Department of Health and Human Services July 2006 – Federal Register Recent Federal Regulation Documents

The Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services (HHS) is providing public notice to clarify a requirement contained in the Federalwide Assurance (FWA) form for international (non-U.S.) institutions, approved by the Office for Human Research Protections (OHRP) under the HHS protection of human subjects regulations. HHS clarifies that the requirements of HHS regulations must be satisfied for all HHS-conducted or -supported research covered by an FWA, regardless of whether the research is conducted domestically or internationally. To date, HHS has not deemed any other procedural standards equivalent to the protection of human subjects.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Altana Inc. The ANADA provides for veterinary prescription use of gentamicin sulfate, betamethasone valerate, clotrimazole ointment for the treatment of canine otitis externa.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by V[eacute]toquinol NA, Inc. The ANADA provides for use of oxytetracycline soluble powder to prepare medicated drinking water for the treatment of various bacterial diseases of livestock.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Lingjie Zhao, University of Iowa: Based on the investigation reports drafted by the University of Iowa (UI) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Lingjie Zhao, former Doctoral Student, UI, engaged in research misconduct. The research was supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant P01 CA66081. PHS found that Ms. Zhao engaged in research misconduct by falsifying research records included in: (a) A manuscript submitted for publication in Cancer Research, (b) drafts of her work reported in the laboratory, and (c) drafts of her work reported to her dissertation committee. Specifically, PHS found: 1. That Ms. Zhao darkened with a marking device the thioredoxin (Trx) band of Lanes 1 and 2 on the autoradiographic film that was to become part of Figure 9 of the manuscript. 2. That Ms. Zhao (a) falsified this same original film of the western blot by darkening Lanes 1, 2, 4, and 5 with a marking device at the origin of the gel and (b) further falsified Figure 9 of the Cancer Research manuscript by claiming falsely that these marked bands were thioredoxin reductase (TR) untreated and with mismatch oligodeoxynucleotide in the presence and absence of tumor necrosis factor alpha. 3. That Ms. Zhao falsified the glutathione reductase (GR) activity data in either Figure 4 or Figure 9 of the Cancer Research manuscript (the data are identical but stated to be from entirely different experimental conditions). 4. That Ms. Zhao falsified the actin data in either Figure 4 or Figure 9 of the Cancer Research manuscript or in the experiments simultaneously using Prx III-As and Phospholipid hydroperoxide glutathione peroxidase-As reported in slide presentations (the actin data are identical under 3 entirely different experimental conditions). 5. That Ms. Zhao falsified the manganese superoxide dismutase (MnSOD) data in either Figure 1A or Figure 4 of the Cancer Research manuscript (these MnSOD data are identical while being clearly described as coming from different experiments). 6. That Ms. Zhao falsified the MnSOD data in Figure 2 of the Cancer Research manuscript by enhancing with a marking device Lanes 6 and 7, mismatch and antisense Prx oligos at 3 days of incubation (unmarked, Prx III-As decreased the expression of MnSOD). Ms. Zhao has entered into a Voluntary Exclusion Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on June 3, 2006: (1) To exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR part 76; (2) To exclude herself from serving 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 consultant.

The Food and Drug Administration (FDA) has determined the regulatory review period for TAXUS EXPRESS Paclitaxel-Eluting Coronary Stent System 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 medical device.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of griseofulvin powder orally as a systemic antifungal agent in horses.

This notice announced the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

In accordance with the requirements of the Privacy Act, the Office of Public Health and Science (OPHS) is publishing notice of a proposal to add a new system of records, 09-90-0160, ``Medical Reserve Corps Unit Information, HHS/OPHS/OSG.''

The Office of Population Affairs (OPA), Office of Family Planning (OFP), announces the anticipated availability of funds for Fiscal Year (FY) 2007 family planning services grants under the authority of Title X of the Public Health Service Act. This notice solicits applications for competing grant awards to serve the areas and/or populations listed in Table I. Only applications which propose to serve the populations and/or areas listed in Table I will be accepted for review and possible funding.