Department of Health and Human Services September 2012 – Federal Register Recent Federal Regulation Documents

This final rule modifies the Department of Health and Human Services (HHS) regulations for medical examinations of underground coal miners. Existing regulations established specifications for providing, interpreting, classifying, and submitting film-based roentgenograms (now commonly called chest radiographs or X-rays) of underground coal miners. The revised standards modify the requirements to permit the use of film-based radiography systems and add a parallel set of standards permitting the use of digital radiography systems. An additional amendment requires coal mine operators to provide the National Institute for Occupational Safety and Health (NIOSH) with employee rosters to assist the Coal Workers' Health Surveillance Program in improving participation by miners.

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with WTC Health Program regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds to the List of WTC-Related Health Conditions the types of cancer proposed for inclusion by the notice of proposed rulemaking.

The Food and Drug Administration (FDA) is confirming the effective date of August 7, 2012, for the final rule that published in the Federal Register of July 6, 2012 (77 FR 39921) and that revised the requirements for D&C Red No. 6 and D&C Red No. 7 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 requesting nominations to serve on the Science Board to FDA (Science Board). FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is announcing the availability of a draft compliance policy guide (CPG) entitled ``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats.'' This draft CPG is intended to provide guidance to FDA staff and industry on how FDA intends to use its enforcement discretion with regard to the labeling and marketing of dog and cat food products that are labeled and/or marketed as intending to diagnose, cure, mitigate, treat, or prevent diseases and to provide nutrients in support of meeting the animal's total daily nutrient requirements.

The Food and Drug Administration (FDA) is withdrawing approval of four new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.

This notice supports expansion of research on the impact of CMS programs on the Indian health care system through a single source award. The Indian Health Service (IHS), Tribes and Tribal Organizations and Urban programs, deliver health care services to American Indian/ Alaska Native (AI/AN) people through a network of hospitals, clinics and other providers. This award expands research on the impact of CMS programs and the delivery of health care to AI/AN beneficiaries.

In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``Partnerships for Sustainable Research and Dissemination of Evidence-Based Medicine (R24)''.

The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill two positions on the Committee membership that will be vacated during the 2013 calendar year.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Marc Hauser, Ph.D., Harvard University: Based on the report of an investigation conducted by Harvard University (Harvard) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Marc Hauser, former Professor, Department of Psychology, Harvard, engaged in research misconduct in research supported by National Center for Research Resources (NCRR), National Institutes of Health (NIH), grants P51 RR00168-37 and CM-5-P40 RR003640-13, National Institute on Deafness and Other Communication Disorders (NIDCD), NIH, grant 5 R01 DC005863, and National Institute of Mental Health (NIMH), NIH, grant 5 F31 MH075298. ORI found that Respondent engaged in research misconduct as follows: Respondent published fabricated data in Figure 2 of the paper Hauser, M.D., Weiss, D., & Marcus, G. ``Rule learning by cotton- top tamarins.'' Cognition 86:B15-B22, 2002, which reported data on experiments designed to determine whether tamarin monkeys habituated to a sound pattern consisting of three sequential syllables (for example AAB) would then distinguish a different sound pattern (i.e., ABB). Figure 2 is a bar graph showing results obtained with 14 monkeys exposed either to the same or different sound patterns than they were habituated to. Because the tamarins were never exposed to the same sound pattern after habituation, half of the data in the graph was fabricated. Figure 2 is also false because the actual height of the bars for the monkeys purportedly receiving the same test pattern that they had been habituated to totaled 16 animals (7.14 subjects as responding and 8.87 subjects as non-responding). Respondent retracted the paper in 2010 (Cognition 117:106). In two unpublished experiments designed to test whether or not tamarin monkeys showed a greater response to certain combinations of unsegmented strings of consonants and vowels than others, Respondent falsified the coding of some of the monkeys' responses, making the results statistically significant when the results coded by others showed them to be non-significant. Respondent acknowledged to his collaborators that he miscoded some of the trials and that the study failed to provide support for the initial hypothesis. This research was never written up for publication. In versions of a manuscript entitled ``Grammatical Pattern Learning by Human Infants and Monkeys'' submitted to Cognition, Science, and Nature, Respondent falsely described the methodology used to code the results for experiments 1 and 3 on ``grammar expectancy violations'' in tamarin monkeys either by claiming coding was done blindly or by fabricating values for inter-observer reliabilities when coding was done by only one observer, in both cases leading to a false proportion or number of animals showing a favorable response. Specifically, in three different experiments in which tamarin monkeys were exposed first to human voice recordings of artificial sounds that followed grammatical structure and then exposed to stimuli that conformed to or violated that structure, Respondent (1) provided an incorrect description of the coding methodology by claiming in the early versions of the manuscripts that ``two blind observers'' coded trials and a third coded trials to resolve differences, while all of the coding for one experiment was done just by the Respondent, and (2) in a revised manuscript, while Respondent no longer mentioned ``two blind observers, he claimed that ``Inter-observer reliabilities ranged from 0.85 to 0.90,'' a statement that is false because there was only one observer for one of the experiments. Furthermore, in an earlier version of the manuscript, Respondent falsely reported that ``16 out of 16 subjects'' responded more to the ungrammatical rather than the grammatical stimuli for the predictive language condition, while records showed that one of the sixteen responded more to grammatical than ungrammatical stimuli, and one responded equally to grammatical and ungrammatical. Respondent and his collaborators corrected all of these issues, including recoding of the data for some of the experiments prior to the final submission and publication in Cognition 2007. In the paper Hauser, M.D., Glynn, D., Wood, J. ``Rhesus monkeys correctly read the goal-relevant gestures of a human agent.'' Proceedings of the Royal Society B 274:1913-1918, 2007, Respondent falsely reported the results and methodology for one of seven experiments designed to determine whether rhesus monkeys were able to understand communicative gestures performed by a human. Specifically, (1) in the ``Pointing without food'' trial, Respondent reported that 31/40 monkeys approached the target box while the records showed only 27 approached the target (both results are statistically significant), and (2) there were only 30 videotapes of the ``Pointing without food'' trials, while Respondent falsely claimed in the paper's Materials and Methods that ``each trial was videotaped.'' Respondent was not responsible for the coding, analyses, or archiving but takes full responsibility for the falsifications reported in the published paper. Respondent and one of his coauthors replicated these findings with complete data sets and video records and published them in Proceedings Royal Society B 278(1702):58-159, 2011. Respondent accepts responsibility for a false statement in the Methodology section for one experiment reported in the paper Wood, J.N., Glynn, D.D., Phillips, B.C., & Hauser, M.D. ``The perception of rational, goal-directed action in nonhuman primates.'' Science 317:1402-1405, 2007. The statement in the paper's supporting online material reads that ``All individuals are * * * readily identifiable by natural markings along with chest and leg tattoos and ear notches.'' In fact, only 50% of the subjects could be identified by this method, thus leading to the possibility of repeated testing of the same animal. Respondent and one of his coauthers replicated these findings with complete data sets and video records and published them in Science 332:537, 2011 (www.sciencemag.org/cgi/content/full/317/5843/1402/DC2 published online 25 April 2011). Respondent engaged in research misconduct by providing inconsistent coding of data in his unpublished playback experiment with rhesus monkeys exploring an abstract pattern in the form of AXA by falsely changing the coding results where the prediction was that habituated animals were more likely to respond to an ungrammatical stimulus than a grammatical one. After an initial coding of the data by his research assistant, in which both Respondent and assistant agreed that an incorrect procedure was used, the Respondent recoded the 201 trials and his assistant coded a subset for a reliability check. The Respondent's codes differed from the original in 36 cases, 29 of them in the theoretically predicted direction, thereby producing a statistically significant probability of p =

On March 4, 2009, the National Institutes of Health (NIH) Office of Biotechnology Activities, Office of Science Policy (NIH/OBA) published a proposal in the Federal Register (74 FR 9411) to revise the NIH Guidelines in two regards. The first was to address biosafety considerations for research with synthetic nucleic acids. The proposal modified the scope of the NIH Guidelines specifically to cover certain basic and clinical research with nucleic acid molecules created solely by synthetic means. The second proposed revision was to modify the criteria for determining whether an experiment to introduce drug resistance into a microorganism must be reviewed by the Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director (as a Major Action under Section III-A-1-a of the NIH Guidelines). Comments submitted were discussed at the ``NIH Public Consultation on Proposed Changes to the NIH Guidelines for Synthetic Nucleic Acids'' on June 23, 2009 (https://oba.od.nih.gov/rdna_rac/rac_pub_con.html''. This notice sets forth final changes to the NIH Guidelines regarding those two proposals. The scope of the NIH Guidelines is being modified to cover certain classes of basic and clinical research with synthetic nucleic acids while exempting others. As discussed herein, the majority of research with synthetic nucleic acids that are not designed to replicate does not raise significant biosafety concerns that warrant oversight under the NIH Guidelines. Because of the modification of the scope of the NIH Guidelines, the title of the NIH Guidelines will be revised from NIH Guidelines for Research Involving Recombinant DNA Molecules to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids Molecules. These changes also clarify the criteria for determining whether an experiment to introduce drug resistance into a microorganism raises sufficient public health issues to warrant the experiment being reviewed by the RAC and approved by the NIH Director under Section III- A-1-a of the NIH Guidelines. While the current criteria for determining whether an experiment requires review under Section III-A-1-a are being retained, additional language is being added regarding the assessment of whether a drug is therapeutically useful. In addition, NIH/OBA has clarified that Institutional Biosafety Committees (IBCs) can consult with NIH/OBA regarding a specific experiment that does not meet the criteria for review under Section III-A-1-a but nonetheless raises important public health issues. Finally, a section is added to give NIH/OBA the authority to approve new experiments utilizing the same drug resistance trait and organism used in an experiment previously reviewed by the RAC and approved by the NIH Director. In March 2009, NIH/OBA also proposed changes to Section III-E-1 of the NIH Guidelines, which sets containment for recombinant experiments involving two-thirds or less of the genome of certain viruses in tissue culture. In response to the comments on the proposed changes to Section III-E-1, NIH/OBA revised the proposal and published a notice for comment on April 22, 2010 (75 FR 21008). Comments received in response to this notice were discussed at the June 16, 2010, public meeting of the RAC and additional discussions of subsequent revisions to the proposed changes took place at the June 7, 2011, meeting of the RAC. As these changes are not yet finalized, NIH/OBA will move forward with the other changes outlined below pending finalization of changes to Section III-E-1.