Department of Health and Human Services September 28, 2015 – Federal Register Recent Federal Regulation Documents
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Proposed Collection; 60-Day Comment Request; Evaluation of the Enhancing Diversity of the NIH-Funded Workforce Program (NIGMS)
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 of General Medical Sciences, 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: Dr. Michael Sesma, Chief, Postdoctoral Training Branch, Division of Training, Workforce Development, and Diversity, NIGMS, 45 Center Drive, Room 2AS43H, Bethesda, MD 20892, or call non-toll-free number (301) 594-3900, or Email your request, including your address to: msesma@nigms.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: Evaluation of the Enhancing the Diversity of the NIH-funded Workforce Program Consortium (DPC), National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH). Need and Use of Information Collection: The goal of the DPC is to address a unique and compelling need identified by NIH, namely to enhance the diversity of well-trained biomedical research scientists who can successfully compete for NIH research funding and/or otherwise contribute to the NIH-funded scientific workforce. The DPC is a national collaborative through which awardee institutions, in partnership with NIH, aim to enhance diversity in the biomedical research workforce through the development, implementation, assessment and dissemination of innovative and effective approaches to: (a) Student outreach, engagement, training, and mentoring, (b) faculty development, and (c) institutional research training infrastructure. The Coordination and Evaluation Center (CEC) will evaluate the efficacy of the training and mentoring approaches implemented across a variety of contexts and populations and will disseminate information to the broader research community. The planned consortium-wide data collection and evaluation will provide comprehensive information about the multi- dimensional factors (individual, institutional, and faculty/mentor) that influence student and faculty success, professional development, and persistence within biomedical research career paths across a variety of contexts. The planned data collection, and the resulting findings, is projected to have a sustained, transformative effect on biomedical research training and mentoring nationwide. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 70,260.
Emergency Funding for New York City Legionella Outbreak
The U.S. Centers for Disease Control and Prevention (CDC) is providing $1,300,000 in urgent funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement to the New York City Department of Health (NYC HD)to combat an outbreak of Legionella. As of August 18, 2015 NYC HD has identified 127 cases and 12 deaths associated with this public health emergency. These funds will be used by NYC HD to (1) create sustainable environmental and laboratory capacity at NYC HD to respond to Legionella outbreak, (2) enhance laboratory capacity of detection, isolation, and molecular characterization of clinical and environmental strains at the New York City public health laboratory, (3) include sequence-based typing and eventually whole genome sequencing, and (4) allow NYC HD to characterize the geographic distribution of Legionella strains throughout New York City, support the new public health engineering program to monitor the compliance of building owners with the new cooling tower regulations, and work with CDC to evaluate the impact of these regulations.
Proposed Collection; 60-Day Comment Request; Collection of Customer Services, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's Cancer Information Service (CIS) Clients (NCI)
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 Cancer Institute (NCI), 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: Mary Anne Bright, NCI Office of Communications and Public Liaison, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number 240-276- 6647 or Email your request, including your address to: brightma@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: Collection of Customer Service, Demographic, and Smoking/Tobacco use Information from the National Cancer Institute'sCancer Information Service (CIS) Clients (NCI), 0925-0208, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Cancer Institute (NCI) currently collects: (1) Customer service and demographic information from clients of the Cancer Information Service (CIS) in order to properly plan, implement, and evaluate cancer education efforts, including assessing the extent by which the CIS reaches and impacts underserved populations; (2) smoking/tobacco use behavior of individuals seeking NCI's smoking cessation assistance through the CIS in order to provide smoking cessation services tailored to the individual client's needs and track their smoking behavior at follow up. This is a request for OMB to approve a revised submission for an additional three years to provide ongoing customer service, collection of demographic information, and brief customer satisfaction information from NCI Cancer Information Service (CIS) Clients for the purpose of program planning and evaluation. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,879.
Biosimilar User Fee Act; Public Meeting
The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect user fees for the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA begin the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment on the BsUFA performance goals as the Agency begins the process to reauthorize the program in FYs 2018-2022.
M7(R1) Addendum to ICH M7; International Conference on Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound- Specific Acceptable Intakes.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance, an addendum to the ICH M7 guidance of May 28, 2015, provides guidance on acceptable intake limits derived for some chemicals that are considered to be mutagens and carcinogens, and that were selected because they are commonly used in pharmaceutical manufacturing or are useful in illustrating the principles for deriving compound-specific intakes as described in ICH M7. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
Labeling Lower-Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on the topic of the labeling for lower-dose estrogen products delivered vaginally, intended to treat moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause. Lower-dose estrogen products means products that contain less than the 0.625 milligrams (mg) of conjugated estrogens used in the Women's Health Initiative Study, and estradiol products containing 0.0375 mg and below. Lower-dose estrogen products are now approved for the treatment of moderate to severe symptoms of VVA due to menopause, and some in the scientific/medical community have questioned whether the current ``Boxed Warnings'' section in the labeling is applicable in whole or in part to these lower-dose estrogen products. This meeting, a scientific workshop, will provide an opportunity for FDA to seek input from experts on the Boxed Warnings section, estrogen exposure data, and pharmacokinetic (PK)/ pharmacodynamic (PD) relationships relative to labeling lower-dose estrogen-alone products intended to treat moderate to severe symptoms of VVA due to menopause.
Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2016 and outlines the payment procedures for such fees.
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