographic Subgroup Data for FDA Approved Products on FDA's Internet Web site. This new posting implements Action 3.1 from Priority 3 of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan designed to improve the availability and transparency of clinical trial demographic subgroup data. FDA is requesting comments on the format, content, and overall usability of the site to determine whether this approach is user friendly to the public.
Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments
Document Number: 2014-27713
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Final Guidance for Industry; Availability
Document Number: 2014-27693
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.'' The guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The guidance is intended to assist human drug compounders that elect to register as outsourcing facilities in registering, re-registering, or de-registering with FDA. The guidance provides information on how an outsourcing facility should submit facility registration information electronically in structured product labeling (SPL) format using FDA's electronic submission system. This guidance reflects the Agency's current thinking on the issues addressed by the guidance.
Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act; Guidance for Industry; Availability
Document Number: 2014-27692
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.'' The guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.
Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance
Document Number: 2014-27691
Type: Notice
Date: 2014-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled ``Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The revised draft guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Such compounders must report information on the drugs they have compounded in Structured Product Labeling (SPL) format using FDA's electronic submissions system. This revised draft guidance supersedes a draft guidance entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.''
Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma
Document Number: 2014-27680
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications:
Request for Comment on Draft Vaccines Adverse Event Reporting System (VAERS) 2.0 Form
Document Number: 2014-27678
Type: Notice
Date: 2014-11-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is publishing this notice requesting public comment on the proposed VAERS 2.0 form, which is intended to replace the current VAERS-1 form (https:// vaers.hhs.gov/resources/vaers_form.pdf). CDC and the U.S. Food and Drug Administration (FDA) co-administer the Vaccines Adverse Event Reporting System (VAERS), a post-licensure (i.e., after vaccines have been licensed by the FDA and are being used in the community) reporting system that accepts submitted reports of adverse events that occur after vaccination from healthcare providers, manufacturers, and the public. Healthcare providers and vaccine manufacturers are required to submit VAERS reports. The National Childhood Vaccine Injury Act of 1986, section 2125 of the Public Health Service Act (42 U.S.C. 300aa- 25) authorized VAERS. The current VAERS form has been used since 1990.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-27674
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2014-27673
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2014-27672
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2014-27671
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2014-27670
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2014-27669
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2014-27668
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2014-27667
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2014-27666
Type: Notice
Date: 2014-11-24
Agency: Department of Health and Human Services, National Institutes of Health