Department of Health and Human Services 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``eCopy Program for Medical Device Submissions.'' The purpose of the draft guidance is to explain the new electronic copy (eCopy) program for medical device submissions. The draft guidance describes how FDA plans to implement the eCopy Program under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version. This draft guidance is not final nor is it in effect at this time.

This document corrects technical errors in the regulations text of the final rule that appeared in the August 31, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers'' (hereinafter referred to as the FY 2013 IPPS/LTCH PPS final rule).

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The U.S. Department of Health and Human Services (HHS) solicits written comments regarding new objectives proposed to be added to Healthy People 2020 since its launch in December 2010 and written comments proposing new objectives to be included within existing Healthy People 2020 Topic Areas. Public participation helps shape Healthy People 2020, its framework, objectives, organization, and targets. Healthy People 2020 will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2020 reflects current public health priorities and public input. The updated set of Healthy People 2020 objectives will be incorporated on www.healthypeople.gov. This set will reflect further review and deliberation by the Topic Area workgroups, Federal Interagency Workgroup on Healthy People 2020, and other Healthy People 2020 stakeholders.

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), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Type of Information Collection Request: New. Need and Use of Information Collection: The objective of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program is to ensure safe and effective blood banking and transfusion medicine practices through a comprehensive, multifaceted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. The conduct of epidemiologic, survey, and laboratory studies is the cornerstone of REDS-III and its predecessors, the REDS and REDS-II programs. Over the past 20 years, the National Heart, Lung, and Blood Institute (NHLBI) REDS programs have proven to be the premier research programs in blood collection and transfusion safety in the United States. Successive renditions of the REDS programs have built upon the many successes that this research network has realized over the years while being responsive to changing research and clinical needs, and adapting to emerging priorities. Research findings have served to improve the screening of donors and collected blood products, blood banking practices, diagnoses, and the basic science principles of transfusion medicine. While significant progress has been made, transfusion therapya very commonly used therapy affecting about six million recipients annually in the U.S.remains one of the least understood medical procedures. REDS-II conducted studies of blood donor health but much more needs to be learned, including how donor genetic or environmental factors may affect the quality of collected blood components and influence non-infectious transfusion complications in recipients. Additionally, there is always the potential that a new, emerging or re- emerging infection may pose a threat to the safety of the U.S. blood supply. Much of the success of the REDS programs was due to their ability to respond in a timely fashion to potential blood safety threats such as West Nile Virus (WNV) in 2002 or Xenotropic Murine Leukemia Virus Related Virus (XMRV) in 2009. Globally, the threat of HIV and other blood-borne infections to blood safety remains real and has to be closely monitored. Therefore, continuing collection of new scientific evidence through REDS-III is both critical to public health in the U.S. and to countries struggling with the HIV epidemic where blood safety and availability are major concerns. Additionally, the research areas encompassed in REDS-III have been and continue to be hypothesis generating, leading to the development of new basic and translational research projects with implications well beyond the fields of blood banking and transfusion medicine. REDS-III has also been charged with the tasks of education and training and integration of these components in a transfusion medicine research network. With this submission, the REDS-III Study seeks approval from OMB to develop research studies with data collection activities using focus groups, cognitive interviews, questionnaires and/or qualitative interviews following all required informed consent procedures for respondents and parents/caregivers as appropriate. With this generic clearance, study investigators will be able to use the OMB-approved data collection methods where appropriate to plan and implement time sensitive studies. Such studies that fall within the overall scope of this submission will be subjected to expedited review and approval by OMB before their implementation. Additionally, studies are reviewed by an NHLBI Observational Study Monitoring Board (OSMB) and by all relevant IRBs. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Males and females 16 years old or older. The annual reporting burden is as follows: Estimated Number of Respondents: 6,882; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 1 hour; Estimated Total Annual Burden Hours Requested: 6,826. The annualized total costs to all respondents except for the Brazil and South Africa studies are estimated at $53,964 (based on $9.00 per hour). The annualized total cost to all respondents for the Brazil and South African studies is $2,940. There are no capital, operating, or maintenance costs to the respondents.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 16, 2012 (FR 77, 41791) and allowed 60-days for public comment. One public comment was received and a response was sent. The comment referenced alternative research that is unrelated to cancer screening. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Attention: NIH Desk Officer, Office of Management and Budget, at OIRA_ submission@omb.eop.gov or by fax to 202-395-6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Christine D. Berg, Chief, Early Detection Research Group, National Cancer Institute, NIH, EPN Building, Room 3100, 6130 Executive Boulevard, Bethesda, MD 20892, or call non-toll-free number 301-496-8544 or email your request, including your address to: bergc@mail.nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Proposed Collection: Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), OMB No: 0925-0407, Expiration Date 9/30/2014, Revision, National Cancer Center (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This trial was designed to determine if screening for prostate, lung, colorectal, and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 255,700 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then through 2014. During the first approval period a pilot study was conducted to evaluate recruitment methods and data collection procedures. Recruitment was completed in 2001, screening was completed in 2006, and data collection continues through 2016. When participants enrolled in the trial they agreed to be followed for at least 13 years from the time of enrollment. In 2011, participants were re-consented for at least an additional five years of follow-up. The current number of respondents is limited to the approximately 94,000 participants being actively followed up. This is down from the initial total. The reports on screening and prostate, lung, colorectal and ovarian cancer mortality based on this trial have been published in peer review medical journals. The additional follow-up will provide data that will clarify further the long term effects of the screening on cancer incidence and mortality for the four targeted cancers. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 31,813.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Birich Technologies, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following U.S. Patent Applications (and all continuing applications and foreign counterparts): Serial No. 61/045,088 entitled, ``COMPOSITIONS AND METHODS FOR DELIVERING INHIBITORY OLIGONUCLEOTIDES'' [HHS Ref. E-051- 2008/0-US-01]; Serial No. 61/333,512 entitled, ``Peptide Inhibitors of Interferon Gamma and Interleukin 10 Signaling'' [HHS Ref. E-167-2010/0- US-01]; and Serial No. 60/987,340 entitled, ``Diagnostic and Therapeutic Applications of a p53 Isoform in Regenerative Medicine, Aging and Cancer'' [HHS Ref. E-033-2008/0-US-01]. The patent rights in these inventions have been assigned or exclusively licensed to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide, and the field of use may be limited to: