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

This final rule establishes data collection standards necessary to implement aspects of section 1302 of the Patient Protection and Affordable Care Act (Affordable Care Act), which directs the Secretary of Health and Human Services to define essential health benefits. This final rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits. This final rule also establishes a process for the recognition of accrediting entities for purposes of certification of qualified health plans.

This notice seeks comments on proposed changes in the State Title V Maternal and Child Health (MCH) Block Grant allocations. Through the Health Resources and Services Administration's Maternal and Child Health Bureau (MCHB), Title V MCH Block Grant funds are allocated to States based in part on a calculation of the number of children living in poverty (in an individual State) as compared to the total number of children living in poverty in the United States, using data for the number of children in poverty in each State from the U.S. Census Bureau's official decennial census. As the Census Bureau has replaced the decennial census long-form sample questionnaire with the American Community Survey (ACS), MCHB likewise plans to use the ACS as its source for this data. The ACS offers broad, comprehensive information on social, economic, and housing data and is designed to provide this information at many levels of geography. ACS child poverty estimates are produced annually and will allow the Block Grant allocation proportions to be updated more frequently than every 10 years. The Census Bureau produces annual State-level poverty estimates based on the most recent 1, 3, and 5 years of ACS data as well as annual model-based Small Area Income and Poverty Estimates (SAIPE). It is proposed that MCHB implement annual changes to the State Title V MCH Block Grant allocations using the 3-year ACS poverty estimates, wherein each annual change is buffered by sharing 2 of 3 data years in a 3-year rolling period estimate.

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 Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41,42 U.S.C. 299b-21-b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the Coalition for Quality and Patient Safety of Chicagoland (CQPS PSO) of its status as a PSO, and has delisted the PSO accordingly.

As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) for reporting patient safety events to Patient Safety Organizations (PSOs). The purpose of this notice is to announce the availability of a new Common FormatReadmissions Version 0.1 Beta for public review and comment.

HHS published a notice in the Federal Register (Volume 77, Number 130, Page 40059) on July 6, 2012 to give notice of a decision to designate a class of employees from the Feed Materials Production Center (FMPC) in Fernald, Ohio, also known as the Fernald Environmental Management Project (FEMP), as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. The designation was incorrect. Therefore, HHS has published this notice of correction. On June 27, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled Survey of ``Health Care Providers' Responses to Medical Device Labeling'' 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 availability of grant funds for the support of the development of a patient-based registry to evaluate the association of gadolinium based contrast agents (GBCAs) exposure and nephrogenic systemic fibrosis (NSF). The goal of the GBCA project is to study the safety of the GBCAs when used as indicated.

The Food and drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 13, 2012 (77 FR 35317). The document announced that Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza had jointly filed a petition proposing that the food additive regulations be amended to provide for the safe use of folic acid in corn masa flour. The document was published with an error in the title of the document signer's signature. This document corrects that error.

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 or the Agency) is amending the food additive regulations to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups) because these uses have been abandoned. The action is in response to a petition filed by the American Chemistry Council.

The Presidential Commission for the Study of Bioethical Issues will conduct its tenth meeting in August. At this meeting, the Commission will continue discussing topics related to the ethical issues associated with the development of medical countermeasures for children. The Commission will also develop and finalize recommendations regarding access to, and privacy of human genome sequence data.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a co-exclusive license to practice the inventions embodied in U.S. Patent Application 61/042,239 entitled ``Human Monoclonal Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-01], PCT Application PCT/ US2009/124109 entitled ``Human and Improved Murine Monoclonal Antibodies Against CD22'' [HHS Ref. E-080-2008/0-PCT-02], US patent application 12/934,214 entitled ``Human Monoclonal Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-03], and all related continuing and foreign patents/patent applications for the technology family, to Customized Therapeutics. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective co-exclusive licensed territory may be worldwide, and the field of use may be limited to:

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 Clinical Center, 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.

The NTP requests comments on Air Pollution and Children's Health, which was nominated for a possible evaluation by the Office of Health Assessment and Translation (OHAT). This nomination focuses on substances, mixtures, and exposure circumstances (collectively referred to as ``substances'') related to traffic/near road air pollution and their association with emerging children's health outcomes.

The Food and Drug Administration (FDA) has determined that TOPOTECAN INJECTION (topotecan hydrochloride) 1 milligram (mg) (base)/1 milliliter (mL), 3 mg (base)/3 mL, 4 mg (base)/4 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for topotecan hydrochloride intravenous solution 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is providing notice of a Statement of Cooperation (SOC) between FDA and Secretariat of Health (SS) of the United Mexican States, through the Federal Commission for Protection from Sanitary Risks (COFEPRIS). The purpose of the SOC is to safeguard public health and to ensure the safety and sanitary quality of fresh and frozen molluscan shellfish harvested from aquacultured and wild populations that are now or may be exported into the United States.

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) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the ``how to'' aspects of improving outsourced product quality through topics such as FDA International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier Qualification, and many more. The experience level of our audience has fostered engaged dialogue that has led to innovative initiatives. Dates and Times: The public conference will be held on September 24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m. to 5:30 p.m.; and September 26, 2012, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2 \1/2\ days of the conference. Early registration ends August 5, 2012. Standard registration ends September 2, 2012. Late registration occurs September 3 to September 23, 2012. There will also be onsite registration. The cost of registration is as follows:

The Indian Health Service published a document in the Federal Register on June 19, 2012, concerning Announcement Type: New. Funding Announcement Number: HHS-2012-IHS-OCPS-HIV-0001. Catalog of Federal Domestic Assistance Number: 93.933. The document contained five incorrect dates.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``American Recovery and Reinvestment Act ``Developing a Registry of Registries''.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 23rd, 2012 and allowed 60 days for public comment. Several comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Office of the National Coordinator for Health Information Technology (ONC) announces the launch of the What's In Your Health Record Video Challenge. This challenge is an open call for the public to create and submit short, compelling videos sharing how getting access to your health record and checking the information can help make sure you or your loved one get the best care. Having access to your health record is fundamental to your ability to participate in your health care. Patients and their families have a legal right under the HIPAA Privacy Rule to request to see and get a copy of their health record (``right to access'') from most doctors, hospitals and other health care providers, such as pharmacies and nursing homes, as well as from their health plans. Patients can use that information to better understand their health, to coordinate their care with other health care providers or to help identify possible errors or omissions in their medical records. Patients can get access to their health information through a patient portal, or a personal health record (PHR) or by email. This is the third in a series of Health IT video contests that will occur throughout 2012. The video contests are one way to crowd source stories from the public about how they are benefiting from health information technology (health IT). This is one way ONC is working to motivate and inspire individuals to play a more active role in their health. Each video contest will be a call to action for members of the public to create a short video clip [2 minutes or less] on a particular topic, and will award cash prizes to winners in several categories.

The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.

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 September 5-6, 2012, at the Rodbell Auditorium, Rall Building at the NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. The meeting is open to the public with attendance limited only by the space available. The meeting will be webcast 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.

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for DURACT (bromfenac sodium) Capsules, held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box 8299, Philadelphia, PA 19101-8299. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human UseLabeling for Products That Contain Acetaminophen.'' The draft guidance is intended to inform manufacturers of certain over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen of the circumstances in which FDA intends to exercise enforcement discretion with regard to the liver warning required in the labeling.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should email acmh@osophs.dhhs.gov.

The Food and Drug Administration (FDA) is announcing the availability of two related guidance documents. The first guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Notification (510(k)) Submissions'' (CADe 510(k) guidance), provides recommendations regarding premarket notification (510(k)) submissions of certain computer-assisted detection (CADe)\1\ devices applied to radiology images and radiology device data. The second guidance, entitled ``Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Approval (PMA) and Premarket Notification (510(k)) Submissions'' (CADe clinical performance assessment guidance), provides recommendations on the design and conduct of clinical performance studies for CADe devices applied to radiology images and radiology device data.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award a programmatic supplement of approximately $800,000 (total costs) for up to one year to the current grantee of the Suicide Prevention Resource Center program. The current grantee is the Education Development Center, Inc. in Newton, Massachusetts. This is not a formal request for applications. Assistance will be provided only to the Education Development Center, Inc. based on receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-12-011. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.

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.