Department of Health and Human Services December 6, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Proposed Collection; Comment Request (60-Day FRN): The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (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 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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 in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact: Jane Hoppin, Sc.D., Epidemiology Branch, National Institute of Environmental Health Sciences, NIH, 111 T.W. Alexander Drive, PO Box 12233, MD A3-05, Research Triangle Park, NC 27709, or call non-toll-free number 919-541-7622, or email your request, including your address to: hoppin1@niehs.nih.gov. 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: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture, 0925-0406, Expiration Date 5/31/2013REVISIONNational Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this information collection is to continue and complete updating the occupational and environmental exposure information as well as medical history information for licensed pesticide applicators and their spouses enrolled in the Agricultural Health Study. This represents a request to complete phase IV (2013-2015) of the study and to continue and complete the buccal cell collection and the Study of Biomarkers of Exposures and Effects in Agriculture (BEEA). The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environment. The phase IV follow up data will be collected by using one of three methods of the cohort member's choosing: self-administered computer assisted web survey (CAWI); self-administered paper-and-pen (Paper/pen); or an interviewer administered computer assisted telephone interview (CATI). Proxy interviews for those cohort members unable to complete the follow up will be completed by using one of the three methods as well. Secondary objectives include evaluating biological markers that may be associated with agricultural exposures and risk of certain types of cancer. Questionnaire data will be collected by using computer assisted telephone interview (CATI) and in- person interview (CAPI) systems for telephone screeners and home visit interviews, respectively. Some respondents will also be asked to participate in the collection of biospecimens including blood, urine, and buccal cells (loose cells from the respondent's mouth). The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10,465.
Announcement of Requirements and Registration for “Mobilizing Data for Pressure Ulcer Prevention Challenge”
According to the Agency for Healthcare Research and Quality (AHRQ), each year more than 2.5 million people in the United States are affected by skin breakdowns that cause pain, increased risk for serious infection, and increased health care utilization. The National Pressure Ulcer Advisory Panel (NPUAP) serves as the authoritative voice for improved patient outcomes in pressure ulcer prevention and treatment through public policy, education and research, and publishes resources and documents at www.npuap.org/. AHRQ has published an acute care toolkit for prevention of pressure ulcers at www.ahrq.gov/ research/ltc/pressureulcertoolkit/putool7b.htm. Many of today's electronic documentation systems require nurses to enter oversimplified text narratives or check boxes. Even when documentation systems include standard terminology, the data is locked inside proprietary software. Development of a mobile health application (app) for iPhone, iPad, or Android devices that implements standards for documenting and exchanging health information about pressure ulcers will facilitate meaningful information exchange and improve the patient experience and coordination of care across the healthcare continuum while reducing health care costs. A mobile health app would support nurses, in partnership with patients, families, caregivers and the multidisciplinary health care team, to reduce the incidence and severity of pressure ulcers. There are two goals for the Mobilizing Data for Pressure Ulcer Prevention Challenge. First, the development of a standard bedside pressure ulcer assessment tool, and second, the broader goal to promote the integration of nursing content into common information models and Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT). With documentation tools that include common information models and standard terminology for structured representation of appropriate nursing knowledge, nurses achieve the ability to track changes in patient status and to exchange information to improve continuity of care. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 11- 358).
Announcement of Requirements and Registration for healthfinder.gov Mobile App Challenge
healthfinder.gov is a free, award-winning federal Web site that features reliable, evidence-based, and actionable health information presented in plain language. The site has approximately 1 million visits each month. The prevention and wellness information and resources educate and motivate users to incorporate healthy behaviors into their lives by taking small steps towards improving their health. healthfinder.gov also provides information about U.S. Preventive Services Task Force recommended preventive services, giving the public personalized information and resources about these services. It also offers decision support for all of the clinical preventive services covered by the Affordable Care Act. The Office of Disease Prevention and Health Promotion (ODPHP) is launching a healthfinder.gov Mobile App Challenge to promote the development of a mobile app that will facilitate the customized use of prevention and wellness information featured on the Web site. The purpose is to provide a customized tool to reach health consumers where they are making health decisions so that they can improve their health and the health of loved ones.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.
Compliance Guidance for Small Business Entities on Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Notice of Availability
The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled ``Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use; Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with the requirements of the final rule addressing labeling and effectiveness testing requirements for over-the counter (OTC) sunscreen drug products. The guidance describes the requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Enforcement Fairness Act.
Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.'' This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular, the guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products, including prescription and nonprescription products.
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Proposed Modification of Dispensing Restrictions for Buprenorphine and Buprenorphine Combination as Used in Approved Opioid Treatment Medications
This final rule amends the federal opioid treatment program regulations by modifying the dispensing requirements for buprenorphine and buprenorphine combination products approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. In particular, this rule would allow opioid treatment programs more flexibility in dispensing take-home supplies of buprenorphineremoving restrictions on the time a patient needs to be in treatment in order to receive take-home suppliesafter the assessment and documentation of a patient's responsibility and stability to receive opioid addiction treatment medication. Opioid treatment programs that use these products in the treatment of opioid dependence will continue to adhere to all other federal treatment standards established for methadone.
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