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

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 Nursing Research (NINR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB). Prosposed Collection: Title: NIH/National Institute of Nursing Research (NINR) Summer Genetics Institute Alumni Survey. Type of Information Collection Request: NEW. Need and Use of Information Collection: The NINR Summer Genetics Institute Alumni Survey will obtain information on the long-term outcomes of this training program for nurse scientists and faculty. Target participants are alumni of this training institute which began in 2000. The survey inquires about career activities, including research, clinical, teaching and educational activities, since completion of the NINR Summer Genetics Institute. This is a 39-item survey that takes an average of 30 minutes to complete. The findings will provide valuable information on the influence of the Institute in developing genetics research capability among Institute alumni, and development and expansion of clinical practice in genetics among alumni who are nurse clinicians. Frequency of Response: Annual for three (3) years. Affected Public: Individual alumni of the NINR Summer Genetics Institute. Type of Respondents: Nurse scientists, clinicians, and faculty. The annual reporting burden is as follows: Estimated Number of Respondents: 150; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .5; and Estimated Total Annual Burden Hours Requested: 75. There are no Capital Costs, Operating or Maintenance Costs to report.

The National Institutes of Health (NIH) is holding a conference titled ``Consensus Development Conference: Diagnosing Gestational Diabetes Mellitus.'' The conference will be open to the public.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Electro Metallurgical site in Niagara Falls, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 11, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Clinton Engineer Works in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 11, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 5, 2012, page 13131 (corrected on March 26, 2012, page 17488), and allowed 60 days for public comment. One public comment was received, which asked for clarification about new reporting burdens. It was noted in follow-up that NIH has seen a 21- percent increase in competing applications since the last clearance, which has resulted in an increase in the burden hours. We are also transitioning to the Research Performance Progress Report as mandated by OMB. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Public Health Service (PHS) Post-award Reporting Requirements. Type of Information Collection Request: Revision, OMB 0925-0002, Expiration Date 06/30/2012. This collection represents a consolidation of post-award reporting requirements under the Paperwork Reduction Act and includes the new Research Performance Progress Report (RPPR). It also includes continued use of the PHS Non- competing Continuation Progress Report (PHS 2590, currently approved under 0925-0001, expiration 06/30/2012), and the NIH AHRQ Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Progress Report for Continuation Support (PHS 416-9). Only one interim progress report (RPPR or PHS2590/416-9) will be utilized for any given award until the RPPR is fully implemented for all awards. This collection also includes other PHS post-award reporting requirements: PHS 416-7 NRSA Termination Notice and PHS 6031-1 NRSA Annual Payback Activities Certification. Post-award reporting requirements previously cleared under OMB 0925-0001 now included under 0925-0002 are: PHS 2271 Statement of Appointment, HHS 568 Final Invention Statement and Certification, Final Progress Report instructions, iEdison, and PHS 3734 Statement Relinquishing Interests and Rights in a PHS Research Grant. Pre-award reporting requirements are simultaneously consolidated under 0925-0001. Need and Use of Information Collection: The RPPR will replace existing interim performance reports used by all NIH, Food and Drug Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ) grantees. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. The phased transition to the RPPR requires the maintenance of dual reporting processes for a period of time. Thus this information collection is for the new use of the RPPR, the continued use of the PHS Non-competing Continuation Progress Report (PHS 2590), and the use of the NIH AHRQ Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Progress Report for Continuation Support (PHS 416-9). Only one interim progress report (RPPR or PHS2590/416-9) will be utilized for any given award. The PHS 416-7, 2271, and 6031-1 are used by NRSA recipients to activate, terminate, and provide for payback of an NRSA. Closeout of an award requires a Final Invention Statement (HHS 568) and Final Progress Report. iEdison allows grantees and federal agencies to meet statutory requirements for reporting inventions and patents. The PHS 3734 serves as the official record of grantee relinquishment of a PHS award when an award is transferred from one grantee institution to another. Frequency of response: Grantees are required to report annually. Affected Public: Universities and other research institutions; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: University administrators and principal investigators. The annual reporting burden is as follows: Total Estimated Number of Respondents: 112,986. Estimated Number of Responses per Respondent: 1. Average Burden Hours per Response: 5.6. Estimated Total Annual Burden Hours Requested: 640,677. The annualized cost to respondents is estimated to be $22,423,709. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov; or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Seleda M. Perryman, Chief, Project Clearance Officer, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3509, 6705 Rockledge Drive, Bethesda, MD 20892-7974; or call non-toll-free number 301-594-7949; or email your request, including your address to: perrymansm@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

This notice advises the public of the published lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of April 1, 2012, available on the Health Resources and Services Administration (HRSA) Web site at https:// bhpr.hrsa.gov/shortage/. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act and 42 CFR part 5.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Mona Thiruchelvam, Ph.D., University of Medicine and Dentistry of New Jersey: Based on the report of an investigation conducted by the University of Medicine and Dentistry of New Jersey (UMDNJ) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Mona Thiruchelvam, former Assistant Professor, Department of Environment and Occupational Health Science Institute (EOHSI), UMDNJ, engaged in research misconduct in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), grants P30 ES05022, P30 ES01247, and R01 ES10791 and the intramural program at the National Institute on Drug Abuse (NIDA), NIH. ORI found that the Respondent engaged in research misconduct by falsifying and fabricating cell count data that she claimed to have obtained through stereological methods in order to falsely report the effects of combined exposure of the pesticides paraquat and maneb on dopaminergic neuronal death and a neuroprotective role for estrogen in a murine model of Parkinson's disease. The Respondent provided to the institution corrupted data files as the data for stereological cell counts of nigrostriatal neurons in brains of several mice and rats by copying a single data file from a previous experiment and renaming the copies to fit the description of 13 new experiments composed of 293 data files when stereological data collection was never performed for the questioned research. The fabricated data, falsified methodology, and false claims based on fabricated and falsified data were reported in two NIEHS, NIH, grant applications, two publications, a poster, and a manuscript in preparation: R01 ES016277, ``Development Pesticide Exposure: The Parkinson's Disease Phenotype'' (Dr. Mona J. Thiruchelvam, Principal Investigator [P.I.]), submitted 1/26/2007 and funded. R01 ES015041, ``Gender and the Parkinson's Disease Phenotype'' (Dr. Mona J. Thiruchelvam, P.I.), submitted 12/19/05. Rodriguez, V.M., Thiruchelvam, M., & Cory-Slechta, D.A. ``Sustained Exposure to the Widely Used Herbicide, Atrazine: Altered Function and Loss of Neurons in Brain Monamine Systems.'' Environ Health Perspect. 113(6):708-715, 2005 (``EHP paper''). Thiruchelvam, M., Prokopenko, O., Cory-Slechta, D.A., Richfield, E.K., Buckley, B., & Mirochnitchenko, O. ``Overexpression of Superoxide Dismutase or Glutathione Peroxidase Protects against the Paraquat + Maneb-induced Parkinson Disease Phenotype.'' J. Biol. Chem. 280(23):22530-22539, 2005 (``JBC paper''). Harvey, K., Victor, A.I., Wang, Y., Kochar, Y., Cory- Slechta, D.A., & Thiruchelvam, M. ``Gene Delivery of GDNF Impedes Progressive Neurodegeneration in Paraquat and Maneb Exposure Model of Parkinson's Disease.'' Poster presentation, Neuroscience 2006 (``Neuroscience poster''). Thiruchelvam, M., Kochar, Y., Mehta, H., Prokopenko, O., Cory-Slechta, D.A., Richfield, E.K., & Mirochnitchenko, O. ``Mechanisms associated with gender difference in the paraquat and maneb animal model of Parkinson's disease, 2006 (``manuscript''). Specifically, ORI finds that the Respondent engaged in research misconduct by knowingly and intentionally: Falsifying and fabricating summary bar graphs and methodology for stereological cell counts in a murine model of Parkinson's disease, when the stereological counts were never performed; Copying and altering in multiple ways a single stereology ``.dat'' computer file generated on August 18, 2002, and renaming it to generate 293 data files representing counts for 13 new experiments that were never performed, by altering the files to make them unreadable and claiming that these files were from valid stereological cell count experiments carried out at UMDNJ between 2004 and 2006; Falsifying a bar graph representing brain proteasomal activity, by selectively altering data for relative fluorescent unit (RFU) values to support the hypothesis that development of Parkinson's disease entails proteasomal dysfunction with a higher effect in males compared to females; By failing to perform stereological cell counts, the following figures of summary bar graphs, reported methodology, and related claims of the Respondent's JBC paper, EHP paper, a manuscript, a poster, and two grant applications were falsified:

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.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

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 that a collection of information entitled ``Implementation of the Food and Drug Administration Amendments Act of 2007'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance published in the Federal Register of June 22, 2010.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 that a collection of information entitled ```Real Time' Surveys of Consumers' Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.