Congress enacted the Medical Device Amendments of 1976, in the words of the statute's preamble, "to provide for the safety and effectiveness of medical devices intended for human use." 90 Stat. 539. The question presented is whether that statute pre-empts a state common law negligence action against the manufacturer of an allegedly defective medical device. Specifically, we must consider whether Lora Lohr, who was injured when her pacemaker failed, may rely on Florida common law to recover damages from Medtronic, Inc., the manufacturer of the device.
Throughout our history the several States have exercised their police powers to protect the health and safety of their citizens. Because these are "primarily, and historically, . . . matter[s] of local concern," Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 719 (1985), the "States traditionally have had great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons." Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 756 (1985) (internal quotation marks omitted).
Despite the prominence of the States in matters of public health and safety, in recent decades the Federal Government has played an increasingly significant role in the protection of the health of our people. Congress' first significant enactment in the field of public health was the Food and Drug Act of 1906, a broad prohibition against the manufacture or shipment in interstate commerce of any adulterated or misbranded food or drug. See 34 Stat. 768; Regier, The Struggle for Federal Food and Drugs Legislation, 1 Law. & Contemp. Probs. 1 (1933). Partly in response to an ongoing concern about radio and newspaper advertising making false therapeutic claims for both "quack machines" and legitimate devices such as surgical instruments and orthopedic shoes, in 1938 Congress broadened the coverage of the 1906 Act to include misbranded or adulterated medical devices and cosmetics. See Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), §§501, 502, 52 Stat. 1049-1051; Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 Law & Contemp. Probs. 2 (1939); H. R. Rep. No. 94-853, p. 6 (1976).
While the FDCA provided for pre-market approval of new drugs, Cavers, 6 Law & Contemp. Probs., at 40, it did not authorize any control over the introduction of new medical devices, see S. Rep. No. 93-670, pp. 1-2 (1974); H. R. Rep. 94-853, at 6. As technologies advanced and medicine relied to an increasing degree on a vast array of medical equipment "[f]rom bedpans to brainscans," [n.1] including kidney dialysis units, artificial heart valves, and heart pacemakers, [n.2] policymakers and the public became concerned about the increasingly severe injuries that resulted from the failure of such devices. See generally Finck, The Effectiveness of FDA Medical Device Regulation, 7 U. C. D. L. Rev. 293, 297-301 (1974); H. R. Rep. 94-853, at 7.
In response to the mounting consumer and regulatory concern, Congress enacted the statute at issue here: the Medical Device Amendments of 1976 (MDA or Act), 90 Stat. 539. The Act classifies medical devices in three categories based on the risk that they pose to the public. Devices that present no unreasonable risk of illness or injury are designated Class I and are subject only to minimal regulation by "general controls." 21 U.S.C. § 360c(a)(1)(A). Devices that are potentially more harmful are designated Class II; although they may be marketed without advance approval, manufacturers of such devices must comply with federal performance regulations known as "special controls." §360c(a)(1)(B). Finally, devices that either "present a potential unreasonable risk of illness or injury," or which are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health," are designated Class III. §360c(a)(1)(C). Pacemakers are Class III devices. See 21 CFR § 870.3610 (1995).
Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a "reasonable assurance" that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this "reasonable assurance," which is known as the "premarket approval," or "PMA" process, is a rigorous one. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34), p. 384 (1987) (hereinafter 1987 Hearings); see generally Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 512-514 (1984).
Not all, nor even most, Class III devices on the market today have received premarket approval because of two important exceptions to the PMA requirement. First, Congress realized that existing medical devices could not be withdrawn from the market while the FDA completed its PMA analysis for those devices. The statute therefore includes a "grandfathering" provision which allows pre-1976 devices to remain on the market without FDA approval until such time as the FDA initiates and completes the requisite PMA. See 21 U.S.C. § 360e(b)(1)(A); 21 CFR § 814.1(c)(1). [n.3] Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act also permits devices that are "substantially equivalent" to pre-existing devices to avoid the PMA process. See 21 U.S.C. § 360e(b)(1)(B).
Although "substantially equivalent" Class III devices may be marketed without the rigorous PMA review, such new devices, as well as all new Class I and Class II devices, are subject to the requirements of §360(k). That section imposes a limited form of review on every manufacturer intending to market a new device by requiring it to submit a "premarket notification" to the FDA (the process is also known as a "§510(k) process," after the number of the section in the original Act). If the FDA concludes on the basis of the §510(k) notification that the device is "substantially equivalent" to a pre-existing device, it can be marketed without further regulatory analysis (at least until the FDA initiates the PMA process for the underlying pre-1976 device to which the new device is "substantially equivalent"). The §510(k) notification process is by no means comparable to the PMA process; in contrast to the 1,200 hours necessary to complete a PMA review, the §510(k) review is completed in an average of only 20 hours. See 1987 Hearings, at 384. As one commentator noted, "[t]he attraction of substantial equivalence to manufacturers is clear. [Section] 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed very quickly." Adler, The 1976 Medical Device Amendments: A Step in the Right Direction Needs Another Step in the Right Direction, 43 Food Drug Cosm. L. J. 511, 516 (1988); see also Kahan, 39 Food Drug Cosm. L. J., at 514-519.
As have so many other medical device manufacturers, petitioner Medtronic took advantage of §510(k)'s expedited process in October of 1982, when it notified FDA that it intended to market its Model 4011 pacemaker lead as a device that was "substantially equivalent" to devices already on the market. (The lead is the portion of a pacemaker that transmits the heartbeat steadying electrical signal from the "pulse generator" to the heart itself.) On November 30, 1982, the FDA found that the model was "substantially equivalent to devices introduced into interstate commerce" prior to the effective date of the Act, and advised Medtronic that it could therefore market its device subject only to the general control provisions of the Act, which could be found in the Code of Federal Regulations. See Respondent's Memorandum in Support of Motion for Summary Judgment in No. 93-482 (MD Fla., Nov. 1, 1993), Exh. A to Exh. 1 (Declaration of Charles H. Swanson) (hereinafter FDA Substantial Equivalence Letter). The agency emphasized, however, that this determination should not be construed as an endorsement of the pacemaker lead's safety. Ibid.
Cross petitioner Lora Lohr is dependent on pacemaker technology for the proper functioning of her heart. In 1987 she was implanted with a Medtronic pacemaker equipped with one of the company's Model 4011 pacemaker leads. On December 30, 1990, the pacemaker failed, allegedly resulting in a "complete heart block" that required emergency surgery. According to her physician, a defect in the lead was the likely cause of the failure.
The District Court initially denied Medtronic's motion, finding nothing in the statute to support the company's argument that the MDA entirely exempted from liability a manufacturer who had allegedly violated the FDA's regulations. See App. to Pet. for Cert. 5d. Not long after that decision, however, the United States Court of Appeals for the Eleventh Circuit concluded that §360k required pre-emption of at least some common law claims brought against the manufacturer of a medical device. See Duncan v. Iolab Corp., 12 F. 3d 194 (1994). After reconsidering its ruling in light of Duncan, the District Court reversed its earlier decision and dismissed the Lohrs' entire complaint.
The Court of Appeals reversed in part and affirmed in part. 56 F. 3d 1335 (CA11 1995). Rejecting the Lohrs' broadest submission, it first decided that "common law actions are state requirements within the meaning of §360k(a)." Id., at 1342. It next held that pre-emption could not be avoided by merely alleging that the negligence flowed from a violation of federal standards. Id., at 1343. Then, after concluding that the term "requirements" in §360k(a) was unclear, it sought guidance from FDA's regulations regarding pre-emption. Those regulations provide that a state requirement is not pre-empted unless the FDA has established " `specific requirements applicable to a particular device.' " Id., at 1344 (citing 21 CFR § 808.1(d) (1995)). Under these regulations, the court concluded, it was not necessary that the federal regulation specifically deal with pacemakers, but only that the federal requirement "should, in some way, be `restricted by nature' to a particular process, procedure, or device and should not be completely open ended," 56 F. 3d, at 1346, and that the specific device at issue should be subject to its requirements.
Under this approach, the Court concluded that the Lohrs' negligent design claims were not pre-empted. It rejected Medtronic's argument that the FDA's finding of "substantial equivalence" had any significance with respect to the pacemaker's safety, or that the FDA's continued surveillance of the device constituted a federal "requirement" that its design be maintained. Id., at 1347-1349. On the other hand, it concluded that the negligent manufacturing and failure to warn claims were pre-empted by FDA's general "good manufacturing practices" regulations, which establish general requirements for most steps in every device's manufacture, see id., at 1350; 21 CFR §§ 820.20-820.198 (1995), and by the FDA labeling regulations, which require devices to bear various warnings, see 56 F. 3d, at 1350-1351; 21 CFR § 801.109 (1995). The Court made a parallel disposition of the strict liability claims, holding that there was no pre-emption insofar as plaintiffs alleged an unreasonably dangerous design, but they could not revive the negligent manufacturing or failure to warn claims under a strict liability theory. 56 F. 3d, at 1351-1352.
Medtronic filed a petition for certiorari seeking review of the Court of Appeals' decision insofar as it affirmed the District Court and the Lohrs filed a cross petition seeking review of the judgment insofar as it upheld the pre-emption defense. Because the Courts of Appeals are divided over the extent to which state common law claims are pre-empted by the MDA, [n.6] we granted both petitions. 516 U. S. ___ (1996).
As in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), we are presented with the task of interpreting a statutory provision that expressly pre-empts state law. While the pre-emptive language of §360k(a) means that we need not go beyond that language to determine whether Congress intended the MDA to pre-empt at least some state law, see id., at 517, we must nonetheless "identify the domain expressly pre-empted" by that language. Ibid. Although our analysis of the scope of the pre-emption statute must begin with its text, see Gade v. National Solid Wastes Management Assn., 505 U.S. 88, 111 (1992) (Kennedy, J., concurring in part and concurring in judgment), our interpretation of that language does not occur in a contextual vacuum. Rather, that interpretation is informed by two presumptions about the nature of pre-emption. See ibid.
First, because the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state law causes of action. In all pre-emption cases, and particularly in those in which Congress has "legislated . . . in a field which the States have traditionally occupied," Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947), we "start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Id., at 230; Hillsborough Cty., 471 U. S., at 715-716; cf. Fort Halifax Packing Co. v. Coyne, 482 U.S. 1, 22 (1987). Although dissenting Justices have argued that this assumption should apply only to the question whether Congress intended any pre-emption at all, as opposed to questions concerning the scope of its intended invalidation of state law, see Cipollone, 505 U. S., at 545-546 (Scalia, J., concurring in judgment in part, and dissenting in part), we used a "presumption against the pre-emption of state police power regulations" to support a narrow interpretation of such an express command in Cipollone. Id., at 518, 523. That approach is consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety.
Second, our analysis of the scope of the statute's pre-emption is guided by our oft repeated comment, initially made in Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963), that "[t]he purpose of Congress is the ultimate touchstone" in every pre-emption case. See, e.g., Cipollone, 505 U. S., at 516; Gade, 505 U. S., at 96; Malone v. White Motor Corp., 435 U.S. 497, 504 (1978). As a result, any understanding of the scope of a pre-emption statute must rest primarily on "a fair understanding of congressional purpose." Cipollone, 505 U. S., at 530, n. 27 (opinion of Stevens, J.). Congress' intent, of course, primarily is discerned from the language of the pre-emption statute and the "statutory framework" surrounding it. Gade, 505 U. S., at 111 (Kennedy, J., concurring in part and concurring in judgment). Also relevant, however, is the "structure and purpose of the statute as a whole," id., at 98 (opinion of O'Connor, J.), as revealed not only in the text, but through the reviewing court's reasoned understanding of the way in which Congress intended the statute and its surrounding regulatory scheme to affect business, consumers, and the law.
With these considerations in mind, we turn first to a consideration of petitioner Medtronic's claim that the Court of Appeals should have found the entire action pre-empted and then to the merits of the Lohrs' cross petition.
In its petition, Medtronic argues that the Court of Appeals erred by concluding that the Lohrs' claims alleging negligent design were not pre-empted by 21 U.S.C. § 360k(a). That section provides that "no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." Medtronic suggests that any common law cause of action is a "requirement" which alters incentives and imposes duties "different from, or in addition to" the generic federal standards that the FDA has promulgated in response to mandates under the MDA. In essence, the company argues that the plain language of the statute pre-empts any and all common law claims brought by an injured plaintiff against a manufacturer of medical devices.
Medtronic's argument is not only unpersuasive, it is implausible. Under Medtronic's view of the statute, Congress effectively precluded state courts from affording state consumers any protection from injuries resulting from a defective medical device. Moreover, because there is no explicit private cause of action against manufacturers contained in the MDA, and no suggestion that the Act created an implied private right of action, Congress would have barred most, if not all, relief for persons injured by defective medical devices. [n.7] Medtronic's construction of §360k would therefore have the perverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation in order "to provide for the safety and effectiveness of medical devices intended for human use," 90 Stat. 539 (preamble to Act). It is, to say the least, "difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured by illegal conduct," Silkwood v. Kerr McGee Corp., 464 U.S. 238, 251 (1984), and it would take language much plainer than the text of §360k to convince us that Congress intended that result.
Furthermore, if Congress intended to preclude all common law causes of action, it chose a singularly odd word with which to do it. The statute would have achieved an identical result, for instance, if it had precluded any "remedy" under state law relating to medical devices. "Requirement" appears to presume that the State is imposing a specific duty upon the manufacturer, and although we have on prior occasions concluded that a statute pre-empting certain state "requirements" could also pre-empt common law damages claims, see Cipollone, 505 U. S., at 521-522 (opinion of Stevens, J.), that statute did not sweep nearly as broadly as Medtronic would have us believe that this statute does.
The pre-emptive statute in Cipollone [n.8] was targeted at a limited set of state requirements--those "based on smoking and health"--and then only at a limited subset of the possible applications of those requirements--those involving the "advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of" the federal statute. See id., at 515. In that context, giving the term "requirement" its widest reasonable meaning did not have nearly the pre-emptive scope nor the effect on potential remedies that Medtronic's broad reading of the term would have in this case. The Court in Cipollone held that the petitioner in that case was able to maintain some common law actions using theories of the case that did not run afoul of the pre-emption statute. See id., at 524-530. Here, however, Medtronic's sweeping interpretation of the statute would require far greater interference with state legal remedies, producing a serious intrusion into state sovereignty while simultaneously wiping out the possibility of remedy for the Lohrs' alleged injuries. [n.9] Given the ambiguities in the statute and the scope of the preclusion that would occur otherwise, we cannot accept Medtronic's argument that by using the term-requirement," Congress clearly signaled its intent to deprive States of any role in protecting consumers from the dangers inherent in many medical devices.
An examination of the basic purpose of the legislation as well as its history entirely supports our rejection of Medtronic's extreme position. The MDA was enacted "to provide for the safety and effectiveness of medical devices intended for human use." 90 Stat. 539. Medtronic asserts that the Act was also intended, however, to-protect innovations in device technology from being `stifled by unnecessary restrictions,' " Brief for Petitioners in No. 95-754, p. 3 (citing H. R. Rep. 94-853, at 12), and that this interest extended to the pre-emption of common law claims. While the Act certainly reflects some of these concerns, [n.12] the legislative history indicates that any fears regarding regulatory burdens were related more to the risk of additional federal and state regulation rather than the danger of preexisting duties under common law. See, e.g., 122 Cong. Rec. 5850 (Mar. 9, 1976) (statement of Rep. Collins) (opposing further "redundant and burdensome Federal requirements"); id., at 5855 (discussing efforts taken in MDA to protect small businesses from the additional requirements of the Act). Indeed, nowhere in the materials relating to the Act's history have we discovered a reference to a fear that product liability actions would hamper the development of medical devices. To the extent that Congress was concerned about protecting the industry, that intent was manifested primarily through fewer substantive requirements under the Act, not the pre-emption provision; furthermore, any such concern was far outweighed by concerns about the primary issue motivating the MDA's enactment: the safety of those who use medical devices.
The legislative history also confirms our understanding that §360(k) simply was not intended to pre-empt most, let alone all, general common law duties enforced by damages actions. There is, to the best of our knowledge, nothing in the hearings, the committee reports, or the debates suggesting that any proponent of the legislation intended a sweeping pre-emption of traditional common law remedies against manufacturers and distributors of defective devices. If Congress intended such a result, its failure even to hint at it is spectacularly odd, particularly since Members of both Houses were acutely aware of ongoing product liability litigation. [n.13] Along with the less than precise language of §360k(a), that silence surely indicates that at least some common law claims against medical device manufacturers may be maintained after the enactment of the MDA.
Medtronic asserts several specific reasons why, even if §360k does not pre-empt all common law claims, it at least pre-empts the Lohrs' claims in this case. In contrast, the Lohrs argue that their entire complaint should survive a reasonable evaluation of the pre-emptive scope of §360k(a). First, the Lohrs claim that the Court of Appeals correctly held that their negligent design claims were not pre-empted because the §510(k) premarket notification process imposes no "requirement" on the design of Medtronic's pacemaker. Second, they suggest that even if the FDA's general rules regulating manufacturing practices and labeling are "requirements" that pre-empt different state requirements, §360k(a) does not pre-empt state rules that merely duplicate some or all of those federal requirements. Finally, they argue that because the State's general rules imposing common law duties upon Medtronic do not impose a requirement "with respect to a device," they do not conflict with the FDA's general rules relating to manufacturing and labeling and are therefore not pre-empted.
The Court of Appeals concluded that the Lohrs' defective design claims were not pre-empted because the requirements with which the company had to comply were not sufficiently concrete to constitute a pre-empting federal requirement. Medtronic counters by pointing to the FDA's determination that Model 4011 is "substantially equivalent" to an earlier device as well as the agency's continuing authority to exclude the device from the market if its design is changed. These factors, Medtronic argues, amount to a specific, federally enforceable design requirement that cannot be affected by state law pressures such as those imposed on manufacturers subject to product liability suits.
The company's defense exaggerates the importance of the §510(k) process and the FDA letter to the company regarding the pacemaker's substantial equivalence to a grandfathered device. As the court below noted, "[t]he 510(k) process is focused on equivalence, not safety." 56F. 3d, at 1348. As a result, "substantial equivalence determinations provide little protection to the public. These determinations simply compare a post-1976 device to a pre-1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective." Adler, 43 Food Drug Cosm. L. J., at 516. The design of the Model 4011, as with the design of pre-1976 and other "substantially equivalent" devices, has never been formally reviewed under the MDA for safety or efficacy.
The FDA stressed this basic conclusion in its letter to Medtronic finding the 4011 lead "substantially equivalent" to devices already on the market. That letter only required Medtronic to comply with "general standards"--the lowest level of protection "applicable to all medical devices," and including "listing of devices, good manufacturing practices, labeling, and the misbranding and adulteration provisions of the Act." It explicitly warned Medtronic that the letter did "not in any way denote official FDA approval of your device," and that "[a]ny representation that creates an impression of official approval of this device because of compliance with the premarket notification regulations is misleading and constitutes misbranding." FDA Substantial Equivalence Letter.
Thus, even though the FDA may well examine §510(k) applications for Class III devices (as it examines the entire medical device industry) with a concern for the safety and effectiveness of the device, see Brief for Petitioner in No. 95-754, pp. 22-26, it did not "require" Medtronics' pacemaker to take any particular form for any particular reason; the agency simply allowed the pacemaker, as a device substantially equivalent to one that existed before 1976, to be marketed without running the gauntlet of the PMA process. In providing for this exemption to PMA review, Congress intended merely to give manufacturers the freedom to compete, to a limited degree, with and on the same terms as manufacturers of medical devices that existed prior to 1976. [n.14] There is no suggestion in either the statutory scheme or the legislative history that the §510(k) exemption process was intended to do anything other than maintain the status quo with respect to the marketing of existing medical devices and their substantial equivalents. That status quo included the possibility that the manufacturer of the device would have to defend itself against state law claims of negligent design. Given this background behind the "substantial equivalence" exemption, the fact that "[t]he purpose of Congress is the ultimate touchstone" in every pre-emption case, 505 U. S., at 516 (internal quotation marks and citations omitted), and the presumption against pre-emption, the Court of Appeals properly concluded that the "substantial equivalence" provision did not pre-empt the Lohrs' design claims.
The Lohrs next suggest that even if "requirements" exist with respect to the manufacturing and labeling of the pacemaker, and even if we can also consider state law to impose a "requirement" under the Act, the state requirement is not pre-empted unless it is "different from, or in addition to," the federal requirement. §360k(a)(1). Although the precise contours of their theory of recovery have not yet been defined (the pre-emption issue was decided on the basis of the pleadings), it is clear that the Lohrs' allegations may include claims that Medtronic has, to the extent that they exist, violated FDA regulations. At least these claims, they suggest, can be maintained without being pre-empted by §360k, and we agree.
Nothing in §360k denies Florida the right to provide a traditional damages remedy for violations of common law duties when those duties parallel federal requirements. Even if it may be necessary as a matter of Florida law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the state law cause of action would make the state requirements narrower, not broader, than the federal requirement. While such a narrower requirement might be "different from" the federal rules in a literal sense, such a difference would surely provide a strange reason for finding pre-emption of a state rule insofar as it duplicates the federal rule. The presence of a damages remedy does not amount to the additional or different "requirement" that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing "requirements" under federal law.
The FDA regulations interpreting the scope of §360k's pre-emptive effect support the Lohrs' view, and our interpretation of the pre-emption statute is substantially informed by those regulations. The different views expressed by the Courts of Appeals regarding the appropriate scope of federal pre-emption under §360k demonstrate that the language of that section is not entirely clear. In addition, Congress has given the FDA a unique role in determining the scope of §360k's pre-emptive effect. Unlike the statute construed in Cipollone, for instance, pre-emption under the MDA does not arise directly as a result of the enactment of the statute; rather, in most cases a state law will be pre-empted only to the extent that the FDA has promulgated a relevant federal "requirement." Because the FDA is the federal agency to which Congress has delegated its authority to implement the provisions of the Act, [n.15] the agency is uniquely qualified to determine whether a particular form of state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. Davidowitz, 312 U.S. 52, 67 (1941), and, therefore, whether it should be pre-empted. For example, Congress explicitly delegated to the FDA the authority to exempt state regulations from the pre-emptive effect of the MDA--an authority that necessarily requires the FDA to assess the pre-emptive effect that the Act and its own regulations will have on state laws. See §360k(b). FDA regulations implementing that grant of authority establish a process by which States or other individuals may request an advisory opinion from the FDA regarding whether a particular state requirement is pre-empted by the statute. See 21 CFR § 808.5 (1995). The ambiguity in the statute--and the congressional grant of authority to the agency on the matter contained within it--provide a "sound basis," post, at 2, for giving substantial weight to the agency's view of the statute. See Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984); Hillsborough Cty., 471 U. S., at 714 (considering FDA understanding of pre-emptive effect of its regulations "dispositive").
The regulations promulgated by the FDA expressly support the conclusion that §360k "does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act." 21 CFR § 808.1(d)(2) (1995); see also §808.5(b)(1)(i). [n.16] At this early stage in the litigation, there was no reason for the Court of Appeals to preclude altogether the Lohrs' manufacturing and labeling claims to the extent that they rest on claims that Medtronic negligently failed to comply with duties "equal to, or substantially identical to, requirements imposed" under federal law.
The requirements identified by the Court of Appeals include labeling regulations which require manufacturers of every medical device, with a few limited exceptions, to include with the device a label containing "information for use, . . . and any relevant hazards, contraindications, side effects, and precautions." 21 CFR §§ 801.109(b) and (c) (1995). Similarly, manufacturers are required to comply with "Good Manufacturing Practices," or "GMP's," which are set forth in 32 sections and less than 10 pages in the Code of Federal Regulations. [n.17] In certain circumstances, the Court of Appeals recognized, the FDA will enforce these general requirements against manufacturers that violate them. See 56 F. 3d, at 1350-1351.
While admitting that these requirements exist, the Lohrs suggest that their general nature simply does not pre-empt claims alleging that the manufacturer failed to comply with other duties under state common law. In support of their claim, they note that §360k(a)(1) expressly states that a federal requirement must be "applicable to the device" in question before it has any pre-emptive effect. Because the labeling and manufacturing requirements are applicable to a host of different devices, they argue that they do not satisfy this condition. They further argue that because only state requirements "with respect to a device" may be pre-empted, and then only if the requirement "relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device," section 360k(a) mandates pre-emption only where there is a conflict between a specific state requirement and a federal requirement "applicable to" the same device.
The Lohrs' theory is supported by the FDA regulations, which provide that state requirements are pre-empted "only" when the FDA has established "specific counterpart regulations or . . . other specific requirements applicable to a particular device." 21 CFR § 808.1(d) (1995). [n.18] They further note that the statute is not intended to pre-empt "State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices . . . or to unfair trade practices in which the requirements are not limited to devices." §808.1(d)(1). The regulations specifically provide, as examples of permissible general requirements, that general electrical codes and the Uniform Commercial Code warranty of fitness would not be pre-empted. See ibid. The regulations even go so far as to state that §360k(a) generally "does not preempt a state or local requirement prohibiting the manufacture of adulterated or misbranded devices" unless "such a prohibition has the effect of establishing a substantive requirement for a specific device." §808.1(d)(6)(ii). Furthermore, under its authority to grant exemptions to the pre-emptive effect of §360k(a), the FDA has never granted, nor, to the best of our knowledge, even been asked to consider granting, an exemption for a state law of general applicability; all 22 existing exemptions apply to excruciatingly specific state requirements regarding the sale of hearing aids. See §§808.53-808.101.
Such a comparison mandates a conclusion that the Lohrs' common law claims are not pre-empted by the federal labeling and manufacturing requirements. The generality of those requirements make this quite unlike a case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers. Rather, the federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation which the statute or regulations were designed to protect from potentially contradictory state requirements.
Similarly, the general state common law requirements in this case were not specifically developed "with respect to" medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements. The legal duty that is the predicate for the Lohrs' negligent manufacturing claim is the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Similarly, the predicate for the failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use. These general obligations are no more a threat to federal requirements than would be a state law duty to comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision of a workforce. These state requirements therefore escape pre-emption, not because the source of the duty is a judge made common law rule, but rather because their generality leaves them outside the category of requirements that §360k envisioned to be "with respect to" specific devices such as pacemakers. As a result, none of the Lohrs' claims based on allegedly defective manufacturing or labeling are pre-empted by the MDA.
In their cross petition, the Lohrs present a final argument, suggesting that common law duties are never "requirements" within the meaning of §360k and that the statute therefore never pre-empts common law actions. The Lohrs point out that our holding in Cipollone is not dispositive of this issue, for as Part IV, supra, suggests, there are significant textual and historical differences between the Cipollone statute and §360k, and the meaning of words must always be informed by the environment within which they are situated. We do not think that the issue is resolved by the FDA regulation suggesting that §360k is applicable to those requirements "having the force and effect of law" that are "established by . . . court decision," 21 CFR § 808.1(b) (1995); that reference, it appears, was intended to refer to court decisions construing state statutes or regulations. See 42 Fed. Reg. 30383, 30385 (June 14, 1977); Brief for Petitioners in No. 95-886, at 26, n. 7.
Nevertheless, we do not respond directly to this argument for two reasons. First, since none of the Lohrs' claims is pre-empted in this case, we need not resolve hypothetical cases that may arise in the future. Second, given the critical importance of device specificity in our (and the FDA's) construction of §360k, it is apparent that few, if any, common law duties have been pre-empted by this statute. It will be rare indeed for a court hearing a common law cause of action to issue a decree that has "the effect of establishing a substantive requirement for a specific device." 21 CFR § 808.1(d)(6)(ii) (1995). Until such a case arises, we see no need to determine whether the statute explicitly pre-empts such a claim. Even then, the issue may not need to be resolved if the claim would also be pre-empted under conflict pre-emption analysis, see Freightliner Corp. v. Myrick, 514 U. S. ___, ___ (1995) (slip op., at 7-8).
1 Medical Device Regulation: The FDA's Neglected Child (Committee Print compiled for the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce), Comm. Print 98-F, p. 1 (1983).
2 S. Rep. No. 94-33, p. 5 (1975).
3 The FDA has not yet initiated nor suggested the initiation of a PMA process for pacemakers or most other grandfathered devices. But see 60 Fed. Reg. 41984, 41986 (1995) (pursuant to Safe Medical Devices Act of 1990, 104 Stat. 4511, calling for submission of information by February 1997 which may lead the FDA to reclassify or initiate PMA process at some time in the future for implantable pacemaker pulse generators and lead adapters).
4 In 1990, Congress enacted amendments to the MDA which were designed to reduce the FDA's reliance on the §510(k) process while continuing to ensure that particularly risky devices received full PMA review. See Safe Medical Devices Act of 1990.
To carry out this grant of authority, the FDA has issued regulations under the statute which both construe the scope of §360k(a) and address the instances in which the FDA will grant exemptions to its pre-emptive effect. See 21 CFR § 808.1 (1995); infra, n. 18.
We note that although it is the FDA that exercises this authority, the Act gives that authority directly to the Secretary of Health and Human Services, who subsequently delegated her authority to the FDA. See, e.g., 21 U.S.C. § 360k(b) ("the Secretary may" exempt state requirements), §321(d) ("Secretary" defined as "the Secretary of Health and Human Services"). Under the FDCA, the Secretary is vested with "[t]he authority to promulgate regulations for the efficient enforcement of" the Act. 21 U.S.C. § 371(a).
6 See, e.g., English v. Mentor Corp., 67 F. 3d 477 (CA3 1995) (§510(k) process creates pre-emptive "requirements"); Feldt v. Mentor Corp., 61 F. 3d 431 (CA5 1995) (§510(k) process does not create pre-emptive "requirements"); Michael v. Shiley Inc., 46 F. 3d 1316 (CA3 1995) (claim alleging violation of federal requirement not pre-empted); 56 F. 3d 1335 (CA11 1995) (case below) (claim alleging violation of federal requirement may be pre-empted; §510(k) process may create pre-emptive requirements; common law claims covered by §360k(a)); Kennedy v. Collagen Corp., 67 F. 3d 1453 (CA9 1995) (common law claims not covered at all by §360k(a)).
7 The FDA's authority to require manufacturers to recall, replace, or refund defective devices is of little use to injured plaintiffs, since there is no indication that the right is available to private parties, the remedy would not extend to recovery for compensatory damages, and the authority is rarely invoked, if at all. See Adler, The 1976 Medical Device Amendments: A Step in the Right Direction Needs Another Step in the Right Direction, 43 Food Drug Cosm. L. J. 511, 526-527 (1988).
8 There were actually two pre-emptive statutes at issue: The first, enacted in 1965, provided that "[n]o statement relating to smoking and health . . . shall be required" on any cigarette package or in any cigarette advertising. See Cipollone v. Liggett Group, Inc., 505 U. S., at 514. That provision, the Court concluded, did not pre-empt any of the petitioner's common law claims. Id., at 518-520. In 1969, Congress superseded the 1965 pre-emption statute with part of the Public Health Cigarette Smoking Act of 1969, which provided that "[n]o requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this Act." Id., at 515. The bulk of Cipollone's analysis involved this later statute; unless otherwise stated, it is this statute to which we refer in subsequent references to the pre-emptive statute in Cipollone.
9 Unlike §360k, the pre-emptive effect of the statute in Cipollone was not dependent on the issuance of any agency regulations. The territory exclusively occupied by federal law was defined in the text of the statute itself; that text specified the precise warning to smokers that Congress deemed both necessary and sufficient. In the MDA, no such specifics exist until the FDA provides them. See also infra, at 24 (reliance on the FDA's interpretation of §360k warranted, inter alia, because of the FDA's role in the administration of §360k). Moreover, the statute in Cipollone was clearly intended to have a broader pre-emptive effect than its 1965 predecessor. See 505 U. S., at 515, 520-521.
10 The text of the statute is quoted supra, at 9, and n. 5.
11 All 22 exemptions at 21 CFR §§ 808.53-808.101 (1995) are exemptions for state statutes and regulations regarding the sale of hearing aids.
12 Special statutory exemptions, for example, permit the FDA (with various oversight provisions) to allow investigative, experimental devices to be used in commerce without either PMA review or "substantial equivalence." See 21 U.S.C. § 360j(g); 21 CFR pt. 813 (1995). Moreover, the very existence of the pre-emption statute demonstrates some concern that competing state requirements may unduly interfere with the market for medical devices.
13 Furthermore, if Congress had intended the MDA to work this dramatic change in the availability of state law remedies, one would expect some reference to that change in the extensive contemporary reviews of the legislation. We have been able to find no such reference. See, e.g., Lesparre, Industry Spokesman Comments on Medical Device Amendments of 1976, 50 Hospitals 99, 103 (Sept. 16, 1976); A. Levine, Device Failure and the Plaintiff's Lawyer, in Proceedings of the Second Annual AAMI/FDA Conference on Medical Device Regulation 54 (1975); Medical Device Amendments of 1975, Hearings Before the Subcommittee on Health and the Environment of the House Committee on Interstate and Foreign Commerce, Ser. No. 94-39, 94th Cong., 1st Sess., 271 (1975) (statement of Anita Johnson, Public Citizen's Health Research Group) (arguing that the pre-emption provision should not be included, but making no mention of common law, and specifically discussing only a positive California enactment regarding the safety of intrauterine contraceptive devices); Medical Devices and Equipment Liability Avoidance (Frost & Sullivan pub. June 1977) (comprehensive 2--volume, 600--page review of published medical device product liability cases from 1910 to 1976, suggesting nowhere that MDA had mooted or even altered the longstanding ability of plaintiffs to seek and receive damages awards under state law).
14 As the FDA Commissioner put it in 1982, "the 510(k) provision of the law is a procompetition mechanism that permits firms to make and quickly market me too versions of pre-1976 devices. The Congress apparently believed that a firm whose device happened to be on the market before enactment of the amendments and was never subject to preclearance by FDA should not enjoy a lengthy monopoly at the expense of other firms and ultimately the consumer." FDA Oversight: Medical Devices, Hearing before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, 97th Cong., 2d Sess., 9 (1982). See also Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 514-515 (1984); D. Kessler, S. Pape, & D. Sundwall, The Federal Regulation of Medical Devices, 317 New England J. Med. 357, 359 (1987).
15 See n. 5, supra; 21 U.S.C. § 371(a).
16 We also note that the agency permits manufacturers of devices that have received premarket approval to make certain labeling, quality control, and manufacturing changes which would "enhance the safety of the device or the safety in the use of the device" without prior FDA approval. See 21 CFR §§ 814.39(d)(1) and (2) (1995).
17 Some GMP's include the duty to institute a "quality assurance program," §820.5, to have an "adequate organizational structure," §820.20, to ensure that personnel in contact with a device are "clean, healthy, and suitably attired" where such matters are relevant to the device's safety, §820.25, and to have buildings, environmental controls, and equipment of a quality adequate to produce a safe product, see §§820.40, 820.46, 820.60.
"(6)(i) Section 521(a) does not preempt State or local requirements respecting general enforcement, e.g., requirements that State inspection be permitted of factory records concerning all devices . . . .
"(ii) Generally, section 521(a) does not preempt a State or local requirement prohibiting the manufacture of adulterated or misbranded devices. Where, however, such a prohibition has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition [may] be preempted." 21 CFR § 808.1(d) (1995).
19 A plurality of this Court concluded in Cipollone that a similar analysis was required under the Public Health Cigarette Smoking Act of 1969. That act pre-empted requirements and prohibitions based on smoking and health "imposed under State law with respect to the advertising or promotion" of cigarettes in packages that were labeled in conformity with the that act. 505 U. S., at 515. We held that the petitioner's fraudulent misrepresentation claims, including those based on allegedly false statements made in advertisements, were not pre-empted because they were "predicated not on a duty `based on smoking and health' but rather on a more general obligation--the duty not to deceive." Id., at 528-529. The general common law duty "not to make fraudulent statements" was not within the specific category of requirements or prohibitions based on smoking and health imposed under State law "with respect to the advertising or promotion" of cigarettes that were pre-empted by the 1969 statute. Id., at 529.
If anything, the language of the MDA's pre-emption statute and its counterpart regulations require an even more searching inquiry into the relationship between the federal requirement and the state requirement at issue than was true under the statute in Cipollone.


National Science Foundation under Grant No. 0000629.
§0. Since 1985, the California Museum of Ancient Art, Los Angeles (Director: Jerome Berman), has added to its collection of Babylonian antiquities a number of Ur III documents, of which one was edited by Daniel Foxvog in 1986 (“A Summary of Non-Sealed Labor Assignments from Umma,” ASJ 8, pp. 59-69). Fifteen of the remaining sixteen texts (excluding for a fuller philological treatment by M. Widell in this journal the text CMAA 015-C0019 documenting a legal proceeding) are offered below with short commentaries and computer-assisted tablet copies. For image documentation, references are made within the individual entries to the texts’ corresponding pages within the data set of the CDLI. The catalogue entries below consist of text numbers, dates (regnal year / month / day), provenience, and measurements height x width x thickness, in millimeters. Numbers 1-13 were a gift of Dr. and Mrs. Julius Winer, number 14 is a loan by Russ Kino, and no. 15 a gift of Russ and Ivonne Kino.
Shulgi 47 / 00 / 25, from Drehem ?
3) mu-us2-sa ki-maški ba-ḫul 3) Year after: “Kimash was destroyed”.
§1a. Although the text seems to be a common Drehem record of animals booked out of the accounts of officials, for which compare PDT 2, 958 i 17, 1026 rev. 2, 1273 obv. 10, Turin Drehem 399 obv. 4, all with the official Ur-Enlila in parallel context, there are also Umma parallels (UTI 3, 2055; UTI 3, 2285 obv. ii 9 (there qualified as a gudu4)). To the official Ur-Enlila in Umma see OrNS 47-49, 268 4: nam-ša3-tam ur-den2- lil2-la2 (his “official” seal reads in the same text ur-den2-lil2-la 2 / dub-sar / dumu lugal-ku3-ga-[ni]; see also MVN 16, 1066 and UTI 3, 1775). Note also Nik 2, 466 obv. 3: ur-d en2-lil2-la2 dub-sar maḫ (Drehem); MVN 7, 581 4: kurušda (Girsu).
3) mu damar-dsuen-ke4 ur-bi2-lumki mu-ḫul 3) year: “Amar-Suen destroyed Urbilum”.
§2a. Lu-dingira son of Ir-ḫula is not seldom found in the Drehem archives, cp. PDT 2, 767 rev. iv 12 describing irregularities in the deliveries of animals by both Lu-dingira and Shulgi-ayamu. Both men receive animals from Abbasaga and Nasa in Drehem; see M. Hilgert, OIP 115, 17, and OIP 121, nos. 480-495 (in press). The dating formula iti u4 n ba-zal / iti month name is with ca. 500 attestations common in the Ur III administrative text corpus from Drehem. C. Wilcke drew attention in M. deJong Ellis, ed., Nippur at the Centennial. Papers Read at the 35e Rencontre Assyriologique Internationale, Philadelphia, 1988 (=Occasional Publications of the Samuel Noah Kramer Fund 14; Philadelphia 1992) 314 n. 10 to the occurrence in TRU 81 rev. 4 and BIN 3, 403 rev. 6 of the variant month name iti šaḫ2-ze2-da-gu7 (and note iti šaḫ2-ku3-gu7 in the so-called “treasury” archive from Drehem, for instance in the texts OIP 115, 466,TCL 2, 5481 and SAT 2, 516, ŠEŠ-ku3-gu7 in the Umma text MVN 14, 348; cp. W. Sallaberger, Der Kultische Kalender der Ur III-Zeit I [Berlin 1993] 8 and 195, OBO 166/3, p. 235, n. 319, and M. Civil in G. Pettinato, MEE 3, 276, note to line 12). P. Steinkeller at the 1993 meeting of the Sumerian Agriculture Group therefore proposed a reading iti zaḫx(ŠEŠ)-da-gu7 of our month name, the second in a Drehem/Ur string of three “animal-roast” month names (the other two animals being the gazelle maš-da3 and the u5-bi2 bird). He would transliterate the variant form iti zaḫdax(ŠAḪ2)ze-da-gu7 and, based above all on the notorious Ur III pig husbandry accounting pair PDT 2, 1049, and MVN 15, 64 (and note CTMMA 1, 15, obv. 1-2 with 1 ud5 / ga-bi ze2-da šaḫ2 gu7-de3, “1 jenny goat to suckle the zeda pig”), with their reference to ze2-da pigs receiving either just 1/3 sila3, or no barley as daily rations, translate “month ‘suckling pig meal’ ”.
3) u4 26-kam 3) 26th day.
ur-bi2-lumki mu-ḫul 4) year: “Amar-Suen destroyed Urbilum”.
5) u4 15-kam 5) 15th day.
5) mu-us2-sa dgu-za den-lil2-la2 ba-dim2 5) year after: “Divine chair of Enlil was fashioned”.
§4a. W. Sallaberger, citing Jacobsen, Foster and Sigrist (particularly his Drehem pp. 158-162), in OLZ 91 (1996) 405 stated that the e2 uz-ga is not a fattening shed as usually believed. Sigrist surveyed the Ur III attestations of this establishment and concluded that it was probably a residence of some importance at Drehem visited by high functionaries including the queen, but that it was within the administrative purview of the “cook”. Its close association with the e2 gu4-gaz, “slaughter house” and the e2 muḫaldim, “household of the cook”, in such texts as the Harvard Semitic Museum household accounts published by A. Uchitel in ASJ 18, 223-228, however, suggests that it may after all be connected to the processing of meat, possibly because of the amount of reeds being transported there connected to a type of “smoke house”. Cp. OrNS 47-49, nos. 23, 26, etc., and the extensive article Wu Yuhong, “The ewes without lambs and the lambs cooked in e2-uz-ga, “the private house of kings”, in the Drehem archives,” JAC 11 (1996) 65-109.
6) 1 sila4 gukkal 6) 1 fat-tailed lamb.
1) u4 25-kam 1) 25th day.
3) dšul-gi-a-a-mu i3-dab5 3) Shulgi-ayamu accepted.
en dnanna ba-ḫun en-priestess of Nanna”.
§5a. W. Heimpel has reviewed in BSA 7 (1993) 130-131 the textual evidence for the meaning of giš-du3, “mounting”, as a qualifier of small cattle, including and particularly gukkal. For the intercalary month iti ezen-mah min3 see W. Sallaberger, Kultischer Kalender 1, 8 n. 22 (with literature).
6) mu en-unu6-˹gal˺ dinanna ba-ḫun 6) year: “Enunugal(ana) of Inanna was installed”.
3) ˹gudu4˺ d[šakkan2] 3) gudu priest of [Shakkan].
§6a. J. Bauer, WO 13, 151, cites MSL 14, 49: 432 (proto-Ea), as evidence of a reading of /ešgar/ for MUNUS.AŠ2.GAR3, assuming an umlaut of /a/ to /e/ in this word (the “pronunciation” section of prEa shows eš(3)-gar; the reading /zeḫ/ was already shown to be incorrect in ZA 69, 208). To maš2 mu mu10aš2-gar3-še3 see OrNS 47-49, 76 obv. 1. The same seal of Lugal-engar is found in the Umma text OrNS 47-49, 149 (Lugal-engar-e); cp. OrNS 47-49, 138 obv. 4: (small cattle) giri3 lugal-engar dumu lu2-den-lil2-la2. Line 1 of the seal legend ends in engar, with no room for a following -e. We should with W. Heimpel, BSA 7 (1993) 116, entertain the possibility that males are being substituted for the expected female kids, that is, that in specific contexts such as that of this text maš2 represents male kids and not “billy goats”.
1) ˹na-lu5˺ i3-dab5 1) Nalu accepted.
4) ˹mu˺ ḫu-uḫ2-nu-riki ba-hul 4) year: “Ḫuḫnuri was destroyed”.
§7a. The phrase “attached to the ox” seems used exclusively to qualify fattened animals (instances of animals not additionally qualified with niga, “grain-fattened”, for example MVN 15, 193 obv. 2, 6, TIM 6, 8 obv. 1, 17, rev. 6, 8, and MVN 18, 376 [=AnOr 7, 376] obv. 4, record sacrificial animals otherwise qualified niga and so are no exception to this rule).
5) a-ru-a lugal 5) royal offerings.
2) ša3 uri5ki-ma 2) In Ur.
ma-daki[-bi u3] ˹ḫu˺-uḫ2-[nu-riki ba-ḫul] and Ḫuḫnuri [were destroyed]”.
§8a. This text belongs to the so-called “treasury” archive, for which see most recently W. Sallaberger, OBO 160/3, 240-252.
4) du11-ga i3-dab5 4) Duga accepted.
6) mu ma2 den-ki ba-dim2 6) year: “The boat of Enki was fashioned”.
§9a. The Drehem tablets PDT 1, 404, AUCT 3, 127, 129, 139 etc., contain parallel accounts, regularly sealed by Ur-mes, recording the transfer from Taḫiš-atal of a number of animals to the official responsibility of Duga. Many more records, including MVN 13, 404, MVN 15, 276, PDT 1, 185, etc. (and see the following text), document the same movement of animals from Inta’ea. Both men regularly received (i3-dab5) animals from the Drehem official Abbasaga (Taḫiš-atal for instance in AUCT 1, 195, BIN 3, 167 and Iraq 41, 125 no. 4, Inta’ea in MVN 13, 449, 473, and AAICAB. 1, pl. 78, 1924-1788). Following BIN 3, 599 rev, 7, Duga appears to be an abbreviation of Duga-Baba.
2) du11-ga i3-dab5 2) Duga accepted.
4) mu ma2 dara3-abzu ba-ab-du8 4) year: “the boat ‘ibex of the abzu’ was caulked”.
§10a. See the note to the previous, and the following text.
1) ab-ba-kal-la šu ba-ti 1) Abbakala received.
3) mu e2 dšara2 ba-du3 3) year: “The house of Shara was built”.
3) dumu lu2-dnin-gir2-su 3) son of Lu-Ningirsu.
§11a. Abbakala is probably brother of the official Ur-kununa seen above (cp. MVN 15, 259, 261, etc. [more than a hundred occurences], in the extended seal legends of which the father Lu-Ningirsu is qualified as kurušda, “fattener” [late Shulgi and Amar-Suen seal impressions of the same official exhibit instead sipa na-kab-tum, “herder of the nakabtum”]). The same seal is found, for instance, on the texts MVN 15, 271, 272, PDT 2, 1043, 1044, 1045, 1046, and 1055. Such texts as the following one, and SAT 3, 1346, suggest that the receiving official Duga(-Baba) was as well a son of the same Lu-Ningirsu.
2) mu e2 dšara2 ummaki ba-du3 2) year: “the house of Shara in Umma was built”.
3) sipa na-kab-tum 3) herdsman of the Nakabtum.
§12a. The scribe Duga often seals for his brother Urkununa (see the note to the preceding text and for instance AnOr 7, 47 [received from Urkununa!], BCT 1, 61). MVN 8, 216 (Shulgi 46), UDT 165 (Amar-Suen 2) and PDT 2, 949 (AS 5) demonstrate that Urkununa did use his own seal in the period before the reign of Shu-Sin.
5) mu aga3-us2 u3˹lu2˺ šuku-ra-ke4-ne[-še3] 5) in the name of the royal guard and prebend-holders.
6) ir11-mu ˹maškim˺ 6) Irmu was maškim.
1) [u4 n-kam] 1) [nth day].
4) ˹giri3˺ d˹nanna˺-[ma-ba] dub-[sar| 4) Via: Nanna-[maba] the scribe.
6) ˹mu˺ di-bi2-dsuen lugal 6) year: “Ibbi-Sin is king”.
§13a. Compare the parallel text Fs. Levine 132-138 (YBC 4190).
3) dingir-ra-ke4 šu ba-ti 3) Dingira received.
1) mu puzur4-˹da-gan ba-du3˺ 1) year: “Puzrish-Dagan was built”.
4) ir11-zu 4) your servant.
§14a. The transliteration follows the inscription of the text’s envelope (the tablet has not been removed from this covering). Lu-duga otherwise seals regularly for Dadaga, for instance on SACT 2, 97 (Shulgi 38), Aleppo 380, MVN 14, 66, Nik 2, 277 (Shulgi 39), Aleppo 382, 383, 384, Hirose 346, MVN 14, 50 (Shulgi 40), Aleppo 385, 386, 387, 388 (Shulgi 41), MVN 14, 10 (Shulgi 42). Note SACT 2, 117: dingir-ra-ke4 i3-dab5 a workman, sealed by Ur-Lisi; the Aleppo 13 (no year) seal has simply 1) lu2-du10-ga 2) dub-sar 3) dumu nigarx(NIGIN3)gar-ki-du10 4) gal5-la2-gal. Finally, A. Uchitel, Mycenaean 7 (=AAICAB 1, pl. 69-70, 1924-668) obv ii 9: 3 ama-gi-na dumu lu2-du10-ga dumu gal5-la2-gal; Or. 47-49, 500 rev. i 4: 1;0,1 nigarx(NIGIN3)gar-ki-du10 ugula gal5-la2-gal.
6) ša3 kab2-ku5 6) in “the reservoir”.
17) e zi-DU 17) ziDU ditch.
4) šu-murgu2-še3 4) to shu-murgu.
9) e sa-dur2-ra a-ga-an-du-ul 9) sadur and agandul ditch.
5) kin e ra-a 5) Work, canal “striking”.
6) a-ša3 en-du8-du 6) Endudu field.
7) mu bad3 mar-tu ba-du3 7) Year: “The Amorite wall was built”.
§15a. The four-column labor account from the collection of the CMAA published by D. Foxvog in ASJ 8, 59-69, contains many of the same toponyms as this canal excavation text and thus doubtless derives from the same bureaucratic archive. These toponyms include giš-gu-la (probably a variant of giškiri6-gu-la) in obv. i 12 (workers assigned to fill the canal bank toward the “great woods (=orchard)”); en-du8-du in obv. ii 1 and 15 (latter reference to our kab2-ku5, “reservoir”); e e2-lugal in obv. ii 8.
§15b. To the “great orchard” see AnOr 7, 186 obv. 2: GAN2 giškiri6-gu-la; AnOr 7, 282 obv. i. 7': giškiri6-gu-la.
The kab2-ku5 doubtless refers to the kab2-ku5 en-du8-du, “reservoir of (the field) Endudu”, known for instance from the Umma texts MVN 15, 94 (=JCS 24,172 94) obv. ii 9, AAICAB 1, pl. 75, 1924-695 obv. 5, M. Civil, Georgica 2.03 (A 4270) 5, and JCS 39,125 13 rev. 6.
§15d. The field a-ga-an-du-ul is known from other texts in association with other fields mentioned here, for instance in M. Civil, Georgica 2.03 with a-ša3 en-du8-du, and in SNAT 482 with giškiri6-gu-la.
Although only known from two further texts (MVN 16, 912 rev. ii 1 and 961 rev. 4), the signification of kin e ra-a as a means of describing the excavation of canals seems straightforward.
§15e. The group of fields (German: Flur) known in many Umma texts as EN.GABA.DU is in various publications transliterated en-gaba-du or en-gaba-ra2, without apparent evidence for one reading over the other. en-du8-du is also chosen as a conventional option.


Actually, that is an extraordinarily-ignorant statement for NPR to make, since almost all expenditures for political activities, no matter what type of organization makes them, are reportable and trackable. They must be reported to the Federal Election Commission and, if made by tax-exempt organizations reporting to the Internal Revenue Service, must be reported to the IRS. Every organization which has to report such expenditures must “isolate or sequester” the money to spend and report it compliantly. And it would be no excuse to say that one tax-exempt organization could transfer funds to another (for example, a 501(c)(3) charity, which cannot make political expenditures, could transfer the funds to a 501(c)(4) advocacy organization, which could make such expenditures), since the donating organization, if it knew or believed that its contribution would be used for political purposes, would have to report the transfer in any case, and likely would have to indicate that the funds would be used for a political expenditure. Indeed, under IRS rules, charities generally have to demonstrate that they have prohibited the use of any grants to other organizations for political purposes.
our test affords protection unless an ad is susceptible of no reasonable interpretation other than as an appeal to vote for or against a specific candidate. It is why we emphasize that (1) there can be no free-ranging intent-and-effect test; (2) there generally should be no discovery or inquiry into the sort of “contextual” factors highlighted by the FEC and intervenors; (3) discussion of issues cannot be banned merely because the issues might be relevant to an election; and (4) in a debatable case, the tie is resolved in favor of protecting speech.
For the reasons regarded as sufficient in Buckley, we decline to adopt a test for as-applied challenges turning on the speaker’s intent to affect an election. The test to distinguish constitutionally protected political speech from speech that BCRA may proscribe should provide a safe harbor for those who wish to exercise First Amendment rights. The test should also “reflec[t] our ‘profound national commitment to the principle that debate on public issues should be uninhibited, robust, and wide-open.’ ” Buckley, supra, at 14 (quoting New York Times Co. v. Sullivan, 376 U. S. 254, 270 (1964)). A test turning on the intent of the speaker does not remotely fit the bill.
A test focused on the speaker’s intent could lead to the bizarre result that identical ads aired at the same time could be protected speech for one speaker, while leading to criminal penalties for another. See M. Redish, Money Talks: Speech, Economic Power, and the Values of Democracy 91 (2001) (“[U]nder well-accepted First Amendment doctrine, a speaker’s motivation is entirely irrelevant to the question of constitutional protection”). “First Amendment freedoms need breathing space to survive.” NAACP v. Button, 371 U. S. 415, 433 (1963). An intent test provides none.
Buckley also explains the flaws of a test based on the actual effect speech will have on an election or on a particular segment of the target audience. Such a test “‘puts the speaker … wholly at the mercy of the varied understanding of his hearers.'” 424 U. S., at 43. It would also typically lead to a burdensome, expert-driven inquiry, with an indeterminate result. Litigation on such a standard may or may not accurately predict electoral effects, but it will unquestionably chill a substantial amount of political speech.
That phrase from Buckley, “at the mercy of the varied understanding of his hearers“, resonates strongly with me. Many years ago, while reviewing the record in one of the pivotal legal decisions upholding “electioneering expenditures” (which are non-political statements reported to the Federal Election Commission because they are made close to an election), I was shocked to see the plaintiffs had included an ad that I had vetted and approved to be run by a charity (which was prohibited from political activity). The ad was a classical “issue ad,” wholly directed at legislation; it asked members of the public to contact their Senator, who was Chair of an important Subcommittee that was marking up a bill critical to the organization’s mission. The markup was scheduled two weeks before the Senator’s unopposed primary election. The ad said nothing about the Senator’s character or fitness for office, and didn’t even mention the upcoming election; it was purely and simply about the bill, the markup and the fact that the Senator was chairing the Subcommittee holding the impending hearing. Yet, in the trial record and with no supporting information other than the date of publication (which was, by the way, before the “electioneering communications” rule was enacted), the ad was cited as a “sham” political ad.
“The freedom of speech … guaranteed by the Constitution embraces at the least the liberty to discuss publicly and truthfully all matters of public concern without previous restraint or fear of subsequent punishment.” Bellotti, 435 U. S., at 776 (internal quotation marks omitted). See Consolidated Edison Co. of N. Y. v. Public Serv. Comm’n of N. Y., 447 U. S. 530, 534 (1980). To safeguard this liberty, the proper standard for an as-applied challenge to BCRA §203 must be objective, focusing on the substance of the communication rather than amorphous considerations of intent and effect. See Buckley, supra, at 43-44. It must entail minimal if any discovery, to allow parties to resolve disputes quickly without chilling speech through the threat of burdensome litigation. See Virginia v. Hicks, 539 U. S. 113, 119 (2003). And it must eschew “the open-ended rough-and-tumble of factors,” which “invit[es] complex argument in a trial court and a virtually inevitable appeal.” Jerome B. Grubart, Inc. v. Great Lakes Dredge & Dock Co., 513 U. S. 527, 547 (1995). In short, it must give the benefit of any doubt to protecting rather than stifling speech. See New York Times Co. v. Sullivan, supra, at 269-270.
In light of these considerations, a court should find that an ad is the functional equivalent of express advocacy only if the ad is susceptible of no reasonable interpretation other than as an appeal to vote for or against a specific candidate. Under this test, WRTL’s three ads are plainly not the functional equivalent of express advocacy. First, their content is consistent with that of a genuine issue ad: The ads focus on a legislative issue, take a position on the issue, exhort the public to adopt that position, and urge the public to contact public officials with respect to the matter. Second, their content lacks indicia of express advocacy: The ads do not mention an election, candidacy, political party, or challenger; and they do not take a position on a candidate’s character, qualifications, or fitness for office.
An expert for the FEC in these cases relied on those observations to argue that WRTL’s ads are especially effective electioneering ads because they are “subtl[e],” focusing on issues rather than simply exhorting the electorate to vote against Senator Feingold. App. 56-57. Rephrased a bit, the argument perversely maintains that the less an issue ad resembles express advocacy, the more likely it is to be the functional equivalent of express advocacy. This “heads I win, tails you lose” approach cannot be correct. It would effectively eliminate First Amendment protection for genuine issue ads, contrary to our conclusion in WRTL I that as-applied challenges to §203 are available, and our assumption in McConnell that “the interests that justify the regulation of campaign speech might not apply to the regulation of genuine issue ads,” 540 U. S., at 206, n. 88. Under appellants’ view, there can be no such thing as a genuine issue ad during the blackout period–it is simply a very effective electioneering ad.


a.(a) In the case of a corporation or association holding a license or permit under this part, if actual or legal control of the corporation or association changes, directly or indirectly, whether by reason of change in stock ownership or control (in the corporation holding a license or permit or in any other corporation), by operation of law, or in any other manner, the licensee or permittee shall, within 30 days of the change, give written notification executed under the penalties of perjury, to the Chief, Federal Explosives Licensing Center. Upon expiration of the license or permit, the corporation or association shall file an ATF F 5400.13 or an ATF F 5400.16 as required by § 555.45, and pay the fee prescribed in § 555.42(b) or § 555.43(b).
b.(b) For all licenses or permits issued on and after May 24, 2003, each person holding the license or permit must report to the Chief, Federal Explosives Licensing Center, any change in responsible persons or employees authorized to possess explosive materials. Such report must be submitted within 30 days of the change and must include appropriate identifying information for each responsible person. Reports relating to newly hired employees authorized to possess explosive materials must be submitted on ATF F 5400.28 for each employee.
c.(c) Upon receipt of a report, the Chief, Federal Explosives Licensing Center, will conduct a background check, if appropriate, in accordance with § 555.33.
d.(d) The reports required by paragraph (b) of this section must be retained as part of a licensee's or permittee's permanent records for the period specified in § 555.121.
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The U.S. District Court for the Eastern District of Louisiana has permitted state common law claims to proceed against a generic drug manufacturer, in stark contrast to the U.S. Supreme Court's holding in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) that such claims are preempted. (Whitener, Sr. v. Pliva, Inc.,2012 U.S. Dist. LEXIS 127993). While numerous other courts have followed Mensing, the Whitener decision highlights the opportunity for ambiguity and inconsistent interpretations of the law. We recognize that many generic drug manufacturers do not engage in any promotion or direct sales of their products. However, for those that do, this recent development may be of particular interest.
In Mensing, the Supreme Court held that all state-law tort claims based on failure to warn of the risks of generic medications are preempted by federal law because it is impossible to comply with both a state law which requires the strengthening of a generic drug warning and the federal mandate that a generic drug's labeling be the same as that of the brand-name drug. (Mensing, 131 S.Ct. at 2577-2578).
In Whitener, plaintiffs allege that Mrs. Whitener and her son were injured as a result of her taking metoclopramide, the generic form of the brand-name drug Reglan, during pregnancy for nausea. The FDA-approved label for Reglan, required to be used with the generic version, did not include prescription to pregnant women for morning sickness. Plaintiffs' initial complaint was dismissed as preempted under Mensing, but the Court granted plaintiffs leave to amend to assert a non-preempted state-law claim predicated on "alleged promotion of metoclopramide for off-label purposes in violation of federal law." (Whitener, 2012 U.S. Dist. LEXIS 127993 *4 citing Rec. Doc. 130 at 9).
Defendants brought a motion to dismiss the amended complaint on the ground that it failed to plead the requisite factual specificity that any Defendant promoted the drug for off-label use in violation of federal law. In response to that motion, the Court held that, "Plaintiffs have (barely) pleaded enough facts to raise a reasonable expectation that discovery will reveal evidence of such conduct." (Id. at 6 citing Rec. Doc. 145 at 5 (internal quotation marks omitted)). The Court further stated that, "[e]ven if a generic manufacturer knows that its product is prescribed for some other purpose, that manufacturer has no mechanism to unilaterally provide any additional warnings relevant to the off-label use; that inability is the crux of the Mensing opinion…" (Id. citing Rec. Doc. 145 at 6-7). Nonetheless, the Court was troubled by the question of whether the preemption analysis changes if a defendant is actively promoting the drug for off-label use in violation of federal law. (Id.). Thus, the Court allowed the state law claims to survive, but noted that "it may be appropriate to revisit the issue at a later time." (Id. at 7).
Defendants next brought a motion for reconsideration based on Mensing, and argued that off-label promotion was among the plaintiffs' allegations found to be preempted in Mensing. Nevertheless, the Court held that, "Defendants simply have not managed to overcome the fundamental distinction between this case and Mensing: unlike in Mensing, Plaintiffs in this case do not allege that Defendants should have changed the contents of the label in violation of federal law. Instead, they allege that Defendants simultaneously violated both state and federal law by actively engaging in off-label promotion despite known risks not listed on the label." (Id. at 16).
Meanwhile, numerous other courts have stood by the Mensing decision and broadly found failure to warn claims brought under state law to be preempted1.
On April 18, 2012, Senator Patrick Leahy sponsored a bill to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so. Despite the language of the bill, Senator Leahy's intent is clearly to eliminate the federal preemption defense available to generics, and to impose on them exposure to all product liability theories confronting the brands. The Bill was referred to the Senate committee and has since been referred to the Committee on Health, Education, Labor, and Pensions. We are keeping a close eye on any developments.
1 See, Guarino v. Wyeth, LLC, 823 F. Supp.2d 1289, 1292 (2011) (Plaintiff's claims are, on their face, premised on an allegedly inadequate warning" are preempted under Mensing); Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) (dismissing three lawsuits as preempted by Mensing); Henderson v. Sun Pharm. Indus. Ltd., 809 F. Supp.2d 1373 (N.D. Ga. Aug. 22, 2011) granting defendant's motion to dismiss because plaintiff's proposed amended complaint failed to state a claim other than failure to warn, which was preempted under Mensing; Gross v. Pfizer 825 F. Supp.2d 654, 658 (Md. 2011) disposing of state law claims post Mensing.

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Persons subject to the jurisdiction of the United States and persons traveling with them who share a common dwelling as a family with them are authorized to engage in the travel-related transactions set forth in § 515.560(c) and such additional transactions as are directly incident to visiting a close relative, as defined in § 515.339, who is a national of Cuba; a person ordinarily resident in Cuba.
Note to § 515.561(a): Each person relying on the general authorization in this paragraph must retain specific records related to the authorized travel transactions. See §§ 501.601 and 501.602 of this chapter for applicable recordkeeping and reporting requirements.
(b) Specific licenses. Specific licenses may be issued on a case-by-case basis authorizing the travel-related transactions set forth in § 515.560(c) and such other transactions as are related to family visits that do not qualify for the general license under paragraph (a) of this section.
(c) An entire group does not qualify for the general license in paragraph (a) of this section merely because some members of the group qualify individually.
(a) The travel-related transactions set forth in § 515.560(c) and such additional transactions as are directly incident to activities in their official capacities by persons who are employees, contractors, or grantees of the United States Government, any foreign government, or any intergovernmental organization of which the United States is a member or holds observer status, and who are traveling on the official business of their government or intergovernmental organization, are authorized.
(b) All transactions otherwise prohibited by this part that are for the conduct of the official business of the United States Government or of any intergovernmental organization of which the United States is a member, or holds observer status, by employees, grantees, or contractors thereof, are authorized.
Note to § 515.562(a) and (b): Each person relying on the general authorization in this paragraph must retain specific records related to the authorized travel transactions. For example, grantees or contractors relying on the authorization in this section must retain a copy of their grant or contract with the United States Government, foreign government, or intergovernmental organization. See §§ 501.601 and 501.602 of this chapter for applicable recordkeeping and reporting requirements.
(d) Specific licenses. Specific licenses may be issued on a case-by-case basis authorizing the travel-related transactions set forth in § 515.560(c) and such other transactions as are related to official government business that do not qualify for the general licenses under paragraph (a) or (b) of this section.
Note to § 515.563(a): Each person relying on the general authorization in this paragraph must retain specific records related to the authorized travel transactions. See §§ 501.601 and 501.602 of this chapter for applicable recordkeeping and reporting requirements.
(c) Specific licenses. Specific licenses may be issued on a case-by-case basis authorizing the travel-related transactions set forth in § 515.560(c) and such other transactions as are related to journalistic activity in Cuba that do not qualify for the general license under paragraph (a) of this section.
(iii) The traveler’s schedule of activities does not include free time or recreation in excess of that consistent with a full-time schedule of professional research.
Example to § 515.564(a)(1): The making of a documentary film in Cuba would qualify for the general license in this section if it is a vehicle for presentation of the research conducted pursuant to this section.
Note to § 515.564(a)(1): A person does not qualify as engaging in professional research merely because that person is a professional who plans to travel to Cuba.
(iv) The traveler’s schedule of activities does not include free time or recreation in excess of that consistent with a full-time schedule of attendance at professional meetings or conferences.
501.602 of this chapter for applicable recordkeeping and reporting requirements.
(b) An entire group does not qualify for the general license in paragraph (a) of this section of this section merely because some members of the group qualify individually.
Example to § 515.564(b): A musicologist travels to Cuba to research Cuban music pursuant to the general license for professional research set forth in paragraph (a) of this section. Others who are simply interested in music may not engage in travel-related transactions with the musicologist in reliance on this general license. For example, an art historian who plays in the same band with the musicologist would not qualify for the general license.
(c) Specific licenses. Specific licenses may be issued on a case-by-case basis authorizing the travel-related transactions set forth in § 515.560(c) and such other transactions as are related to professional research or professional meetings in Cuba that do not qualify for the general license under paragraph (a) of this section.
Note to § 515.565(a)(5): See § 515.571(a) for authorizations related to certain banking transactions by Cuban nationals.
(6) Educational exchanges sponsored by Cuban or U.S. secondary schools involving secondary school students’ participation in a formal course of study or in a structured educational program offered by a secondary school or other academic institution and led by a teacher or other secondary school official. This includes participation by a reasonable number of adult chaperones to accompany the secondary school students to Cuba.
Note 2 to § 515.565(a): This paragraph authorizes all members of the faculty and staff (including adjunct faculty and part-time staff) of the sponsoring U.S. academic institution to participate in the activities described in this paragraph. A student currently enrolled in a U.S. academic institution is authorized pursuant to this paragraph to participate in the academic activities in Cuba described above through any sponsoring U.S. academic institution.
Example to § 515.565(b): An organization wishes to sponsor and organize educational exchanges not involving academic study pursuant to a degree program for individuals to learn side-by-side with Cuban individuals in areas such as environmental protection or the arts. The travelers will have a full-time schedule of educational exchange activities that will result in meaningful interaction between the travelers and individuals in Cuba. The organization’s activities qualify for the general license.
Note to § 515.565(b): An organization that sponsors and organizes trips to Cuba in which travelers engage in individually selected and/or self-directed activities would not qualify for the general license. Authorized trips are expected to be led by the organization and to have a full-time schedule of activities in which the travelers will participate.
Note to § 515.565(a) and (b): Each person relying on the general authorizations in these paragraphs, including entities sponsoring travel pursuant to the authorization in § 515.565(b), must retain specific records related to the authorized travel transactions. See §§ 501.601 and 501.602 of this chapter for applicable recordkeeping and reporting requirements.
(c) Transactions related to activities that are primarily tourist-oriented, including self-directed educational activities that are intended only for personal enrichment, are not authorized pursuant to this section.
(d) Specific licenses. Specific licenses may be issued on a case-by-case basis authorizing the travel-related transactions set forth in § 515.560(c) and such other transactions as are related to educational activities that do not qualify for the general licenses under paragraph (a) or (b) of this section.
(a) General license. Persons subject to U.S. jurisdiction, including religious organizations located in the United States and members and staff of such organizations, are authorized to engage in the travel-related transactions set forth in § 515.560(c) and such additional transactions as are directly incident to engaging in religious activities in Cuba, provided that the travel-related transactions pursuant to this authorization must be for the purpose of engaging, while in Cuba, in a full-time schedule of religious activities.
Note to § 515.566(a): Each person relying on the general authorization in this paragraph must retain specific records related to the authorized travel transactions. See §§ 501.601 and 501.602 of this chapter for applicable recordkeeping and reporting requirements.
(b) Financial and material donations to Cuba or Cuban nationals are not authorized by this section.
Note to § 515.566(b): See § 515.570 regarding authorized remittances to religious organizations in Cuba and for other purposes. See § 515.533 regarding the exportation of items from the United States to Cuba.
(c) Specific licenses. Specific licenses may be issued on a case-by-case basis authorizing the travel-related transactions set forth in § 515.560(c) and such other transactions as are related to religious activities that do not qualify for the general license under paragraph (a) of this section.
Note to § 515.566: Religious organizations engaging in activities authorized pursuant to this section are permitted to open and maintain accounts at Cuban financial institutions for the purpose of accessing funds in Cuba for transactions authorized pursuant to this section.
(3) The competition is open for attendance, and in relevant situations, participation, by the Cuban public.
(3) Any clinics or workshops in Cuba must be organized and run, at least in part, by the authorized traveler.
(b).Note to § 515.567(a) and (b): Each person relying on the general authorizations in these paragraphs must retain specific records related to the authorized travel transactions. See §§ 501.601 and 501.602 of this chapter for applicable recordkeeping and reporting requirements.
(c) An entire group does not qualify for the general license in paragraph (a) or (b) of this section merely because some members of the group qualify individually.
(d) Specific licenses. Specific licenses may be issued on a case-by-case basis authorizing the travel-related transactions set forth in § 515.560(c) and such other transactions as are related to public performances, clinics, workshops, athletic and other competitions, and exhibitions that do not qualify for the general licenses under paragraphs (a) or (b) of this section.
(a) General license. Transactions, including the travel-related transactions set forth in § 515.560(c), that are related to the humanitarian projects in or related to Cuba that are designed to directly benefit the Cuban people as set forth in paragraph (b) are authorized, provided that the traveler’s schedule of activities does not include free time or recreation in excess of that consistent with a full-time schedule.
Note to § 515.575(a): Each person relying on the general authorization in this paragraph must retain specific records related to the authorized travel transactions. See §§ 501.601 and 501.602 of this chapter for applicable recordkeeping and reporting requirements.
(b) Authorized humanitarian projects. The following projects are authorized by paragraph (a) of this section: medical and health-related projects; construction projects intended to benefit legitimately independent civil society groups; environmental projects; projects involving formal or non-formal educational training, within Cuba or off-island, on the following topics: entrepreneurship and business, civil education, journalism, advocacy and organizing, adult literacy, or vocational skills; community-based grassroots projects; projects suitable to the development of small-scale private enterprise; projects that are related to agricultural and rural development that promote independent activity; microfinancing projects, except for loans, extensions of credit, or other financing prohibited by § 515.208; and projects to meet basic human needs.
Example to § 515.575(b): A U.S. group of medical professionals that specializes in disease treatment wishes to support a community in Cuba by providing the latest techniques and literature in disease education and prevention directly to the Cuban people. Provided that the medical professionals in the group maintain a full-time schedule related to disease education and prevention, these activities qualify for the general license.
the travel-related transactions set forth in § 515.560(c) and such other transactions as are related to humanitarian projects that do not qualify for the general license under paragraph (a) of this section.
(a) General license. The travel-related transactions set forth in § 515.560(c) and such additional transactions as are directly incident to activities by private foundations or research or educational institutes with an established interest in international relations to collect information related to Cuba for noncommercial purposes are authorized, provided that the traveler’s schedule of activities does not include free time or recreation in excess of that consistent with a full-time schedule.
Example to § 515.576(a): A private research foundation that produces essays on international relations issues wishes to send a team made up of its employees and consultants to Cuba to collect information for a current study of the relationship that countries in the Western Hemisphere have with European countries. Provided that all of the employees and consultants on the team maintain a full-time schedule of activities relating to the collection of information for the study, these activities qualify for the general license.
Note to § 515.576(a): Each person relying on the general authorization in this paragraph must retain specific records related to the authorized travel transactions. See §§ 501.601 and 501.602 of this chapter for applicable recordkeeping and reporting requirements.
to activities of private foundations or research or educational institutes that do not qualify for the general license under paragraph (a) of this section.
Authorized or Licensed Goods (Section 515.533(d)): Persons may travel under a general license for travel related transactions set forth CFR 515.560(c0) and such incidental transactions as are directly incident to the conduct of market research, commercial marketing, sales negotiation, accompanied delivery or servicing in Cuba of items consistent with the export or reexport licensing policy of the Department of Commerce are authorized, provided that a traveler’s schedule of activities does not include free time or recreation in excess of that consistent with a full time schedule may travel under a general license.