Department of Health and Human Services April 2011 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; CONVENIA
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.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012; Changes in Size and Square Footage of Inpatient Rehabilitation Units and Inpatient Psychiatric Units
This proposed rule would implement section 3004 of the Affordable Care Act, which establishes a new quality reporting program that provides for a 2 percent reduction in the annual increase factor beginning in 2014 for failure to report quality data to the Secretary of Health and Human Services. This proposed rule would also update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year 2012 (for discharges occurring on or after October 1, 2011 and on or before September 30, 2012) as required by the Social Security Act (the Act). The Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each FY the classification and weighting factors for the IRF prospective payment system (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are also proposing to consolidate, clarify, and revise existing policies regarding IRF hospitals and IRF units of hospitals to eliminate unnecessary confusion and enhance consistency. Furthermore, in accordance with the general principles of the President's January 18, 2011 Executive Order entitled ``Improving Regulation and Regulatory Review,'' we are proposing to amend existing regulatory provisions regarding ``new'' facilities and changes in the bed size and square footage of IRFs and inpatient psychiatric facilities (IPFs) to improve clarity and remove obsolete material.
Prospective Granting of an Exclusive License
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office of the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is contemplating granting a worldwide exclusive license to AES Raptor, LLC, located in North Kansas City, Missouri. Under this exclusive license, only AES Raptor, LLC would be permitted to commercialize the technology described in the patent applications listed below. CDC intends to grant rights to commercialize this invention to no other licensees. The patent rights in this invention have been assigned to the government of the United States of America. The invention to be licensed is: Title: Barricade System and Barricade Bracket for Use Therein, CDC Ref. : I-016-04, a safety rail system that provides protection to individuals working on inclined structures. The system is designed to prevent individuals from falls to a lower level. U.S. Patent No.: 7,509,702. U.S. Application No.: 11/257,472. Filing date: 10/24/2005. Canadian Application No.: 2,565,354. Filing date: October 23, 2006. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Online Direct-to-Consumer Prescription Drug Promotion
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.
Guidance for Industry on Fish and Fishery Products Hazards and Controls, Fourth Edition; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition.'' The updated guidance supports and complements FDA's regulations for the safe and sanitary processing and importing of fish and fishery products using hazard analysis and critical control point (HACCP) methods.
Guidance for Industry: “Computer Crossmatch” (Computerized Analysis of the Compatibility Between the Donor's Cell Type and the Recipient's Serum or Plasma Type); Availability
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.
New Proposed Collection; Comment Request; Environmental Science Formative Research Methodology Studies for the National Children's Study
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.
New Proposed Collection; Comment Request; Study Logistic Formative Research Methodology Studies for the National Children's Study
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.
Submission for OMB Review; Comment Request; National Institutes of Health Loan Repayment Programs
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment of 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 February 10, 2011, at page numbers 7570-7571 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. The NIH 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. Proposed Collection: Title: National Institutes of Health Loan Repayment Programs. Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/11). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674- 4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674- 15, NIH 2674-16, NIH 2674-17, NIH 2674-18, and NIH 2674-19. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., PhD, Pharm.D., D.D.S., D.M.D., D.P.M., D.C., and N.D. degree holders, or the equivalent, who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic nonprofit organizations for a minimum of 2 years (3 years for the General Research Loan Repayment Program (LRP)) in research areas supporting the mission and priorities of the NIH. The AIDS Research LRP (AIDS-LRP) is authorized by Section 487A of the Public Health Service (PHS) Act (42 U.S.C. 288-1), and the Clinical Research LRP for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42 U.S.C. 288-5). The General Research LRP (GR-LRP) is authorized by Section 487C of the PHS Act (42 U.S.C. 288- 3), and the Clinical Research LRP (LRP-CR) is authorized by Section 487F (42 U.S.C. 288-5a). The Pediatric Research LRP (PR-LRP) is authorized by Section 487F of the PHS Act (42 U.S.C. 288-6), and the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42 U.S.C. 288-5). The Contraception and Infertility Research LRP (CIR-LRP) is authorized by Section 487B of the PHS Act (42 U.S.C. 288-2), and the Health Disparities Research LRP (HD-LRP) is authorized by Section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and one- or two-year renewal application. Affected Public: Individuals or households; nonprofits; and businesses or other for-profit. Type of Respondents: Physicians, other scientific or medical personnel, and institutional representatives. The annual reporting burden is as follows:
Revision to Proposed Collection; Comment Request; Formative Research Methodology Studies for the National Children's Study
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.
New Proposed Collection; Comment Request; Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study
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. Proposed Collection: Title: Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study (NCS) Type of Information Collection Request: Generic Clearance Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:
Findings of Research Misconduct
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.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Vipul Bhrigu, PhD, University of Michigan Medical School: Based on the findings of an investigation by the University of Michigan Medical School (UMMS) and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, ORI found that Vipul Bhrigu, PhD, former postdoctoral fellow, Department of Internal Medicine, UMMS, engaged in research misconduct in research funded by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA098730-05. Specifically, ORI found that the Respondent knowingly and intentionally tampered with research materials related to five (5) immunoprecipitation/Western blot experiments and switched the labels on four (4) cell culture dishes for cells used in the same type of experiments to cause false results to be reported in the research record. ORI also found that the Respondent tampered with laboratory research materials by adding ethanol to his colleague's cell culture media, with the deliberate intent to effectuate the death of growing cells, which caused false results to be reported in the research record. ORI has concluded that these acts seriously deviated from those that are commonly accepted within the scientific community for proposing, conducting, and/or reporting research. ORI found that the Respondent's intentional tampering of his colleague's laboratory research constitutes research misconduct as defined by 42 CFR part 93. ORI determined that the Respondent engaged in a pattern of dishonest conduct through the commission of multiple acts of data falsification. ORI also determined that the subterfuge in which he freely engaged for several months constitutes an aggravating factor. The Respondent attempted to mislead the University of Michigan (UM) police by initially denying involvement in the tampering and refusing to accept responsibility for this misconduct. The Respondent eventually made an admission only after the UM police informed him that his actions in the laboratory had been videotaped. This dishonest conduct established the Respondent's lack of present responsibility to be a steward of Federal funds (2 CFR 376 et seq.; 42 CFR 93.408). The following administrative actions have been implemented for a period of three (3) years, beginning on April 7, 2011: (1) Dr. Bhrigu is debarred from eligibility for any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement programs of the United States Government, referred to as ``covered transactions,'' pursuant to HHS' Implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (2 CFR 376 et seq.); and (2) Dr. Bhrigu is prohibited from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Availability of Draft Toxicological Profile
This notice announces the availability of the Toxicological Profile for Uranium (Update) for review and comment. These comments can include additional information or reports on studies about the health effects of uranium. Although ATSDR considered key studies for uranium during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible addition to the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3), [42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare toxicological profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.
Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563
In accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review,'' the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation. The goal of this review of existing regulations, as with our other reviews, is to help ensure that FDA's regulatory program is more effective and less burdensome in achieving its regulatory objectives. FDA is requesting comment and supporting data on which, if any, of its existing rules are outmoded, ineffective, insufficient, or excessively burdensome and thus may be good candidates to be modified, streamlined, expanded, or repealed. As part of this review, FDA also invites comment to help us review our framework for periodically analyzing existing rules.
Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of SACATM on June 16-17, 2011, at the Hilton Arlington Hotel, 950 North Stafford Street, Arlington, VA 22203. The meeting is open to the public with attendance limited only by the space available. The meeting will be videocast through a link at (https://www.niehs.nih.gov/ news/video/live). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.
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