Federal Register/Vol. 85, No. 136/Wednesday, July 15, 2020
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42868 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices the SUPPLEMENTARY INFORMATION section to CVM to demonstrate substantial DEPARTMENT OF HEALTH AND for electronic access to the draft evidence of effectiveness for new animal HUMAN SERVICES guidance document. drug applications or a reasonable FOR FURTHER INFORMATION CONTACT: expectation of effectiveness for Food and Drug Administration Susan Storey, Center for Veterinary applications for conditional approval of [Docket No. FDA–2008–N–0567] Medicine (HFV–131), Food and Drug a new animal drug. It also describes Administration, 7500 Standish Pl., how sponsors may obtain feedback from Notice of Decision Not To Designate Rockville, MD 20855, 240–402–0578, CVM regarding the incorporation of data Clonorchiasis as an Addition to the [email protected]. from foreign countries into Current List of Tropical Diseases in the SUPPLEMENTARY INFORMATION: investigations and study protocols Federal Food, Drug, and Cosmetic Act I. Background before the submission of an application. AGENCY: Food and Drug Administration, FDA is committed to supporting data FDA is announcing the availability of HHS. that may be recognized globally in order draft GFI #265 entitled ‘‘Use of Data ACTION: Notice. to enhance animal drug development, from Foreign Investigational Studies to facilitate the use of foreign data, and SUMMARY: The Food and Drug Support Effectiveness of New Animal Administration (FDA or Agency), in Drugs.’’ Section 305 of the Animal Drug minimize the need to conduct duplicative studies. response to suggestions submitted to the and Animal Generic Drug User Fee public docket FDA–2008–N–0567, Amendments of 2018 (Pub. L. 115–234), This level 1 draft guidance is being between June 20, 2018, and November among other things, directed FDA to issued consistent with FDA’s good 21, 2018, has analyzed whether the hold a public meeting for interested guidance practices regulation (21 CFR foodborne trematode infection parties to discuss innovative animal 10.115). The draft guidance, if finalized, clonorchiasis meets the statutory criteria drug investigation designs and to issue will represent the current thinking of for designation as a ‘‘tropical disease’’ guidance addressing the incorporation FDA regarding the use of data from for the purposes of obtaining a priority of the use of such elements of foreign investigational studies to review voucher (PRV) under the Federal investigations as complex adaptive and support the effectiveness of new animal Food, Drug, and Cosmetic Act (FD&C other novel investigation designs, data drugs. It does not establish any rights for Act), namely whether it primarily from foreign countries, real-world any person and is not binding on FDA affects poor and marginalized evidence (including ongoing or the public. You can use an alternative populations and whether there is ‘‘no surveillance activities, observational approach if it satisfies the requirements significant market’’ for drugs that studies, and registry data), biomarkers, of the applicable statutes and prevent or treat clonorchiasis in and surrogate endpoints into clinical regulations. developed countries. The Agency has investigation protocols and applications determined at this time that to support the effectiveness of new II. Paperwork Reduction Act of 1995 clonorchiasis does not meet the animal drugs. statutory criteria for addition to the In the Federal Register of July 9, 2019 FDA tentatively concludes that this tropical diseases list under the FD&C (84 FR 32749), FDA’s Center for draft guidance contains no collection of Act. Although clonorchiasis Veterinary Medicine (CVM) published a information. Therefore, clearance by the disproportionately affects poor and notice of a public meeting entitled Office of Management and Budget marginalized populations, it is an ‘‘Incorporating Alternative Approaches (OMB) under the Paperwork Reduction infectious disease for which there is a in Clinical Investigations for New Act of 1995 (PRA) (44 U.S.C. 3501– significant market in developed nations; Animal Drugs’’ giving interested 3521) is not required. therefore, FDA declines to add it to the persons until August 17, 2019, to However, this draft guidance refers to list of tropical diseases. comment on the topics discussed at the previously approved FDA collections of DATES: July 15, 2020. public meeting and the questions information found in FDA regulations ADDRESSES: Submit electronic published in the meeting notice (84 FR comments on additional diseases 1 for new animal drug applications 32749 at 32750–32751). On August 13, suggested for designation to https:// 2019, we published a notice announcing submitted under sections 512(b) (21 U.S.C. 360b(b)) and 571 (21 U.S.C. www.regulations.gov. Submit written the extension of the comment period to comments on additional diseases September 16, 2019 (84 FR 40071). CVM 360ccc) of the FD&C Act. These collections of information are subject to suggested for designation to the Dockets received numerous comments on the Management Staff (HFA–305), Food and review by the OMB under the PRAct. topics discussed at the public meeting Drug Administration, 5630 Fishers The collections of information in 21 and the questions published in the Lane, Rm. 1061, Rockville, MD 20852. meeting notice and those comments CFR part 514 have been approved under All comments should be identified with were considered as the draft GFI #265 OMB control number 0910–0032. the docket number found in brackets in entitled ‘‘Use of Data from Foreign III. Electronic Access the heading of this document. Investigational Studies to Support FOR FURTHER INFORMATION CONTACT: Effectiveness of New Animal Drugs’’ Persons with access to the internet Katherine Schumann, Center for Drug was developed. may obtain the draft guidance at either Evaluation and Research, Food and This draft guidance describes https://www.fda.gov/animal-veterinary/ Drug Administration, 10903 New principles for designing, conducting, guidance-regulations/guidance-industry Hampshire Ave., Bldg. 22, Rm. 6242, and reporting the results for or https://www.regulations.gov. Silver Spring, MD 20993–0002, 301– investigations or studies, including data Dated: July 9, 2020. 796–1300, Katherine.Schumann@ from foreign countries, in submissions fda.hhs.gov; or Stephen Ripley, Center Lowell J. Schiller, for Biologics Evaluation and Research, 1 https://www.fda.gov/animal-veterinary/ Principal Associate Commissioner for Policy. workshops-conferences-meetings/public-meeting- Food and Drug Administration, 10903 [FR Doc. 2020–15242 Filed 7–14–20; 8:45 am] incorporating-alternative-approaches-clinical- New Hampshire Ave., Rm. 7301, Silver investigations-new-animal-drugs. BILLING CODE 4164–01–P Spring, MD 20993–0002, 240–402–7911. VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\15JYN1.SGM 15JYN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices 42869 SUPPLEMENTARY INFORMATION: section 524 of the FD&C Act; thus, FDA 1. Significant Market in Developed will not add it to the list of tropical Nations Table of Contents diseases whose applications may be FDA was unable to make the I. Background: Priority Review Voucher eligible for a priority review voucher. determination that no significant market Program II. Decision Not To Designate Clonorchiasis II. Decision Not To Designate exists for the treatment or prevention of A. Clonorchiasis Clonorchiasis clonorchiasis in developed nations, as B. FDA Determination the most recent data shows significant III. Process for Requesting Additional FDA has considered all disease prevalence of clonorchiasis in a Diseases To Be Added to the List suggestions submitted to the public developed nation. As stated above, IV. Paperwork Reduction Act docket (FDA–2008–N–0567) between clonorchiasis occurs as a result of V. References June 20, 2018, and November 21, 2018, infection by C. sinensis, which has been I. Background: Priority Review as potential additions to the list of reported in North Korea, South Korea, Voucher Program tropical diseases under section 524 of China, Taiwan, Vietnam, Japan, and the Section 524 of the FD&C Act (21 the FD&C Act, under the docket review Russian Far East. The limited range of U.S.C. 360n), which was added by process explained on the Agency’s web C. sinensis means that individuals are section 1102 of the Food and Drug page at https://www.fda.gov/AboutFDA/ infected only in those countries noted, Administration Amendments Act of CentersOffices/OfficeofMedical and infections in other countries only 2007 (Pub. L. 110–85), uses a PRV ProductsandTobacco/CDER/ occur from the movement of infected incentive to encourage the development ucm534162.htm. Based on an persons. North Korea, China, Vietnam, of new drugs, including biological assessment of currently available and the Russian Federation (Russia) are products, for prevention and treatment information, and using the criteria from not on the World Bank’s list of high- of certain diseases that, in the aggregate, its August 2015 final order, FDA has income countries (Ref. 6). However, affect millions of people throughout the determined that clonorchiasis will not South Korea, Japan, and Taiwan are world. Further information about the be designated as a ‘‘tropical disease’’ for high-income economies, based on World Bank’s list of high-income tropical disease PRV program can be purposes of the tropical disease PRV countries, and