Soliciting Public Comment on Appendix A of the Food and Drug Administration's July 2018 Guidance Entitled “Abbreviated New Drug Application Submissions-Amendments To Abbreviated New Drug Applications Under Generic Drug User Fee Amendments;” Notice; Establishment of a Public Docket; Request for Comments, 50088-50089 [2022-17414]

Download as PDF 50088 Federal Register / Vol. 87, No. 156 / Monday, August 15, 2022 / Notices khammond on DSKJM1Z7X2PROD with NOTICES in occupational safety and health; (2) address currently relevant needs in the fields of occupational safety and health either alone or in conjunction with other known activities inside and outside of NIOSH; and (3) produce their intended results in addressing important research questions in occupational safety and health, both in terms of applicability of the research findings and dissemination of the findings. Purpose: The BSC, NIOSH National Firefighter Registry Subcommittee (the Subcommittee) provides scientific expertise to the Board of Scientific Counselors that will assist the BSC in advising the Director about NIOSH’s efforts to establish and operate the National Firefighter Registry. Specifically, the Subcommittee advises the Board of Scientific Counselors on the following issues pertaining to the ‘‘required strategy’’ as mandated by the Firefighter Cancer Registry Act of 2018 (the Act): (1) Increase awareness of the National Firefighter Registry and encourage participation among all groups of firefighters; (2) consider data collection needs; (3) consider data storage and electronic access of health information; and (4) in consultation with subject matter experts, develop a method for estimating the number and type of fire incidents attended by a firefighter. Additional responsibilities of the Subcommittee are to provide guidance to the BSC regarding inclusion and the maintenance of data on firefighters as required by the Act. Matters To Be Considered: The agenda for the meeting addresses issues related to: The National Firefighter Registry project overview and status, protocol updates, enrollment system demonstration, project launch, and future planning applicable to stakeholders. Agenda items are subject to change as priorities dictate. The agenda is posted on the NIOSH website at https://www.cdc.gov/niosh/ bsc/nfrs/. Public Participation Written Public Comment: Written comments will be accepted per the instructions provided in the ADDRESSES section above. Comments received in advance of the meeting are part of the public record and are subject to public disclosure. They will be included in the official record of the meeting. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your VerDate Sep<11>2014 17:24 Aug 12, 2022 Jkt 256001 comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket. Written comments received by August 30, 2022, will be provided to the Subcommittee prior to the meeting. Oral Public Comment: The public is welcome to participate during the public comment period, from 3:15 p.m. to 3:30 p.m., EDT, September 6, 2022. Each commenter will be provided up to 5 minutes for comment. A limited number of time slots are available and will be assigned on a first-come, firstserved basis. Members of the public who wish to address the Subcommittee are requested to contact Designated Federal Officer for scheduling purposes (see FOR FUTHER INFORMATION CONTACT above). The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2022–17476 Filed 8–12–22; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–1633] Soliciting Public Comment on Appendix A of the Food and Drug Administration’s July 2018 Guidance Entitled ‘‘Abbreviated New Drug Application Submissions— Amendments To Abbreviated New Drug Applications Under Generic Drug User Fee Amendments;’’ Notice; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit comments on the content of Appendix A in the July 2018 guidance for industry entitled ‘‘ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA’’ (ANDA Amendments Guidance). We are soliciting comments on the content of Appendix A. The Agency is taking this action to fulfill the Agency’s commitment described in section IX.B. of the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027 Commitment Letter (GDUFA III Commitment Letter). DATES: Either electronic or written comments must be submitted by October 14, 2022. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 14, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. SUMMARY: 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: E:\FR\FM\15AUN1.SGM 15AUN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 87, No. 156 / Monday, August 15, 2022 / Notices • 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– 2022–N–1633 for ‘‘Soliciting Public Comment on Appendix A of FDA’s July 2018 Guidance Entitled ‘ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA’; Notice; Establishment of a Public Docket; Request for Comments.’’ 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-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the VerDate Sep<11>2014 17:24 Aug 12, 2022 Jkt 256001 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: Martha Nguyen, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 301–796–3471. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, the President signed the Generic Drug User Fee Amendments (GDUFA I) into law. GDUFA must be reauthorized every 5 years so FDA can continue to assess and collect GDUFA fees, and was most recently authorized in the FDA Reauthorization Act of 2017, Public Law 115–52 (GDUFA II) on August 18, 2017, for fiscal years 2018– 2022. In a joint effort in anticipation of GDUFA reauthorization in 2022, the Agency and representatives from the generic drug industry negotiated the draft agreement reflected in the GDUFA III Commitment Letter.1 Specifically, FDA agreed to performance goals and program enhancements regarding aspects of the generic drug assessment program that build on the GDUFA program established and enhanced through previous authorizations. New enhancements to the program are designed to maximize the efficiency and utility of each assessment cycle, with the intent of reducing the number of assessment cycles for abbreviated new drug applications (ANDAs) and facilitating timely access to quality, affordable, safe, and effective generic medicines. In the GDUFA III Commitment Letter, FDA agreed to issue a Federal Register notice on or before April 30, 2023, to solicit public comment on the content of Appendix A in the ANDA Amendments Guidance.2 The ANDA Amendments Guidance describes amendment classifications (‘‘major’’ or ‘‘minor’’ amendments) and categories (amendments subject to ‘‘priority’’ or 50089 ‘‘standard’’ review goals) and explains how amendment submission classification and category may affect an amendment’s performance goal date. The guidance superseded a 2001 guidance entitled ‘‘Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications’’ (2001 guidance), which contained descriptions of major and minor amendments; however, these descriptions were considered during GDUFA II negotiations and were incorporated into the GDUFA II Commitment Letter.3 Accordingly, the ANDA Amendments Guidance incorporates the descriptions from the 2001 guidance, and provides further description of these amendments, including general descriptions and examples of the types of deficiencies that would classify an applicant’s response to these deficiencies as a major or minor amendment. Appendix A in the ANDA amendments guidance (Appendix A: Major Deficiencies) is a non-exhaustive list of examples of deficiencies that the FDA may consider major. With this notice, FDA is seeking comments on the examples of major deficiencies listed in Appendix A of the ANDA amendments guidance, as well as comment on how any proposed revisions to that list could be beneficial to industry in understanding ANDA amendment classification. II. Paperwork Reduction Act of 1995 This notice contains no new collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: August 9, 2022. Lauren K. Roth, Associate Commissioner for Policy. 1 See ‘‘GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027,’’ available at https://www.fda.gov/ media/153631/download. 2 See the guidance for industry entitled ‘‘ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA,’’ available at https://www.fda.gov/media/89258/download. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 [FR Doc. 2022–17414 Filed 8–12–22; 8:45 am] BILLING CODE 4164–01–P 3 See ‘‘GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018–2022,’’ available at https://www.fda.gov/ media/101052/download. E:\FR\FM\15AUN1.SGM 15AUN1

Agencies

[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50088-50089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1633]


Soliciting Public Comment on Appendix A of the Food and Drug 
Administration's July 2018 Guidance Entitled ``Abbreviated New Drug 
Application Submissions--Amendments To Abbreviated New Drug 
Applications Under Generic Drug User Fee Amendments;'' Notice; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the establishment of a docket to solicit comments on the 
content of Appendix A in the July 2018 guidance for industry entitled 
``ANDA Submissions--Amendments to Abbreviated New Drug Applications 
Under GDUFA'' (ANDA Amendments Guidance). We are soliciting comments on 
the content of Appendix A. The Agency is taking this action to fulfill 
the Agency's commitment described in section IX.B. of the GDUFA 
Reauthorization Performance Goals and Program Enhancements Fiscal Years 
2023-2027 Commitment Letter (GDUFA III Commitment Letter).

DATES: Either electronic or written comments must be submitted by 
October 14, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 14, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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:

[[Page 50089]]

     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-2022-N-1633 for ``Soliciting Public Comment on Appendix A of FDA's 
July 2018 Guidance Entitled `ANDA Submissions--Amendments to 
Abbreviated New Drug Applications Under GDUFA'; Notice; Establishment 
of a Public Docket; Request for Comments.'' 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.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Office of Generic 
Drugs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver 
Spring, MD 20993-0002, 301-796-3471.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed the Generic Drug User Fee 
Amendments (GDUFA I) into law. GDUFA must be reauthorized every 5 years 
so FDA can continue to assess and collect GDUFA fees, and was most 
recently authorized in the FDA Reauthorization Act of 2017, Public Law 
115-52 (GDUFA II) on August 18, 2017, for fiscal years 2018-2022. In a 
joint effort in anticipation of GDUFA reauthorization in 2022, the 
Agency and representatives from the generic drug industry negotiated 
the draft agreement reflected in the GDUFA III Commitment Letter.\1\ 
Specifically, FDA agreed to performance goals and program enhancements 
regarding aspects of the generic drug assessment program that build on 
the GDUFA program established and enhanced through previous 
authorizations. New enhancements to the program are designed to 
maximize the efficiency and utility of each assessment cycle, with the 
intent of reducing the number of assessment cycles for abbreviated new 
drug applications (ANDAs) and facilitating timely access to quality, 
affordable, safe, and effective generic medicines.
---------------------------------------------------------------------------

    \1\ See ``GDUFA Reauthorization Performance Goals and Program 
Enhancements Fiscal Years 2023-2027,'' available at https://www.fda.gov/media/153631/download.
---------------------------------------------------------------------------

    In the GDUFA III Commitment Letter, FDA agreed to issue a Federal 
Register notice on or before April 30, 2023, to solicit public comment 
on the content of Appendix A in the ANDA Amendments Guidance.\2\ The 
ANDA Amendments Guidance describes amendment classifications (``major'' 
or ``minor'' amendments) and categories (amendments subject to 
``priority'' or ``standard'' review goals) and explains how amendment 
submission classification and category may affect an amendment's 
performance goal date. The guidance superseded a 2001 guidance entitled 
``Major, Minor, and Telephone Amendments to Abbreviated New Drug 
Applications'' (2001 guidance), which contained descriptions of major 
and minor amendments; however, these descriptions were considered 
during GDUFA II negotiations and were incorporated into the GDUFA II 
Commitment Letter.\3\ Accordingly, the ANDA Amendments Guidance 
incorporates the descriptions from the 2001 guidance, and provides 
further description of these amendments, including general descriptions 
and examples of the types of deficiencies that would classify an 
applicant's response to these deficiencies as a major or minor 
amendment. Appendix A in the ANDA amendments guidance (Appendix A: 
Major Deficiencies) is a non-exhaustive list of examples of 
deficiencies that the FDA may consider major.
---------------------------------------------------------------------------

    \2\ See the guidance for industry entitled ``ANDA Submissions--
Amendments to Abbreviated New Drug Applications Under GDUFA,'' 
available at https://www.fda.gov/media/89258/download.
    \3\ See ``GDUFA Reauthorization Performance Goals and Program 
Enhancements Fiscal Years 2018-2022,'' available at https://www.fda.gov/media/101052/download.
---------------------------------------------------------------------------

    With this notice, FDA is seeking comments on the examples of major 
deficiencies listed in Appendix A of the ANDA amendments guidance, as 
well as comment on how any proposed revisions to that list could be 
beneficial to industry in understanding ANDA amendment classification.

II. Paperwork Reduction Act of 1995

    This notice contains no new collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

III. Electronic Access

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

    Dated: August 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17414 Filed 8-12-22; 8:45 am]
BILLING CODE 4164-01-P
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