Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 65820-65824 [2020-22968]

Download as PDF 65820 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993–0002, 240– 402–7930. In the Federal Register of June 1, 2020 (85 FR 33169), FDA published a notice with a 90-day comment period to solicit comments on the listing of patent information in the FDA publication, ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations’’ (commonly known as the ‘‘Orange Book’’). jbell on DSKJLSW7X2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 The Agency has received a request for an extension of the comment period for the public docket in order to develop a response to the request for comment. FDA has considered the request and is reopening the comment period for the public docket for 30 days, until November 16, 2020. The Agency believes that an additional 30 days will allow adequate time for interested persons to submit comments. Dated: October 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22969 Filed 10–15–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–D–1136 and FDA– 2020–D–1106] Guidance Documents Related to Coronavirus Disease 2019 (COVID–19); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID–19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID–19-related guidances. The guidances identified in this notice address issues related to the COVID–19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency’s good guidance practices. DATES: The announcement of the guidances is published in the Federal Register on October 16, 2020. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency’s good guidance practices. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the name of the guidance document that the comments address and the docket number for the guidance (see table 1). Received comments will be placed in the docket(s) and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in E:\FR\FM\16OCN1.SGM 16OCN1 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of these guidances to the address noted in table 1. Send two selfaddressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidances. FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993–0002, 301– 796–2357. SUPPLEMENTARY INFORMATION: I. Background On January 31, 2020, as a result of confirmed cases of COVID–19, and after consultation with public health officials as necessary, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d) (PHS Act), determined that a PHE exists and has existed since January 27, 2020, nationwide.1 On March 13, 2020, President Donald J. Trump declared that the COVID–19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.2 In the Federal Register of March 25, 2020 (the March 25, 2020, notice) (available at https://www.govinfo.gov/ content/pkg/FR-2020-03-25/pdf/202006222.pdf), FDA announced procedures for making available FDA guidances related to the COVID–19 PHE. These procedures, which operate within FDA’s established good guidance practices regulations, are intended to allow FDA to rapidly disseminate Agency recommendations and policies related to COVID–19 to industry, FDA staff, and other stakeholders. The March 25, 2020, notice stated that due to the need to act quickly and efficiently to respond to the COVID–19 PHE, FDA believes that prior 65821 public participation will not be feasible or appropriate before FDA implements COVID–19-related guidances. Therefore, FDA will issue COVID–19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2) (§ 10.115(g)(2))). The guidances are available at FDA’s web page entitled ‘‘COVID–19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders’’ (https:// www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders) and through FDA’s web page entitled ‘‘Search for FDA Guidance Documents’’ available at https://www.fda.gov/ regulatory-information/search-fdaguidance-documents. The March 25, 2020, notice further stated that, in general, rather than publishing a separate NOA for each COVID–19-related guidance, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID–19-related guidances that FDA issued during the relevant period, as included in table 1. This notice announces COVID–19related guidances that are posted on FDA’s website. II. Availability of COVID–19-Related Guidance Documents Pursuant to the process described in the March 25, 2020, notice, FDA is announcing the availability of the following COVID–19-related guidances: jbell on DSKJLSW7X2PROD with NOTICES TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY Docket No. Center Title of guidance Contact information to request single copies FDA–2020–D–1136 CDER ............. druginfo@fda.hhs.gov. Please include the docket number FDA–2020–D–1136 and complete title of the guidance in the request. FDA–2020–D–1136 CDER ............. FDA–2020–D–1106 CDER ............. Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID–19 Public Health Emergency Questions and Answers (August 2020). Resuming Normal Drug and Biologics Manufacturing Operations During the COVID–19 Public Health Emergency (September 2020). FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID–19 Public Health Emergency (March 2020) (Updated September 2020). druginfo@fda.hhs.gov. Please include the docket number FDA–2020–D–1136 and complete title of the guidance in the request. Clinicaltrialconduct-COVID19@fda.hhs.gov. Please include the docket number FDA–2020–D–1106 and complete title of the guidance in the request. Although these guidances have been implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate (see § 10.115(g)(3)). These guidances are being issued consistent with FDA’s good guidance practices regulation (§ 10.115). The 1 On April 21, 2020, the PHE Determination was extended, effective April 26, 2020; on July 23, 2020, it was extended, effective July 25, 2020; on October 2, 2020, it was extended, effective October 23, 2020. These PHE Determinations are available at https:// www.phe.gov/emergency/news/healthactions/phe/ Pages/default.aspx. 2 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID–19) Outbreak (Mar. 13, 2020), available at https://www.whitehouse.gov/ presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1 65822 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices guidances represent the current thinking of FDA. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 CDER Guidances The guidances listed in the table below 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 these guidances. However, these previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table: jbell on DSKJLSW7X2PROD with NOTICES TABLE 2—CDER GUIDANCES AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance Another guidance title referenced in COVID– 19 guidance OMB control No(s). Guidance for Industry: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID–19 Public Health Emergency. 21 CFR 210 and 211, 21 CFR 514.80, 21 CFR 600. 0910–0001, 0910– 0032, 0910–0139, 0910–0338, 0910– 0669, 0910–0675, 0910–0759, 0910– 0806. Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID–19 Public Health Emergency; Questions and Answers. 21 CFR 314.50; 314.95, 314.125, 314.127; 601.2 and 601.20. —Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. —Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products. —Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act. —Reporting and Mitigating Animal Drug Shortages During the COVID–19 Public Health Emergency. —Prioritization of the Review of Original ANDAs, Amendments, and Supplements. —Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes. —Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA). —Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. —Changes to an Approved Application: Biological Products. —Changes to an Approved NDA or ANDA; Questions and Answers. —Changes to an Approved NDA or ANDA. —CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports. —Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture. —CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. —Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. —Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. —SUPAC–IR: Questions and Answers about SUPAC–IR Guidance. —Nonsterile Semisolid Dosage Forms; ScaleUp and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation. —SUPAC–MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1 0910–0001, 0910– 0014, 0910–0338, 0910–0045, 0910– 0139, 0910–0759. 65823 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices TABLE 2—CDER GUIDANCES AND COLLECTIONS—Continued CFR cite referenced in COVID–19 guidance COVID–19 guidance title Another guidance title referenced in COVID– 19 guidance OMB control No(s). —SUPAC: Manufacturing Equipment Addendum. The guidance listed in the table below refers to previously approved FDA collections of information. Therefore, clearance by OMB under the PRA is not required for this guidance. However, these collections of information are subject to review by OMB under the PRA. The previously approved collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the table below. This guidance also contains a collection of information not approved under a current collection. This collection of information has been granted a PHE waiver from the PRA by the Department of Health and Human Services (HHS) on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/publichealth-emergency-declaration-prawaivers. jbell on DSKJLSW7X2PROD with NOTICES TABLE 3—CDER GUIDANCES AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance Another guidance referenced in COVID–19 guidance OMB control No(s). Guidance on Conduct of Clinical Trials of Medical Products during COVID– 19 Public Health Emergency (Updated September 21, 2020). 21 CFR part 11, 21 CFR part 50, 21 CFR part 56, 21 CFR part 312, 21 CFR part 314, 21 CFR part 320, 21 CFR part 601, 21 CFR part 812. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products. Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans. Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Design. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials. Part 11, Electronic Records; Electronic Signatures Scope and Application. Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11— Questions and Answers. Safety Reporting Requirements for INDs and BA/BE Studies. Adverse Event Reporting to IRBs—Improving Human Subject Protection. Use of Electronic Informed Consent In Clinical Investigations. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. Best Practices for Communication Between IND Sponsors and FDA During Drug Development. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.. 0910–0001, 0910– 0014, 0910– 0130, 0910– 0303, 0910– 0338, 0910– 0119, 0910– 0581, 0910– 0733, 0910– 0078 IV. Electronic Access Persons with access to the internet may obtain COVID–19-related guidances at: • The FDA web page entitled ‘‘COVID–19-Related Guidance VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 Documents for Industry, FDA Staff, and Other Stakeholders,’’ available at https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders; PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Collection covered by PHE PRA waiver Submission by investigators of informed consent forms to third parties. • the FDA web page entitled ‘‘Search for FDA Guidance Documents’’ available at https://www.fda.gov/ regulatory-information/search-fdaguidance-documents; or • https://www.regulations.gov. E:\FR\FM\16OCN1.SGM 16OCN1 65824 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices Dated: October 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22968 Filed 10–15–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–2031] Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing its Quality Management Maturity for Finished Dosage Forms Pilot Program (QMM FDF Pilot Program) for domestic drug product manufacturers of prescription and over-the-counter (OTC) drug products. The purpose of the QMM FDF Pilot Program is to gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an FDA rating system to characterize quality management maturity (QMM). Such a rating system would allow a cross-sectional comparison of manufacturers. Manufacturers that choose to disclose their facility ratings could benefit from a competitive advantage, as knowledge of QMM ratings would enable health systems and other purchasers and payers of medications to differentiate among drug manufacturers. This notice invites manufacturers that are interested in participating in the QMM FDF Pilot Program to submit a request to participate. SUMMARY: FDA will accept requests to participate in the QMM FDF Pilot Program through November 30, 2020, and the QMM FDF Pilot Program will run through December 31, 2021. See the ‘‘Participation’’ section for selection criteria and instructions on how to submit a request to participate. FOR FURTHER INFORMATION CONTACT: For general questions about the QMM FDF Pilot Program: Jennifer Maguire, Center for Drug Evaluation and Research (CDER), 10903 New Hampshire Ave., Silver Spring, MD 20993, Bldg. 51, Rm. jbell on DSKJLSW7X2PROD with NOTICES DATES: VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 4134, 240–402–4817, Jennifer.Maguire@ fda.hhs.gov. To submit a request to participate in the QMM FDF Pilot Program: Seongjin (Cindy) Pak, CDER, Bldg. 51, Rm. 4220, 301–796–1673, Seongjin.Pak@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In 2002, FDA launched an initiative, ‘‘Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach,’’ to enhance and modernize the regulation of pharmaceutical manufacturing and product quality.1 One objective, among others, was to facilitate the implementation of a modern, risk-based pharmaceutical quality assessment system. The desired state has been described as a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces highquality drug products without extensive regulatory oversight. There has been significant progress toward this vision as evidenced by FDA programs and initiatives in such areas as pharmaceutical development and quality by design, quality risk management and pharmaceutical quality systems, process validation, and emerging technologies. These programs and initiatives promote use of the best pharmaceutical science and engineering principles throughout the product life cycle. Another example is the FDA Quality Metrics Program, described in the November 2016 revised draft guidance for industry ‘‘Submission of Quality Metrics Data’’ (81 FR 85226). When final, this guidance will represent FDA’s current thinking on this issue. In June 2018, FDA initiated two voluntary programs that sought additional industry input on quality metrics. FDA solicited industry participation for a Site Visit Program (83 FR 30751) for manufacturing establishments to present the advantages and challenges associated with implementing and managing a quality metrics program, and for a Quality Metrics Feedback Program (83 FR 30748) to engage stakeholders in identifying mutually useful and objective quality metrics. The Agency continues to develop the FDA Quality Metrics Program but recognizes that quality metrics are only one element within a manufacturer’s larger effort to increase the maturity of their quality management system. Manufacturers that demonstrate QMM 1 See FDA’s final report: ‘‘Pharmaceuticals CGMPs for the 21st Century—A Risk-Based Approach’’ (September 2004) at https:// www.fda.gov/media/77391/download. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 operate under an enhanced quality management system that exceeds the minimum standards specified in current good manufacturing practice regulations and focuses on continual improvement. Characteristics of a mature quality management system include, for example, the ability to consistently and reliably deliver quality product over time, operational stability, and a strong quality culture. Additionally, for manufacturers with a mature quality management system, FDA can exercise a more flexible regulatory approach, leading toward the goal of producing high-quality drug products without extensive regulatory oversight. A transparent method of evaluating and communicating QMM is needed to fully realize the 21st century pharmaceutical quality vision. Toward that end, FDA is announcing the start of the QMM FDF Pilot Program. Through this pilot program, a third-party contractor identified by FDA will conduct an assessment of a manufacturer’s quality management system, accompanied by FDA staff. The Agency will gain insight from the results of the QMM assessments to inform the development of a rating system to measure and rate QMM. Assessments under the QMM FDF Pilot Program will cover multiple topics. Examples include but are not limited to: 1. Supply chain management; 2. manufacturing strategy and operations; 3. safety, environmental, and regulatory compliance; 4. inventory management; 5. performance management and continual improvement; 6. risk management; 7. management review and responsibility; 8. planning; 9. workforce management; 10. quality culture; and 11. customer experience. In the same timeframe as the QMM FDF Pilot Program, FDA will conduct a QMM pilot program for foreign manufacturers of active pharmaceutical ingredients (APIs), including facilities manufacturing drug substance intermediates used to produce APIs. These pilot programs are funded separately and are intended to provide FDA with representative information about QMM from different types of drug manufacturers (API and FDF). Elsewhere in this issue of the Federal Register, FDA is publishing ‘‘Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement.’’ E:\FR\FM\16OCN1.SGM 16OCN1

Agencies

[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65820-65824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22968]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1106]


Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of FDA guidance documents related to the Coronavirus 
Disease 2019 (COVID-19) public health emergency (PHE). This notice of 
availability (NOA) is pursuant to the process that FDA announced, in 
the Federal Register of March 25, 2020, for making available to the 
public COVID-19-related guidances. The guidances identified in this 
notice address issues related to the COVID-19 PHE and have been issued 
in accordance with the process announced in the March 25, 2020, notice. 
The guidances have been implemented without prior comment, but they 
remain subject to comment in accordance with the Agency's good guidance 
practices.

DATES: The announcement of the guidances is published in the Federal 
Register on October 16, 2020. The guidances have been implemented 
without prior comment, but they remain subject to comment in accordance 
with the Agency's good guidance practices.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the name of the 
guidance document that the comments address and the docket number for 
the guidance (see table 1). Received comments will be placed in the 
docket(s) and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in

[[Page 65821]]

its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of these guidances to the 
address noted in table 1. Send two self-addressed adhesive labels to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidances.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19, 
and after consultation with public health officials as necessary, Alex 
M. Azar II, Secretary of Health and Human Services, pursuant to the 
authority under section 319 of the Public Health Service Act (42 U.S.C. 
247d) (PHS Act), determined that a PHE exists and has existed since 
January 27, 2020, nationwide.\1\ On March 13, 2020, President Donald J. 
Trump declared that the COVID-19 outbreak in the United States 
constitutes a national emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ On April 21, 2020, the PHE Determination was extended, 
effective April 26, 2020; on July 23, 2020, it was extended, 
effective July 25, 2020; on October 2, 2020, it was extended, 
effective October 23, 2020. These PHE Determinations are available 
at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning 
the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), 
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (the March 25, 2020, 
notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making available 
FDA guidances related to the COVID-19 PHE. These procedures, which 
operate within FDA's established good guidance practices regulations, 
are intended to allow FDA to rapidly disseminate Agency recommendations 
and policies related to COVID-19 to industry, FDA staff, and other 
stakeholders. The March 25, 2020, notice stated that due to the need to 
act quickly and efficiently to respond to the COVID-19 PHE, FDA 
believes that prior public participation will not be feasible or 
appropriate before FDA implements COVID-19-related guidances. 
Therefore, FDA will issue COVID-19-related guidances for immediate 
implementation without prior public comment (see section 701(h)(1)(C) 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec.  10.115(g)(2))). The 
guidances are available at FDA's web page entitled ``COVID-19-Related 
Guidance Documents for Industry, FDA Staff, and Other Stakeholders'' 
(https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled ``Search for FDA 
Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    The March 25, 2020, notice further stated that, in general, rather 
than publishing a separate NOA for each COVID-19-related guidance, FDA 
intends to publish periodically a consolidated NOA announcing the 
availability of certain COVID-19-related guidances that FDA issued 
during the relevant period, as included in table 1. This notice 
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice, 
FDA is announcing the availability of the following COVID-19-related 
guidances:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                          Contact information to
            Docket No.                        Center               Title of guidance      request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1136..................  CDER.......................  Manufacturing, Supply    [email protected].
                                                                 Chain, and Drug and      Please include the
                                                                 Biological Product       docket number FDA-2020-
                                                                 Inspections During       D-1136 and complete
                                                                 COVID-19 Public Health   title of the guidance
                                                                 Emergency Questions      in the request.
                                                                 and Answers (August
                                                                 2020).
FDA-2020-D-1136..................  CDER.......................  Resuming Normal Drug     [email protected].
                                                                 and Biologics            Please include the
                                                                 Manufacturing            docket number FDA-2020-
                                                                 Operations During the    D-1136 and complete
                                                                 COVID-19 Public Health   title of the guidance
                                                                 Emergency (September     in the request.
                                                                 2020).
FDA-2020-D-1106..................  CDER.......................  FDA Guidance on Conduct  Clinicaltrialconduct-
                                                                 of Clinical Trials of    [email protected]
                                                                 Medical Products         Please include the
                                                                 during COVID-19 Public   docket number FDA-2020-
                                                                 Health Emergency         D-1106 and complete
                                                                 (March 2020) (Updated    title of the guidance
                                                                 September 2020).         in the request.
----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without 
prior comment, FDA will consider all comments received and revise the 
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good 
guidance practices regulation (Sec.  10.115). The

[[Page 65822]]

guidances represent the current thinking of FDA. They do not establish 
any rights for any person and are not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

CDER Guidances

    The guidances listed in the table below 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 these 
guidances. However, these previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidances have been 
approved by OMB as listed in the following table:

                                     Table 2--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                Another guidance title
      COVID-19 guidance title        CFR cite referenced in     referenced in COVID-19      OMB control No(s).
                                        COVID-19 guidance              guidance
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: Resuming      21 CFR 210 and 211, 21  --Q7 Good Manufacturing      0910-0001, 0910-0032,
 Normal Drug and Biologics            CFR 514.80, 21 CFR      Practice Guidance for        0910-0139, 0910-0338,
 Manufacturing Operations During      600.                    Active Pharmaceutical        0910-0669, 0910-0675,
 the COVID-19 Public Health                                   Ingredients.                 0910-0759, 0910-0806.
 Emergency.                                                  --Planning for the Effects
                                                              of High Absenteeism to
                                                              Ensure Availability of
                                                              Medically Necessary Drug
                                                              Products..
                                                             --Notifying FDA of a
                                                              Permanent Discontinuance
                                                              or Interruption in
                                                              Manufacturing Under
                                                              Section 506C of the FD&C
                                                              Act..
                                                             --Reporting and Mitigating
                                                              Animal Drug Shortages
                                                              During the COVID-19 Public
                                                              Health Emergency..
Manufacturing, Supply Chain, and     21 CFR 314.50; 314.95,  --Prioritization of the      0910-0001, 0910-0014,
 Drug and Biological Product          314.125, 314.127;       Review of Original ANDAs,    0910-0338, 0910-0045,
 Inspections During COVID-19 Public   601.2 and 601.20.       Amendments, and              0910-0139, 0910-0759.
 Health Emergency; Questions and                              Supplements.
 Answers.                                                    --Requests for Expedited
                                                              Review of New Drug
                                                              Application and Biologics
                                                              License Application Prior
                                                              Approval Supplements
                                                              Submitted for Chemistry,
                                                              Manufacturing, and
                                                              Controls Changes..
                                                             --Administrative Processing
                                                              of Original Biologics
                                                              License Applications (BLA)
                                                              and New Drug Applications
                                                              (NDA).
                                                             --Changes to an Approved
                                                              Application for Specified
                                                              Biotechnology and
                                                              Specified Synthetic
                                                              Biological Products.
                                                             --Changes to an Approved
                                                              Application: Biological
                                                              Products.
                                                             --Changes to an Approved
                                                              NDA or ANDA; Questions and
                                                              Answers.
                                                             --Changes to an Approved
                                                              NDA or ANDA.
                                                             --CMC Postapproval
                                                              Manufacturing Changes To
                                                              Be Documented in Annual
                                                              Reports.
                                                             --Changes to an Approved
                                                              Application: Biological
                                                              Products: Human Blood and
                                                              Blood Components Intended
                                                              for Transfusion or for
                                                              Further Manufacture.
                                                             --CMC Postapproval
                                                              Manufacturing Changes for
                                                              Specified Biological
                                                              Products To Be Documented
                                                              in Annual Reports.
                                                             --Chemistry, Manufacturing,
                                                              and Controls Changes to an
                                                              Approved Application:
                                                              Certain Biological
                                                              Products.
                                                             --Immediate Release Solid
                                                              Oral Dosage Forms; Scale-
                                                              Up and Postapproval
                                                              Changes: Chemistry,
                                                              Manufacturing, and
                                                              Controls, In Vitro
                                                              Dissolution Testing, and
                                                              In Vivo Bioequivalence
                                                              Documentation.
                                                             --SUPAC-IR: Questions and
                                                              Answers about SUPAC-IR
                                                              Guidance.
                                                             --Nonsterile Semisolid
                                                              Dosage Forms; Scale-Up and
                                                              Postapproval Changes:
                                                              Chemistry, Manufacturing,
                                                              and Controls; In Vitro
                                                              Release Testing and In
                                                              Vivo Bioequivalence
                                                              Documentation.
                                                             --SUPAC-MR: Modified
                                                              Release Solid Oral Dosage
                                                              Forms; Scale-Up and
                                                              Postapproval Changes:
                                                              Chemistry, Manufacturing,
                                                              and Controls; In Vitro
                                                              Dissolution Testing and In
                                                              Vivo Bioequivalence
                                                              Documentation.

[[Page 65823]]

 
                                                             --SUPAC: Manufacturing
                                                              Equipment Addendum.
----------------------------------------------------------------------------------------------------------------

    The guidance listed in the table below refers to previously 
approved FDA collections of information. Therefore, clearance by OMB 
under the PRA is not required for this guidance. However, these 
collections of information are subject to review by OMB under the PRA. 
The previously approved collections of information in the following FDA 
regulations and guidance have been approved by OMB as listed in the 
table below. This guidance also contains a collection of information 
not approved under a current collection. This collection of information 
has been granted a PHE waiver from the PRA by the Department of Health 
and Human Services (HHS) on March 19, 2020, under section 319(f) of the 
PHS Act. Information concerning the PHE PRA waiver can be found on the 
HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 3--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                       CFR cite        Another guidance
     COVID-19 guidance title         referenced in       referenced in    OMB control No(s).  Collection covered
                                   COVID-19 guidance   COVID-19 guidance                       by PHE PRA waiver
----------------------------------------------------------------------------------------------------------------
Guidance on Conduct of Clinical   21 CFR part 11, 21  Formal Meetings     0910-0001, 0910-    Submission by
 Trials of Medical Products        CFR part 50, 21     Between the FDA     0014, 0910-0130,    investigators of
 during COVID-19 Public Health     CFR part 56, 21     and Sponsors or     0910-0303, 0910-    informed consent
 Emergency (Updated September      CFR part 312, 21    Applicants of       0338, 0910-0119,    forms to third
 21, 2020).                        CFR part 314, 21    PDUFA Products.     0910-0581, 0910-    parties.
                                   CFR part 320, 21   Formal Meetings      0733, 0910-0078
                                   CFR part 601, 21    Between the FDA
                                   CFR part 812.       and Sponsors or
                                                       Applicants of
                                                       BsUFA Products..
                                                      Pediatric Study
                                                       Plans: Content of
                                                       and Process for
                                                       Submitting
                                                       Initial Pediatric
                                                       Study Plans and
                                                       Amended Pediatric
                                                       Study Plans..
                                                      Draft Guidance for
                                                       Industry on
                                                       Demonstrating
                                                       Substantial
                                                       Evidence of
                                                       Effectiveness for
                                                       Human Drug and
                                                       Biological
                                                       Products..
                                                      Enhancing the
                                                       Diversity of
                                                       Clinical Trial
                                                       Populations--Elig
                                                       ibility Criteria,
                                                       Enrollment
                                                       Practices, and
                                                       Trial Design..
                                                      Pregnant Women:
                                                       Scientific and
                                                       Ethical
                                                       Considerations
                                                       for Inclusion in
                                                       Clinical Trials..
                                                      Part 11,
                                                       Electronic
                                                       Records;
                                                       Electronic
                                                       Signatures Scope
                                                       and Application..
                                                      Use of Electronic
                                                       Records and
                                                       Electronic
                                                       Signatures in
                                                       Clinical
                                                       Investigations
                                                       under 21 CFR Part
                                                       11--Questions and
                                                       Answers.
                                                      Safety Reporting
                                                       Requirements for
                                                       INDs and BA/BE
                                                       Studies..
                                                      Adverse Event
                                                       Reporting to
                                                       IRBs--Improving
                                                       Human Subject
                                                       Protection..
                                                      Use of Electronic
                                                       Informed Consent
                                                       In Clinical
                                                       Investigations..
                                                      E6(R2) Good
                                                       Clinical
                                                       Practice:
                                                       Integrated
                                                       Addendum to ICH
                                                       E6(R1)..
                                                      Providing
                                                       Regulatory
                                                       Submissions in
                                                       Electronic
                                                       Format--Certain
                                                       Human
                                                       Pharmaceutical
                                                       Product
                                                       Applications and
                                                       Related
                                                       Submissions Using
                                                       the eCTD
                                                       Specifications..
                                                      Best Practices for
                                                       Communication
                                                       Between IND
                                                       Sponsors and FDA
                                                       During Drug
                                                       Development..
                                                      Requests for
                                                       Feedback and
                                                       Meetings for
                                                       Medical Device
                                                       Submissions: The
                                                       Q-Submission
                                                       Program..
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related 
guidances at:
     The FDA web page entitled ``COVID-19-Related Guidance 
Documents for Industry, FDA Staff, and Other Stakeholders,'' available 
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     the FDA web page entitled ``Search for FDA Guidance 
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.


[[Page 65824]]


    Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22968 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P