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human consumption are not considered designation and to impose conditions if regulated human food, including dietary prohibited cattle materials, and their use a request is granted. supplements, and cosmetics does not render human food or Sections 189.5 and 700.27 further manufactured from, processed with, or cosmetics adulterated. Sections 189.5(e) state that countries designated under otherwise containing material derived and 700.27(e) provide that a country §§ 189.5(e) and 700.27(e) will be subject from cattle, as well as, with regard to seeking to be designated must send a to future review by FDA to determine §§ 189.5(e) and 700.27(e), foreign written request to the Director of the whether their designations remain governments seeking designation under Center for Food Safety and Applied appropriate. As part of this process, we those regulations. may ask designated countries to confirm Nutrition. The information the country In the Federal Register of August 14, that their BSE situation and the is required to submit includes 2020 (85 FR 49657), we published a 60- information submitted by them, in day notice requesting public comment information about a country’s BSE case support of their original application, has on the proposed collection of history, risk factors, measures to prevent remained unchanged. We may revoke a information. Although some comments the introduction and transmission of country’s designation if we determine were received, only one pertained to the BSE, and any other information relevant that it is no longer appropriate. information collection. The comment to determining whether SRMs, the small Therefore, designated countries may suggested requiring greater than a 2-year intestine of cattle not otherwise respond to periodic FDA requests by excluded from being a prohibited cattle submitting information to confirm their retention period for records; however, material, material from nonambulatory designations remain appropriate. We we believe that additional retention disabled cattle, or MS beef from the use the information to ensure their requirements may impose undue burden country seeking designation should be designations remain appropriate. on respondents to the information collection without providing greater considered prohibited cattle materials. Description of Respondents: utility to the Agency. We use the information to determine Respondents to this information whether to grant a request for collection include manufacturers, We estimate the burden of this processors, and importers of FDA- collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 21 CFR section; activity Number of responses per Total annual Average burden per Total hours respondents respondent responses response

189.5(c)(6) and 700.27(c)(6); affirmation of compli- 54,825 1 54,825 0.033 (2 minutes) ...... 1,809 ance. 189.5(e) and 700.27(e); request for designation ..... 1 1 1 80 ...... 80 189.5(e) and 700.27(e); response to request for re- 1 1 1 26...... 26 view by FDA.

Total ...... 1,915 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Number of Type of respondent Number of records per Total annual Average burden per Total hours recordkeepers recordkeeper records recordkeeper

Domestic facilities ...... 697 52 36,244 0.25 (15 minutes) ...... 9,061 Foreign facilities ...... 916 52 47,632 0.25 (15 minutes) ...... 11,908

Total ...... 20,969 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information DEPARTMENT OF HEALTH AND SUMMARY: The Department of Health and collection since our last request for HUMAN SERVICES Human Services is issuing this Notice to OMB approval, we have made no withdraw FDA’s Marketed Unapproved adjustments to our burden estimate. Food and Drug Administration Drugs—Compliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Dated: November 18, 2020. Termination of the Food and Drug Approved NDAs or ANDAs, and to Lauren K. Roth, Administration’s Unapproved Drugs request information from the public Acting Principal Associate Commissioner for Initiative; Request for Information regarding drugs that may be Policy. Regarding Drugs Potentially Generally grandfathered or generally recognized as [FR Doc. 2020–26059 Filed 11–24–20; 8:45 am] Recognized as Safe and Effective safe and effective. BILLING CODE 4164–01–P DATES: AGENCY: Food and Drug Administration Part I of this Notice shall be (FDA), Department of Health and effective thirty days from the date of publication in the Federal Register. To Human Services (HHS). be considered, responses and comments ACTION: Notice; request for information. related to Part II of this Notice must be received electronically at the email

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address listed below. The Department definition of ‘‘new drug.’’ 1 First, when from the FDA approval requirement will consider information submitted by Congress enacted the modern FD&C Act obtained market exclusivity for those the public in response to Part II of this in 1938, it exempted from the definition products after FDA took unapproved Notice on a rolling basis, and until of ‘‘new drug’’ all drugs ‘‘subject to the versions off the market. An unintended further notice. Food and Drugs Act of June 30, 1906, as consequence of the ‘‘period of de facto ADDRESSES: Responses to Part II must be amended, and if at such time its labeling market exclusivity’’ provided by the submitted electronically, and should be contained the same representations UDI allowed manufacturers an addressed to [email protected]. In the concerning the conditions of its use.’’ opportunity to raise prices in an subject line of the email message, FD&C Act 201(p)(1), 21 U.S.C. 321(p)(1). environment largely insulated from submissions should include ‘‘GRASE Second, drugs that are generally market competition. Based on its ongoing review of FDA RFI Response.’’ recognized as safe and effective which have also ‘‘been used to a material regulatory programs, the Department FOR FURTHER INFORMATION CONTACT: Nick extent or for a material time’’ are not has decided to withdraw the 2006 and Uehlecke, 200 Independence Ave. SW, ‘‘new drugs.’’ FD&C Act 201(p)(1) and 2011 Guidance, effective thirty days Washington, DC 20201; or by email at (2), 21 U.S.C. 321(p)(1) and (2). Drugs after the date of publication of this [email protected]; or by telephone at 1– that meet either of these exceptions may Notice in the Federal Register. All 877–696–6775. be legally marketed without FDA pre- compliance manuals, website SUPPLEMENTARY INFORMATION: The approval for safety and efficacy, subject statements, and other informal Trump Administration, through the to the agency’s other regulatory issuances with respect to the 2006 and Department of Health and Human authorities. 2011 Guidance are also hereby Services (HHS), is continuing its efforts Through a guidance document issued withdrawn. The withdrawal of the 2006 to reduce the price of prescription in 2006 and later revised in 2011, and and 2011 Guidance Documents drugs. This Notice addresses two related without conducting notice-and- complies with FDA’s current Good but distinct issues: (1) The Food and comment rulemaking, FDA launched a Guidance Practices regulation, which Drug Administration’s (FDA) program called the Unapproved Drugs allows for ‘‘periodic[ ] review of [of] Unapproved Drugs Initiative (UDI) and Initiative (UDI).2 The UDI sprang from existing guidance documents to (2) the construction of the statutory a laudable objective, namely to reduce determine whether they need to be exemptions from the definition of ‘‘new the number of unapproved drugs on the changed or withdrawn.’’ 21 CFR drugs’’ subject to FDA approval under market. To achieve this end, FDA 10.115(k)(1). Nothing in this Notice the federal Food, Drug, and Cosmetic provided in its 2011 UDI Guidance that otherwise limits FDA’s authority to take Act (FD&C Act), namely so-called pre- ‘‘the first company to obtain an approval action against manufacturers of 1938 grandfathered drugs and drugs that [of a previously unapproved drug] will unapproved drugs that meet the are ‘‘generally recognized as safe and have a period of de facto market statutory definition of a ‘‘new drug’’ effective’’ or ‘‘GRASE.’’ exclusivity before other products obtain (such as, for example, an unapproved approval.’’ 3 The agency ‘‘hope[d] that drug that claims to mitigate, treat, or I. Unapproved Drugs Initiative this period of market exclusivity will cure COVID–19) or violate the FD&C Act In 1938, Congress created the modern provide an incentive to firms to be the in other ways. Further, nothing in this scheme for federal regulation of drugs. first to obtain approval to market a Notice limits FDA’s grant of regulatory 4 Before 1938, there was no requirement previously unapproved drug.’’ exclusivities authorized by statute, such under federal law for a manufacturer to Ultimately, manufacturers of older as a new chemical entity exclusivity, obtain FDA approval before marketing a drugs previously thought to be exempt orphan drug exclusivity, or pediatric drug. Today, as a general rule, under the exclusivity. This Notice does not apply 1 There is a third, related exemption which to drugs subject to (1) Investigational FD&C Act, a ‘‘new drug’’ must be relieves manufacturers from the obligation of approved by the FDA for safety and showing their drugs are effective prior to marketing. New Drug applications (IND) that are in efficacy pursuant to an approved New In section 107(c)(4) of the Drug Amendments of effect as of the effective date of this Drug Application (NDA) or Abbreviated 1962, Public Law 87–81, 76 Stat. 780, 789 (Oct. 10, Notice, (2) any subsequent NDA based 1962), Congress exempted from the efficacy on new clinical trial investigations New Drug Application (ANDA) before requirement ‘‘product[s] that, on the day before the the drug is introduced into interstate 1962 amendments became effective, (A) [were] used (other than bioavailability studies) commerce. See FD&C Act 201(p), 21 or sold commercially in the United States, (B) derived under such IND, and (3) U.S.C. 321(p) (defining ‘‘new drug’’ [were] generally recognized by the experts as safe; existing approved NDAs. and (C) [were] not ‘covered’ by an ‘effective’ The Department is withdrawing the under the Act); FD&C Act 505(a), 21 application.’’ USV Pharmaceutical Corp. v. U.S.C. 355(a) (‘‘No person shall Weinberger, 412 U.S. 655, 653 (1973). In 2006 and 2011 Guidances for several introduce or deliver for introduction Weinberger, the Supreme Court held that so-called evidence-based reasons. After the UDI into interstate commerce any new drug, ‘‘me-too drugs,’’ i.e., drugs that were copies of NDA began, reports emerged that Americans drugs, were effectively ‘‘covered’’ by an effective were paying significantly more for unless an approval of an application application and thus subject to the efficacy . . . is effective with respect to such requirement just like drugs covered by NDAs. Id. at prescription drugs approved by FDA drug.’’). A ‘‘person’’ that introduces a 664–65. Practically, Weinberger left as the lone through the UDI than they had paid ‘‘new drug’’ into interstate commerce is remaining candidates for this exemption from the previously. One report noted that a drug efficacy requirement drugs (a) on the market prior approved through the UDI ‘‘sells for subject to, among other sanctions, to 1962, (b) generally recognized as safe, and (c) not injunctions and/or having the subject themselves subject to a 1938–1962 ‘‘effective’’ NDA. about $4.50 a tablet—nearly 50 times product seized in an ex parte 2 FDA, Marketed Unapproved Drugs— the price of the unapproved version.’’ 5 proceeding under admiralty rules. See Compliance Policy Guide Sec. 440.100, Marketed Another report asserted that ‘‘[t]hanks at New Drugs Without Approved NDAs or ANDAs least partially to the FDA program, the FD&C Act 302, 21 U.S.C. 332 (injunction (June 2006) (hereinafter the 2006 Guidance); FDA, authority); FD&C Act 304, 21 U.S.C. 334 Marketed Unapproved Drugs—Compliance Policy price of vasopressin . . . has risen 10- (seizure authority). Guide Sec. 440.100, Marketed New Drugs Without fold’’ and the cost of ‘‘a vial of Not all drugs are ‘‘new drugs’’ which Approved NDAs or ANDAs (Sept. 19, 2011) (hereinafter the 2011 Guidance). 5 Harris Meyer, The High Price of FDA Approval, require FDA approval. There are two 3 2011 Guidance at 8. Kaiser Health News, Dec. 29, 2009, https://khn.org/ primary carve-outs from the FD&C Act’s 4 Id. news/fda-approval/.

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neostigimine . . . has gone from less Moreover, the fact that the program under the Administrative Procedure than $5 to $90.’’ 6 was initiated through guidance, as Act. In 2017, scholars from the Yale opposed to notice-and-comment Even if there were cognizable reliance School of Medicine and the University rulemaking, further supports the interests in the UDI, the Department has of Utah published a peer-reviewed Department’s decision to withdraw the ample evidence-based justification for study corroborating the previous 2006 and 2011 Guidances, because the rescinding the 2006 and 2011 7 reports. The study reviewed 34 drugs Department has serious legal concerns Guidances. After more than fourteen subject to the UDI between 2006 and about whether the UDI was years of experience with the program, implemented through legally 2015. The scholars found the average evidence has emerged that the UDI has permissible procedures.14 The wholesale unit price of 26 of the 34 caused significant prescription drug Department recognizes that some drugs for which pricing data was price increases and drug shortages while persons might contend that they have available increased by a median of 37% providing limited new clinical data on 8 reliance interests in the 2011 Guidance (interquartile range of 23%–204%). older drugs. The Department believes The average wholesale unit price of 11 remaining in effect. In Dep’t of Homeland Sec. v. Regents of the Univ. these costs imposed on American of the drugs surveyed in the study patients and taxpayers outweigh any increased by more than 128%.9 of California, 140 S. Ct. 1891 (2020), the reliance interests that may exist in the The study also linked the UDI to drug Supreme Court struck down the program. The Department has also shortages, which the authors defined as Department of Homeland Security’s considered the public health effects of ‘‘a supply issue that affects how a rescission of the Deferred Action for withdrawing the 2006 and 2011 pharmacy prepares or dispenses a drug Childhood Arrivals (DACA) Guidances. As the 2011 Guidance product that influences patient care immigration program, in part based on acknowledges, there are ‘‘several when prescribers must use an the reliance interests of persons eligible thousand’’ products on the market that alternative agent.’’ 10 In this regard, the to obtain the benefits of the program. lack FDA approval.17 To the extent this scholars found that 24 of the 34 drugs Notably, in that case, immigration program has limited patient access to experienced shortages after FDA took authorities ‘‘solicited applications from important, safe medications due to price enforcement action after an entity eligible aliens, instituted a standardized increases or drug shortages, the obtained FDA approval of a previously review process, and sent formal notices withdrawal of the 2006 and 2011 unapproved drug. The median shortage indicating whether the alien would Guidances will have a positive impact was 217 days.11 receive the two-year forbearance.’’ Id. on public health. Moreover, eliminating Finally, the authors considered As the Court explained, DACA ‘‘created this program allows FDA’s resources to whether the UDI generated new clinical a program for conferring affirmative be directed toward monitoring data evidence for older drugs. The immigration relief.’’ Id. unapproved ‘‘new drugs’’ that fall authors found that, of the nineteen The UDI is distinguishable from the squarely within the traditional scope of drugs that obtained FDA approval DACA program. Unlike DACA, the 2011 the definition of that term in the FD&C during the study period, only two were Guidance described how the FDA Act. At the same time, the Notice allows supported by ‘‘new clinical trial intended to exercise its enforcement FDA to use its limited review resources evidence.’’ 12 The other seventeen drugs discretion, but stopped short of on innovative potential therapies, as ‘‘were supported by literature reviews committing FDA to any particular opposed to older drugs with and bioequivalence to older drug action. FDA stated that it was ‘‘more likely to take enforcement action’’ longstanding use. products.’’ 13 against unapproved competitors of Therefore, the Department has Besides, any reliance interests (if they newly approved drugs under the UDI, concluded that while the UDI began existed) would be minimal. This Notice but that the agency ‘‘intend[s] to take with laudable goals, it has had does not apply to drugs subject to (1) into account the circumstances once the numerous negative, unintended INDs in effect as of the effective date of product is approved in determining how consequences on Americans’ access to this Notice, (2) any subsequent NDA to exercise our enforcement discretion prescription drugs and generated very based on new clinical investigations with regard to the unapproved (other than bioavailability studies) limited benefits. 15 products.’’ Moreover, the 2011 derived under such IND, and (3) Guidance stated that it ‘‘does not create 6 Michael Hiltzik, The little-known FDA program existing approved NDAs. that’s driving drug prices higher, L.A. Times (Sept. or confer any rights for or on any person 23, 2015), https://www.latimes.com/business/ and does not operate to bind FDA or the II. Pre-1938 Grandfathered and GRASE hiltzik/la-fi-mh-the-little-known-fda-program- public.’’ 16 Any reliance interests are Drugs; Request for Information 20150923-column.html. thus illusory. Furthermore, Congress 7 Ravi Gupta et al., The FDA Unapproved Drugs vested FDA with the sole authority to As noted above, when Congress Initiative: An Observational Study of the enacted the FD&C Act in 1938 and later Consequences for Drug Prices and Shortages in the enforce the FD&C Act. FD&C Act 310, 21 United States, 23 J. of Man. Care & Specialty Pharm. U.S.C. 337. Under Heckler v. Chaney, amended the Act in 1962, it exempted 1066 (Oct. 2017). 470 U.S. 821 (1985), FDA’s decision certain drugs from the FDA approval 8 Id. at 1071. about the extent to which it shall requirement. Section 201(p) of the FD&C 9 See id. at 1072. enforce the FD&C Act is unreviewable Act, 21 U.S.C. 321(p), excludes from the 10 Id. at 1068. definition of ‘‘new drug’’ certain drugs 11 Id. at 1073. 14 See, e.g., 5 U.S.C. 553. The Department also has marketed prior to June 25, 1938 and 12 Id. concerns regarding whether the issuance of the drugs generally recognized as safe and 13 Id.; see also Aaron S. Kesselheim and Daniel 2011 Guidance complied with FDA’s good guidance effective, or GRASE. In the 2011 H. Solomon, Incentives for Drug Development—The practices regulation, 21 CFR 10.115, in effect at the Curious Case of Colchicine, N. Engl. J. Med. 362;22 time. FDA issued the 2011 Guidance ‘‘without Guidance, FDA stated that ‘‘it is not at 2046 (noting the dramatic rise in the price of public comment because the Agency has likely that any currently marketed Colchicine after implementation of the UDI, but that determined that prior public participation is not prescription drug is grandfathered or is ‘‘there is no evidence of any meaningful feasible or appropriate.’’ 76 FR 58398 (Sept. 21, improvement to the public health’’ from the 2011). otherwise not a new drug,’’ though the regulatory changes). 15 2011 Guidance at 7. 13 36 FR 14662, 14662–63 (Aug. 7, 1971). 16 Id. at 2. 17 Id. at 3.

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agency stated ‘‘that it is at least was also approved through the UDI. The The Department wishes to engage theoretically possible.’’ 18 interpretation of the definition of ‘‘new with the public on the contours of the That was not always the case. For drug’’ espoused in the 2011 Guidance exceptions to the definition of ‘‘new many years, FDA acknowledged that at essentially foreclosed the possibility drug.’’ In this regard, HHS is reviewing least some drugs are not ‘‘new drugs’’ that these two century-old drugs were whether certain drugs, including the subject to FDA approval prior to pre-1938 grandfathered drugs exempt drug subject to Congressional scrutiny marketing. In a 1980 version of the from the approval process. The 2017 in 2016, might qualify as exempt from Orange Book, FDA stated that ‘‘[t]he law study discussed above found that the the FDA approval requirement. To aid also permits drugs to be legally average wholesale unit price of that effort, HHS asks for input from marketed without such fully approved epinephrine and colchicine increased patients, health care providers, industry, applications under certain by 58.3% and 3,323.5%, respectively,25 and other stakeholders to provide circumstances,’’ including ‘‘drugs costs absorbed by American patients information responsive to any of the marketed prior to 1938 that are not and taxpayers. topics below: subject to the pre-market clearance The regulatory history of the 1. Lists of drugs marketed prior to procedures of the law’’ and ‘‘drug prescription drug Daraprim raises June 25, 1938 that are currently products marketed between 1938 and similar issues. FDA originally approved available on the market. 1962 that were approved for safety but Daraprim (pyrimethamine) for safety in 2. The extent to which drugs not effectiveness.’’ 19 In the same 1953, and later deemed the drug marketed prior to June 25, 1938, or publication, the agency went on to effective through the Drug Efficacy drugs that might qualify as GRASE, have identify specific products, noting Study Implementation, or DESI review regulatory approvals in countries ‘‘commonly used large volume process.26 The drug is listed on the outside the United States. intravenous products are not included World Health Organization’s List of 3. Whether there would be adverse on the List [of FDA-approved drugs] Essential Medications, ‘‘a list of clinical or economic consequences to (e.g., dextrose 5% with water, dextrose minimum medicine needs for a basic deeming as GRASE those drugs 10% with water, sodium chloride 0.9% health-care system, listing the most previously approved by the FDA for injection),’’ since ‘‘all of these drug efficacious, safe and cost-effective which patent and regulatory exclusivity products came on the market in glass medicines for priority conditions.’’ 27 In have expired. containers before 1938 and have not 2015, the company Turing 4. Any published literature reviews or been required to obtain an approved Pharmaceuticals ‘‘raised the price [of clinical studies related to any drugs new drug application as a condition of the drug] to $750 a tablet from $13.50, potentially exempt from the new drug 20 marketing.’’ In the 2000 edition of the bringing the annual cost of treatment for approval requirement. Orange Book, FDA cited to the some patients to hundreds of thousands Dated: November 20, 2020. barbiturate ‘‘Phenobarbital Tablets’’ as of dollars.’’ 28 Turing came by this Alex M. Azar II, an example of ‘‘pre-1938 drugs.’’ 21 The windfall, at least in part, because of Secretary, Department of Health and Human 2011 Guidance, issued absent notice- FDA’s interpretation of the definition of Services. and-comment rulemaking and without ‘‘new drug’’ in the FD&C Act as [FR Doc. 2020–26133 Filed 11–24–20; 8:45 am] prior public comment, contains no articulated in the 2006 and 2011 acknowledgement of these prior BILLING CODE 4150–26–P 22 Guidances, a view that foreclosed the positions. possibility that Daraprim, a drug more This evolution in the agency’s than sixty years old, could ever qualify DEPARTMENT OF HEALTH AND thinking has had consequences. Under as GRASE. That position effectively HUMAN SERVICES the UDI, FDA required the manufacturer prevented other manufacturers of of an epinephrine brand which Food and Drug Administration originally came onto the market in 1901 generic versions of this product from to submit an NDA.23 The drug entering the market without an [Docket No. FDA–2010–D–0529] colchicine, a product FDA approved abbreviated new drug Qualification Process for Drug acknowledged ‘‘was available in oral application, allowing Turing to enjoy a Development Tools; Guidance for dosage form during the 19th century,’’ 24 single-source position in the marketplace while potential competitors Industry; Availability went through the regulatory process. In 18 Id. at 12 (emphasis in original). AGENCY: Food and Drug Administration, 19 February 2016, Congress held a hearing FDA, Approved Prescription Drug Products HHS. with Therapeutic Equivalence Evaluations (herein on this widely-publicized issue. ACTION: the Orange Book), at I–3 (1st ed. 1980). Ultimately, FDA approved a generic Notice of availability. 20 Id. at I–13. competitor for this single-source drug in SUMMARY: 21 Id. at I–13. FDA, Orange Book, at v (2000); see The Food and Drug also FDA, Orange Book, at iv (29th ed. 2009) February 2020. Administration’s (FDA or Agency) (containing same reference to ‘‘pre-1938 drugs’’ and Center for Drug Evaluation and Research phenobarbital tablets). FDA included a reference to 25 Gupta, supra note 7, at 1072; see also Aaron S. (CDER) and Center for Biologics ‘‘pre-1938 drugs’’ like phenobarbital tablets in the Kesselheim and Daniel H. Solomon, Incentives for Orange Book as late as 2016, FDA, Orange Book, at Drug Development—The Curious Case of Evaluation and Research (CBER) are iv (36th ed. 2016), but removed the reference in its Colchicine, N. Engl. J. Med. 362;22 at 2046 (noting announcing the availability of a final 2017 edition and subsequent versions. the dramatic rise in the price of Colchicine after guidance for industry and FDA staff 22 Cf. F.C.C. v. Fox Television Stations, Inc., 556 implementation of the UDI, but that ‘‘there is no entitled ‘‘Qualification Process for Drug U.S. 502, 515 (2009) (‘‘To be sure, the requirement evidence of any meaningful improvement to the that an agency provide reasoned explanation for its public health’’ from the regulatory changes). Development Tools.’’ Under the 21st action would ordinarily demand that it display 26 36 FR 14662, 14662–63 (Aug. 7, 1971). Century Cures Act (Cures Act), enacted awareness that it is changing position.’’) 27 World Health Organization, 20th WHO Model on December 13, 2016, a new section 23 FDA, Ctr. For Drug Evaluation and Research, List of Essential Medications, at 24 (Mar. 2017). was added to the Federal Food, Drug, Application Number: 204200Origs1s000, 28 Andrew Pollack, Drug Goes From $13.50 a and Cosmetic Act (FD&C Act), which 204200Orig2s000, Summary Review, at 3, https:// Tablet to $750, Overnight, N.Y. Times, Sept. 20, www.accessdata.fda.gov/drugsatfda_docs/nda/ 2015, https://www.nytimes.com/2015/09/21/ defined a three-stage qualification 2012/204200Orig1Orig2s000SumR.pdf. business/a-huge-overnight-increase-in-a-drugs- process for drug development tools 24 75 FR 60768 (Oct. 1, 2010). price-raises-protests.html. (DDTs). This guidance meets the Cures

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