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

The Food and Drug Administration (FDA) has determined the regulatory review period for CONVENIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a series of studies, Examination of Online Direct-to-Consumer Prescription Drug Promotion. These studies are designed to test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug Web sites.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: `Computer Crossmatch' (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type)'' dated April 2011. The guidance document provides blood establishments that perform compatibility testing using a computer crossmatch system to perform computerized matching of blood with recommendations consistent with current good manufacturing practice (CGMP) requirements. Blood establishments are required to have standard operating procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type. The guidance describes practices that we believe satisfy those requirements to help ensure detection of an incompatible crossmatch when using a computerized system for matching a donor's cell type with a recipient's serum or plasma type. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: `Computer Crossmatch' (Electronic Based Testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type)'' dated June 2007.

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 Child Health and Human Development (NICHD), 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.

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 Child Health and Human Development (NICHD), 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.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Junghee J. Shin, PhD, New York Medical College: Based on the report of an investigation conducted by New York Medical College (NYMC) and additional analysis by the Office of Research Integrity (ORI) in its oversight review, the U.S. Public Health Service (PHS) found that Junghee J. Shin, PhD, former graduate student, NYMC, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI048856 and R01 AI043063. PHS found that the Respondent engaged in research misconduct by falsifying data in Figure 4 of a manuscript submitted to the journal Infection and Immunity (Shin, J.J., Godfrey, H.P., & Cabello, F.C. ``Expression and localization of BmpC in Borrelia burgdorferi after growth under various environmental conditions.'' Submitted to Infection and Immunity; hereafter referred to as the ``manuscript'') and Figure 5 of a paper published in Infection and Immunity (Shin, J.J. Bryksin, A.V., Godfrey, H.P., & Cabello, F.C. ``Localization of BmpA on the exposed outer membrane of Borrelia burgdorferi by monospecific anti- recombinant BmpA rabbit antibodies.'' Infection and Immunity 72(4):2280-2287, April 2004; hereafter referred to as the ``paper.'' Retracted in: Infection and Immunity 76(10):4792, October 2008). Specifically, NYMC and ORI found that: Dr. Shin falsified microscopic immunofluorescence blank images in Figure 4 of the manuscript (top row, 1st, 2nd, 4th, and 5th panels, and bottom row, 1st panel) and Figure 5 of the paper (top row, 1st and 5th panels, lower 1st panel) by using one blank image from an unknown experiment to falsely represent the preimmunization control conditions (intact cells and methanol fixation) as well as the negative staining of anti-BmpC and anti-FlaB in Figure 4 and anti-FlaB in Figure 5 on intact cells. Dr. Shin falsified at least one of two images in Figure 4 of the manuscript and Figure 5 of the paper by using different portions of a green-red pair of microscopic immunofluorescence images (1230036.tif and 1230037.tif) because unfixed cells staining positive for BmpA in the top row, 4th panel, of Figure 5 were the same unfixed cells purportedly positive for OspA in the top row, 3rd panel, of Figure 4. Dr. Shin falsified at least one of two images in Figure 4 of the manuscript and Figure 5 of the paper by using different photo cropping from a single microscopic immunofluorescence image (1230039.tif) to represent fixed cells positive for BmpA and labeled with anti-FlaB in the lower row, 5th panel, of Figure 5 and to also represent fixed cells positive for BmpC and stained with anti-FlaB in the lower row, 5th panel, of Figure 4. Dr. Shin has entered into a Voluntary Settlement Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on April 5, 2011: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses her in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which she is involved, must concurrently submit a plan for supervision of her duties to ORI for approval; the supervisory plan must be designed to ensure the scientific integrity of her research contribution; Respondent agrees that she will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; and (2) to exclude herself voluntarily from service in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

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.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Aging (NIA), 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 January 11, 2011 (Vol. 76, No. 7, p. 1621) and allowed 60-days for public comment. No comments were received. Proposed Collection: Title: NIH Toolbox for Assessment of Neurological and Behavioral Function. Type of Information Collection Request: New. Need and Use of Information Collection: The overall goal of the Toolbox project is to develop unified, integrated methods and measures of four domains of neurological and behavioral functioning (cognitive, emotional, motor and sensory) for use in large longitudinal or epidemiological studies where functioning is monitored over time. The current phase (``Norming''), will involve a large sample of 12,900 for the purpose of establishing comparative norms. The targeted population will be non-institutionalized U.S. residents, aged 3-85 years, with 70% English-speaking and 30% Spanish-speaking. Frequency of Response: Once or twice (depending on subsample). Affected Public: Individuals. Type of Respondents: U.S. residents (persons aged 3-85 years). The annual reporting burden is as follows: Estimated Number of Respondents: 12,900; Estimated Number of Responses per Respondent: 1-2; Average Burden Hours per Response: 1.96; and Estimated Total Annual Burden Hours Requested: 29,700. The annualized cost to respondents is estimated at: $414,375. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

On March 16, 2011, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) published a notice in the Federal Register requesting public comment on the draft, A Public Health Action Plan to Combat Antimicrobial Resistance (76 FR 14402). Written and electronic comments were to be received on or before April 15, 2011. CDC/HHS received requests asking for a 60-day extension of the comment period. In consideration of those requests, HHS/CDC is extending the comment period by 60 days to June 14, 2011.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``How to Write a Request for Designation (RFD).'' This guidance is intended to clarify the type of information the Office of Combination Products (OCP) recommends that a sponsor include in a Request for Designation (RFD). This final guidance supersedes the previous RFD guidance document issued August 2005.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, AHRQ [has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register on December 22nd, 2010 (75 FR 80542) and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Experiment to Evaluate Risk Perceptions of Produce Growers, Food Retailers, and Consumers After a Food Recall Resulting From a Foodborne Illness Outbreak.''

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 21, 2011 (76 FR 15323). The document announced the determination of the regulatory review period for ATRYN. The document was published with an incorrect docket number. This document corrects that error.

This proposed rule would revise the regulations implementing Medicaid home and community-based services (HCBS) waivers under section 1915(c) of the Social Security Act by providing States the option to combine the existing three waiver targeting groups as identified in Sec. 441.301. In addition, we are proposing other changes to the HCBS waiver provisions to convey expectations regarding person-centered plans of care, to provide characteristics of settings that are not home and community-based, to clarify the timing of amendments and public input requirements when States propose modifications to HCBS waiver programs and service rates, and to describe the additional strategies available to CMS to ensure State compliance with the statutory provisions of section 1915(c) of the Act.

This final rule makes revisions to the Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit Program (Part D) to implement provisions specified in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) (ACA) and make other changes to the regulations based on our experience in the administration of the Part C and Part D programs. These latter revisions clarify various program participation requirements; make changes to strengthen beneficiary protections; strengthen our ability to identify strong applicants for Part C and Part D program participation and remove consistently poor performers; and make other clarifications and technical changes.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.

The Food and Drug Administration (FDA) is proposing to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products.

The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.

The Food and Drug Administration (FDA) is announcing that Sun Chemical Corp. has filed a petition proposing that the color additive regulations for D&C Red No. 6 and D&C Red No. 7 be amended by replacing the current specification for ``Ether-soluble matter'' with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4- methylphenyl)azo]-2-naphthalenol.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Safety Labeling ChangesImplementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). This draft guidance provides information on the implementation of the new provisions, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes.'' This document provides guidance on the type of changes to an approved application that FDA believes may qualify for submission as 30-day notices, the type of information to submit in a 30-day notice, and the user fees associated with these submissions. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices (GGP).

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 requirements for a New Drug Application (NDA) holder to notify the Agency if an authorized generic drug is marketed by clearly including this information in an easily accessible place in the annual report and by sending a copy of the relevant portion of the annual report to a central contact point in the Agency.

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 collection of information concerning requests by sponsors of investigational new drugs and applicants for new drug approvals or biologics licenses for fast track designation as provided in the guidance for industry on fast track drug development programs.