November 25, 2020/Notices
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Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices 75331 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 VerDate Sep<11>2014 16:27 Nov 24, 2020 Jkt 253001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\25NON1.SGM 25NON1 jbell on DSKJLSW7X2PROD with NOTICES 75332 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices 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