Saturday, April 24, 2021

Act A10 Answers

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    Federal funding of basic research is allowed at the discretion of the Director of NIH. Q2: In the summer of , the Center for Medical Progress released videos exposing the sale of baby body parts. These undercover videos showed Planned Parenthood...

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    The company no longer lists fetal tissues at its website. This company was contracted by the U. FDA to source fetal tissue from PP for use in government biomedical research. Though ethically objectionable, these transfers would still have been...

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    Many modern vaccines use animal cell lines, even insect cell lines, as well as modern human cells that are not from fetal tissue. As just a couple of examples, the new Ebola vaccine — recently shown to be Q4 a : If NIH is not funding aborted fetal tissue research for vaccines, what basic research is being funded? NIH also gives out millions of federal dollars in contracts for specific projects using fetal tissue. Projects funded for fetal tissue research include studies on normal and abnormal development, including brain development, retinal formation and degeneration, and infectious diseases including HIV infection. Note that this means NIH and its researchers are purchasing aborted fetal brains, eyes, livers, hearts, and other organs for these studies. Q4 b : Are there alternatives to use of aborted fetal tissue in research? There are many alternatives.

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    One is use of miscarried tissue, which can be used to study development as well as causes of pregnancy loss. Organoids are organ-like structures and tissues that have been shown to mimic normal development and can also be used to study abnormal development and causes of birth defects. The concern is that if a pregnant mom is bitten by a mosquito carrying Zika, the baby may develop something called microcephaly which shrinks their brains. Is fetal tissue research necessary to learn more about Zika? Some researchers perform direct observational studies on the brains while others will isolate stem cells from the tissue to study the mechanism of infection. We know from published studies that organoids, three-dimensional organ-like structures constructed using modern stem cell techniques, are incredible models for studying Zika infection. These organoids have been instrumental in deciphering both normal brain development and the mechanism of Zika virus action on the developing brain.

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    In one example, a seminal study in the journal Scienceshowed that brain organoids can recapitulate the mechanism of how Zika infects human cells and causes the same microcephaly observed in humans. Resources for Question 5: Garcez PP et al. What is that contract for? In fact, NIH requires the use of aborted fetal organs in this contract. NIH renewed the contract for 90 days in December , and again in March It is up for possible renewal in June, just days away.

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    Q7 a : What are humanized mice? Humanized mice are mice with a human immune system. These mice are severely immune compromised and unable to fight off infection and disease, but researchers are able to regenerate a functional human immune system in these mice by engrafting transplanting human immune cells and tissues derived from fetal or non-fetal sources. There are several ways to make a humanized mouse. Human fetal bone fragments are also transplanted into mice to study multiple myeloma.

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    Q7 b : Are all humanized mice bad? Are there other ways to make humanized mice? There are many ways to make humanized mice using cells and tissues from adults and discarded tissues, without killing the fetus to harvest its tissue. References for Question 7: Brown ME et al. However, the BLT mouse is only one model among many other animal and non-fetal models that have been used to study HIV. Therefore, humanized BLT mice were not the only means available to understand the mechanism of HIV infection and test safety and efficacy of therapies before use in humans. Q8 b : Can those goals be achieved using alternative research methods? We can use peripheral blood, cord blood, bone marrow, and neonatal thymus tissue, as discussed earlier. In fact, a recent study by Cheng et al.

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    And hu-PBMC mice are an ideal model for rapid drug discovery and were used in early testing of therapeutics including Enbrel for rheumatoid arthritis. Finally, severalexamples exist of non-fetal sources used in the production of currently approved biotherapeutic agents including plant cells, insect cells, bacteria, yeast, Chinese hamster ovary CHO cells, murine cells, and HT cells created from a tissue biopsy of a fibrosarcoma from a year-old human male. This does not include insulin made in bacteria and yeast to treat diabetes, and more than 70 successful treatments developed using adult stem cell sources.

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    If we stop harvesting aborted fetal tissue today and focus solely on alternatives, it will not stop one person from being treated. Resources for Question 8: Cheng et al. Even if we look only at the use of fetal tissue for generating humanized mice, we know that there are several advantages to using alternatives—the mice are easier to prepare at lower cost, more animals can be generated per cohort, there is negligible graft-versus-host disease and longer life span, chronic HIV infection is longer-lasting, and long-term safety and toxicity assessments are possible Akkina et al.

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    There is no form of biomedical research that is absolutely necessary for any desired advance. If that were true, we would not have made the many wonderful advances in biomedical science that we now enjoy and even take for granted. Scientific discovery can be engineered or serendipitous, and serendipity abounds. We often make life-changing discoveries in places where we never expected, and the best discoveries are those that are revealed by multiple approaches. Respecting the bodies of our presently misfortunate innocents is not going to cost us anything. It is going to improve us. Q These babies would die anyway, so why not bring some good out of it? Though seemingly pragmatic, this attitude is certainly not a moral one, as defined by having regard for the essentiality of human life in civilized human societies.

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    Actually, it is not pragmatic either, because the stated position depends on a fallacy, that the means are necessary. But elective abortions are not necessary. They are elective. These babies would not die anyway, and the CMP revelation of the true face of PP teaches us that the desired end can soon begin to dictate the means, motivating a demand for more electively aborted human beings. Never was and never will be. All government-funded research is subject to rules and regulation that safeguard both the born and the unborn i. So, we have never and never will allow scientific research to be boundless. The continuing challenge, of course, is deciding as a society where to set those bounds for everyone.

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    And in most cases, as now, the most important consideration for defining limits on science will be the quality of our regard for our impacted fellow human beings when we anticipate personal benefits at their expense.

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    Yes Was your business profitable in ? Yes Qualification Questions If questions 1 or 2 below are answered "Yes," the loan will not be approved. Is the Applicant or any owner of the Applicant presently suspended, debarred, proposed for debarment, declared ineligible, voluntarily excluded from participation in this transaction by any Federal department or agency, or presently involved in any bankruptcy? Yes No 2. Has the Applicant, any owner of the Applicant, or any business owned or controlled by any of them, ever obtained a direct or guaranteed loan from SBA or any other Federal agency that is currently delinquent or has defaulted in the last 7 years and caused a loss to the government? Yes No 3. Is the Applicant or any owner of the Applicant an owner of any other business, or have common management with, any other business?

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    If yes, list all such businesses and describe the relationship on a separate sheet identified as addendum A. Yes No Please select "Yes" if you or the Applicant Business or any Owner has an ownership stake or common management with any other business. Addendum A will be made available prior to finalizing your application. Addendum A Please list all businesses owned and describe the relationship below: 4. If yes, provide details on a separate sheet identified as addendum B. Yes No 6. Within the last 5 years, for any felony, has the Applicant if an individual or any owner of the Applicant 1 been convicted; 2 pleaded guilty; 3 pleaded nolo contendere; 4 been placed on pretrial diversion; or 5 been placed on any form of parole or probation including probation before judgment?

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    Yes No 7. Yes 8. Yes No 9. Are all owners of the applicant company U. Citizens or Lawful Permanent Residents? If no, please explain below.

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    How can I get more information on the CPI? What is the CPI? The Consumer Price Index CPI is a measure of the average change overtime in the prices paid by urban consumers for a market basket of consumer goods and services. How is the CPI market basket determined? The CPI market basket is developed from detailed expenditure information provided by families and individuals on what they actually bought. There is a time lag between the expenditure survey and its use in the CPI.

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    For example, CPI data in and was based on data collected from the Consumer Expenditure Surveys for and In each of those years, about 24,consumers from around the country provided information each quarter on their spending habits in the interview survey. To collect information on frequently purchased items, such as food and personal care products, another 12,consumers in each of these years kept diaries listing everything they bought during a 2-week period. Over the 2 year period, then, expenditure information came from approximately24, weekly diaries and 48, quarterly interviews used to determine the importance, or weight, of the item categories in the CPI index structure. How is the CPI sample created?

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    A particular item enters the CPI sample through a process called initiation. This initiation process, typically carried out in person by a CPI data collector, involves selecting a specific item to be priced from the category that has been designated to be priced at that store. For example, suppose a particular grocery store has an outlet where cheese will be priced. A particular type of cheese item will be chosen, with its likelihood of being selected roughly proportional to its popularity. If, for example, cheddar cheese in 8 oz. After probabilities are assigned, one type, brand, and container size of cheese is chosen by an objective selection process based on the theory of random sampling. The particular kind of cheese that is selected will continue to be priced each month in the same outlet. This item will be repriced, monthly or bimonthly, until it is replaced after four years through sample rotation. Repricing is usually done in person, but may be done via telephone or the internet.

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    The process of selecting individual quotes results in the sample as a whole containing a wide variety of specific items of a category roughly corresponding to consumer purchases. So the cheese sample or the new vehicle sample, the television sample, etc. How is the CPI calculated? The CPI is a product of a series of interrelated samples. First, using data from the U. Census we select the urban areas from which data on prices are collected. Next, another sample of about 14, families each year serves as the basis for a Telephone Point-of-Purchase Survey TPOPS that identifies the places where households purchase various types of goods and services, forming the basis for the CPI outlet sample. Recorded price changes are weighted by the importance of the item in the spending patterns of the appropriate population group.

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    The combination of carefully selected geographic areas, retail establishments, commodities and services, and associated weight, gives a weighted measurement of price change for all items in all outlets, in all areas priced for the CPI. How is the CPI used? The CPI affects nearly all Americans because of the many ways it is used. Some examples of how it is used follow: As an economic indicator. The CPI is the most widely used measure of inflation and is sometimes viewed as an indicator of the effectiveness of government economic policy.

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    It provides information about price changes in the Nation's economy to government, business, labor, and private citizens and is used by them as a guide to making economic decisions. As a deflator of other economic series. The CPI and its components are used to adjust other economic series for price changes and to translate these series into inflation-free dollars. Examples of series adjusted by the CPI include retail sales, hourly and weekly earnings, and components of the National Income and Product Accounts. The CPI is also used as a deflator of the value of the consumer's dollar to find its purchasing power. The purchasing power of the consumer's dollar measures the change in the value to the consumer of goods and services that a dollar will buy at different dates. In other words, as prices increase, the purchasing power of the consumer's dollar declines.

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    As a means of adjusting dollar values. The CPI is often used to adjust consumers' income payments for example, Social Security , to adjust income eligibility levels for government assistance, and to automatically provide cost-of-living wage adjustments to millions of American workers. As a result of statutory action, the CPI affects the income of millions of Americans. Another example of how dollar values may be adjusted is the use of the CPI to adjust the Federal income tax structure. These adjustments prevent inflation-induced increases in tax rates. In addition, eligibility criteria for millions of food stamp recipients, and children who eat lunch at school, are affected by changes in the CPI.

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    Many collective bargaining agreements also tie wage increases to the CPI. Whose buying habits does the CPI reflect? The CPI reflects spending patterns for each of two population groups: all urban consumers and urban wage earners and clerical workers. The all urban consumer group represents about 93 percent of the total U. It is based on the expenditures of almost all residents of urban or metropolitan areas, including professionals, the self-employed, the unemployed, and retired people, as well as urban wage earners and clerical workers.

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    Not included in the CPI are the spending patterns of people living in rural nonmetropolitan areas, those in farm households, people in the Armed Forces, and those in institutions, such as prisons and mental hospitals. The Consumer Price Index for Urban Wage Earners and Clerical Workers CPI-W is based on the expenditures of households included in the CPI-U definition that also meet two additional requirements: more than one-half of the household's income must come from clerical or wage occupations, and at least one of the household's earners must have been employed for at least 37 weeks during the previous 12 months. The CPI does not necessarily measure your own experience with price change. It is important to understand that BLS bases the market baskets and pricing procedures for the CPI-U and CPI-W populations on the experience of the relevant average household, not of any specific family or individual.

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    For example, if you spend a larger-than-average share of your budget on medical expenses, and medical care costs are increasing more rapidly than the cost of other items in the CPI market basket, your personal rate of inflation may exceed the increase in the CPI. Conversely, if you heat your home with solar energy, and fuel prices are rising more rapidly than other items, you may experience less inflation than the general population does. A national average reflects millions of individual price experiences; it seldom mirrors a particular consumer's experience. What types of data are published? Many types of data are published as outputs from the CPI program; the most popular are indexes and percent changes. Requested less often are relative importance or relative expenditure weight data, base conversion factors to convert from one CPI reference period to another , seasonal factors the monthly factors used to convert unadjusted indexes into seasonally adjusted indexes , and average food and energy prices.

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    Index and price change data are available for the U. Indexes for various groupings of items are available for all geographic areas and size classes. Index levels are published along with short-term percent changes and month percent changes. At the national item and group level, unadjusted and where appropriate seasonally adjusted percent changes are also published. Average prices for select utility, automotive fuel, and food items are published at the U. If the sample size is sufficient, all average prices are also published monthly at the regional level. Average prices for utility gas, electricity, and automotive fuel prices are also published at the size class and area level. Congress amended the Social Security Act of with public law in Part of that amendment called for automatic annual cost of living increases to be made to Social Security payments based on the CPI. BLS calculates the CPI-W and other CPI series, but we do not determine policy regarding how these series are used by other agencies, nor are we involved in making or adjusting Social Security payments.

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    Is the CPI a cost-of-living index? The CPI frequently is called a cost-of-living index, but it differs in important ways from a complete cost-of-living measure. We use a cost-of-living framework in making practical decisions about questions that arise in constructing the CPI. A cost-of-living index is a conceptual measurement goal, however, and not a straightforward alternative to the CPI. A cost-of-living index would measure changes over time in the amount that consumers need to spend to reach a certain utility level or standard of living.

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    Both the CPI and a cost-of-living index would reflect changes in the prices of goods and services, such as food and clothing that are directly purchased in the marketplace; but a complete cost-of-living index would go beyond this role to also take into account changes in other governmental or environmental factors that affect consumers' well-being. It is very difficult to determine the proper treatment of public goods, such as safety and education, and other broad concerns, such as health, water quality, and crime, that would constitute a complete cost-of-living framework.

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    Since the CPI does not attempt to quantify all the factors that affect the cost-of-living, it is sometimes termed a conditional cost-of-living index. Traditionally, the CPI was considered an upper bound on a cost-of-living index in that the CPI did not reflect the changes in buying or consumption patterns that consumers would make to adjust to relative price changes. The ability to substitute means that the increase in the cost to consumers of maintaining their level of well-being tends to besome what less than the increase in the cost of the mix of goods and services they previously purchased. Since January , a geometric mean formula has been used to calculate most basic indexes within the CPI; in other words, the prices within most item categories for example, apples are averaged with the use of a geometric mean formula.

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    This improvement moves the CPI closer to a cost-of-living measure, because the geometric mean formula allows for a modest amount of consumer substitution as relative prices within item categories change. However, the expenditure data used to compute the final C-CPI-U isn't available until months after the reference month, so a preliminary estimate of the index is published and later revised. What goods and services does the CPI cover?

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