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The working group shall- (A)not later than 2 years after the date of enactment of this Act, develop or update a summary of- (i)ongoing tick-borne disease research, adult cht including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases; (ii)advances made pursuant to such research; (iii)Federal activities related to tick-borne diseases, including- (I)epidemiological activities related to tick-borne diseases; and (II)basic, clinical, webcam porn sites and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases; (iv)gaps in tick-borne disease research described in clause (iii)(II); (v)the Working Group’s meetings required under paragraph (4); and (vi)the comments received by the Working Group; (B)make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and (C)solicit input from States, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.

The guidance documents described in subsection (a) shall address- (1)methodological approaches that a person seeking to collect patient experience data for submission to, and proposed use by, the Secretary in regulatory decisionmaking may use, that are relevant and objective and ensure that such data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and chaterba analysis; (2)methodological approaches that may be used to develop and identify what is most important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient’s disease; (3)approaches to identifying and developing methods to measure impacts to patients that will help facilitate collection of patient experience data in clinical trials; (4)methodologies, standards, and technologies to collect and analyze clinical outcome assessments for purposes of regulatory decisionmaking; (5)how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the Secretary may submit such proposed draft guidance to the Secretary; (6)the format and content required for submissions under this section to the Secretary, including with respect to the information described in paragraph (1); (7)how the Secretary intends to respond to submissions of information described in paragraph (1), if applicable, including any timeframe for response when such submission is not part of a regulatory application or other submission that has an associated timeframe for response; and (8)how the Secretary, if appropriate, anticipates using relevant patient experience data and related information, including with respect to the structured risk-benefit assessment framework described in section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Committee to the Director of the National Institutes of Health (referred to in this section as the Advisory Committee), appointed under section 222 of the Public Health Service Act (42 U.S.C. Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall issue a report to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives regarding recommendations developed under subsection (a) and any subsequent policy changes implemented, to enhance rigor and reproducibility in scientific research funded by the National Institutes of Health.

In developing and issuing recommendations through the Advisory Committee under subsection (a), the working group established under such subsection shall consider, as appropriate- (1)preclinical experiment design, including analysis of sex as a biological variable; (2)clinical experiment design, including- (A)the diversity of populations studied for clinical research, with respect to biological, social, and other determinants of health that contribute to health disparities; (B)the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and (C)the circumstances under which clinical studies, including clinical trials, should conduct an analysis of the data collected during the study on the basis of biological, social, and other factors that contribute to health disparities; (3)applicable levels of rigor in statistical methods, methodology, and analysis; (4)data and information sharing in accordance with applicable privacy laws and regulations; and (5)any other matter the working group determines relevant. Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Director of the National Institutes of Health and in collaboration with the Commissioner of Food and Drugs, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report that describes education and outreach, guidance, enforcement, and other activities undertaken to encourage compliance with section 402(j) of the Public Health Service Act (42 U.S.C.

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