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Federal Register/Vol. 86, No. 79/Tuesday, April 27, 2021/Notices 22214 Federal Register / Vol. 86, No. 79 / Tuesday, April 27, 2021 / Notices to a unique genetic variant or variants establish any rights for any person and DEPARTMENT OF HEALTH AND that may be amenable to RNA-directed is not binding on FDA or the public. HUMAN SERVICES treatment. You can use an alternative approach if The draft guidance addresses the it satisfies the requirements of the Request for Information (RFI): nonclinical information that FDA applicable statutes and regulations. Developing the National Public Health recommends to support an IND for the Strategy for the Prevention and development of an antisense II. Paperwork Reduction Act of 1995 Control of Vector-Borne Diseases in oligonucleotide from a well- FDA tentatively concludes that this Humans characterized chemical class, for which draft guidance contains no collection of AGENCY: Office of the Assistant there is substantial nonclinical information. Therefore, clearance by the Secretary for Health (OASH), Office of information and clinical experience that Office of Management and Budget the Secretary, Department of Health and is publicly available or to which the (OMB) under the Paperwork Reduction Human Services (HHS). sponsor has a right of reference. The Act of 1995 (PRA) (44 U.S.C. 3501– ACTION: Request for information. draft guidance discusses the importance 3521) is not required. of sponsors providing convincing in However, this draft guidance refers to SUMMARY: The development of a vitro and/or in vivo proof of concept previously approved FDA collections of national strategy on vector-borne data as part of any such IND information. These collections of diseases including tickborne diseases submission. The draft guidance information are subject to review by was mandated by Congress. To inform describes recommended nonclinical OMB under the PRA. development of the national strategy to safety studies that should be submitted • The following collections of address vector-borne diseases, HHS is with such IND submissions, the information in 21 CFR part 312 (IND issuing this Request for Information duration and timing of general toxicity regulations) have been approved under (RFI). The RFI solicits specific input studies, first-in-human dose selection, OMB control number 0910–0014: (1) regarding strategic goals, benchmarks, and dose escalation, each within the Submissions of IND applications, gaps, duplicative federally funded context stipulated above. Finally, the amendments, safety reports, and programs, and opportunities to enhance draft guidance describes certain factors, investigator brochures and (2) requests coordination data collection, research, present in the context of an IND for an for pre-IND meetings. and the development of diagnostics, individualized investigational antisense • treatments, vaccines and other related oligonucleotide developed to treat a The collections of information in 21 CFR parts 50 and 56 for obtaining activities across HHS and other federal rapidly progressing SDLT disease, that departments. The set of questions is support differences in the nonclinical informed consent for prospective patients have been approved under available in the SUPPLEMENTARY safety package recommended in this INFORMATION section below. context from that generally OMB control number 0910–0130. DATES: To be considered, public recommended for non-SDLT diseases, • The collections of information for paper submissions of Form FDA 3500A comments must be received for modalities other than antisense electronically no later than midnight oligonucleotides, and for use in larger (Mandatory Reporting) have been approved under OMB control number eastern standard time (EST) on June 11, patient populations. 2021. The draft guidance is intended to help 0910–0291. sponsors of such development • The collections of information in ADDRESSES: Public comments should be programs, who may be relatively the final guidance entitled ‘‘Formal submitted online at http:// unfamiliar with FDA regulations, Meetings Between the FDA and www.regulations.gov. All submissions processes, and practices, seek feedback Sponsors or Applicants’’ have been must be submitted to the Docket named from FDA on their development approved under OMB control number HHS–OASH–2021–0001 to ‘‘Request for programs and make regulatory 0910–0429. Information (RFI) from Non-Federal Stakeholders: Developing the National submissions related to these • The collections of information Public Health Strategy for the development programs. The draft relating to electronic submissions of Prevention and Control of Vector-Borne guidance is expected to facilitate the Form FDA 3500 used for voluntary Diseases in Humans.’’ Comments preparation of adequate pre-IND and reporting (not mandated by law or submitted electronically, including IND submissions for review by the regulation) by healthcare professionals, attachments, will be posted to the Agency that will enable prompt including safety reporting submissions docket unchanged and available to view initiation of the clinical trial. relating to bioavailability and by the public. Evidence and information This draft guidance represents the bioequivalence studies under 21 CFR supporting your comment can be second in a series of guidances FDA 320.31(d)(3), have been approved under submitted as attachments. Please intends to publish to advise and help OMB control number 0910–0645. sponsors developing individualized provide your contact information or ASO drug products for individuals who III. Electronic Access organization name on the web-based form for possible follow up from HHS. have SDLT diseases or conditions and Persons with access to the internet There is a 5,000 character limit on no approved products available to them may obtain the draft guidance at either comments and maximum number (10) to treat their disease. https://www.fda.gov/drugs/guidance- of attached files and maximum size (10 This draft guidance is being issued compliance-regulatory-information/ MB) of each attached file. consistent with FDA’s good guidance guidances-drugs or https:// practices regulation (21 CFR 10.115). www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Dr. The draft guidance, when finalized, will Kristen Honey, Chief Data Scientist, represent the current thinking of FDA Dated: April 20, 2021. Senior Advisor, Office of the Assistant on ‘‘Nonclinical Testing of Lauren K. Roth, Secretary for Health, Department of Individualized Antisense Acting Principal Associate Commissioner for Health and Human Services, 200 Oligonucleotide Drug Products for Policy. Independence Avenue SW, Washington, Severely Debilitating or Life- [FR Doc. 2021–08675 Filed 4–26–21; 8:45 am] DC 20201, [email protected], Threatening Diseases.’’ It does not BILLING CODE 4164–01–P (202) 853–7680. VerDate Sep<11>2014 18:52 Apr 26, 2021 Jkt 253001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\27APN1.SGM 27APN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 79 / Tuesday, April 27, 2021 / Notices 22215 SUPPLEMENTARY INFORMATION: The their use as effective measures to 3 Rosenberg, R., N.P. Lindsey, M. Fischer, development of a national strategy on prevent vector-borne disease. C.J. Gregory, A.F. Hinckley, P.S. Mead, G. vector-borne diseases including Recognizing the numerous public Paz-Bailey, S.H. Waterman, N.A. Drexler, G.J. tickborne diseases was mandated by health challenges and stakeholders Kersh, et al. 2018. Vital signs: Trends in Congress through Section 404 of H.R. involved in the prevention of vector- reported vectorborne disease cases—United borne diseases, OASH is working States and territories, 2004–2016. MMWR. 1865, the Further Consolidated Morb. Mortal. Wkly. Rep. 67: 496–501. Appropriations Act. Section 404 is closely with a range of federal partners https://www.cdc.gov/mmwr/volumes/67/wr/ Section 317u of the Public Service Act to lead the development of the National mm6717e1.htm. and is named the Kay Hagan Tick Act Strategy. This five-year strategy will 4 Centers for Disease Control and (Act), in honor of Senator Kay Hagan, establish goals to address vector-borne Prevention. 2018. Lyme Disease. https:// who died from complications of having diseases including improving www.cdc.gov/lyme/stats/humancases.html. tickborne Powassan virus disease. The surveillance, diagnosis, prevention, 5 Marx et al. Ann Intern Med. Act requires HHS to develop a national treatment, and research. It will also 2020;172(3):222–224. DOI: 10.7326/L19– identify strategies and benchmarks to 0483. strategy to address vector-borne diseases 5 including tickborne diseases (National measure and drive progress toward National Association of County and City Health Officials. 2017. NACCHO report: Strategy). Preparation of the National achieving the goals. To develop this plan, OASH seeks input from subject Vector control assessment in Zika virus Strategy builds upon an inter- priority jurisdictions. Washington, DC: departmental effort to develop A matter experts, non-federal National Association of County and City National Public Health Framework for stakeholders, and other members of the Health Officials; http:// the Prevention and Control of Vector- public. Examples of these stakeholders nacchopreparedness.org/naccho-report- Borne Diseases in Humans, released in may include health care providers, vector-control-assessment-in-zika-virus- September 2020.1 national professional organizations, priority-jurisdictions. Vector-borne diseases, including state and local health departments, [FR Doc. 2021–08167 Filed
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