Abbreviated New Drug Application Submissions-Amendments and Requests for Final Approval To Tentatively Approved Abbreviated New Drug Applications; Guidance for Industry; Availability, 61014-61016 [2020-21470]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES 61014 Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices 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 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 the 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: LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: PCNS@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On November 6, 2020, the committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease. FDA intends to make the meeting’s background material and pre-recorded presentations available to the public no VerDate Sep<11>2014 22:59 Sep 28, 2020 Jkt 250001 later than 2 business days before the meeting. The pre-recorded presentations will be viewed by the committee prior to the meeting and will not be replayed on meeting day. If FDA is unable to post the background material and/or prerecorded presentations on its website prior to the meeting, the background material and/or pre-recorded presentations will be made publicly available on FDA’s website at the time of the advisory committee meeting. The meeting will include brief summaries of the pre-recorded presentations. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 23, 2020, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 15, 2020. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 16, 2020. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/ PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 22, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–21448 Filed 9–28–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–4726] Abbreviated New Drug Application Submissions—Amendments and Requests for Final Approval To Tentatively Approved Abbreviated New Drug Applications; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs.’’ This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (earliest lawful approval date). This guidance finalizes the draft guidance of the same title issued on February 1, 2019. DATES: The announcement of the guidance is published in the Federal Register on September 29, 2020. 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: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the E:\FR\FM\29SEN1.SGM 29SEN1 Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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 Docket No. FDA– 2018–D–4726 for ‘‘ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs.’’ Received comments will be placed in the docket 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 VerDate Sep<11>2014 18:14 Sep 28, 2020 Jkt 250001 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 this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, 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, elizabeth.giaquinto@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs.’’ This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 61015 ANDAs, including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (earliest lawful approval date). If an ANDA meets the substantive requirements for approval but cannot be finally approved by FDA because of unexpired patents or exclusivities, FDA will tentatively approve the ANDA. Under section 505 of the Federal Food, Drug, and Cosmetic Act) (21 U.S.C. 355), a drug product that is the subject of a tentatively approved ANDA is not an approved drug and does not have an effective approval until FDA issues an approval after any necessary additional review of the application. An ANDA applicant may submit amendments to a tentatively approved application that propose changes to the application, request final approval, or propose changes and request final approval. As described in the guidance, an amendment proposing changes to the application may delay FDA’s final approval of the ANDA, depending on the timing of submission of the amendment and the nature of the changes proposed and any related deficiencies identified upon review. The guidance is intended to assist applicants in preparing an amendment for submission in a timely fashion to enable final approval on the earliest lawful approval date. In particular, applicants that wish to request final approval should determine whether changes are necessary before requesting this final approval, review any changes that have been made to their application since the tentative approval was granted, and consider the possible review goal dates that may be assigned to the request for final approval to request final approval in a timely fashion. In the Federal Register of February 1, 2019 (84 FR 1164), FDA announced the availability of the draft guidance of the same title dated January 2019. The draft guidance was posted on FDA’s website on January 16, 2019, during the lapse in appropriations to provide advance notice of the document to the public. The comment period opened upon publication in the Federal Register. FDA received five comments on the draft guidance and those comments were considered as the guidance was finalized. The final guidance contains minor clarifications to the draft guidance. The guidance announced in E:\FR\FM\29SEN1.SGM 29SEN1 61016 Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices this notice finalizes the draft guidance dated January 2019. 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 ‘‘ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs.’’ 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. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: September 22, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–21470 Filed 9–28–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice To Announce Supplemental Award To Support Training and Technical Assistance To Address Clinical Workforce Development Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Announcing supplemental award to support training and technical assistance to address clinical workforce development. AGENCY: HRSA provided supplemental funding to Community Health Center, Inc. (CHCI), a currently-funded National Training and Technical Assistance Partner (NTTAP) award recipient. CHCI will expand training and technical assistance (T/TA) to health centers and HRSA-funded State and Regional Primary Care Associations (PCAs) to support implementation of a tool developed for health centers to assess and improve their readiness to engage in health professional training programs and address national health care workforce shortages. FOR FURTHER INFORMATION CONTACT: Tracey Orloff, Director, HRSA, Strategic Partnerships Division, Office of Quality Improvement, at TOrloff@hrsa.gov or (301) 443–3197. SUPPLEMENTARY INFORMATION: Thomas J. Engels, Administrator. [FR Doc. 2020–21514 Filed 9–28–20; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:14 Sep 28, 2020 Jkt 250001 Health Resources and Services Administration Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Centers for Disease Control and Prevention (CDC)/ HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting. SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 November 5, 2020, 2:00 p.m.– 5:15 p.m. Eastern Time (ET) and November 6, 2020, 2:00 p.m.–5:15 p.m. ET. The deadline for online registration is 12:00 p.m. ET on November 2, 2020. ADDRESSES: This meeting will be held virtually. Please visit the meeting information page to register: https:// chacfall2020.org. FOR FURTHER INFORMATION CONTACT: Theresa Jumento, Senior Public Health Advisor, HIV/AIDS Bureau, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301–443–5807; or CHACAdvisoryComm@hrsa.gov. SUPPLEMENTARY INFORMATION: CHAC was established under section 222 of the Public Health Service Act, [42 U.S.C. 217a], as amended. The purpose of CHAC is to advise the Secretary, HHS; the Director, CDC; and the Administrator, HRSA regarding objectives, strategies, policies, and priorities for HIV, viral hepatitis, and other STDs; prevention and treatment efforts including surveillance of HIV infection, viral hepatitis, and other STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV, viral hepatitis, and other STDs; identification of policy issues related to HIV/viral hepatitis/STD professional eduction, patient healthcare delivery, and prevention services; agency policies about prevention of HIV, viral hepatitis and other STDs; treatment, healthcare delivery, and research and training; strategic issues influencing the ability of CDC and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV, viral hepatitis, and other STDs; and support to the agencies in their developoment of responses to emerging health needs related to HIV, viral hepatitis, and other STDs. During the November 5–6, 2020, meeting, CHAC will discuss community engagement activities related to the President’s initiative on ‘‘Ending the HIV Epidemic: A Plan for America’’ and the COVID–19 pandemic. CHAC will also discuss the needs and challenges of HIV prevention and care for women. Agenda items are subject to change as priorities dictate. Refer to the CHAC meeting information page for any updated information concerning the meeting. While this meeting is open to the public, advance registration is required. Members of the public will have the opportunity to provide comments. Requests to offer oral comments will be accepted in the order they are received and may be limited as time allows. DATES: Recipient of the Award: Community Health Center, Inc. Amount of Non-Competitive Award: $320,000. Period of Supplemental Funding: August 2020 to June 2022. CFDA Number: 93.129. Authority: Section 330(l) of the Public Health Service Act, 42 U.S.C. 254b(l). Justification: The National Center for Health Workforce Analysis estimates a shortage of over 23,000 primary care physician positions by 2025. Residency programs are needed for health centers to address health care workforce shortages that limit their ability to deliver comprehensive, culturally competent, high quality primary health care services. CHCI created the Readiness to Train Assessment Tool (RTATTM) for health centers to assess their own readiness to engage in health professional training programs and use the results to manage their workforce shortages. Supplemental funding is necessary to ensure timely implementation of the RTATTM in order to complete the data collection, analysis, and results dissemination needed for health centers to address critical workforce shortages. As the organization that developed the RTATTM, and the only NTTAP currently funded to provide enhanced T/TA on clinical workforce development to health centers, CHCI has the necessary expertise, organizational systems, and structure in place to immediately expand T/TA efforts in this area. E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61014-61016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21470]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4726]


Abbreviated New Drug Application Submissions--Amendments and 
Requests for Final Approval To Tentatively Approved Abbreviated New 
Drug Applications; Guidance for Industry; 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 a final guidance for industry entitled ``ANDA 
Submissions--Amendments and Requests for Final Approval to Tentatively 
Approved ANDAs.'' This guidance is intended to assist applicants in 
preparing and submitting amendments to tentatively approved abbreviated 
new drug applications (ANDAs), including requests for final approval. 
This guidance provides recommendations on the timing and content of 
amendments to tentatively approved ANDAs to facilitate submission in a 
timely fashion to enable final approval on the earliest date on which 
the ANDA may lawfully be approved based on patent and/or exclusivity 
protections (earliest lawful approval date). This guidance finalizes 
the draft guidance of the same title issued on February 1, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on September 29, 2020.

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

[[Page 61015]]

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 Docket No. 
FDA-2018-D-4726 for ``ANDA Submissions--Amendments and Requests for 
Final Approval to Tentatively Approved ANDAs.'' Received comments will 
be placed in the docket 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 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 this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, 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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDA Submissions--Amendments and Requests for Final Approval 
to Tentatively Approved ANDAs.'' This guidance is intended to assist 
applicants in preparing and submitting amendments to tentatively 
approved ANDAs, including requests for final approval. This guidance 
provides recommendations on the timing and content of amendments to 
tentatively approved ANDAs to facilitate submission in a timely fashion 
to enable final approval on the earliest date on which the ANDA may 
lawfully be approved based on patent and/or exclusivity protections 
(earliest lawful approval date).
    If an ANDA meets the substantive requirements for approval but 
cannot be finally approved by FDA because of unexpired patents or 
exclusivities, FDA will tentatively approve the ANDA. Under section 505 
of the Federal Food, Drug, and Cosmetic Act) (21 U.S.C. 355), a drug 
product that is the subject of a tentatively approved ANDA is not an 
approved drug and does not have an effective approval until FDA issues 
an approval after any necessary additional review of the application.
    An ANDA applicant may submit amendments to a tentatively approved 
application that propose changes to the application, request final 
approval, or propose changes and request final approval. As described 
in the guidance, an amendment proposing changes to the application may 
delay FDA's final approval of the ANDA, depending on the timing of 
submission of the amendment and the nature of the changes proposed and 
any related deficiencies identified upon review. The guidance is 
intended to assist applicants in preparing an amendment for submission 
in a timely fashion to enable final approval on the earliest lawful 
approval date. In particular, applicants that wish to request final 
approval should determine whether changes are necessary before 
requesting this final approval, review any changes that have been made 
to their application since the tentative approval was granted, and 
consider the possible review goal dates that may be assigned to the 
request for final approval to request final approval in a timely 
fashion.
    In the Federal Register of February 1, 2019 (84 FR 1164), FDA 
announced the availability of the draft guidance of the same title 
dated January 2019. The draft guidance was posted on FDA's website on 
January 16, 2019, during the lapse in appropriations to provide advance 
notice of the document to the public. The comment period opened upon 
publication in the Federal Register. FDA received five comments on the 
draft guidance and those comments were considered as the guidance was 
finalized. The final guidance contains minor clarifications to the 
draft guidance. The guidance announced in

[[Page 61016]]

this notice finalizes the draft guidance dated January 2019.
    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 ``ANDA Submissions--Amendments and Requests 
for Final Approval to Tentatively Approved ANDAs.'' 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. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: September 22, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21470 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P

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