Department of Health and Human Services April 2011 – Federal Register Recent Federal Regulation Documents

The Federal Health IT Strategic Plan: 2011-2015 (``the Plan'') was posted on the ONC Web site on March 25, 2011 and originally open for public comment through Friday, April 22 at 11:59 p.m. (Eastern). This notice serves to announce that the public comment period for the Plan has been extended through Friday, May 6 at 11:59 p.m. (Eastern). In order for your comments to be read and considered, you must submit your comment via the Federal Health IT Buzz Blog: https:// www.healthit.gov/buzz-blog/from-the-onc-desk/hit-strat-plan/.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Civil Money Penalties and No- Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document describes FDA's current policies with respect to civil money penalties and no-tobacco-sale orders for retailers who violate requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to tobacco products, including the FD&C Act requirement that tobacco products may not be sold or distributed in violation of FDA's ``Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' With the release of this final guidance document, several provisions in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) that relate to civil money penalties and no-tobacco-sale orders become effective.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Ames Laboratory in Ames, Iowa, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Ames Laboratory. Location: Ames, Iowa. Job Titles and/or Job Duties: All Department of Energy (DOE) employees, its predecessor agencies, and its contractors and subcontractors who worked in any area of the DOE facility. Period of Employment: January 1, 1942 through December 31, 1970.

The Food and Drug Administration (FDA) is announcing that Ferm Solutions, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of erythromycin thiocyanate as an antimicrobial processing aid in fuel-ethanol fermentations with respect to its consequent presence in byproduct distiller grains used as an animal feed or feed ingredient.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled, ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.'' This guidance document was developed as a special control to support the reclassification of the topical oxygen chamber for extremities (TOCE) from class III (premarket approval) into class II (special controls). This guidance document describes a means by which manufacturers of TOCE may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III into class II (special controls).

This notice announces the application of the American Society for Histocompatibility and Immunogenetics (ASHI) for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas: General Immunology; Histocompatibility; and ABO/Rh typing. We have determined that the ASHI meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant ASHI deeming authority for a period of 5 years.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, 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. This proposed information collection was previously published in the Federal Register in Volume 75, No. 242, pages 79008-79009, on December 17, 2010 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Study of Substance Abuse doc.com Module Project. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a two-year clearance to conduct a research study to assess the efficacy of a specific interactive Web-based teaching module in the field of professional education of healthcare providers. This online module was developed as a work product by the same team of investigators from Drexel University College of Medicine (DUCOM) and University of Pennsylvania School of Medicine (Penn Med) under a contract as part of NIDA's Centers of Excellence (CoE) for Physician Information. This project will assess efficacy of the NIDA CoE online teaching module with educational interventions in enhancing: (1) The knowledge of healthcare professionals about substance use disorders; (2) attitudes of healthcare professionals toward patients with these disorders; and (3) communication skills of healthcare professionals in providing assessment and referral to treatment for patients who abuse substances. The overall goal of this project is to assess the efficacy of an educational intervention, which should result in an increase in the involvement of primary care providers in the screening, managing and, when appropriate, referring patients with substance use disorders. This effort is made according to Executive Order 12862, which directs Federal agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. The project will utilize a randomized cluster controlled trial design that compares the group that receives educational exposure to the set of new educational interventions (NIDA online teaching module plus educational adjuncts) to a control group that receives exposure to the standard medical school or residency educational curriculum related to substance use disorders. The project will use a repeated measures approach to assess the educational intervention's efficacy (i.e., individuals will take surveys before and after exposure to the intervention or to the control curriculum). The outcomes of the study will be based on changes in knowledge, attitudes, and indirect measures of communication skills before and after the intervention, compared with the changes in these parameters in the control group. Frequency of Response: This project will be conducted annually or biennially. Affected Public: Individuals and businesses. Type of Respondents: Medical students and resident physicians. The annual reporting burden is calculated as follows: Estimated Total Annual Number of Respondents: 708; Estimated Number of Responses per Respondent: 4 for medical students; 2 for resident physicians; Average Burden Hours per Response: 0.17. Estimated Total Annual Burden Hours Requested: 377. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of the collection of information concerning requirements relating to FDA's adverse experience reporting (AER) for licensed biological products, and general records associated with the manufacture and distribution of biological products.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of March 23, 2011 (76 FR 16292). The document announced the classifying of ovarian adnexal mass assessment score test system into class II (special controls). The document was published with an incorrect docket number. This document corrects that error.