Investigational COVID-19 Convalescent Plasma; Guidance for Industry; Withdrawal of Guidance, 59320-59321 [2020-20801]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES 59320 Federal Register / Vol. 85, No. 183 / Monday, September 21, 2020 / Notices emergency. The guidance announced in this notice supersedes the guidance of the same title dated April 2020 and updated in May 2020, and provides recommendations and additional information related to the August 23, 2020, EUA for COVID–19 convalescent plasma for the treatment of hospitalized patients with COVID–19.1 Accordingly, FDA is replacing the May 2020 guidance to provide recommendations to healthcare providers for administering COVID–19 convalescent plasma under the EUA. The new guidance also provides recommendations to blood establishments on collection of COVID– 19 convalescent plasma under the EUA, including on donor eligibility and qualification, testing plasma for antiSARS-CoV2 antibodies, and labeling. In addition, the guidance describes FDA’s interim compliance and enforcement policy regarding the IND requirements for the use of investigational convalescent plasma. Following issuance of the EUA for COVID–19 convalescent plasma on August 23, 2020, FDA has received numerous inquiries from blood establishments and healthcare providers regarding investigational convalescent plasma that was collected prior to the EUA and that remains in inventory. FDA understands that investigational convalescent plasma collected prior to the EUA may not meet the Conditions of Authorization set forth in the EUA. FDA also understands that it will take time for blood establishments to develop the necessary operating procedures to manufacture COVID–19 convalescent plasma pursuant to the Conditions of Authorization in the EUA. In addition, the Agency is aware that enrollment into the National Expanded Access Treatment Protocol sponsored by the Mayo Clinical was discontinued as of August 28, 2020. Considering these issues and recognizing the immediate need for convalescent plasma to treat hospitalized patients with COVID–19, the guidance explains that FDA intends to exercise enforcement discretion with respect to the IND requirements for the collection, shipment, and administration of investigational convalescent plasma for a period of 90 days following the issuance of the guidance document provided certain circumstances are present. The guidance outlines these circumstances and explains that during this period of 1 Emergency Use Authorization for COVID–19 Convalescent Plasma available at https:// www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policyframework/emergency-useauthorization#coviddrugs. VerDate Sep<11>2014 19:59 Sep 18, 2020 Jkt 250001 enforcement discretion and beyond, FDA will continue to work with any investigators who wish to submit INDs for the study of investigational convalescent plasma and that ongoing clinical trials of investigational convalescent plasma should not be amended because of this enforcement discretion policy. The guidance also provides recommendations for healthcare providers who wish to administer and study convalescent plasma under an IND. In light of this public health emergency, FDA has determined that prior public participation for this guidance is not feasible or appropriate and is issuing this guidance without prior public comment (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and § 10.115(g)(2)). Although this guidance is immediately in effect, FDA will consider all comments received and revise the guidance document as appropriate. In the Federal Register of May 26, 2020 (85 FR 31513), FDA announced the availability of a guidance of the same title. Elsewhere in this issue of the Federal Register, FDA is announcing the withdrawal of the guidance of the same title that was announced on May 26, 2020. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on investigational COVID–19 convalescent plasma. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR 606.121 and 21 CFR part 630 have been approved under OMB control number 0910–0116; and the collections of information in Form FDA 3926 have been approved under OMB control number 0910–0814. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances or https:// www.regulations.gov. Dated: September 16, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–20800 Filed 9–18–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1825] Investigational COVID–19 Convalescent Plasma; Guidance for Industry; Withdrawal of Guidance Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice; withdrawal. AGENCY: The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a final guidance for industry entitled ‘‘Investigational COVID–19 Convalescent Plasma,’’ which was issued in April 2020 and updated in May 2020. FDA is withdrawing the guidance because the Agency is issuing a new guidance for industry of the same title. DATES: The withdrawal is applicable September 21, 2020. FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: FDA is withdrawing the guidance for industry entitled ‘‘Investigational COVID–19 Convalescent Plasma’’ (May 2020 guidance) dated April 2020 and updated May 2020. The availability of this guidance was announced in the Federal Register of May 26, 2020, (85 FR 31513) and was posted on FDA’s website on May 1, 2020. On August 23, 2020, the Agency issued an emergency use authorization (EUA) (available at: https:// www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization#coviddrugs) for COVID– 19 convalescent plasma for the SUMMARY: E:\FR\FM\21SEN1.SGM 21SEN1 Federal Register / Vol. 85, No. 183 / Monday, September 21, 2020 / Notices 2012, respectively.2 Human papillomavirus (HPV), the most common STI, accounts for 14 million new STI infections each year.3 Left untreated, STIs can lead to significant health consequences. To spur action to reduce STI rates and their adverse public health impact, OASH through OIDP, in collaboration with federal partners throughout HHS and other departments, led and coordinated development of the inaugural STI Plan. Opportunities for public input were provided, and public Dated: September 16, 2020. comments received were reviewed, and Lauren K. Roth, analyzed and helped inform the Associate Commissioner for Policy. components of the STI Plan. [FR Doc. 2020–20801 Filed 9–18–20; 8:45 am] The STI Plan is intended to serve as BILLING CODE 4164–01–P a roadmap for all stakeholders at all levels to guide development of policies, initiatives, and actions for STI DEPARTMENT OF HEALTH AND prevention and control. The STI Plan HUMAN SERVICES focuses on four of the STIs that have the greatest impact on the health of the Request for Information: STI National nation: chlamydia, gonorrhea, syphilis, Strategic Plan 2021–2025 Available for and HPV. However, most of its Public Comment components are also applicable to other prevalent STIs. AGENCY: Office of the Secretary, The STI Plan presents a strategic Department of Health and Human framework for integrating and Services. leveraging synergistic policies, ACTION: Notice. programs, and resources. It sets forth a SUMMARY: The Department of Health and vision and goals for the nation, with objectives and strategies for each goal. Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy The objectives and strategies offered in this plan are interrelated and may be (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces used to make progress toward more than one goal. The STI Plan identifies the draft Sexually Transmitted Infections National Strategic Plan 2021– priority populations (i.e., those populations disproportionately 2025 (STI Plan) available for public impacted by STIs based on national comment. The draft STI Plan may be data) to guide national efforts to realize reviewed at www.hhs.gov/STI. the highest impact on reducing STIs. DATES: All comments must be received The STI Plan also includes indicators to by 5:00 p.m. ET on October 1, 2020 to measure progress and quantitative ensure consideration. targets for each indicator. Although it is ADDRESSES: All comments must be a 5-year plan, it sets 10-year quantitative submitted electronically to STDPlan@ targets for each indicator—reflecting the hhs.gov. reality that it will take more than 5 years FOR FURTHER INFORMATION CONTACT: to reverse, not just slow, the upward Carol Jimenez, OIDP, Carol.Jimenez@ trajectory of rising STI rates, and to hhs.gov, 202–401–5131. eliminate the epidemic. The order in SUPPLEMENTARY INFORMATION: Persistent which the goals, objectives, strategies, rises in the rates of sexually transmitted and indicators are presented is not infections (STIs) in the United States associated with any prioritization. The following are the STI Plan’s constitute an epidemic and public health crisis with profound implications vision and goals. Vision: The United States will be a place where sexually for all Americans. In recent decades, transmitted infections are prevented and rates of chlamydia, gonorrhea, syphilis, where every person has high-quality STI congenital syphilis, and human prevention, care, and treatment while papillomavirus have increased significantly. The rate of chlamydia, the living free from stigma and most prevalent STI, increased by greater discrimination. This vision includes all people, regardless of age, sex, gender than 200% from 2011 to 2018.1 In just over a decade, the rate of gonorrhea rose identity, sexual orientation, race, by greater than 80% from a historic low. ethnicity, disability, geographic location, or socioeconomic The rates of primary and secondary circumstance. Goals: syphilis and of congenital syphilis 1. Prevent new STIs increased every year since 2001 and jbell on DSKJLSW7X2PROD with NOTICES treatment of hospitalized patients with COVID–19. Given the issuance of this EUA, FDA is issuing a new guidance of the same title that provides recommendations and additional information related to the EUA for the use of COVID–19 convalescent plasma to treat hospitalized patients with COVID–19. The new guidance supersedes the May 2020 guidance. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the new guidance. VerDate Sep<11>2014 19:59 Sep 18, 2020 Jkt 250001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 59321 2. Improve the health of people by reducing adverse outcomes of STIs 3. Accelerate progress in STI research, technology, and innovation 4. Reduce STI-related health disparities and health inequities 5. Achieve integrated, coordinated efforts that address the STI epidemic A roadmap for stakeholders at all levels and sectors, the STI Plan envisions a whole-of-nation response to preventing and controlling STIs in the United States. The STI Plan assumes the active participation of state, local, and tribal health departments and organizations, health plans and health care providers, schools and other academic institutions, community- and faith-based organizations, scientists, researchers, and the public in this effort. The priority populations, indicators, and quantitative targets, especially the methods used to determine them, are intended to help focus efforts and limited resources to realize the most impact. Stakeholders are encouraged to focus on activities that resonate the most with the needs of the populations they serve and services they provide, and, using the STI Plan as a framework, develop their own plans to reverse the rise of STIs and improve the health of their communities, states, tribal nations, and the nation. Information Needs The draft STI Plan may be reviewed at: www.hhs.gov/STI. OIDP seeks to obtain feedback from external stakeholders on the following: 1. Do the draft plan’s goals, objectives, and strategies appropriately address the STI epidemic? 2. Are there any critical gaps in the STI Plan’s goals, objectives, and strategies? If so, please specify the gaps. 3. Do any of the STI Plan’s goals, objectives and strategies cause concern? If so, please specify the goal, objective or strategy, and describe the concern regarding it. Please be succinct and limit your comments to a maximum of seven pages. Authority: 77 FR 15761 (March 16, 2012). Dated: September 15, 2020. B. Kaye Hayes, Acting Director, Office of Infectious Disease and HIV/AIDS Policy. Footnotes 1. Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2018. U.S. Department of Health and Human Services; 2019. Accessed June 22, 2020. https://www.cdc.gov/std/ E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 85, Number 183 (Monday, September 21, 2020)]
[Notices]
[Pages 59320-59321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1825]


Investigational COVID-19 Convalescent Plasma; Guidance for 
Industry; Withdrawal of Guidance

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; withdrawal.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the withdrawal of a final guidance for industry entitled 
``Investigational COVID-19 Convalescent Plasma,'' which was issued in 
April 2020 and updated in May 2020. FDA is withdrawing the guidance 
because the Agency is issuing a new guidance for industry of the same 
title.

DATES: The withdrawal is applicable September 21, 2020.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: FDA is withdrawing the guidance for industry 
entitled ``Investigational COVID-19 Convalescent Plasma'' (May 2020 
guidance) dated April 2020 and updated May 2020. The availability of 
this guidance was announced in the Federal Register of May 26, 2020, 
(85 FR 31513) and was posted on FDA's website on May 1, 2020.
    On August 23, 2020, the Agency issued an emergency use 
authorization (EUA) (available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs) for COVID-19 convalescent 
plasma for the

[[Page 59321]]

treatment of hospitalized patients with COVID-19. Given the issuance of 
this EUA, FDA is issuing a new guidance of the same title that provides 
recommendations and additional information related to the EUA for the 
use of COVID-19 convalescent plasma to treat hospitalized patients with 
COVID-19. The new guidance supersedes the May 2020 guidance. Elsewhere 
in this issue of the Federal Register, FDA is announcing the 
availability of the new guidance.

    Dated: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20801 Filed 9-18-20; 8:45 am]
BILLING CODE 4164-01-P
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