ACLA is a not-for-profit association representing the nation’s leading providers of clinical laboratory services, including local, regional, and national laboratories. Our diverse membership represents a broad array of clinical laboratories, includes large national independent labs, reference labs, esoteric labs, hospital labs, and nursing home laboratories. ACLA members are actively engaged in the creation and performance of innovative and much-needed Laboratory-Developed Tests (LDTs) that have helped to transform the standard of clinical care in this country and provide great hope for further improvements in the future.
ACLA and its member laboratories are committed to developing and providing safe, reliable, and clinically-meaningful diagnostic testing services to patients and ensuring adequate and appropriate regulatory oversight of the tests they perform. We do appreciate the willingness of the FDA to engage in a dialogue with our organization regarding its proposal, and the Agency has reached out to us. ACLA and its member laboratories are in the process of analyzing the documents released on July 31, 2014, and we fully intend to provide detailed and thoughtful comments on the documents once they are formally released as draft guidance. However, ACLA and the FDA fundamentally disagree on several key issues, including their statutory authority to regulate LDTs and the promulgation of new regulatory oversight through guidance documents, and ACLA has other concerns related to the framework as outlined in the Congressional notification documents, all of which will be addressed in the following written statement.
Laboratory-Developed Tests (LDTs) are tests that laboratories develop and validate in their own laboratories and that are not sold as kits to other laboratories or to other facilities. LDTs also include tests where laboratories modify an existing FDA-approved or FDA-cleared kit and then validate the modified test internally. LDTs are an extremely common part of laboratory medicine. Laboratory-Developed Tests are the backbone of clinical care in the United States. The diagnostic information they yield empowers patients and their doctors with the tools they need to best manage patient care.
A large proportion of the clinical laboratory tests performed in this country are performed as LDTs, from routine tests such as pap smears and complete blood counts, to the most cutting-edge molecular and genetic tests in cancer, heart disease, and rare and infectious diseases. These are tests developed by physicians, scientists and other highly-trained personnel working in a single laboratory, according to its own processes, to furnish a diagnostic result for use by a clinician. These tests most often are created in response to an unmet clinical need, or where the existing diagnostic tests are insufficient or fail to incorporate the latest in scientific and medical research. Nearly all FDA-approved and FDA-cleared test kits begin as LDTs, and, in many cases, LDTs represent the standard of care.
Through the innovations in clinical laboratories, we are diagnosing and characterizing diseases earlier and more precisely than ever before imagined – whether for diabetes, infectious disease, cancers, and rare diseases. With these powerful diagnostic tools, patients have access to more targeted therapies sooner, which inevitably lowers costs, increases the quality of care, and saves lives.
LDTs have transformed clinical practice and dramatically altered treatment guidelines, as illustrated by the impact of Oncotype Dx, a genomic LDT shown to predict whether chemotherapy is likely to benefit women with early-stage invasive breast cancer. Whereas 50 years ago, all women with breast cancer were referred for intensely toxic and debilitating chemotherapy treatments, we now know that only about 4 in 100 women diagnosed with early-stage breast cancer actually receive benefit from chemotherapy. In the last ten years, the Oncotype Dx breast cancer test has helped over a hundred thousand patients around the world avoid chemotherapy and its side effects while saving the healthcare system an estimated more than $2.5 billion in treatment costs.
As detailed in the Citizen Petition filed by ACLA last year, ACLA strongly believes that the FDA cannot regulate LDTs, through guidance or otherwise, because the Agency lacks the requisite statutory authority to regulate these vital diagnostic services. FDA lacks the jurisdiction to regulate LDTs for several reasons.
LDTs are not “devices” as defined in the Food, Drug and Cosmetics Act (FDCA). As the text and legislative history of the “device” definition show, this term encompasses only articles. LDTs are proprietary procedures for performing a diagnostic test using reagents and laboratory equipment. They are essentially know-how, not physical articles. Therefore, they are not subject to regulation under the FDCA.
Additionally, FDA’s assertion of jurisdiction over LDTs is incompatible with the 1988 Amendment to the CLIA program (CLIA ’88) and its legislative history. In amending CLIA, Congress explained its intent to regulate laboratory testing under a single statute: the amended CLIA. To that end, Congress created a comprehensive statutory framework for precisely the services that FDA now seeks to regulate under the device authorities of the FDCA. Congress made no mention of FDA having any authority to regulate LDTs under the previously enacted “device” definition.
Lastly, LDTs do not present an essential prerequisite for FDA jurisdiction under the FDCA: commercial distribution. FDA has defined “commercial distribution” in various contexts to require that a product be delivered, distributed, or placed on the market. LDTs are created and performed in a single laboratory, not manufactured and distributed. As non-tangible know-how and testing services at clinical laboratories, LDTs do not meet any of these conditions.
The FDA says that Congress gave the agency statutory authority to regulate LDTs nearly forty years ago when Congress passed the Medical Device Amendments of 1976 (MDA). The agency said that, since that time, it has opted to “exercise enforcement discretion” until now. That claim is contradicted by a review of actions and statements by Congress and the FDA throughout the years. It was not until twenty years after passage of the Medical Device Amendments that the FDA publicly stated that it could – but chose not to – regulate LDTs.
The legislative history of the Medical Device Amendments of 1976 contains no statement by the FDA or documentation submitted by the FDA to Congress that the agency considered LDTs to be “devices” under the framework of the MDA. Indeed, the legislative history shows that Congress itself believed that “devices” are tangible products and articles, but not processes such as LDTs. Subsequent to passage of the MDA, when the agency undertook the rulemaking process and established advisory committees to classify all known devices, it did not mention then-existing LDTs as being “devices” subject to classification and regulation. If, in fact, the FDA thought at that time that LDTs were “devices” that it had the authority to regulate, then one would expect that the FDA would have explained to stakeholders why it was declining to classify them for regulation, but it did no such thing.
In 1988, Congress passed the Clinical Laboratory Improvement Amendments, which established a comprehensive statutory and regulatory framework for oversight of all clinical laboratory testing on humans in the United States. During the time that Congress was debating the legislation, the FDA stood by in silence, never once claiming that it had jurisdiction over any clinical laboratory tests developed in-house. The CLIA regulations that were finalized in 1992 did not include a regulatory role for the FDA with respect to LDTs or any other lab processes, and we are not aware that the FDA sought to assert such a role at the time.
The first time that the FDA made a public claim about its authority to regulate LDTs as devices was in a draft guidance document in 1992. Stakeholders objected, and the FDA removed any reference to LDTs in the final guidance, released in 1996.
It was not until 1996 – two decades after the Medical Device Amendments – when the FDA claimed in a statement in an official publication, the Federal Register, that it had jurisdiction over LDTs but that it was not exercising its authority to regulate them. It hinted at its jurisdictional authority and its exercise of enforcement discretion, stating that although it had not “actively regulated” LDTs, it might do so in the future. At the time, ACLA and other stakeholders filed comments challenging the FDA’s assertion that it had the authority to oversee LDTs for twenty years but simply never used that authority. In 1998, in its denial of a citizen petition on LDTs, the FDA again stated that it “may regulate assays developed by clinical reference laboratories strictly for in-house use as medical devices.” This assertion has been repeated in the years since then, although it was not until recently that FDA determined that it would use its purported enforcement authority for the first time.
The FDA takes the position that it has the jurisdiction to regulate LDTs but has always chosen to exercise its regulatory discretion with regard to those tests. The clearest statement of that discretion is found in the FDA’s announcement of the Final Rule regulating Analyte Specific Reagents, which are the component of many LDTs. In promulgating the ASR Rule, the FDA declined to classify Laboratory-Developed Tests as Class II or III medical devices because, as the agency stated, “FDA recognizes that the use of in-house developed tests has contributed to enhanced standards of medical care in many circumstances and that significant regulatory changes in this area could have negative effects on the public health.” In announcing a change to that policy, FDA cannot proceed simply through the issuance of guidance documents.
First, given that the original announcement of this policy was as part of a notice and comment rulemaking, the reversal of the policy—which FDA is asserting here—must be done in the same way. Because FDA set forth its policy regarding Laboratory-Developed Tests in the Federal Register, pursuant to notice-and-comment procedures, if the agency is going to change its policy, then it must follow that same notice-and-comment procedure.
There is little question that by its actions, FDA is expanding its current regulations to an entirely new industry. The FDA cannot newly regulate an entire industry sector merely by issuing a few guidance documents. Federal courts long have held that when a guidance document significantly broadens the application of a regulation or set of regulations, it is invalid without actual notice-and-comment rulemaking. It is also well-established that an agency cannot sidestep notice-and-comment rulemaking requirements by claiming that a major legal addition to a rule is merely an interpretation of an existing obligation. Here, if the FDA’s guidance is in any way similar to the documents the FDA shared with Congress in July, it would expand the application of existing regulations that currently are not applicable to laboratories offering LDTs. In some cases, the guidance would completely contradict what is in current regulation, which in itself would require notice-and-comment rulemaking. Expansion of the FDA’s regulatory regime to LDTs significantly broadens the scope of current regulations to an entire industry, and it would be far more than an interpretation of an existing obligation on labs. Therefore, according to years and years of federal court rulings, the FDA cannot regulate LDTs through subregulatory guidance documents alone.
Furthermore, the FDA cannot claim, as it often does with regard to guidances, that these documents “do not establish legally enforceable responsibilities” and that they merely “describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.” It includes such language in all of its guidance documents, including those it shared with Congress in July. But, if finalized, the LDT guidance documents most certainly would impose legally enforceable responsibilities on labs, and they contain far more than just “recommendations.” The documents we have seen are packed with citations to specific existing statutory and regulatory provisions and very direct statements that LDTs for the first time would be subject to those provisions. As an example, the FDA states that any lab that fails to follow certain other requirements in the document “will have opted to not be within the scope” of the FDA’s current policy under which labs do not have to register and list their tests. If device registration and listing is not a “legally enforceable responsibility” that suddenly would be imposed on labs, then it is hard to see what would be. There are many other examples of legally enforceable responsibilities on virtually every page of the documents the FDA shared with Congress that completely contradict the agency’s claim that the guidance is just describing its current thinking and making recommendations.
Moreover, though the Agency stated that in its July 31, 2014 response to the ACLA Citizen Petition [attached] that “any such guidance would not establish any legal obligations” under the theory that the legal obligations arise under the FDCA itself, this is plainly not true. As summarized to Congress, the final guidance would clearly obligate laboratories, under threat of enforcement action to newly comply with FDA regulations and guidances. Some of these obligations are the same as seen by device manufacturers, but others are completely novel and not grounded in any statute or regulation.
The difference between proceeding through guidance and proceeding through regulation is not merely an academic one. The FDA’s “Good Guidance Practices” do not extend the same rights and protections to all stakeholders that notice-and-comment rulemaking would. There are key differences in the obligations imposed upon the FDA – or any federal agency – when engaging in rulemaking, versus the requirements the FDA follows with respect to guidance. Although the FDA plans to accept public comment on the draft guidance, unlike notice-and-comment rulemaking, the FDA is not required to respond to stakeholder comments and explain its rationale for amending draft guidance – or not. This is critically important to understanding the “agency’s current thinking.” The FDA is also not required to conduct any burden analysis or regulatory impact analysis when it issues guidance, both of which are standard features of notice-and-comment rulemaking. If the agency did proceed through notice-and-comment rulemaking, there is no doubt that it would have to put the public on notice that its plans to start regulating an entire industry sector are likely to have a major impact on the entire laboratory industry.
ACLA strongly opposes the claim that the FDA has the authority to regulate Laboratory-Developed Tests. However, if the agency nevertheless moves forward in its attempt to regulate LDTs, it most certainly cannot do so merely through guidance documents. It must use notice-and-comment rulemaking to vastly expand the application of existing regulation and to amend those regulations that do not apply to LDTs or that contradict its plans for regulating LDTs.
The documents released by the Agency on July 31, 2014 go far beyond reflecting current Agency thinking, as they propose an entirely new regulatory framework that will be applied to clinical laboratories developing LDTs for the first time. If the FDA were to finalize this guidance, it would represent nothing short of a wholesale reimagining of the regulation of laboratories, subjecting laboratories to an entirely new set of requirements that they have never faced before.
The Agency has put forth a high-level, conceptual vision of how it would regulate LDTs, while providing very little concrete guidance to the laboratories as to what specifically the FDA will require and how to devise a compliance strategy or operationalize the requirements.
There is no discussion of how any additional regulation by the FDA would interact with the regulation already in place under the CLIA program, including those functions performed by deemed authorities. There are many areas of commonality and overlap, specifically with respect to validation, inspections, and quality systems regulation, and yet there is no discussion of how two separate regulatory authorities would regulate the laboratory industry in a way that would not impede innovation. The Agency had discussed a third guidance document that it planned to release with the actual draft guidance, a document which was to specifically address how the Quality Systems Regulation (QSR) requirements applicable to devices under the FDA would interplay with the quality requirements under CLIA. The Agency has stated that it no longer plans to release such a document with the actual guidance documents. Rather, it has said it will rely on a third-party organization to explain how CLIA and FDA’s QSR requirements can be reconciled. ACLA believes it is wholly inappropriate for FDA to leave such a vital issue to an unaccountable third party to resolve.
The documents released by the FDA fail to address the fundamental differences between device manufacturers and clinical laboratories. Unlike manufacturers of IVD test kits, laboratories are both the innovators and providers of clinical laboratory services, utilizing their advanced knowledge, training, and education in the practice of laboratory medicine to deliver the highest quality health care services for millions of real, every day patients. Knowing this, it would be unreasonable to deem a laboratory, “a manufacturer” and claim that there is a “level playing field,” when manufacturers and laboratories run fundamentally different operations.
Unlike a device manufacturer, which produces a test kit or device that then is sold to another entity that ultimately performs the test, a clinical laboratory is an integrated operation consisting of highly trained and certified personnel who design, validate, perform, and interpret laboratory tests to furnish test reports that then can be used by ordering physicians, in concert with other information, to make treatment decisions. Defining exactly what the “device” is that FDA seeks to regulate, or where the “manufacture” of the test ends and the performance of the test begins, has yet to be explained.
What are “High Risk” and “Moderate Risk” LDTs?
Under the proposed regulatory framework described in the documents released on July 31, 2014, the FDA will not issue draft guidance describing the risk classification of LDTs for 18 months after the finalization of the guidance, with final guidance on risk classification not being issued for two years after the finalization of the guidance. The Agency and stakeholders have spent years attempting to define “high risk” and “moderate risk” in the context of clinical diagnostics, and it is crucial that the Agency clearly define such fundamental principles before instituting a new regulatory framework based on those definitions.
It is unclear in the context of LDTs what constitutes an “adverse event” that must be reported by a laboratory. For example, how precisely would a laboratory test contribute to the death of, or serious injury to, a patient? Would the FDA consider it an “adverse event” if a patient’s cancer returned after an LDT test predicted a 90 percent chance that cancer would not return? Even if “adverse events” were defined in a way that applied in the diagnostic context, it is not clear from an operational standpoint how laboratories could be expected to report adverse events. Referring physicians use LDT test results as one part of a broader clinical picture to make treatment decisions for patients, and these clinical decisions and patient encounters often occur outside the laboratories’ knowledge or involvement. Thus, laboratories would not have access to information on a patient’s other clinical inputs or prognosis after the test results are reported to referring physicians.
Similarly, it is unclear in the context of LDTs what constitutes a “device malfunction” that the LDT “manufacturer” would be required to report to the FDA under 21 C.F.R. § 830.50(a). This issue arises in part because the FDA is seeking to regulate a service rather than a product, and in part because of the FDA’s expansive view of the test system as including, for example, patient demographics, sample procurement and preparation, and reporting. Would an error in patient demographic data entry constitute a “device malfunction” if it had no effect on the test result? What if a momentary interruption in result reporting were to occur due to information system technical difficulties, but the problem was promptly resolved without significantly affecting the timeliness of result delivery? If broadly interpreted and enforced, the requirement to report “device malfunctions” could overwhelm laboratories with reporting incidents that have no adverse effect on the test results or patient care.
High complexity clinical laboratories frequently purchase FDA-approved or FDA-cleared test kits from device manufacturers and modify these test kits, thereby creating LDTs, to improve the performance of the diagnostics, address problems or issues with the FDA-approved or cleared devices, or to incorporate the latest research and clinical knowledge. For instance, a well-known FDA-approved ALK gene FISH test kit, an in vitro companion diagnostic used to aid in treatment selection for patients with Non-Small Cell Lung Cancer, was found by one lab to suffer from poor assay performance. These tests, as LDTs, current are regulated by CLIA and undergo the necessary validations as outlined earlier in this document.
The Agency has stated in the framework documents released to Congress on July 31, 2014 that any modifications to “an FDA cleared/approved device in a way that affects device performance or intended use is considered to be a device manufacturer… [and] [t]hese modified devices must meet premarket submission requirements.” To force a laboratory to undergo such a burdensome and expensive premarket review process in order to make modifications to an FDA-approved or cleared test kit is unreasonable, an encroachment on the practice of medicine, and will be a disincentive for laboratories that otherwise would make such changes to improve diagnostic capabilities of FDA-approved or FDA-cleared tests, which will negatively impact patient access to cutting edge diagnostics.
Are anatomic pathology services considered LDTs subject to FDA regulation?
The anticipated details of this draft guidance leave unclear the regulatory status of many anatomic pathology services provided by laboratories. Anatomic pathology services typically involve the preparation of a biopsy or cellular specimen on a slide (the “technical component”) for microscopic examination and interpretation by a pathologist (the “professional component”). Examples of such services include histopathology or surgical pathology, cytopathology (including the Pap smear test), and hematology. These procedures may include FDA-approved or -cleared components and instruments, components that are exempt from FDA premarket review, or modifications of FDA-approved, -cleared or -exempt components or instruments, and are often performed in laboratories that are independent of health care facility laboratories.
It is difficult to see how the FDA could consider a pathologist reviewing a slide as an in vitro diagnostic or an LDT; in this instance, the pathologist is practicing his or her field of medicine just as any other physician when practicing medicine in his or her office. However, the Agency has written the anticipated details of the draft guidance so broadly that they appear to sweep into the risk-based framework any procedure a laboratory performs that is intended for clinical use and is not an unmodified FDA-approved or -cleared test kit, unless specifically excepted. Under what circumstances, if any, would the FDA view the technical component, the professional component, or the technical and professional components of anatomic pathology together, as a “test system” constituting an LDT subject to the risk-based framework?
We also have very real concerns about resource constraints within the Agency to effectively manage this entirely new area of diagnostic regulation. There are tens of thousands of LDTs in existence today, with hundreds of new tests created every year.
According to CMS, of the 36,432 non-waived laboratories regulated under CLIA, 11,633 CLIA certified laboratories perform at least one or more specialties categorized as high-complexity, which is the only category of labs that are permitted to perform LDTs. A majority of these 11,633 laboratories develop and perform LDTs, many of which could be classified as moderate- or high-risk, depending upon how FDA tailors the risk classifications two years after the finalization of the framework guidance.
In 2013, the FDA approved 23 pre-market approval applications. The Agency has stated in calls with industry stakeholders that it anticipates that the initial set of submissions for the “highest risk” LDTs will be around 100 tests, a number we believe falls far short of the actual number. This is an incredible workload for any agency or organization to undertake, and ACLA has serious concerns about the FDA’s ability to handle this additional workload.
Subjecting LDTs to FDA regulation would eliminate the very characteristics which makes LDTs and the regulatory framework that presently govern them so vital: flexibility and nimbleness in their ability to respond to unmet needs. The flexibility afforded under the CLIA regulatory framework allows laboratories to develop tests quickly and to update them regularly as research and medicine advances, giving patients access to the most current diagnostic testing available. Such flexibility would be lost under the FDA device regulatory framework.
Additionally, FDA regulation of LDTs as medical devices would dramatically slow not only the initial premarket approval of new tests, but also improvements to existing tests, delaying access to new and improved diagnostic testing services for patients and clinicians. Under the current CLIA regulatory framework, laboratories may continually modify and update their tests to reflect medical research advances, provided that the laboratory appropriate validate and document test modifications. Under the FDA device regulatory framework, and as outlined in the proposed LDT framework provided to Congress on July 31, 2014, these modifications would require supplemental filings and authorizations from the FDA. These additional authorizations can take months to obtain, and in many cases, laboratories could not implement the modifications in the interim. Therefore, FDA regulation would impede scientific progress in clinical diagnostics.
As ACLA stated in its June 2013 Citizen Petition to the FDA, “The CLIA framework has worked very well. Over the past few decades, health care providers have ordered millions of LDTs for their patients with few problems. With regard to genetic tests, for example, the Secretary’s Advisory Committee on Genetics, Health, and Society has stated that ‘there have been few documented cases in which patients experienced harm because of errors in a CLIA-regulated genetic test.’ Even though laboratories are not required to report adverse events, litigation or other publicity likely would have revealed more widespread incidence of harm if such harm had in fact occurred. Thus, regulation of LDTs under CLIA has effectively protected the public health.
ACLA and its member laboratories have always been committed to ensuring patient access to accurate, reliable, and meaningful clinical laboratory tests that improve the quality of care, decrease costs, and improve the lives of patients. ACLA has long supported modernizing the regulatory requirements under the CLIA program to keep pace with changing technology. We are confident there are policies that can be developed to accomplish this without doubling or tripling the regulation, oversight and cost.
Chairman Pitts, Ranking Member Pallone, and members of the Subcommittee, thank you for this opportunity to testify today. ACLA is grateful for the opportunity to share our view on the regulation of Laboratory-Developed Tests. The Path to 21st Century Cures Initiative has shown that medical innovation in the U.S. has moved health care ahead by leaps and bounds and even more exciting innovations are just on the horizon. The Initiative has also shown that clinical laboratory diagnostics are a critical and powerful tool in this effort and will enable us to provide patients with higher quality health care at lower costs. To the extent that additional oversight of LDTs is necessary, we continue to believe that the best vehicle for that is modification of CLIA, which already extensively regulates LDTs. ACLA commends you for your leadership and looks forward to working with you, the FDA, and the Administration to ensure regulation of LDTs strikes the right balance between innovation, safety, and patient access.
 Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006; 24(23): 3726-34.
 ACLA Citizen Petition, Docket No. FDA-2013-P-0667 (Jun. 4, 2013), available at https://www.acla.com/wp-content/uploads/2013/12/060413-Citizen-Petition-to-FDA-Regarding-Laboratory-Developed-Tests-LDTs.pdf.
 75 Fed. Reg. 34463 , 34463 (June 17, 2010).
 ACLA Citizen Petition at 2.
 S. Rep. No. 94-33, 94th Cong., 1st Sess. at 17 (Mar. 11, 1975).
 Draft Compliance Policy Guidance: Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (undated) at 4.
 See FDA, Compliance Policy Guide 7124.32, Commercialization of In Vitro Diagnostic Devices (IVDs) Labeled for Research Use Only and Investigational Use Only (May 1996).
 Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents, 61 Fed. Reg. 10484 (Mar. 14, 1996).
 FDA Response to Hyman Phelps & McNamara, P.C., Citizen Petition, Docket No. 92P-0405 (Aug. 12, 1998).
 62 Fed Reg. 62243, 62249 (Nov. 21, 1997).
 See, e.g., Ball Memorial Hospital v. Leavitt, 2006 WL 2714920 (D.D.C. 2006).
 See, e.g., Appalachian Power Co. v. EPA, 208 F.3d 1015 (D.C. Cir. 2000).
 See Paralyzed Veterans of America v. D.C. Arena L.P., 117 F.3d 579 (D.C. Cir. 1997).
 Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories, Framework for Regulatory Oversight of Laboratory-Developed Tests (LDTs) at 17.
 FDA Response to ACLA Citizen Petition, Docket No. FDA-2013-P-0667 (Jul. 31, 2014).at 15.
 See, e.g., Anticipated Details of the Draft Guidance at 16. The FDA plans to require laboratories to submit “notification” of basic information about LDTs to the Agency, yet no such framework exists in statute or regulations for other “device” manufacturers.
 Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115 (1997), § 405; 65 Fed. Reg. 56468 (Sept. 19, 2000).
 See 21 C.F.R. § 10.115(g)(iv).
 See, e.g., Minutes from Negotiation Meeting on MDUFA III Reauthorization: June 27, 2011, at 3, available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm263026.htm.
 Anticipated Details of the Draft Guidance at 26.
 See, e.g., FDCA § 515(d)(6), 21 C.F.R. §§ 807.81(a)(3), 814.39; Anticipated Details of the Draft Guidance.
 Secretary’s Advisory Committee on Genetics, Health, and Society, “U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services” (Apr. 2008), at 32, available at https://oba.od.nih.gov/sacghs/sacghs_oversight)report.pdf.
 ACLA Citizen Petition at 18.


Prof. Colleen Chien, along with her student Jiun-Ying Wu, recently published an analysis of the impact of § 101 on patent prosecution. While their analysis clarifies which art units are impacted by § 101 decisions like Alice and Mayo, the published article doesn’t clearly answer the question of how each art unit contributes to the overall impact on prosecution from § 101. Fortunately, thanks to Prof. Chien and Wu’s decision to publish the code used to derive their data from the Google Patents public dataset for BigQuery, it’s easy to answer that question.
And the answer isn’t surprising. Essentially the entire increase in rejections from § 101 is driven by increased rejections of business method patents.
The USPTO groups its examiners into two main hierarchical divisions. The first, called “tech centers” or “TCs”, groups examiners into broad technical areas like semiconductors, biotechnology, or mechanical engineering. (There are 8 tech centers for utility patents, plus a 9th for design patents.) The second, called “art units” or “AUs”, divides each tech center into smaller groupings that handle one or more specific technologies. The USPTO publishes a list of the classes of technology handled by each art unit.
So, for example, art unit 3711 in tech center 3700 (mechanical engineering) handles toys and gaming devices, particularly those with tangible projectiles, while art unit 3714 handles data processing systems for toys and gaming devices.
To examine the impact of each technological area on § 101 rejections, we start by extracting the raw number of § 101 non-statutory subject matter rejections issued by each tech center. Taking these raw numbers, we can graph rejections as a stacked area chart to show how both total rejections under § 101 have changed, and the relative contribution of each tech center to this change.
Proportionally, business method rejections go from approximately 20% of all § 101 subject matter rejections to almost 40% post-Alice.
There are small increases in other areas. For example, tech center 3700 (mechanical engineering) sees a meaningful increase in post-Alice rejections. However, that increase isn’t spread equally across the tech center—as is made clear by the same data showing that non-business method art units in tech center 3600 (which includes business methods, but also includes everything from cars to nuclear power plants to beekeeping) did not experience the same increase as business method units.
So before assuming that the increase in TC3700 is being broadly applied, we can look further into the data to see if any specific art units are seeing a particularly high impact.
Looking at TC3700, the primary drivers of the increase are art units 3714, 3715, and 3716. AU3714, as I described above, is about methods for games. AU3715 deals with educational methods. And AU3716 primarily handles methods used for video games, such as video game matchmaking and similar applications.
In other words, rather than revealing an increase in mechanical engineering rejections, the data actually shows that art units in the mechanical engineering tech center that deal with methods of organizing human activity are where the increase comes from. And that’s exactly to be expected, given the Supreme Court’s clear statements in Bilski and Alice regarding methods of organizing human activity falling within the scope of an abstract idea.
In short, § 101 isn’t making it hard to get patents—it’s making it hard to get business method patents. It’s making it hard to get patents on abstract ideas and fundamental economic concepts. And that’s exactly what the Court has held § 101 requires.


[T]o all contracts for carriage of goods by sea to or from ports of the United States in foreign trade. As used in this Act the term “United States” includes its districts, territories, and possessions. . . . The term “foreign trade” means the transportation of goods between the ports of the United States and ports of foreign countries.
[C]ontracts of carriage covered by a bill of lading or any similar document of title, insofar as such document relates to the carriage of goods by sea, including any bill of lading or any similar document as aforesaid issued under or pursuant to a charter party from the moment at which such bill of lading or similar document of title regulates the relations between a carrier and a holder of the same.
Typically, it is a Bill of Lading which constitutes the “contract for carriage.” Bills of Lading also typically contain a “clause paramount” which expressly incorporates COGSA. However, even where such clause is absent, where the parties intend, as is very often the case, to have the Bill of Lading act as the “contract for carriage,” COGSA will apply.
(1) Bareboat Charter – the shipowner transfers full possession and control of the vessel to the charterer for a specified period of time and the charterer operates the vessel as owner pro hac vice, whereby it crews the vessel and has sole discretion over the vessel’s trade.
(2) Time Charter – the shipowner retains full possession and control of the vessel and the charterer directs the vessel’s trade for a specified period of time.
(3) Voyage Charter – is similar to a Time Charter, but the charterer has use of the vessel only for a single voyage or a series of pre-determined voyages.
The law governing charter parties, be they bareboat, time, or voyage charters, is federal maritime law. The Ada, 250 Fed. 194 (2nd Cir. 1918).
The Limitation of Liability Act, 46 USC §30501, et seq., enacted in 1851, allows a shipowner, domestic or foreign, to limit its liability following an incident to the “value of the vessel and pending freight” provided that the loss is “occasioned or incurred without the privity or knowledge of the owner.” The “value of the vessel” is the fair market value of the vessel or what remains of the vessel following a casualty; the “pending freight” is the compensation to be paid to the shipowner for the carriage of cargo or other service performed by the vessel. In situations where the claim(s) is/are for personal injury or death as a result of a casualty involving a “seagoing vessel,” the Act provides for an increase of the limitation fund of $420 per gross ton. The amount to which a shipowner can limit its liability is known as the “limitation fund.” If limitation of liability is allowed, the limitation fund will be shared proportionately among all claimants.
It is not uncommon for shipowners to pursue Limitation of Liability Actions following major marine casualties such as a sinking. Most recently, following the tragic loss of EL FARO during Hurricane Joaquin in October 2015, the shipowner filed a Limitation Action in the U.S. District Court for the Middle District of Florida. In addition to the obvious benefit of limiting financial exposure, Limitation Actions afford shipowners the added benefit of concursus, which involves the consolidation of all claims in federal court, traditionally considered more conservative and preferred by institutional defendants. Moreover, as a Limitation Action invokes the court’s “admiralty” jurisdiction, filing of a Limitation Action serves to deny claimants a trial by jury. Ex Parte Green, 286 U.S. 437, 52 S.Ct. 602 (1932).
In contrast to typical litigation, the burden of proof in a Limitation Action is divided among the litigants. Initially, the claimant(s) carries the burden of proving that negligence or unseaworthiness caused the casualty. Thereafter, if the claimant carries his/her burden, in order to succeed in limiting liability, the shipowner has the burden of proving that such negligence or unseaworthiness was not within its “privity or knowledge.” It is the “privity or knowledge” aspect of these actions that is most hotly contested and litigated. An experienced Cruise Line Accident Lawyer/Maritime Accident Lawyer is best positioned to defeat a shipowner’s argument of lack of privity or knowledge.
Very many times shipowners will attempt to limit liability by arguing that the “corporate office” was not involved in events leading up to the casualty. Courts generally hold that “privity or knowledge” involves the shipowner’s participation in, or knowledge of, negligence or unseaworthiness which causes a casualty. M/V Sunshine II v. Beavin, 808 F.2d 762 (11th Cir. 1987). Where the shipowner is a corporation, the company will not be able to deny “privity and knowledge” where the negligence or unseaworthiness causing the casualty was the result of the act or failure to act of an individual sufficiently high on the corporate ladder, such as a corporate officer or manager. Patton-Tully Transportation Co. v. Ratcliff, 797 F.2d 212 (5 th Cir. 1986).
Generally, where a vessel is deemed unseaworthy at commencement of the voyage and the shipowner knew or should have known of the unseaworthy condition, the shipowner will not succeed in limiting its liability. Villers Seafood Co. v. Vest, 813 F.2d 339 (11th Cir. 1987). Conversely, where a casualty is as a result of the master’s negligence, for example, an error in navigation, the shipowner may nonetheless succeed in limiting its liability. Matheny v. Tennessee Valley Authority, 557 F.3d 311 (6th Cir. 2009).
Recreational vessels, even jet skis, are generally considered “vessels” for purposes of the Limitation Act.
U.S. Coast Guard requires the reporting of marine casualties and serious marine incidents. 46 USC §6101; CFR Part 4. A “marine casualty” is defined as “any casualty or accident involving any vessel other than public vessels if such casualty or accident occurs upon navigable waters of the United States or its territories or possessions. . . .” 46 CFR 4.03-1(a). A “serious marine incident” is defined as any accident resulting in “injury to a crewmember, passenger, or other person which requires professional medical treatment beyond first aid, and, in the case of a person employed aboard a vessel in commercial service, which renders the individual unfit to perform routine vessel duties. . . .” 46 CFR 4.03-2.
Reporting of a marine casualty/serious marine incident takes two (2) forms: (1) immediate reporting to the nearest USCG Sector Office, Marine Inspection Office, or Group Office, and (2) written reporting on a USCG Form 2692 within five (5) days of the incident.
(8) An occurrence involving significant harm to the environment as defined first aid) and, if the person is engaged or employed onboard a vessel in commercial service, that renders the individual unfit to perform his or her routine duties; damage including the cost of labor and material to restore the property to its condition before the occurrence, but not including the cost of salvage, cleaning, gas-freeing drydocking or demurrage; or in CFR 4.03-65.
(a) The owner, agent, master, operator, or person in charge shall, within five days file a written report of any marine casualty required to be reported under §4.05-1. This written report is in addition to the immediate notice required by §4.05-1. This written report must be delivered to a Coast Guard Sector Office or Marine Inspection Office. It must be provided on Form CG-2692 (Report of Marine Accident, Injury or Death), supplemented as necessary by Appended Forms CG-2692A (Barge Addendum) and CG-2692B (Report of Required Chemical Drug and Alcohol Testing Following a Serious Marine Incident).
(b) If filed without delay of the occurrence of the marine casualty, the report required by paragraph (a) of this section suffices as the notice required by §4.05-1(a).
(d) The victim or perpetrator is a U.S. national on any vessel during a voyage that departs or returns to a U.S. port.
In the case of an incident aboard a cruise ship, following the occurrence of any covered crime, the shipowner/operator must telephonically notify the FBI Field Office or FBI Legal Attaché (Legat) closest to the vessel’s location and thereafter follow up with a written “Cruise Line Report of Serious Violation of U.S. Law” transmitted to the FBI and the USCG National Command Center.
A Cruise Line Accident Lawyer experienced in conducting these post-incident investigations knows exactly what the cruise line should have done in investigating the incident and what questions to ask in later pursing a claim on behalf of a passenger or crewmember.
In addition to damage to vessels themselves as result of collisions, vessels may damage marine shore structures (bridges, docks, jetties, piers, ramps, terminals) as a result of contact with these structures known as allisions.
Related, but not coming under admiralty jurisdiction, are cases of injury or damage occurring on marine shore structures, but not involving a vessel on navigable waters. For example, injury to a longshoreman as a result of being struck by a loader or fork-lift on a terminal or damage to loading equipment. Generally, it is state law that will apply to situations such as this.
The International Safety Management (ISM) Code refers to the International Management Code for the Safe Operation of Ships and for Pollution Prevention adopted by the International Maritime Organization (IMO) in 1993. The ISM Code became applicable to passenger ships, bulk carriers, cargo high speed ships in excess of 500 gross tons, chemical tankers, gas carriers, and oil tankers in 1998 and to all other cargo ships in 2002. The objectives of the ISM are to ensure safety at sea, prevention of human injury and loss of life, and the avoidance of environmental damage.
(f) procedures for internal audits and management reviews.
The International Convention on Standards of Training, Certification, and Watchkeeping for Seafarers (STCW) was adopted by the International Maritime Organization (IMO) in 1978 and went into effect in 1984. The STCW sets qualification standards for masters, officers, and watch personnel aboard cruise ships and merchant ships and defines minimum standards relating to training, certification, and watch-keeping for seafarers.
Experience with and thorough knowledge of these and other maritime regulations applicable to cruise ships and merchant ships not only allow a Cruise Line Accident Lawyer to advise clients who may not be aware that a violation has occurred, but also allows the lawyer to ask the necessary questions in later pursuing a claim on behalf of a passenger or crewmember.


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In 1986, the Supreme Court held in Ford v. Wainwright that it is unconstitutional to execute an inmate who is presently insane. The U.S. Court of Appeals for the 5th Circuit ruled that Scott Panetti, who was allowed to defend himself in his Texas trial despite his schizophrenia and 14 stints in mental hospitals, and who said the devil compelled his actions, was aware that he committed a crime and that he was to be punished and that was sufficient for competency. The question for the Supreme Court was whether mere awareness of one's acts can be equated with mental competetence, or whether the person also needs to rationally understand what is taking place.
The Court ruled (5-4) on June 28, 2007, that Panetti deserves a rehearing on his claim of mental incompetence. The Court said the Fifth Circuit had used an overly restrictive definition of what constitutes insanity. The Court also said that the Texas state court failed to provide Panetti with the kind of review guaranteed under the Constitution for claims of mental incompetence.
Writing for the majority, Justice Anthony M. Kennedy wrote, "Gross delusions stemming from a severe mental disorder may put an awareness of a link between a crime and its punishment in a context so far removed from reality that the punishment can serve no proper purpose. It is therefore error to derive. . . a strict test for competency that treats delusional beliefs as irrelevant once the prisoner is aware the State has identified the link between his crime and the punishment to be inflicted."
The dissent asserted that Panetti's appeal was barred under the Anti-Terrorism and Effective Death Penalty Act because it constituted a second habeas corpus petition. They also said that greater deference should have been given to the state court's determination of competency.
This case involved the removal of a potential juror from a death penalty trial because of the juror's views about capital punishment. During jury selection in a Washington state murder case, the trial judge dismissed the juror because he expressed doubts about imposing a death sentence. The defendant was granted habeas corpus relief by the U.S. Court of Appeals for the 9th Circuit (Judge Alex Kozinski writing), which ruled that excluding a juror is allowed only if it is clear that the juror would not follow the law.
In a 5-4 decision overturning the 9th Circuit, the Supreme Court held that the ruling of the trial judge should be given deference and upheld. Such deference is required both because the trial judge is in a better position to determine the juror's demeanor than an appellate court and because of the requirements of the Anti-Terrorsim and Effective Death Penalty Act.
sentence without the possibility of parole is the severest sentence that should be imposed in all but the most heinous cases does not even arguably "prevent or substantially impair the performance of his duties as a juror in accordance with his instructions and his oath."
Justice Stevens concluded that the majority had interpreted the law "horribly backward" and "appears to be under the impression that trial courts should be encouraging the inclusion of jurors who will impose the death penalty rather than only ensuring the exclusion of those who say that, in all circumstances, they cannot."
DPIC's commentary based on its recent poll.
Case dismissed as improvidently granted.
Since this court has neither held a prosecutor's penalty phase closing argument to violate due process, nor articulated, in response to a penalty phase claim, what the standard of error and prejudice would be, does a court of appeals exceed its authority under 28 U.S.C. 2254 (d)(1) by overturning a capital sentence on the ground that the prosecutor's penalty phase closing argument was "unfairly inflammatory?"
The Court's per curiam opinion noted that the prosecutor had made similar inflammatory arguments in two other cases. In all three cases, the defendant filed a habeas corpus petition prior to the effective date of the Anti-Terrorism and Effective Death Penalty Act (AEDPA). In the other two cases, the defendant was granted relief. In Weaver's case, however, the U.S. District Court had stayed the filing of the habeas petition until the defendant pursued a certiorari petition to the U.S. Supreme Court on the state's denial of his request for post-conviction relief. Once cert. was denied, the defendant refiled his habeas petition, which was then filed after the effective date of the AEDPA.
The Court held that its decision in Lawrence v. Florida (see below) made clear that a petition for cert. in post-conviction proceedings is not a continuation of that process. Hence, Weaver's petition for habeas should have been accepted by the U.S. District Court, and it would not have come under the AEDPA. Since the other two similar cases had been granted relief, the Court held that it would be unfair to deny Weaver relief (which the 8th Circuit had granted). They thus dismissed their earlier cert. grant.
Justice Scalia, with Justices Thomas and Alito concurring, dissented, saying that the Court should have decided the case.
At his trial, Jeffrey Landrigan objected to his defense attorney's attempts to present mitigating evidence. He later appealed to the Arizona Supreme Court and then petitioned for habeas corpus relief from the federal courts, challenging the effectiveness of his trial representation. His petition was denied by the District Court, and that decision was upheld by a panel of the U.S. Court of Appeals for the 9th Circuit. However, after a rehearing en banc by the 9th Circuit, the decision was reversed. The court said that Landrigan had presented a colorable claim of ineffectiveness and was entitled to an evidentiary hearing. Landrigan v. Stewart, 397 F.3d 1235 (9th Cir. 2005). The U.S. Supreme Court ruled (5-4) that the District Court was correct in denying Landrigan an evidentiary hearing and that the 9th Circuit did not give sufficient deference to the state court's findings under the Anti-Terrorism and Effective Death Penalty Act. Moreover, the Court held that even if further mitigating evidence had been discovered, it was not unreasonable to assume that the defendant would have prevented his attorney from presenting this evidence at the sentencing hearing. Justice Thomas wrote for the Court.
Justice Stevens, with Ginsburg, Breyer, and Souter concurring, filed a dissent stating that without an evidentiary hearing, the conclusions that the defendant would have waived putting on mitigating evidence or that insufficient evidence would have been found to make a difference in the sentence, were "pure guesswork."
The Court overturned the death sentences of three Texas inmates in separate 5-4 rulings. In all three cases (see Abdul-Kabir, below), the juries had been prevented by the Texas statute (since changed) from fully considering the mitigating evidence presented by the defendants. In Smith v. Texas (No. 05-11304), the Texas Court of Criminal Appeals had reconsidered Smith's death sentence after the case had been previously reviewed and sent back by the U.S. Supreme Court. The Supreme Court had held (7-2) in 2004 that Texas' jury instructions did not allow the jury sufficient latitude to consider Smith's low IQ and other mitigating evidence. The Texas court held that any error on the mitigation issue was harmless and therefore did not require a reversal. Four former federal appeals court judges submittied an amicus brief urging the Supreme Court to take the case a second time. (Associated Press, Oct. 6, 2006). This time the Supreme Court rejected the harmless error analysis and remanded the case for a new sentencing hearing. (Lyle Denniston, scotusblog.com, April 25, 2007; Associated Press, April 25, 2007).
In Abdul-Kabir v. Quarterman (No. 05-11284) and Brewer v. Quarterman (No. 05-11287), the trial juries had been prevented from fully considering the defendants' mitigating evidence. The trial judges had instructed the jury that they could simply answer "no" to the question about the defendant's future dangerousness if they did not want to sentence the person to death, even though they thought the proper answer based on the mitigating facts should be "yes." The death sentences were affirmed by the Texas Court of Criminal Appeals and by lower federal courts on habeas corpus review. The U.S. Supreme Court reversed the U.S. Court of Appeals for the 5th Circuit, holding that it had not properly applied the holdings of prior cases in which the High Court made it clear that "sentencing juries must be able to give meaningful consideration and effect to all mitigating evidence that might provide a basis for refusing to impose the death penalty on a particular individual, notwithstanding the severity of his crime or his potential to commit similar offenses in the future." (Abdul-Kabir). The Court issued separate opinions, with Justice Stevens writing for the majority.
The Justices for the majority and in dissent in all three cases (see Smith above) were the same. There are 47 remaining Texas death row inmates who were sentenced under the same flawed statute, which was amended in 1991. (Lyle Denniston, scotusblog.com, April 25, 2007; Associated Press, April 25, 2007).
The Court granted certiorari to decide whether Lawrence's petition for a federal writ of habeas corpus was filed in a timely manner under the Anti-Terrorism and Effective Death Penalty Act of 1996 (AEDPA). AEDPA requires that such a petition be filed within one year from the time that a defendant's conviction becomes final, which is generally at the end of the direct appeal process. However, the expiration of time is held in abeyance while an inmate has a state post-conviction appeal pending. Lawrence maintained that his appeal was still pending while the U.S. Supreme Court considered whether to review the state court's decision in the post-conviction matter. Florida maintained that the tolling of AEDPA's 1-year time limit ends once the state court has ruled on the post-conviction appeal. The Supreme Court ruled (5-4) that, under ordinary circumstances, the time to file under AEDPA is not tolled while the Court is considering whether to grant certiorari regarding a state post-conviction petition. Read the Court's decision here.
The U.S. Court of Appeals for the Ninth Circuit had ruled that California's mitigating factors concerning the defendant's background and character inadequately allowed for consideration of the likelihood that the defendant would behave well in prison. California challenged that ruling. (NY Times, May 2, 2006). DECISION BELOW: 414 F.3d 1094 (9th Cir. 2005).
or has a bearing on, his future prospects as a life prisoner?
rule" under Teague v. Lane, 489 U.S. 288 (1989)?
The Court upheld California's death penalty law in a 5-4 decision on Nov. 13. The majority held that the state's law allowed the jury to consider all appropriate mitigating evidence. Justice Kennedy, writing for the majority, said the Ninth Circuit was mistaken in overturning Belmontes' sentence. He said that various comments by the trial judge "made it clear that the jury was to take a broad view of mitigating evidence." (See N.Y. Times, Nov. 14, 2006).
U. S. 349, 358 (1977) (plurality opinion).
(Stephens, J., dissenting) (emphasis added). See Time on Death Row.
Barbour v. Allen, No. 06-10605, the Court denied certiorari on June 18, 2007. The petition was filed by the Equal Justice Initiative of Alabama (with significant amicus support), challenging the constitutionality of Alabama’s failure to provide appointed counsel to death-sentenced defendants for state post-conviction proceedings.
Chambers v. Quarterman, No. 06-7263. On January 22, 2007, the Court granted a stay of execution to Ronald Chambers of Texas, who was to be executed on January 25. The Court did not provide a reason for its stay while it is reviewing whether to take his case, but his attornyes had raised the issue presented in Smith v. Texas (above) concerning the jury's ability to weigh mitigating evidence of mental problems, which is pending before the Court. (Associated Press, Jan. 22, 2007). See DPIC note on Chambers, the longest-serving inmate on Texas' death row.
Update: On April 30, 2007, the Court remanded Chambers' case to the U.S. Court of Appeals for the Fifth Circuit in light of the Court's recent decision in Abdul-Kabir v. Quarterman (see above) granting Abdul-Kabir a new sentencing hearing.

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Pennsylvania R. Co. v. St. Louis, A. & T. H. R. Co.
Buttz v. Northern Pacific R. Co.
Coit v. Gold Amalgamating Co.
Hamilton v. Vicksburg, S. & P. R. Co.
Campbell v. Laclede Gas Co.
Johnson v. Chicago & Pacific Elevator Co.
Newton v. Furst & Bradley Co.
Gilbert v. Moline Plough Co.
Greenwich Ins. Co. v. Providence & Stonington S. S. Co.
Cope v. Vallette Dry Dock Co.
Hartshorn v. Saginaw Barrel Co.
Kirby v. Lake Shore & Michigan Southern R. Co.
Crescent City Live Stock Co. v. Butchers' Union Slaughter-House Co.
Hibernia Ins. Co. v. St. Louis Transp. Co.
Indianapolis Rolling Mill v. St. Louis, F. S. & W. R. Co.
United States v. Pacific R. Co.
Robbins v. Shelby County Taxing Dist.
Schley v. Pullman Car Co.
Porter v. Pittsburg Bessemer Steel Co.
Lawrence v. Morgan's Railroad & S. S. Co.
Snow v. Lake Shore & Michigan Southern R. Co.
Barnes v. Chicago, M. & St. P. R. Co.
Bullard v. Des Moines & Fort Dodge R. Co.
Tuttle v. Detroit, G. H. & M. R. Co.
Clinton v. Missouri Pacific R. Co.
Goodlett v. Louisville & Nashville R. Co.
Whitsitt v. Union Depot & R. Co.

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This matter is before the United States Magistrate Judge, under the standing orders of the Court and 28 U.S.C. § 636 for a report and recommendation. Plaintiff's claims for Disability Insurance Benefits and Supplemental Security Income were denied administratively by Defendant Commissioner following a hearing before an Administrative Law Judge [“ALJ”]. This is an action for judicial review of that final decision of the Commissioner. The plaintiff has filed a pro se Complaint [Doc. 2], asking the Court to award her benefits, and Defendant Commissioner has filed a Motion for Summary Judgment [Doc. 14]. Plaintiff has not filed any other pleadings besides her complaint.
The sole function of this Court in making this review is to determine whether the findings of the Commissioner are supported by substantial evidence in the record. McCormick v. Secretary of Health and Human Services, 861 F.2d 998, 1001 (6th Cir. 1988). “Substantial evidence” is defined as evidence that a reasonable mind might accept as adequate to support the challenged conclusion. Richardson v. Perales, 402 U.S. 389 (1971). It must be enough to justify, if the trial were to a jury, a refusal to direct a verdict when the conclusion sought to be drawn is one of fact for the jury. Consolo v. Federal Maritime Commission, 383 U.S. 607 (1966). The Court may not try the case de novo nor resolve conflicts in the evidence, nor decide questions of credibility. Garner v. Heckler, 745 F.2d 383, 387 (6th Cir. 1984). Even if the reviewing court were to resolve the factual issues differently, the Commissioner's decision must stand if supported by substantial evidence. Listenbee v. Secretary of Health and Human Services, 846 F.2d 345, 349 (6th Cir. 1988). Yet, even if supported by substantial evidence, “a decision of the Commissioner will not be upheld where the SSA fails to follow its own regulations and where that error prejudices a claimant on the merits or deprives the claimant of a substantial right.” Bowen v. Comm'r of Soc. Sec., 478 F.3d 742, 746 (6th Cir. 2007).
20 C.F.R. § 404.1520(a)(4). A claimant bears the ultimate burden of establishing disability under the Social Security Act's definition. Key v. Comm'r of Soc. Sec., 109 F.3d 270, 274 (6th Cir. 1997). It is important to note, especially in this case, that even if the ALJ finds a severe impairment, that does not end the analysis. The ALJ still must continue along the sequential process in order to determine whether a particular claimant satisfies the disability criteria.
Plaintiff was born in 1978 and was a younger person under the applicable regulations at the time she filed her application. She alleges that she became disabled on August 21, 2012 due to limitations from bipolar disorder, depression, headaches, neuropathy, back injury, stomach problems, bowel problems, fibromyalgia, endometriosis, and breathing problems (Tr. 241, 244, 278). Her insured status expired on December 31, 2015 (Tr. 62). Accordingly, she must establish disability on or before that date in order to be entitled to benefits. 20 C.F.R. § 404.130.
On August 21, 2012, Plaintiff injured her back doing a patient transfer in the scope of her employment as a CNA (Tr. 684). She went to the emergency room three days later complaining of low-back pain (Tr. 543-46). An MRI of her lumbar spine revealed no fractures or subluxations (Tr. 544, 547-48). In October 2012, Dr. Paul Johnson, an orthopedist, treated Plaintiff for low back pain. (Tr. 425). He noted that Plaintiff stood well with good balance and could flex and extend appropriately (Tr. 425). Another MRI of her lumbar spine revealed no fractures, but showed a small annular tear between L5-L5 as well as a protruding disc at the level mildly displacing the origin of the L5 nerve root (Tr. 424). Dr. Johnson released her to work, limiting her to lifting objects weighing less than 10 pounds (Tr. 424).
She then continued to be treated for her low-back pain by Dr. Steve Sanders, a neurologist and Dr. Mohamed Abdelrahman, also a neurologist. (Tr. 429-430, 502-06). Kent Sauter, M.D., in December 2012, performed an independent medical examination for worker's compensation. (Tr. 436-441). He assessed Plaintiff with chronic low-back pain from a lumbar strain, which he concluded had been treated appropriately and recommended no further treatment. He recommended over-the-counter anti-inflammatory medications for her symptoms. (Tr. 441). He opined that she had no restrictions and could return to work. (Tr. 441).


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DESCRIPTION (provided by applicant): The WHS began in 1992 as a randomized controlled trial testing aspirin, beta-carotene, and vitamin E for preventing cancer and cardiovascular disease (CVD) in 39,876 healthy women, aged >45, The trial ended in 2004, and women have been followed observationally since that time. At study entry and annually, women report via questionnaires on a wide range of exposures and endpoints, including cancer and CVD. We confirm these self-reported endpoints with medical records, and cause of death in decedents is ascertained using medical records and death certificates. At baseline, 28,345 women also provided a blood sample, from which plasma, buffy coat, and red blood cells were obtained and stored at -170 ?C. GWAS data on common variation are available for all women with blood, measurement of rare variants in exomes have just been completed for >23,000 women; and all samples have been assayed for several biomarkers. Objectively assessed 7-day physical activity by accelerometer is being collected on ~18,000 women. The WHS cohort is unique in having GWAS and objectively-assessed physical activity in such a large cohort. Follow-up is excellent; after almost 20 years, morbidity follow-up is 94 percent; and mortality follow-up is virtually 100 percent. At the end of current funding, 6,086 confirmed cancers (2,440 breast, 583 colorectal, 537 lung, 1,517 cancer deaths) will have occurred. During the proposed funding period, cancer and CVD endpoints will increase by 30 percent and 51 percent. The WHS has actively provided data to internal and external researchers, with 444 papers published, 89 ancillary studies funded, and participation in 19 NCI Cohort Consortium collaborative projects. In the proposed funding period, we intend to: (1) continue to update exposure and endpoint information, and maintain the repository of biospecimens, to further facilitate data sharing and collaboration, and (2) use the WHS infrastructure to address specific aims related to physical activity; evaluate the translational potential of gene-based risk and explore gene-by-environment interactions; and examine long-term chemo-protection of low-dose aspirin on cancer. None of the ancillary studies provides funding for ascertainment and validation of cancer (and CVD) endpoints. Continued infrastructure support and follow-up is crucial for maximizing the cost-effective use of this valuable large-scale cohort of women with a rich bank of already collected phenotypic and genetic data. RELEVANCE: This application seeks support over the next 5 years for the infrastructure of the Women's Health Study, a large-scale cancer epidemiology cohort of 39,876 women followed since 1992, Data are available on a wide range of characteristics, chronic disease development, blood biomarkers, genetic information, and objectively measured physical activity. Continued follow-up is crucial for building on the enormous amount of data already collected in order to answer critical questions related to cancer.
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Strength Training and the Risk of Type 2 Diabetes and Cardiovascular Disease.
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matches: V. V. V. V. V. V. V.


§ 74-1 Definitions and word usage.
§ 74-2 Dangerous buildings declared nuisances.
§ 74-3 Standards for repair, vacation, or demolition.
§ 74-4 Duties of enforcement officer.
§ 74-6 Removal of notice prohibited.
§ 74-8 Abatement by township.
§ 74-9 Violations and penalties.
Ordinance Enforcement Officer — See Ch. 28.
Building construction — See Ch. 72.
An independent structure having a roof supported by columns or walls resting on its own foundation, and includes a dwelling, garage, barn, stable, shed, greenhouse, mobile home, plant, factory, warehouse, school or similar structure.
Those which have been inspected by the Fire Department and found to be fire hazards by reason of age, condition, dilapidation, obsolescence or abandonment.
Any building which is wholly or partly used or intended to be used for living or sleeping by human occupants.
Any room or group of rooms located within a dwelling and forming a single habitable unit with facilities which are used or intended to be used for living or sleeping by human occupants.
The Zoning Officer, Building Inspector, Fire Official, Ordinance Enforcement Officer or any other person designated by the Board of Commissioners to enforce township ordinances.
Control and elimination of insects, rodents or other pests by eliminating their harborage places, removing or making inaccessible the materials that may serve as their food, poisoning, spraying, fumigating, trapping or by any other recognized and legal pest-elimination methods.
Animal and vegetable wastes resulting from the handling, preparation, cooking and consumption of food.
The Township Board of Commissioners.
Presence within or around a dwelling of any insects, rodents or other pests.
Shall have charge, care or control of any dwelling or dwelling unit, as owner or agent of the owner or as executor, executrix, administrator, administratrix or guardian of the estate of the owner. Any such person thus representing the actual owner shall be bound to comply with the provisions of this chapter and with rules and regulations adopted pursuant thereto to the same extent as if he/she were the owner.
Any individual, firm, corporation, association or partnership or other legal entity.
A piece, parcel, lot or tract of land.
Combustible and noncombustible waste materials, except garbage, including residue from the burning of wood, coal, coke and other combustible material, paper, rags, cartons, boxes, wood, excelsior, rubber, leather, tree branches, yard trimmings, tin cans, metals, mineral matter, glass, crockery and dust.
Anything constructed or erected with a fixed or ascertainable location on the ground or in water, whether or not affixed to the ground or anchored in the water, including buildings, walls, fences, platforms, docks, wharves, billboards, signs and walks.
Whenever the words "dwelling," "dwelling unit," or "premises," are used in this chapter, they shall be construed as though they were followed by the words "or any part thereof."
All dangerous buildings within the terms of § 74-1 of this chapter are hereby declared to be public nuisances and shall be repaired, vacated or demolished as herein provided.
If the dangerous building can reasonably be repaired so that it will no longer exist in violation of the terms of this chapter, it shall be ordered to be repaired.
If the dangerous building is in such condition as to make it dangerous to the health, safety or general welfare of its occupants or the public and is so placarded, it shall be ordered to be vacated within such length of time, not exceeding 30 days, as is reasonable.
No dwelling or dwelling unit which has been placarded as unfit for human habitation shall again be used for human habitation until written approval is secured from and such placard is removed by the enforcement officer. The enforcement officer shall remove such placard whenever the defect or defects upon which the placarding action were based have been eliminated.
If the dangerous building, whether or not vacant, has not been repaired in accordance with the notice and order herein provided and if it is in such condition as to make it dangerous to the health, safety, morals or general welfare of its occupants or of the public and the vacation of the building would not eliminate such condition, it shall be ordered to be demolished.
The enforcement officer shall inspect, on a regular basis, dwellings, buildings and structures to determine whether any conditions exist which render such premises dangerous buildings within the terms of § 74-1 above.
Shall include a statement of the reasons it is being issued.
Shall state a reasonable time to rectify the conditions constituting the nuisance or to remove and demolish the dwelling, building or structure.
Shall be served upon the owner or his agent or the occupant, as the case may require.
Except in emergency cases and where the owner, occupant, lessee or mortgagee is absent from the township, all notices shall be deemed to be properly served upon the owner, occupant or other person having an interest in the dangerous building if a copy thereof is served upon him/her personally or if a copy thereof is posted in a conspicuous place in or about the structure affected by the notice or if he/she is served with such notice by any other method authorized or required under the laws of the commonwealth.
Except emergency cases, in all other cases where the owner, occupant, lessee or mortgagee is absent from the township, all notices or orders provided for herein shall be sent by certified mail to the owner, occupant and all other persons having an interest in said building as shown by the records of the County Recorder of Deeds to the last known address of each, and a copy of such notice shall be posted in a conspicuous place on the dangerous building to which it relates. Such mailing and posting shall be deemed adequate service.
May contain an outline of remedial action which, if taken, will affect compliance with the provisions of this chapter and with the rules and regulations adopted pursuant thereto.
Shall contain notice of the right to appeal to the governing body.
The enforcement officer shall appear at all hearings conducted by the governing body or hearing officer and testify as to the condition of the dangerous building.
Any person affected by any notice which has been issued in connection with the enforcement of any provision of this chapter may request and shall be granted a hearing on the matter before the governing body or a hearing officer appointed by the governing body, provided that such person shall file with the Municipal Secretary a written petition requesting such hearing and setting forth a brief statement of the grounds therefor within 10 days after the day the notice was served. Upon receipt of such petition, the Municipal Secretary shall set a time and place for such hearing and shall give the petitioner written notice thereof. At such hearing, the petitioner shall be given an opportunity to be heard and to show why such notice should be modified or withdrawn. The hearing shall be commenced not later than 30 days after the day on which the petition was filed.
After such hearing, the governing body or hearing officer shall sustain, modify or withdraw the notice. If the governing body or hearing officer sustains or modifies such notice, it shall be deemed to be an order. Any notice served pursuant to this chapter shall automatically become an order if a written petition for a hearing is not filed with the Municipal Secretary within 10 days after such notice is served.
Any aggrieved party may appeal the final order to the Court of Common Pleas in accordance with the provisions of the Judicial Code.
No person shall remove or deface the notice of a dangerous building except as provided in § 74-3C.
Whenever the enforcement officer finds that an emergency exists which requires immediate action to protect the public health, he/she may, without notice or hearing, issue an order reciting the existence of such an emergency and requiring that such action be taken as is necessary to meet the emergency. Notwithstanding the other provisions of this chapter, such order shall be effective immediately. Any person to whom such order is directed shall comply therewith immediately, but upon petition to the enforcement officer shall be afforded a hearing as soon as possible. After such hearing, depending upon the findings as to whether the provisions of this chapter have been complied with, the enforcement officer shall continue such order in effect or modify or revoke it. The costs of such emergency repair, vacation or demolition of such dangerous building shall be collected in the same manner as provided herein for other cases.
If the owner, occupant, mortgagee or lessee fails to comply with the order of the enforcement officer within the time specified in the notice issued by him/her and no petition for a hearing is filed within 10 days thereafter or following a hearing by the governing body or hearing officer where the order is sustained thereby, the enforcement officer shall cause such building or structure to be repaired, vacated or demolished, as determined by the governing body or hearing officer in accordance with the standards hereinbefore provided. The township may collect the cost of such repair, vacation or demolition together with a penalty of 10% of such cost, in the manner provided by law, or the township may seek injunctive relief in a court of competent jurisdiction pursuant to the rules of civil procedure.
Any person who shall violate any provision of this chapter shall, upon conviction thereof, be sentenced to pay a fine not exceeding $1,000, plus costs of prosecution, and, in default of payment thereof, to undergo imprisonment for a term not to exceed 30 days. Each day that a violation continues beyond the date fixed for compliance shall constitute a separate offense.