text:
UNITED STATES v. BACTO-UNIDISK
UNITED STATES v. BACTO-UNIDISK, 394 U.S. 784 (1969)
UNITED STATES v. BACTO-UNIDISK(1969)
Argued: January 23, 1969Decided: April 28, 1969
Antibiotic sensitivity disc used as laboratory screening test to help determine proper antibiotic drug to administer to patients held not merely a "device" but a "drug" within definition of 201 (g) (1) (B) of the Federal Food, Drug, and Cosmetic Act and thus subject to pre-market clearance regulations issued pursuant to 507 of the Act. Pp. 791-801.
392 F.2d 21, reversed.
Lawrence G. Wallace argued the cause for the United States. With him on the brief were Solicitor General Griswold, Assistant Attorney General Vinson, Beatrice Rosenberg, Ronald L. Gainer, and William W. Goodrich.
Edward Brown Williams argued the cause and filed a brief for respondent.
MR. CHIEF JUSTICE WARREN delivered the opinion of the court.
At issue here is the scope of the statutory definition of drug contained in the Federal Food, Drug, and Cosmetic Act and the extent of the Secretary of Health, Education, and Welfare's regulatory authority under that definition. The specific item involved in this definitional controversy is a laboratory aid known as an antibiotic sensitivity disc, used as a screening test for help in determining the proper antibiotic drug to administer to patients. If the article is a "drug" within the general definition of 201 of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C. 321 (1964 ed., Supp. II)), then the Secretary can subject it to pre-market clearance regulations [394 U.S. 784, 785] promulgated pursuant to 507 of the Act (21 U.S.C. 357). Section 507 authorizes the Secretary to require batch certification of any antibiotic product which also meets the general drug definition of 201. If, on the other hand, the article is merely a "device" under the Act, it is subject only to the misbranding and adulteration proscriptions of the Act and does not have to be pre-tested before marketing; and, of course, if the disc does not fall under either definition, the Act itself is totally inapplicable.
When the discs were marketed without complying with the certification regulations of the Secretary, the Government condemned them pursuant to 334 of the Act (21 U.S.C. 331) on the assumption that the discs were drugs and thus validly subject to pre-market regulation. In this action following the condemnation, however, the United States District Court for the Eastern District of Michigan held that the discs were not drugs within the meaning of the Act, suggesting that, if anything, they were devices. It therefore ruled that, since pre-market clearance was not required or authorized, the seizure was improper. The Court of Appeals for the Sixth Circuit affirmed on the same reasoning. We reverse.
Some background information about the development of the discs and the controlling legislation is necessary for an understanding of the determinations made by the Secretary and the courts below. Various antibiotics, known more commonly as "wonder drugs" under such familiar names as penicillin, aureomycin, terramycin, tetracycline, and streptomycin, have proved very useful since World War II in treating numerous infectious diseases. 1 Produced biologically, however, these drugs [394 U.S. 784, 786] tend to vary greatly in their quality and potency unless developed, and thereafter tested, under very carefully controlled conditions. Consequently, 2 Congress enacted 507 of the Food, Drug, and Cosmetic Act, directing the Secretary of Health, Education, and Welfare to [394 U.S. 784, 787] promulgate regulations establishing such standards of identity, potency, quality, and purity as necessary to ensure the "safety" and "efficacy" of those antibiotics. At present, more than 30 antibiotic drugs are listed (21 CFR 145.3) with accompanying regulations covering more than 700 pages in the Code of Federal Regulations (21 CFR 141.1-148z.4).
With the proliferation of the various types of antibiotics, doctors found a need for a screening test to help choose which antibiotic to use in treating a particular infection. A diffusion test, using antibiotic sensitivity discs like the one in question here, soon became a widely employed screening method. 3 In this test, a round paper disc, which has been impregnated with a specific antibiotic, is placed in contact with sample cultures, or isolates, of a patient's virus, grown in a special culture medium (agar) from a specimen of the patient's fluid (blood, spinal fluid, sputum, urine, etc.). In those places impregnated with an antibiotic to which the patient's infection is sensitive, no new isolate will grow, leaving a clear area (an "inhibition zone"); in those places impregnated with a drug to which the infection is resistant, the isolate will grow, leaving no clear area. The disc is used, in conjunction with a patient's specimen, in laboratory work exclusively, and never comes in contact with any part of the patient's body itself. [394 U.S. 784, 788]
The discs had been in general use for some four years when, in 1960, the Secretary of Health, Education, and Welfare determined to regulate them pursuant to 507. After notice and an opportunity for public participation, the Commissioner of Food and Drugs, under authority delegated by the Secretary, promulgated regulations requiring pre-clearance, batch-testing, and certification of antibiotic sensitivity discs (25 Fed. Reg. 9369). The Commissioner's action, the regulations noted, followed "numerous complaints by the medical profession, hospitals, and laboratory technicians" and a resulting extensive survey of the use of the discs. That study found the discs unreliable in their statements of potency with resulting loss of safety and efficacy, and thus found it "vital for the protection of the public health" to adopt the regulations (25 Fed. Reg. 9370).
This case arose in May 1962 as an in rem seizure proceeding against an interstate shipment of a number of cases of sensitivity discs, manufactured by Difco Laboratories, Inc., under the trade name of "Bacto-Unidisk." In condemning the product pursuant to 301 et seq. of the Food, Drug, and Cosmetic Act, the United States claimed, inter alia, that the product, as a "drug" within the meaning of the Act, had not been certified nor exempted from certification as required by 507 (21 U.S.C. 357) and the regulations thereunder and was therefore misbranded under 502 (21 U.S.C. 352). 4 The seizure was proper only if the Secretary's [394 U.S. 784, 789] regulations subjecting the discs to the pre-market clearance requirements were authorized by the Act. Since the scope of the Secretary's pre-market regulatory power over antibiotic drugs under 507 depends ultimately on the Act's general definition of "drug" in 201 (g), the validity of the disc regulations allegedly violated turned on the coverage of the drug definition:
"For the purposes of this chapter -
"(g) (1) The term `drug' means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph; but does not include devices or their components, parts, or accessories." 21 U.S.C. 321 (1964 ed., Supp. II).
If, on the other hand, the product was a "device," only the misbranding, adulteration, and labeling provisions of 501 and 502 applied, and the Secretary's disc certification regulations were invalidly promulgated. Although a "device" expressly cannot be a "drug" under the last phrase of the drug definition above, a device is given almost a parallel definition in 201 (h):
"The term `device' . . . means instruments, apparatus, and contrivances, including their components, [394 U.S. 784, 790] parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals." 21 U.S.C. 321 (h).
Finally, it was established at trial that of the various definitions given above, the operative ones in this case were 201 (g) (1) (B) of the drug provision and 201 (h) (1) of the parallel device definition; 5 the essential question underlying the validity of the regulations, then, was whether the Bacto-Unidisks were "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."
In resolving this question in the negative and holding the seizure invalid, the District Court noted in a memorandum opinion 6 that the concept of drug is limited in a medical sense to articles administered to man either externally or internally, and ruled that the "evidence affords no basis for the conclusion that the definition of `drug' in the Federal Food, Drug, and Cosmetic Act . . . was intended by Congress to extend beyond the meaning of that term in medical science, to encompass these sensitivity disks." The District Court pointed out that although a "literal reading" of 201 (g) (1) (B) "clearly has application to the article libeled herein," enforcing such an application would be "ridiculous and contrary to common sense." The court therefore held that the Bacto-Unidisk did not fall within the purview of the Act for the reason that it was not medically a drug, and [394 U.S. 784, 791] suggested, without deciding, that the discs would be more appropriately classified as "devices" under the Act.
On appeal, the Court of Appeals for the Sixth Circuit affirmed, accepting the District Court's conclusions that the Bacto-Unidisk was not a "drug" in the medical sense of the term and that Congress did not intend the statutory definition of "drug" to be any broader than the medical one. 392 F.2d 21, 23. The court noted that the discs did aid physicians in the determination of what antibiotic to use for the cure, mitigation, or treatment of disease by furnishing useful information, but held that Congress did not intend to apply the statutory phrase "intended for use in the . . . cure, mitigation, [or] treatment" in such an indirect manner. 392 F.2d 21, 22. We granted the Government's petition for certiorari because this interpretation of the Act raised issues of importance in the administration of the Federal Food, Drug, and Cosmetic Act ( 393 U.S. 911 (1968)).
Although there was some testimony below debating the precise extent of the public health dangers posed by the sensitivity discs, the courts below declined to substitute their judgment for that of the Commissioner of Food and Drugs by determining whether his action was really necessary to protect the public health from a purely medical viewpoint. Rather, the courts below quite properly confined the inquiry to an examination of whether the disc regulations, even if medically unwise, were authorized by the Act, and more specifically, by the Act's definition of "drug." Despite the renewed effort here to relitigate the public health issue, we agree with the decision implicitly made by the courts below not to base a resolution of this case on the public need for, or medical wisdom of, the Secretary's regulations requiring pre-market clearance of antibiotic sensitivity discs. It [394 U.S. 784, 792] is enough for us that the expert agency charged with the enforcement of remedial legislation has determined that such regulation is desirable for the public health, for we are hardly qualified to second-guess the Secretary's medical judgment. Our sole concern is whether the statute's definition of "drug" authorizes the disc regulations contested here; and while we agree with the lower courts' limited conception of the issue, for reasons outlined below, we reverse their disposition of it.
Respondent's primary contention here is that the sensitivity discs are not subject to any of the provisions of the Act because Congress did not intend it to cover articles used so indirectly in the "cure, mitigation, [and] treatment" of disease. Respondent uses the same two-step analysis relied on by the courts below: (1) Congress did not intend to write the drug definition more broadly than does the medical profession, and (2) the medical concept of drug is limited to articles that are administered to man either internally or externally. Alternatively, respondent argues, even if the Act's "intended for use" language does cover the discs, they must clearly be classified as devices. In view of the legislative history discussed below and the broad, remedial purpose of the Act itself, however, we hesitate to give the critical language such a narrow, restrictive reading in the absence of congressional direction to do so, and we therefore reject the contention that the discs do not properly fall within the purview of the Act. For the same basic reasons, we furthermore reject the argument that the discs, once found to come under the Act's coverage, must be classified specifically as devices and not drugs.
We need not stop to parse the language of the Act's definition of drug, for the District Court found, and the parties do not disagree here, that a literal reading of the words "intended for use in the . . . cure, mitigation, [or] treatment" of disease "clearly has application" to [394 U.S. 784, 793] the Bacto-Unidisk. Although respondent again urges that the disc itself does not "treat" a patient in the same way an antibiotic does in terms of personal application, the disc plays at least some role in the selection of the appropriate drug. Thus, the essential question for our determination is whether Congress intended the definition of drug to have the broad coverage the courts below and the parties agree its words allow. Viewing the structure, the legislative history, and the remedial nature of the Act, we think it plain that Congress intended to define "drug" far more broadly than does the medical profession. The reason for including a separate, almost parallel, definition of "devices" in the Act is, as the legislative history shows, relevant to congressional intent. It is therefore helpful to consider both the question of the Act's initial application and the question of the drug-device dichotomy at the same time.
At the outset, it is clear from 201 that the word "drug" is a term of art for the purposes of the Act, encompassing far more than the strict medical definition of that word. If Congress had intended to limit the statutory definition to the medical one, it could have so stated explicitly, or simply have made reference to the official United States Pharmacopoeia (or the National Formulary), as it did in the first of the three subsections of 201 (g) (1), and let the definition rest there. The historical expansion of the statute's definition, furthermore, clearly points out Congress' intention of going beyond the medical usage. The 1906 Food and Drug Act, for instance, defined "drug" in a rather limited way to include "all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, [394 U.S. 784, 794] or prevention of disease of either man or other animals." 34 Stat. 768, 769. As subsequent congressional action clearly indicates, however, the scope of that original definition has since been greatly enlarged.
The enactment of the 1938 Federal Food, Drug, and Cosmetic Act illustrates the expansion of the definition of drug. One of the changes contemplated in S. 2800, an early version of the Act, 7 defined "drug" to include
"(1) all substances and preparations recognized in the United States Pharmacopoeia, Homoeopathic Pharmacopoeia of the United States, or National Formulary or supplements thereto; and (2) all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) all substances and preparations, other than food, and all devices intended to affect the structure or any function of the body." (See S. Rep. No. 493, 73d Cong., 2d Sess. (1934).) (Emphasis added.)
Senator Copeland of New York, who sponsored the Act, remarked about the inclusion of the word "devices" in his prepared statement introducing S. 2800 as follows:
"The present law defines drugs as substances or mixtures of substances intended to be used for the cure, mitigation, or prevention of disease. This narrow definition permits escape from legal control of all therapeutic or curative devices like electric belts, for example. It also permits the escape of [394 U.S. 784, 795] preparations which are intended to alter the structure or some function of the body, as, for example, preparations intended to reduce excessive weight. There are many worthless and some dangerous devices and preparations falling within these classifications. S. 2800 contains ample authority to control them." (78 Cong. Rec. 8960 (1934).)
The definition was revised in S. 5, 74th Cong., 1st Sess. (1935), to include substances, preparations, and devices intended for diagnostic purposes, as well as for cure, mitigation, treatment, or prevention of disease (S. 5, 201 (b), S. Rep. No. 361, 74th Cong., 1st Sess. (1935)). 8 As the inclusion of the word "diagnosis" came before the Senate for consideration, a controversy developed on the floor, aimed more at the word "devices," which was not then before the Senate, than at the word "diagnosis." 79 Cong. Rec. 4841-4845 (1935). 9 Senator Clark contended that it was not proper to classify devices as drugs, and that diagnostic devices were so broadly defined as to make even a bathroom scale a drug:
"[I]f the devices ought to be outlawed, they ought to be outlawed, and I have no objection to that; but to maintain that a purely mechanical device is a drug and to be treated as a drug in law and in logic and in lexicography is a palpable absurdity, in my opinion." Id., at 4841.
In answer to Senator Clark's remark that a bathroom scale would be classified as a drug, Senator Copeland made the following comment:
"Mr. President, I desire to state the effect of this amendment. There are on the market certain electrical devices. A man takes hold of the handles of the machine, and the indicator spins around. [394 U.S. 784, 796] It stops at `appendicitis,' or it stops at `meningitis' . . . . Such a device is manifestly a fraud upon society. That is what the amendment is designed to deal with." Id., at 4842.
Despite Senator Copeland's proffered explanation, there was continued criticism during the Senate debates (79 Cong. Rec. 4905-4920, 5215-5234) 10 of the definition on the ground that it would lead to the incongruous result of calling the following items "drugs": shoulder braces (id., at 4841), radium belts (ibid.), electrical devices (id., at 4842), bathroom weight scales (ibid.), and hospital air conditioning apparatus (id., at 5231). 11 The opposition finally settled on "crutches" (id., at 4913) 12 to signify the ultimate absurdity of the drug definition's broad coverage.
As a result of the criticism on the Senate floor, Senator Copeland proposed an amendment to add a definition of "device" to parallel that of drug, an amendment which was included 13 when the bill was returned to the Senate Committee on Commerce and later agreed to by the Senate without debate. (Id., at 8351-8355. 14 ) The [394 U.S. 784, 797] ultimate effect of the various amendments, of course, was still to include devices under the control of the Act for the first time, the goal Senator Copeland had originally set out to achieve. As Congressman Chapman of Kentucky explained to the House after the bill had passed the Senate, "For the first time it is proposed in a bill before Congress to control therapeutic devices . . . . There are hundreds of worthless contrivances being sold to and used by gullible people. Suffice it to say that a fake contraption for the cure of consumption is just as serious a menace to health as is a worthless drug sold for the same disease." 80 Cong. Rec. 10236 (1936). 15 According to the Chief of the Food and Drug Administration, the reason for providing a separate definition of devices, instead of using Senator Copeland's original drug definition, was simply to avoid "the incongruity of classifying certain devices, such as the electric belt, therapeutic lamps, and so forth, as drugs . . . ." (Testimony given during hearings held on S. 5 by a subcommittee of the House Committee on Interstate and Foreign Commerce, 74th Cong., 1st Sess. (1935). 16 ) Because of that incongruity as "pointed out by the Senate in the last consideration of the bill," the official explained, "[t]hey felt it proper to provide an independent definition of `devices.'" Thus, it is clear that two parallel definitions were provided for semantic reasons only; for the purposes of the Act, the two definitions had the same effect of subjecting both drugs and devices to the adulteration and misbranding provisions. No practical significance to the distinction between the two words arose until the pre-market clearance provisions, similar to the certification regulations for antibiotics enacted in 1945, were added after a drug [394 U.S. 784, 798] tragedy in the fall of 1937. 17 (S. 3073, 75th Cong., 2d Sess.) The excepting clause of 201 (g) (1), stating clearly that a drug cannot be a device, was also added in 1938 (S. 5, 75th Cong., 3d Sess., H. R. Rep. No. 2139).
The historical expansion of the definition of drug, and the creation of a parallel concept of devices, clearly show, we think, that Congress fully intended that the Act's coverage be as broad as its literal language indicates - and equally clearly, broader than any strict medical definition might otherwise allow. Strong indications from legislative history that Congress intended the broad coverage the District Court thought "ridiculous" should satisfy us that the lower courts erred in refusing to apply the Act's language as written. But we are all the more convinced that we must give effect to congressional intent in view of the well-accepted principle that remedial legislation such as the Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the Act's overriding purpose to protect the public health, and specifically, 507's purpose to ensure that antibiotic products marketed serve the public with "efficacy" and "safety." Cf. United States v. Sullivan, 332 U.S. 689, 693 -695 (1948); United States v. Dotterweich, 320 U.S. 277, 283 -284 (1943).
Respondent's alternative contention, that even if its product does fall within the purview of the Act, it is plainly a "device" and therefore by definition necessarily [394 U.S. 784, 799] not a "drug," must also be rejected, we believe, in light of the foregoing analysis. At the outset, it must be conceded that the language of the statute is of little assistance in determining precisely what differentiates a "drug" from a "device": to the extent that both are intended for use in the treatment, mitigation and cure of disease, the former is an "article" and the latter includes "instruments," "apparatus," and "contrivances." Despite the obvious areas of overlap in definition, we are not entirely without guidance in determining the propriety of the Secretary's decision below, given the overall goals of the Act and its legislative history.
More specifically, as we have previously held in an analogous situation where the statute's language seemed insufficiently precise, the "natural way" to draw the line "is in light of the statutory purpose" (SEC v. Ralston Purina Co., 346 U.S. 119, 124 -125 (1953)). 18 Since the patient will tend to derive less benefit and perhaps some harm from a particular antibiotic if, though the drug itself was properly batch-tested, it was not the proper antibiotic to use, it was entirely reasonable for the Secretary to determine that the discs, like the antibiotics they serve, are drugs and similarly subject to pre-clearance certification under 507. An opposite conclusion might undercut the value of testing the antibiotics themselves, for such testing would be a useless exercise if the wrong drug were ultimately administered, even partially as the result of an unreliable disc.
Furthermore, the legislative history, read in light of the statute's remedial purpose, directs us to read the classification "drug" broadly, and to confine the device exception as nearly as is possible to the types of items [394 U.S. 784, 800] Congress suggested in the debates, 19 such as electric belts, quack diagnostic scales, and therapeutic lamps, as well as bathroom weight scales, shoulder braces, air conditioning units, and crutches. In upholding the Secretary's determination here, without deciding the precise contours of the "device" classification, we need only point out that the exception was created primarily for the purpose of avoiding the semantic incongruity of classifying as drugs (1) certain quack contraptions and (2) basic aids used in the routine operation of a hospital - items characterized more by their purely mechanical nature than by the fact that they are composed of complex chemical compounds or biological substances. Finally, we are supported in the decision to uphold the FDA's determination that the sensitivity discs fall under the coverage of the Act and specifically under the drug provision thereof by the knowledge that the classification of these discs as drugs may not be as contrary to common medical usage as the District Court and respondent would have us believe. 20
In upholding the Secretary's construction of the Act, we are not unmindful of our warning that "[i]n our anxiety to effectuate the congressional purpose of protecting the public, we must take care not to extend the scope of the statute beyond the point where Congress indicated it would stop." 62 Cases of Jam v. United States, [394 U.S. 784, 801] 340 U.S. 593, 600 (1951). Our holding here simply involves an obvious corollary to that principle, that we must take care not to narrow the coverage of a statute short of the point where Congress indicated it should extend.
MR. JUSTICE DOUGLAS, being of the view that an antibiotic sensitivity disc used by physicians to aid them in determining what antibiotic drug, if any, to give to a patient, is a "device" as defined in 201 (h) * of the Act, not a "drug" as defined in 201 (g), would affirm the judgment.
[ Footnote 1 ] See generally L. Goodman & A. Gilman, The Pharmacological Basis of Therapeutics (3d ed., 1965).
[ Footnote 2 ] See H. R. Rep. No. 702, 79th Cong., 1st Sess. (1945). Section 507, as set forth in 21 U.S.C. 357, reads as follows:
"(a) The Secretary of Health, Education, and Welfare, pursuant to regulations promulgated by him, shall provide for the certification of batches of drugs composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof. A batch of any such drug shall be certified if such drug has such characteristics of identity and such batch has such characteristics of strength, quality, and purity, as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. For purposes of this section and of section 352 (l) of this title, the term `antibiotic drug' means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of any such substance).
"(b) Regulations providing for such certifications shall contain such provisions as are necessary to carry out the purposes of this section, including provisions prescribing (1) standards of identity and of strength, quality, and purity; (2) tests and methods of assay to determine compliance with such standards; (3) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (4) administration and procedure; and (5) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe only such tests and methods of assay as will provide for certification or rejection within the shortest time consistent with the purposes of this section."
[ Footnote 3 ] See generally Bauer, Kirby, Sherris, & Turck, Antibiotic Susceptibility Testing by a Standardized Single Disk Method, 45 American Journal of Clinical Pathology 493 (1966); Petersdorf & Sherris, Methods and Significance of In Vitro Testing of Bacterial Sensitivity to Drugs, 39 American Journal of Medicine 766 (1965); Gould, The Laboratory Control of Antibiotic Therapy, 3 Chemotherapia 477 (1961); Second Report of the Expert Committee on Antibiotics, Standardization of Methods for Conducting Microbic Sensitivity Tests, World Health Organization Technical Report Series No. 210, pp. 12-17 (1961).
[ Footnote 4 ] Section 502, as set forth in 21 U.S.C. 352, reads, in part, as follows:
"A drug or device shall be deemed to be misbranded -
"(l) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 357 of this title, and (2) such certificate or release is in [394 U.S. 784, 789] effect with respect to such drug: Provided, That this subsection shall not apply to any drug or class of drugs exempted by regulations promulgated under section 357 (c) or (d) of this title."
[ Footnote 5 ] Respondent's witnesses established that sensitivity discs are not listed in the United States Pharmacopoeia or the National Formulary, and thus do not come within that portion of the definition of "drug" in 201 (g) (1) (A).
[ Footnote 6 ] The District Court's opinion is unreported; its pertinent findings of fact and conclusions of law are quoted in the opinion of the Court of Appeals, 392 F.2d 21, 22-23 (1968).
[ Footnote 7 ] The earliest versions were S. 1944, 73d Cong., 1st Sess. (1933), and S. 2000, 73d Cong., 2d Sess. (1934). S. 2800 was succeeded by S. 5, 74th Cong., 1st Sess. (1935). S. 5 died in the House, but was succeeded by S. 5, 75th Cong., 1st Sess. (1937), and was the bill eventually enacted into law, as supplemented by S. 3073, 75th Cong., 2d Sess. (1937), and H. R. 9341, 75th Cong., 3d Sess. (1938).
Most of the Act's legislative history is reprinted in C. Dunn, Federal Food, Drug, and Cosmetic Act (1938).
[ Footnote 8 ] See Dunn, supra, n. 7, at 214, 237, 239.
[ Footnote 9 ] Id., at 286-296.
[ Footnote 10 ] Id., at 348-385, 429-476.
[ Footnote 11 ] Id., at 429 (remarks of Senator Clark).
[ Footnote 12 ] Id., at 369. Senator Bailey of North Carolina remarked:
"I do not think the President of the United States would tolerate for a moment a piece of legislation that described crutches as `drugs' and advertising as `adulteration,' carrying the English language and the law very far."
[ Footnote 13 ] The substitute committee report noted only that: "A definition of devices is provided paralleling that of drugs. This expansion of the definition of the term `drug' and the inclusion of devices are essential if the consumer is to be protected against a multiplicity of abuses not subject to the present law." (S. Rep. No. 646, 74th Cong., 1st Sess. (1935).) See Dunn, supra, n. 7, at 477.
[ Footnote 14 ] Id., at 495-496.
[ Footnote 15 ] Id., at 571.
[ Footnote 16 ] Id., at 1235, 1247.
[ Footnote 17 ] This was the "Elixir-Sulfanilamide" tragedy of September-October, 1937, where nearly 100 persons died as the result of consuming an untested drug. See Report of the Secretary of Agriculture on Deaths Due to Elixir Sulfanilamide-Massengill (submitted in response to S. Res. 194 of November 16, 1937), in Dunn, supra, n. 7, at 1316-1327.
[ Footnote 18 ] Cf. Cawley v. United States, 272 F.2d 443, 445 (C. A. 2d Cir. 1959): "[U]nless they explicitly forbid it, the purpose of a statutory provision is the best test of the meaning of the words chosen."
[ Footnote 19 ] Cf. AMP Inc. v. Gardner, 389 F.2d 825, 830 (C. A. 2d Cir.), cert. denied sub nom., AMP Inc. v. Cohen, 393 U.S. 825 (1968), petition for rehearing pending.
[ Footnote 20 ] See W. Dorland's Illustrated Medical Dictionary 449 (24th ed., 1965), where "drug" is defined as "Any chemical compound or any non-infectious biological substance, not used for its mechanical properties, which may be administered to or used on or for patients, either human or animal, as an aid in the diagnosis, treatment or prevention of disease or other abnormal condition, for the relief of pain or suffering, or to control or improve any physiological or pathological condition."
[ Footnote * ] "The term `device' . . . means instruments, apparatus, and contrivances . . . for use in the diagnosis . . . of disease in man . . . ." It would indeed be difficult to write a clearer description of an antibiotic sensitivity disc. [394 U.S. 784, 802]


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New Book for World AIDS Day
Today – December 1 2021 – we are proud to launch a new title that remembers 40 years since AIDS came to Australia in 1981. Always Remember by Geoff Allshorn: 40 years – 40 objects and images from the AIDS epidemic, 1981 ~ 2021. With contributions from Dennis Altman, Phil Carswell, Henry von Doussa, Alison Thorne, Marcus O'Donnell, and Paul Cholewinski.
Always Remember by Geoff Allshorn
The book is available now as a free downloadable pdf, and some articles can be read on the Clouds of Magellan website HERE.
Always Remember by Geoff Allshorn – free web versionDownload
The eBook version and paperback will be available soon – follow this website for updates.
Always Remember is a brief history of AIDS in Australia, expressed through forty objects and images – newspaper clippings, books, films, TV, music, memorials, activism and art. Not to mention badges and milk cartons. Geoff Allshorn tenderly recalls his own experiences and struggles. More broadly, Allshorn probes the meanings behind the many silences, exclusions and (mis)representation, while at the same time celebrating the heroic work of many 'heroes of the epidemic'.
Geoff Allshorn is a former school teacher who has recently been undertaking postgraduate research on the history of HIV/AIDS. He has been a member of many LGBT, HIV/AIDS and other community/activist groups, and has received a number of awards relating to this activism. He is also a former member of various atheist/humanist groups, and is currently the co-convenor of the Rainbow Atheists Facebook and MeetUp pages.
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Breakaway Broadcast Processor contains a line-up tone generator capable of generating several useful tones. Whether you're using the Left/Right outputs with an outboard stereo generator, or Breakaway Broadcast Processor's MPX output directly into an exciter, the procedure is the same.
Connect the oscilloscope signal and ground to Breakaway Broadcast Processor's output, in parallel with the load (exciter or stereo generator).
The oscilloscope must be DC coupled. AC coupling will yield disastrously incorrect results.
Processed audio contains many waveforms resembling squarewaves. Most sound cards are not DC straight, and will thus cause squarewaves to tilt inwards, in turn causing as must as 20% overmodulation with no increase in loudness! The good news is that this can be compensated for.
Nice, sharp edges, and free of tilt. All lines are parallel. If it looks like this, you're lucky -- your sound card needs no tilt compensation!
If the squarewave is tilting inwards like this, turn up the tilt control in Breakaway Broadcast Processor to make it as square as possible.
If the squarewave looks like this, you have overcorrected. Turn down the tilt control.
If the squarewave is this bad, either your wiring is bad, or your sound card is unsuitable for Breakaway Broadcast Processor. Please see the Recommended Hardware page for a list of recommended sound cards.
Some sound cards have slight high frequency rolloff. This is not as critical as tilt -- slight HF rolloff will only slightly reduce stereo separation on a composite signal, but since we have the oscilloscoped connected already, let's make it perfect.
Select the Quick Sweep from the Test Tone menu. The Quick Sweep waveform is a quick spike followed by a very rapid sweep - 1000 - 56000 Hz for MPX, 1000 - 18000 Hz for L/R. The sweep is very quick, repeating roughly 50 times per second, thus essentially turning the oscilloscope into a spectrum analyzer!
Adjust the oscilloscope trig level until the sweep waveform is stationary, and set sweep time as appropriate.
This is a perfect QuickSweep. Frequency response is 1000 to 56000hz is perfectly flat. This will yield excellent loudness and stereo separation on air.
This QuickSweep shows HF rolloff. Adjust the PEQ in Breakaway Broadcast Processor to make the sweep perfectly flat.
This is a BAD QuickSweep. The missing high frequencies indicate the sound card is locked to 96 KHz (instead of 192 KHz), either because of a setting, or because it is incapable of 192 KHz sampling rates. This is unusable for MPX output and would yield a severe lack of stereo separation, and poor peak control.
This QuickSweep is even worse. This sound card is locked to 48 KHz sampling rate. The stereo pilot will still get through (and turn on the stereo light on the FM tuner) but there will be NO stereo separation, since the entire stereo subcarrier is filtered out.
When you have achieved perfect tilt and frequency response, the only thing remaining is to set the modulation level. This can be done either by using a modulation monitor, spectrum analyzer, or the modulation meter on your exciter, although the latter may not always be trustworthy. Spectrum Analyzer (Bessel Null) is the most accurate way -- if you happen to have access to one, read on.
If you have a spectrum analyzer capable of displaying your FM carrier frequency, you can use the built in Bessel Null tone generator in Breakaway Broadcast Processor. This is the single most accurate way to adjust deviation; This is how mod monitors themselves are calibrated.
Input attenuation is dependent on input level.
Settings for digital signal processor (DSP) analyzers will be different but should provide equivalent results.
Turn the Ref Level in Breakaway Broadcast Processor all the way down. Select the 31187.6 Hz test tone. This tone is called a Bessel Null Tone. At this exact frequency, the carrier will null (disappear) when your transmitter is at exactly +/- 75 KHz deviation, leaving only sidebands.
Adjust Ref level (in Breakaway Broadcast Processor), or Input Gain (on your exciter) as necessary to achieve the best possible null.
The spectrum analyzer readout should look roughly equal to the following images. Notice that it's the single center carrier that must null, not any of the sidebands.
Calibration may take a few minutes, or even require a token investment in hardware, but it guarantees the difference between a mediocre station and a station that really jumps out of the speakers.


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Sun and a few passing clouds. High near 65F. Winds NNE at 10 to 20 mph..
A few clouds from time to time. Low 51F. Winds NE at 10 to 20 mph.
Carl Henry DalColletto, Jr.
Carl Henry DalColletto, Jr. passed away in Auburn, CA on December 10, 2021 at the age of 71.
Carl was born and raised in San Mateo, CA He was an avid hunter, and enjoyed racing dirt bikes and cruising the town in his hot rods.
He moved to the coastal hamlet of Loma Mar, CA in 1976 where he made many friends, and participated in coed softball, horseshoes, and coached Little League baseball. He also took up the sport of golf at that time. It was here that he met and married Kim, his third wife, and had a daughter, his only child.
He began his career as a heavy equipment mechanic and operator. He then became an underground utilities locator, ending his career as supervisor of the electric utilities department. He retired from the City of Palo Alto in 2003 and moved to a 40 acre ranch in Georgetown, CA where he indulged his creative side by carving wood spirits from pine knots found on the property. He resided in the town of Cool, CA for the last 12 years of his life, where he was active in the local golf club the HOGGS (Happy Old Geezer Golfers).
He is survived by a daughter, Haley DalColletto, ex-wife and significant other of 28 years Kimberly McIntosh, his younger sister Yvonne Myers and niece Alexis, as well as his six cousins.
A memorial service will be held in Pescadero, CA at a future date, per Carl's wishes.
Carl Henry Dalcolletto Jr.
Kimberly Mcintosh
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Home → Actor and Actress
Josh Turner Biography
Biography Editer — September 29, 2019 in Actor and Actress • add comment
Name: Joshua Otis Turner Birthday: November 20, 1977 Origin: Florence, SC
"The existence that I live and the encounters that I have consistently influence what leaves me innovatively. I imagine that is the thing that makes music genuine."
In the wake of tuning in to the Hank Williams Sr. box set in the Belmont University library, Josh Turner was propelled to state "Long Black Train." After leaving the library, Josh clarifies, "Out of the blue, I got this vision of a wide open space, out on the fields. There was a train running out in the center of no place, and individuals were remaining next to the tracks, simply watching it pass by. It occurred to me that the train was a physical similitude for allurement. These individuals were remaining there, choosing whether or not to jump on it." After returning to his room, the melody just spilled out of him.
Melodic Influences
"I think the absolute first [country music] I at any point heard was at grandmother's home. She cherished music – The Stanley Brothers, The Osborne Brothers, a great deal of gospel groups of four and old Opry stars, Waylon and Johnny Cash."
Joshua Otis Turner was born on November 20, 1977, in Florence, SC. Since early on, religion assumed an enormous job in Turner's life, and he would sing lead and bass parts in the ensemble. He was a piece of the gospel group of four called Thankful Hearts, where he visited all through South Carolina. After secondary school, Josh moved to Nashville and took a crack at Belmont University.
Long Black Train
Josh showed up on the Grand Ole Opry on December 21, 1997, and when he presented a tune he had stated, "Long Black Train," the individuals fired standing up and cheering. After he was done, the host, Bill Anderson requesting that he play it once more, and he got a second overwhelming applause.
Soon after his Opry execution, he was marked by MCA Nashville and recorded his first collection, Long Black Train in 2003. The tune crested at No. 13, however different singles didn't work out quite as well.
Josh discharged his sophomore discharge, Your Man in 2006. That collection earned him two No. 1 melodies, with the title track, and "Would You Go With Me", just as a two part harmony with his legend, Ralph Stanley, "Me and God". In under a year after it was discharged, the collection earned Josh his first Platinum circle.
The Opry Calls
The fall of 2007 is presumably one of Josh's preferred occasions. Over the course of about a while, he was approached to join the Opry, drafted, at that point seven days after the fact, his better half brought forth the couple's first youngster, a child, Hampton Otis Turner, at that point, his third collection, Everything is Fine, was discharged a little while after that.
The principal single, "Sparkler," was another solid hit, topping at No. 2, and the following single, a two part harmony with Trisha Yearwood called "Another Try," was discharged in late January 2008 and climbed the diagrams.
With a solid customary foundation, Josh Turner is remaining on strong ground. Also, he's simply showing signs of improvement constantly.
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About the Author: Biography Editer


Sorry, Because of lacl of Man power, We cannnot prepare the packages for enough. But many Packages are maintained with debian official repostory.
Then you will be able to use the Dennou Ruby Products.
The packages list is as follows.


I have prepared a Guide for students preparing written theses, research papers, or planning projects. It contains my practices and recommendations about such activities.
In addition, if you are a graduate student and would like me to be on your thesis or dissertation committee, I will only do so if you have taken or plan to take one of my courses. I am happy to provide advice on which course might be the best fit as well as advice about my upcoming teaching schedule.
For undergraduates wishing to do a thesis with me I advise you to sign up for office hours. Undergraduates do not need to have taken a course with me.


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kcinterfaithproject.org
Global Interfaith
KC 1920's-1980
KC 1980-Present
Oral History Archive
KC Harmony
Harmony formed in 1989, out of a lack of open discussions about prejudice and racial bias. It began as a merger of two different projects, with the goal of "improving race relations, reducing prejudice, and celebrating diversity."[1] Immanuel Cleaver had the initial idea for Harmony, a combined effort with the local branch of "A World of Difference." This was a national group, connected to the Anti-Defamation League. Together, these groups formed an organization called "Harmony in a World of Difference." Maggie Finefrock and Luther Washington were the first co-directors. The coalition initially began as an 18-month campaign, and as it reached the end of its term, there was a strong desire to continue the initiative. [2] It became evident that efforts to improve race relations could not be accomplished within the framework of a short-term project; this was an ongoing process.[3] As a result, this temporary merge became an organization, with a focus on media, education and community.[4]
Harmony's mission was to "improve race relations, increase appreciation for cultural diversity, and eliminate intolerance." They hoped to create a "model community," which values and celebrates diversity. They sought to unite classrooms, families, cultures and races, instilling values which would transfer to future generations.[5] Structurally, Harmony was built around four different components. The first involved media exposure in collaboration with Channel 9. The second initiative was to build coalitions with other human rights groups within the community. The third, focused on education, through the development of curriculum and trainings. The fourth, and final component, was to build relationships with religious groups, businesses, and other important community organizations in a unified effort to end discrimination.[6]
Harmony built a coalition which brought all the groups in the community together to share information and events. They also developed task forces and training which educated thousands of teachers on bias and prejudice reduction. Harmony provided the materials and created a study guide that maintained a local perspective. The Harmony media campaign made significant efforts to humanize groups, by providing footage of different cultures, as well as coverage of local interfaith events.[7]
The Kansas City Harmony Religious Task Force drafted a "Covenant" which was signed at Loose Park by representatives of various faith traditions. CRES was part of the effort to ensure that the covenant represented all faiths, including those which are non-Abrahamic. Drue Jennings, from Kansas City Power and Light, presided over the signing. The interfaith declaration proclaimed that all people are worthy of respect and dignity, and that such dignity is betrayed by discrimination, or any form of human exploitation. It also offered suggestions for a path towards harmony.[8]
In 2005, Harmony merged with the NCCJ.[8] The programs set forth by Harmony eventually became institutionalized and incorporated into other areas of Kansas City, such as Lee's Summit and Raytown. Their curriculum set a standard for schools, businesses, nonprofits, and faith communities, shaping their mission, values, strategic plans, and congregations for many generations to come. In a sense, Harmony never truly dismantled; it successfully achieved its goal of creating systematic change towards eliminating bias and bigotry in the framework of the city and its institutions.[9]
[1] Harmony. About Us. Accessed February 6, 2019. http://www.asjes.com/links/Susan%20Asjes%20-%20About%20Harmony.htm.
[2] Finefrock, Maggie, interview by Geneva Blackmer. 2016. KC Harmony (March 16).
[3] Harmony. About Us.
[6] Finefrock, Maggie, interview by Geneva Blackmer. 2019. KC Harmony (January 25).
[8] "Harmony Religion Task Force Covenant" The CRES Many Paths Archives, Kansas City, Missouri.
[9] Guillot, Lawrence, interview by Geneva Blackmer. 2016. Interfaith History in Kansas City (February 15).
[10] Finefrock, Maggie, interview by Geneva Blackmer. 2019. KC Harmony (January 25).


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Category: Movie review
Bo Burnham: Make Happy movie review
Posted on September 27, 2016 by Paul Jones
I've enjoyed every one of Bo Burnham's specials, and Make Happy is no exception. His unique musical take on the monologue is smart, entertaining, and not always funny – and this is a good thing. There are plenty of time in Make Happy that I didn't laugh but I enjoyed, and don't get me wrong, there are gut splitting laughs to be had. But occasionally, and the last 30 minutes in particular, are only incidentally funny to make his performance palatable, like he's pushing what's possible for the comedy special. He constantly maintains the element of surprise, faking the audience out only to reveal it was a double fake out, etc. At times, it's relatable, and you feel as though the Burnham is talking directly to you, and others, it's incredibly self-indulgent: he constantly walks the line of being "one of the audience" and being a performer on some other plane of existence. Make Happy contains enough of his previous work in that some of the songs in the special are reminiscent of his earlier work, but not strenuously so, and the jokes have that same rapid-fire wit and irony that they've always had. But the comedy special goes deeper, and I recommend that you check out his specials chronologically to really get it, and that'll it'll be worth your while. Burnham is a master of medium, he adopts and sheds genres and comedic styles and media as his comedy requires. Make Happy is evocative enough of his previous work to please his fans and yet evolutionary enough to not be stale or boring, I recommend it wholeheartedly.
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Sausage Party Movie Review
Seth Rogen's latest star-studded comedy is as silly as it is sublime, but it's a little too ambitious for its own good. The slapstick and and off-color jokes are pretty well-delivered and funny, but a couple times these narratives tried to be critical and edgy, and this fell flat. Specifically, the way the food objects deal with race and religion should have stuck to just getting (admittedly cheap) laughs instead of trying to make a point about the Israel/Palestine conflict. It was also too ambitious with the number of storylines and themes it tried to address: the food-item protagonists explored skepticism, atheism, racism, the forth wall, love, and more, when one of these topics would have done. The consequence of this is there is never a dull moment, but that's at least in part that you're trying to make sure you remember which big topic the sausages are now addressing. All-in-all, this was a high-quality stupid movie, and I highly recommend you go see it in a dirty moving theater with stale popcorn for the full cinematic immersion.
Posted in Movie reviewTagged Sausage PartyLeave a Comment on Sausage Party Movie Review
James Bond: Spectre Movie Review
Posted on July 31, 2016 by Paul Jones
Spectre is as absurd as it is enjoyable, even given the high standard that everyone holds James Bond movies to. The cinematography goes to new heights, featuring bigger explosions and wilder stunts than ever before. The native marketing does too, where every scene plugs some alcohol, watch, car, exotic destination, or clothing. Further, there's the more subliminal message that it's plausible to do any of the things Bond does while intoxicated, motion-limited by tight (and expensive) clothes, in extreme weather, in old and unreliable cars, et cetera. The storyline also tries its hand at one-upmanship, attempting to weave together the disparate prior plots of Daniel Craig's James Bond. In doing so, Spectre positions itself as the magnum opus of the era and maximally silly: that in the whole life of a psychopathic spy, in the background has been a would-be brother plotting to both make Bond suffer as much as possible and run a supranational surveillance program (all without thinking maybe you could just kill James Bond). Having said that, the plot is virtuous in that it makes a villain out of the globalist surveillance state. Spectre has all the right elements in all the right doses, but the genre needs to go deeper than the whole "James Bond is an outdated view on the world" self-referential plot. Rather than espionage and villains being outdated, it's the campy and sexist antics of the 60s that are outdated. The James Bond franchise blew the potential of a dark, gritty reboot, analyzing the ethics of espionage and depicting a plausible version of Ian Flemings character. Maybe I'm being too harsh, because I enjoyed almost every minute of Spectre.
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Star Wars: The Force Awakens Review
Posted on December 22, 2015 by Paul Jones
There has been a great disturbance in the nerd Universe, coming from a a long time ago in a galaxy far, far away; Star Wars: The Force Awakens has come out and it has shattered all previous records and been met with great acclaim. The run up to the release was one of the most relentless marketing campaigns I have ever experienced: it seemed like Star Wars, now owned by Disney, found a way to insert itself into every conceivable market, from make-up to fast-food to toys. Anecdotally, there hasn't been such hype around the franchise since the first release in the prequel trilogy, and considering that film was panned by critics and fans alike, the obvious question is, how does the 7th episode fare?
This weekend I had the tremendous pleasure of experiencing the film in IMAX 3D, and I'm happy to report that like his Star Trek adaptation before this film, J.J. Abrams and co. did excellent work with the latest episode. The film is very aware of its history, and sufficiently forward looking. In this compliment is a thinly veiled criticism however: part of the magic of Star Wars originally was that it offered a vision of the future (well, the past, but you know, spaceships) which was unprecendently exciting. It's no longer 1977, however, and the future of today is very different from the future of yesterday, to put it obscurantly. For instance, we are today conducting automated warfare, and yet a future society which has seemingly sentient robots still places ace pilots physically in space craft to conduct war. Seems unlikely.
But we could likely bracket this concern in the same way that we suspend our disbelief in the Force, the magical power which permeates through all like of the Star Wars universe. And while we're being as charitable as we can, it's worth noting that the action and swash-buckling and the snappy comebacks, all cornerstones of the Star Wars tone, are present and stronger than ever. The CGI in The Force Awakens is masterful and tasteful, BB-8 has the personality and presence of Wall-E, the Millenium Falcon has never looked as believable or exciting (even if it struggled to be as nimble after all these years), and I could feel the savage, uncontrolled power of Kylo Ren's red light saber. The mechanics of what makes a Star Wars film were present in as full a force as ever: the spaceships and lightsabers, the blowing up of spherical super-weapons, and the unlikely tales of supreme heroism against all odds are bigger and better than they've ever been.
Yet again in complimenting the film I've stumbled across a thinly veiled criticism: if this film didn't carry the Star Wars moniker, it would be a copy that was better funded than the original, taking what was good about its predecessors and increasing the size 100 times, quite literally in the case of Starkiller Base. Not only that, but its demise of Starkiller is quickly met by the standard old way of sending your ace pilot to shoot it in its soft spot. I emphasize quickly because the terrible destructive nature of Starkiller Base is difficult to take seriously when it's destroyed in a dozen scenes after it was introduced: it would have been much more imposing and compelling had it been looming in the collective fandom's psyche for destruction in an upcoming film. Han Solo himself seems to recognize in a moment of prescient self-awareness, asking where Stakiller's soft spot is and that "they always have one." And while we're at it, it seems Jakku is rather like Tattooine, Starkiller rather like Hoth, and Takodana rather like Endor (I recognize that I maybe just be pointing out that it's desert, snow, and forest biomes but this is an entire Universe we're talking about).
These are the ways in which the film draws on the previous installments, but the film does have a lot of new ideas that excite me. For instance, Star Wars has always been about the father-son dynamic, being principally about the struggle between Luke and Vader née Anakin. The Force Awakens brings something that no Star Wars film has seen before: a strong female lead, with the brilliantly casted and written Rey. I only presume that Rey is the daughter of Luke, the principal evidence being that Star Wars is the story of the Skywalkers, and I'm excited to learn how Rey will grow to defeat her clear adversary: Kylo Ren née Ben Solo. Similarly, I'm excited to learn what the killing of his father does to Kylo Ren, because while he desperately tries to emulate his grandfather, little does he know of Vader's struggle with the Light, setting him up to strive for version of the Dark Side which never really existed.
I don't know why Kylo does what he does: it seems he is a Good Guy who desperately wants to be the Bad Guy, and this uncertainty makes me like his story. With the mask on, he plays the Bad Buy perfectly, executing entire villages, successfully torturing and extracting information, and capturing important rebels. But when his mask is off, so does his evil falter: Rey manages to push back his Force mind-reading, he need's his father's help in his father's execution, and Rey manages to keep him at bay in a lightsaber duel even as a total amateur. I look forward to learning what about Luke's training caused Kylo to fall to the Dark Side, how Kylo's failure will be internalized, and why Snoke has such control over the clearly powerful Kylo. In this film, Kylo seems to be a childish poseur, exercising his evil in futile ways like destroying things and relying on physical pain for Dark Side strength. For these reasons, Kylo Ren is my favorite new character, because even though he's cowardly and undisciplined, he's also the most complicated and has the most potential for growth, even if it is into the series worst villain.
A reason that I find Kylo more exciting than Rey or Finn could also be that Kylo's story is more singular, while Rey and Finn tell a disjointed, stop-and-go story. Finn is much more important to the narrative early in the story, delivering Po from the certain continued torture and interrogation of Kylo back to Jakku and safely delivering Rey and BB-8 to the rebel base. When he's knocked unconscious however, Rey takes the Light Side's narrative flag, and continues the struggle against Kylo. I hope that in the next film, Rey and Finn get their own distinct stories as opposed to sharing one. The Light Side's story is made even more confusing by the myriad throwback appearances, which while I throughly enjoyed, I only enjoyed them because of how good previous movies were, not necessarily because of their performance in this film.
Finally, Snoke has really captured my attention. He's not complex like Ren because we simply do not know enough about him, but I desperately want to know his backstory and what motivates him.
The Force Awakens is an excellent entry into the Star Wars franchise, and it makes the sequel trilogies proud with its tasteful effects and operatic conflict. While it may seem I'm being very harsh on the film, it's only because I hold the franchise to such a high standard, and J.J. Abrams and co. have done a better job than anyone else could have today.
Posted in Movie reviewTagged Star Wars


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Assurance of Salvation
September 24, 2019 Doctrine of the Holy Spirit
https://dts.podtrac.com/redirect.mp3/traffic.libsyn.com/simplyput/023_Assurance_Of_Salvation.mp3
Walking an aisle and praying a prayer can never assure us of our salvation. Today, Barry Cooper asserts that true assurance accompanies a life truly changed by the gospel.
When I was younger, I struggled to be sure that I was really saved.
I was a serial go-to-the-fronter during the 1980s, first as a kid, and then as a teenager. As a fourteen-year-old, I'd already "prayed the prayer" on multiple occasions. I went to the front at a Billy Graham rally and said the prayer. I went to the front at a Luis Palau meeting and said the prayer. I sat with head bowed at numerous churches, in numerous denominations over the years, and said the prayer. I said it ever more fervently, ever more anxiously, and often with tears. And I kept praying and going to the front because I was never entirely convinced that I'd prayed and gone to the front enough.
What would you say to fourteen-year-old Barry, once you'd told him to get rid of that ridiculous fluff on his upper lip? Many Christians, I think, would say something like this: "As long as you were sincere when you prayed the prayer, you are saved."
The thing is, looking back, I'm really not sure I was.
It wasn't until I was twenty, and in my second semester at university, that I felt a deep, inner assurance that I was truly saved.
Where did that suddenly come from? According to Scripture, this profound inner sense of assurance is something that the Holy Spirit gives us.
As it says in Romans chapter 8, "You have received the Spirit of adoption as sons, by whom we cry, 'Abba! Father!' The Spirit himself bears witness with our spirit that we are children of God."
We have to be careful, of course. It's not that our feelings are the basis of our assurance. After all, it's possible to feel very good about yourself and yet be living in opposition to God. Only Christ's life and death can be the basis of our assurance.
Some might say it's not good to pursue a sense of assurance about our salvation. Doesn't it lead to arrogance or complacency? Well, there's no room for arrogance, because you know that salvation is the free gift of God's grace—you're not saved by anything you've done, so there's no room for boasting.
And as for complacency, listen to 2 Peter chapter 1: "Therefore, brothers, be all the more diligent to confirm your calling and election, for if you practice these qualities you will never fall."
What are these "qualities" Peter refers to? He's talking about virtue, knowledge, self-control, steadfastness, godliness, brotherly affection, and love. There's no room for complacency, because it's only when a person is practicing these qualities, says Peter, that they are confirming their calling and election.
There's a similar train of logic in the Apostle Paul's writings. For example, when he wrote to the Philippians, he said, "I am sure of this, that he who began a good work in you will bring it to completion at the day of Jesus Christ." How could Paul be so sure of their salvation? Because of their "partnership in the gospel"—because they'd demonstrated their love and brotherly affection for him.
To be clear, it's not that those actions earned their salvation—not at all. Only the finished work of Christ is the basis for our salvation. But the actions of those Philippian Christians proved that their salvation was genuine and gave them grounds for assurance. Paul saw in them the fruit that invariably appears in the life of a person who is truly saved.
That's why, as I look back, it was only when I was twenty years old that I had any assurance of salvation. Because it was only at that point that I started to live in light of the gospel. Though those first steps were definitely faltering—embarrassingly so—I started to have the inward desire to practice the qualities Peter and Paul talk about. Not begrudgingly or dutifully, as if I were trying to earn salvation. But because I already had it—and God had changed me inwardly, so that I genuinely wanted to obey Him.
And with that change came the deep inner assurance about my salvation that I had been searching for ever since I was a kid.


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The Eco-concrete Friendly Invention
An environmentally friendly concrete that was invented by UP Engineering students recently won the championship in an international competition in Quebec, Canada last March 24, 2019. Their entry topped a field of over 20 major universities competing from all over the globe.
This student competition aims to promote the idea of environmental performance in concrete mix design as an important aspect of sustainability. Teams thus have the mission to develop an innovative concrete mixture, which will have the lowest possible environmental impacts while maintaining optimal mechanical and durability performances.
To achieve this goal, teams are encouraged to seek out and use local resources of concrete materials such as supplementary cementitious materials (SCMs), alternative SCMs, fillers, recycled and alternative aggregates, and other environmentally friendly materials.
Filipino- World-class
The Philippine entry, submitted by Angelica Anne Munar, Ryan Christopher Ramelo, Paulo Santos and Alexis Declaro, a group of civil engineering students from the University of the Philippines, who were advised by UP Diliman faculty Justin Jesse Limbo Seranilla and Christian Orozco won over the 20 different top universities in the world.
Source: GMA
They used recycled materials such as fly ash and waste glass combined with pozzolanic tuff, a common type of porous rock found within and around the university campus in Quezon City instead of gravel and cement. The team took home the $750 prize after winning the competition. Indeed, another proof that Filipino talents are world class. "Embodying excellence as one of our core values, they serve as inspirations to the rest. Your EWB Family is proud of you!" – EWB Family posted.
The Champion – Invention
The invention was measured using the five parameters which are global warming, carcinogenic impact, ozone depletion, ecotoxicity, and fossil fuel depletion. It has an average improvement of 23.9 percent of its environmental performance.
With its further testing, the UP said, that the strength and durability of the eco-concrete invention are comparable with regular concrete, proves that an environmentally friendly yet strong and durable can produce.
"Free Jeepney Rides" of Mang Jose Como
"The Three Minor Planets" – Keith Russel Cadores, Joscel Kent Manzanero, and Eugene Rivera-


Fevers have hit the Klee household this week. I'm so bummed that I missed my Girl's Night this week, but I got lots of snuggles from the hubs and Lucy so it made it all worth it! Let's jump into the things that were good this week!
5 // Before anyone got sick, Preston and I finally got the chance to celebrate Valentine's Day together. He took me out for some vintage shop browsing (one of our favorite things to do!) and a delicious dinner at a new restaurant near our house, Cork & Barrel. It was great and I loved having some solo time with my favorite guy.
4 // I finally had a chance to do another $10 at Target post this week! There were lots of goodies for me in this one, including a great eyeshadow palette for under $7!
3 // The weather has been amazing here this week! I jumped on the opportunity to break out my spring whites and chambray in a new OOTD post. Also on the blog this week: a Trend Spin post featuring lots of fun spring accessories! It was so fun co-hosting this link up with some lovely ladies!
2 // Can we talk about this Lilly Pulitzer jumpsuit? I'm sure you all remember the insanity that was the Lilly for Target sale. This Boom Boom jumpsuit was one of my BIG wishlist items and of course I never got my hands on it. I watched eBay and Poshmark forever and everyone always wanted upwards of $50....I just couldn't do it. But the Lilly Pulitzer angels smiled upon me last week when I scored this beauty for just $20 (+ Free Shipping)! I can't wait to rock it this summer!
So what are you all up to this weekend? If the weather keeps up, I'm thinking a trip to the zoo is in order!
I love that you waited until that awesome jumpsuit was just the right price! Finding deals like that makes it even more fun to enjoy your goodies!!


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Violence Against Women in Literature: the Trending Topic of the '10s.
4 weeks ago Diane Morrison
"Sad Woman" by George Hogan. Courtesy Public Domain Pictures.
Oh God, I just realized something: every single one, every SINGLE one, of the top 10 bestsellers of the decade turns almost entirely on the plot of a woman's suffering, dying, or abuse. How did I not see this until just now? And how soon can I go back to bed today https://t.co/HaAg3nIxu2
— Anna Sproul-Latimer (@annasproul) December 20, 2019
When I originally took Thursday as my day to publish articles here, I visualized publishing book reviews, maybe an interview or two with our authors. But it seems this is not my destiny; at least, not the past couple of weeks. I suppose it should be no surprise to me that so many of the social issues of our time spill over into the world of literature. Indeed, literature by nature often reflects the time that it's in. So when this happened across my feed, followed by a request that a freelancer examine this in more detail, I felt I needed to reply.
Elephant in the Living Room
Let's talk about the elephant in the living room. The fact is, we're in the middle of a culture war. There are those who think life was better in the 50s, and we should all crawl back into our hole. And then there are those who think that the sweeping social changes we have made in this time have not gone far enough.
The truth is, we (the magazine) are by definition on the side of the latter. We have to be. To accept otherwise would mean accepting that we should always be marginalized, always be regarded as lesser than male writers, always accept not being given the opportunity to advance beyond the point that a shrinking class of entrenched gatekeepers think is acceptable. We're not prepared to do that. Here, sisters are doin' it for themselves.
And I think this is true of the entire literary world. The explosion of fiction by women and other marginalized genders, for women and other marginalized genders, since the 1970s has been awesome in its scope. Just pick up any 1970s sci-fi book to see how far we've come; at least, if it wasn't written by pioneer voices like Joanna Russ, Ursula LeGuin, James Tiptree Jr., and so forth.
So why, then, in this age of unprecedented literary freedom, is the most popular subject a woman's suffering, pain and death?
Is it Men?
I know many would probably expect me to say that, but it isn't. Women buy 80% of all novels; men only purchase about 20%. So no, this isn't about evil men getting their jollies on hearing about suffering women. The numbers simply don't add up to support that. Women are buying these books that celebrate the suffering of women. Seriously, the boys are off the hook, and I'm glad to know that.
Is it the Publishing Industry?
There's an argument for that. We've known about the bias against women and marginalized genders in publishing for some time. In part, this is why many of us have opted at least in part for self-publishing, and it's certainly why most of us who write for this site are here. If you scroll down to the last heading in this article at The Pudding, which examines author gender parity in the New York Times bestseller list over the past decades, you will find those figures repeated again. Women don't get as much promotion by publishing companies. We don't get high profile reviews. We don't get taken seriously even when we are reviewed. It's an old song and dance to us, even if it's new to you.
BUT. But, 8 out of 10 of those bestselling books of the '10s were written by women. So what gives here? Are publishers only promoting works by women if the plot involves the suffering of women?
I doubt it. I mean, it's possible, and I'd love to see a study. But I find it difficult to believe that such conscious malice could be so systemic. Unconscious bias tends to be systemic, and that's why it has to be called out and examined when it's seen. But something this reaching and broad? I just can't see it.
Is it Internalized Misogyny?
Have we absorbed this from the culture around us? Do women believe we are destined to a legacy of pain and suffering?
You could make that argument too. Certainly that criticism has been leveled at E.L. James in the past, and not unfairly.
But… again with the but… many of these stories involve the women who are suffering either standing up against, or indeed, overcoming, the source of their torment. Not the Fifty Shades series (Christian Grey is a child and just… never mind. That's what a toxic relationship looks like, friends). But The Hunger Games and its clone, Divergent, are all about girls overturning the exploitative system that they're in. The Help is about standing up to intersectional racism (even though there's some troubling history about how the author may have stolen a black woman's life story with no credit IRL.) The Girl on the Train is about a woman who has been dismissed as a mess, who has been gaslit for years, realizing this and standing up to her dangerous abuser. The Fault in Our Stars is about dying with grace and strength, which is all any of us can do in the face of the inevitable. Even Gone Girl or The Girl with the Dragon Tattoo, which are horrible stories about abusive men and the women they torment, involve these women standing up to, or getting away from, the abuse, even if it's not in a healthy way.
So What Gives, Then?
In part, it's probably just that there is no story without great challenges for characters to deal with. Common current writing advice is: "The rule for finding plots for character-centered novels, which is to ask: 'So what's the worst possible thing I can do to this guy?' And then do it."
But I think it's more likely that the reason these stories are so popular right now is that they represent a collective anxiety.
Women collectively sense the hostility that's been rising out there since the start of the decade. We know that so-called "Men's Rights Groups" (not really about men or their rights, it's more about feeling they deserve sex and have been deprived of their entitled due — I would love to see some actual men's rights groups because they're needed) have been gaining in numbers. We know that many of our leaders actively hate us, and if they don't, they sure don't respect us. We know that our reproductive rights are being peeled back, or that governments are threatening to do so.
What will we do when the abuser comes in to control our lives, to hurt us or kill us, and the system supports them and not us? What will we do when that abuse and oppression is supported by intersectional racism? What will we do when we live under the yoke of an oppressive dystopian regime, which it feels like the world is edging closer towards every single day?
And maybe, this in part represents the fears of young women, who are coming into their adulthood in this turbulent time. It's worth considering, since 3 of these 10 books are specifically written for young adults.
I'd like to think that the women who are buying these books want to examine the worst case scenarios, and mentally, be prepared. Christian Grey seems like everything the world tells us we should want; he's rich, handsome, successful, a take-charge kind of guy in every aspect. Do we really want to give up our autonomy, let someone else take on the stress of making decisions, like we sometimes consider in our most exhausted fantasies? Would we flee? Would we try to bend the abuser to our will? Or would we fight like Katniss?
I don't know what the right answer is for everyone. All I know is what the right answer is for me.
I'd love to hear your thoughts on this. Why do you think these books have been so popular? Do you have data that refutes mine? Have you come up with a different conclusion? Feel free to join the discussion in the comments below, because yes, I think this is worth talking about, and this is an answer we should seek.
Thank you to Anna Sproul-Latimer for putting this idea in my head. You can follow her Twitter by clicking on the above link.
Tags: Bestsellers misogyny New York Times Women in Literature
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Diane Morrison
Diane Morrison is a short and long-form fiction hybrid author and editor. She likes pickles and bluegrass, and hates talking about herself. An avid National Novel Writing Month participant and gaming geek, she is proudly Canadian and proudly LGBTQ. She manages the official SFWA YouTube channel, where she gets to interview some of her favourite authors and other interesting people in the SFF field. Under her pen name "Sable Aradia" she is a successful Pagan author, a musician, and a professional blogger. She lives with her partners and a three-legged rescue cat in Vernon, BC, where she was born and raised.
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3 thoughts on "Violence Against Women in Literature: the Trending Topic of the '10s."
Sarah Buhrman says:
I completely believe that it's about what we collectively fear. In many ways, we look for our own stories in the fiction we read, and so many women/NBs are gaslight, abused, tormented… and ignored by the system even if we do speak out. We cling to tales of those who survived. We search for those glimmers of hope from those who break or even crack the system that fosters our abuse. And we even appreciate those stories of being broken but still loved, valued, strong enough to keep going.
Sadly, it's a trending thing now, but it's also an old, old story. It's what we do.
Katje van Loon says:
When I first saw that tweet, I admit I rolled my eyes — because what the list said to me was the following:
1. Characters suffer, or there's no plot.
2. Women-led books are more popular now.
3. Women authors are bestsellers now.
To me, that list was mostly a positive thing — not only are female main characters more popular now, but it's mostly women authors who are the bestsellers behind them. That's tremendous progress.
Sproul-Latimer's response felt like, to me, the encapsulation of this:
"More female characters!"
"No, not like that."
If a book is led by a female character, she will have to suffer. Note, "suffer" doesn't just mean major tragedy. It's a broad term, when applied to characters, because all characters must suffer in some way — or they're not particularly interesting. I don't want to read a book where my heroine has a perfectly lovely life and nothing bad ever happens to her. It's *boring* and it gives her *no room to grow*. Even if it's something as small as a pipe ruptures in her house, disrupting her day off, there needs to be *something*. A protagonist needs a challenge.
(Slice of life, fluff fanfic without suffering? Sure. But in *addition* to the main course, not replacing it.)
As for why these books are bestsellers — well, yes, *something* in these stories is resonating. I'm personally not inclined to say it's because of women's collective anxiety, though I don't have data to back that feeling up. My opinion is that it's because people are just hungering for more female-led stories — more heroines, more female characters to read about, and these books on the list happen to hit some other points that make them bestsellers. Bigger stakes is definitely one of those points — so we have more bestsellers where the suffering is on the worse end of the spectrum.
The hunger for more female-led books will lead to more books being sold that hinge on a female character's suffering…because most times you don't have a story without that.
(I think Fifty Shades is an outlier. A lot of the phenomenon around that book stimulated sales, from people needing to know what it was all about, to see the truth behind the controversy, the fact that it started as fanfic of Twilight, etc. And then there's the fact that it's ostensibly erotica — I feel we shouldn't be looking at erotica sales to measure what's resonating for people on a deeper level. Sometimes people just want to get off to things that are inexplicable to others — and sometimes those fantasies are more broadly popular than we might have guessed.)
Claire Ryan says:
Funnily enough, Fifty Shades being so popular has everything to do with the market. As far as I can gather from fandom historical records around that time, FSOG really got started because everyone knew it was Twilight fanfic with lots of sex added, even if the names were changed. That gave it enough of a boost to get it going on Amazon, and then it kinda took off because it's the progenitor of the erotica market; before FSOG, selling straight up non-purple-prose porn on Amazon wasn't really a thing. But FSOG blew that open and now women could get their porn fix without having to worry about people judging them on the bus, because a Kindle = no obvious embarrassing cover with naked men, or whatever.
I think it's an interesting case study in its own right, but yeah, have to agree – it's an outlier.
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Batman: A Death in the Family (partially lost "Jason Todd lives" version of comic; 1988)
From The Lost Media Wiki
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Batman: A Death in the Family (partially lost unfinished "Jason Todd lives" version of comic; 1988)
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Q: What is a good format of getting the parse from HTML using Django I needed help for this small project that I am doing. I tried getting the output from a form in base.html through a function in Views.py. The value I am getting has an extra blank element in the QueryDict I have put the code below:
views.py

        def addToDo(request):
        contents = request.POST['content']
        print(contents)
        added_Time = timezone.now()
        print(added_Time)
        print(contents)
        return render(request,'index.html')

models.py

    class ToDoList(models.Model):
    ToDoText = models.TextField()
    ToDoDate = models.DateField()

base.html

      To Do App

Good Day!

        <form class="form-inline" action="addToDo/" method="POST">
          <input type="text" name="content" placeholder='What are you planning today?'>
          <button class='btn waves-effect waves-light btn-small' type="submit" name="content">Submit</button>
        </form>
      {% block body_block %}
      {% endblock %}

The error is <QueryDict: {'content': ['Hello', '']}> instead of <QueryDict: {'content': ['Hello']}>
when print(contents) is given, the value is a blank instead of 'Hello

A: Found the answer, the name in the  tag in html to be removed to avoid extra "" in the output. Thanks!

redpajama_set_name: RedPajamaStackExchange


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HomeIran News NowIran Human RightsMullah's Latest Reprisal Against Maryam Akbari Monfared Is Further Evidence of the...
Iran News NowIran Human RightsWomen's Rights in Iran
Mullah's Latest Reprisal Against Maryam Akbari Monfared Is Further Evidence of the Iranian Regime's Inhumane Nature
Written by Mansoureh Galestan
On Tuesday, the Iranian regime's judiciary abruptly and forcibly transferred female political prisoner Maryam Akbari Monfared from Evin Prison to Semnan Prison, sparking protests from fellow detainees over continuing mistreatment for Ms. Monfared now in her 13th year of a 15-year sentence.
Maryam Akbari Monfared was arrested in 2009 and was held in solitary confinement for the first 43 days and denied all contact with her loved ones for a further four months after that. Her detention conditions seemed to worsen once again in 2016 after she penned an open letter following up on a formal complaint about unresolved human rights abuses from earlier in the history of the Iranian regime.
The letter highlighted that two of Monfared's siblings – one brother and one sister – had been executed by the Iranian regime in the summer of 1988 as part of a massacre of political prisoners that have claimed over 30,000 lives. After presenting various details of those killings and the process behind them, Monfared urged other family members of the massacre's victims to join in, demanding that its perpetrators be identified and prosecuted.
To Stop Executions in Iran Permanently, World Should Hold Mullahs to Account for 1988 Massacre
In a secondary complaint on October 30, 2016, Monfared appealed for an investigation into the matter. In response, the regime accused her of "defaming Islam" by calling attention to the theocratic regime's crimes. Her privileges in prison were summarily reduced, and in the month after the publication of her open letter, Maryam Akbari Monfared became subject to an "Urgent Action" campaign by Amnesty International.
As well as calling attention to the prisoner's excessive isolation and lack of access to legal counsel during pre-trial detention, the Amnesty campaign pointed out that Monfared had been denied all requests for medical leave from prison, in spite of the need for specialized treatment for rheumatoid arthritis and thyroid problems. Although appointments for such treatment had previously been scheduled, authorities allegedly canceled them after explicitly stating that her protests had been "too brazen."
For the same reason, Evin Prison halted all family visits and phone calls for Monfared while the judiciary threatened to bring fresh charges against her. These pressure tactics were repeated in 2018 for her and two other female political prisoners – Golrokh Ebrahimi Iraei and Atena Daemi – after the three had banded together to protest being subjected to unlawful interrogations.
The prospect of new charges being filed is arguably especially threatening as Monfared approaches the end of her 15-year sentence. The Iranian regime's judiciary has a long history of arbitrarily extending terms of imprisonment after they have technically reached their end, either by securing spurious new convictions or simply by denying the prisoner's release without explanation.
According to Amnesty International and other human rights advocates, the primary basis for Monfared's conviction was that she had made phone calls to surviving siblings who live in exile as members of the leading Iranian opposition group's Mojahedin Organization of Iran (PMOI-MEK).
It was alleged connections to the MEK that spurred the regime's execution of her brother and sister in 1988, as well as the overwhelming majority of the massacre's victims. Two other brothers were killed earlier in the 1980s for the same reason, one of whom died under torture while the other was executed outright. When Tehran's Revolutionary Court sentenced Ms. Monfared in May 2010, it was on charges including "enmity against God," a term closely associated with the 1988 massacre and regularly used to justify capital punishment for members of the MEK and other pro-democracy groups.
These facts underscore the potential danger of Monfared being subject to additional prosecution in the wake of her protests. By extension, they also underscore the courage underlying those protests themselves. Her 2016 complaint was the first such action taken over the 1988 massacre by any Iranian prisoner. It has made her something of a cause célèbre among Iranian opposition activists and a subject of particular anxiety and concern.
With ongoing pressure and suppression of political prisoners in general and especially female prisoners in Iran, it is time for the Western countries and especially the EU, to stop their appeasement policy towards the Iranian regime and put more pressure on the regime to release the political prisoners and accept International bodies to visit Iran's prisons. The European countries must clarify to the regime that any relationship with the regime is conditional on respecting Iranian people's human rights.
On Wednesday, Mrs. Maryam Rajavi, the President-elect of the National Council of Resistance of Iran (NCRI), reiterated a longstanding call for international inspections of Iran's prisons and especially their political wards. She also urged the United Nations' special rapporteur on violence against women to investigate the health conditions of Ms. Monfared and other female political prisoners who have been similarly denied access to vital medical care.
Once again, I reiterate the need for an international delegation to visit Iranian prisons and meet with prisoners, esp. the political prisoners in #Iran. #FreePoliticalPrisoners
— Maryam Rajavi (@Maryam_Rajavi) March 10, 2021
1988 Massacre
women's rights in iran
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