83 FR 62589 - Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 233 (December 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 233 (December 4, 2018)
| Page Range | 62589-62590 | |
| FR Document | 2018-26285 |
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)] [Notices] [Pages 62589-62590] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26285] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5928] Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments; 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 ``Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.'' This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II). DATES: The announcement of the guidance is published in the Federal Register on December 4, 2018. 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 Docket No. FDA-2017-D-5928 for ``Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.'' 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. 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.thefederalregister.org/fdsys/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. 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: Lisa Bercu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6902. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.'' GDUFA was reauthorized (GDUFA II) on August 18, 2017, in order to facilitate timely access to high quality, affordable generic medicines. In accordance with the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter) that accompanied the legislation, FDA committed to schedule and conduct 90 percent of post- CRL meetings within prescribed time frames. [[Page 62590]] As described in the GDUFA II Commitment Letter, post-CRL meetings will be used by applicants ``to seek clarification concerning deficiencies identified in a CRL.'' Under GDUFA II, post-CRL meetings are available for both major and minor CRLs and for first and subsequent review cycles. FDA will grant any complete post-CRL meeting request that satisfies the criteria outlined in section IV of this guidance. FDA will only grant post-CRL meeting requests that pose questions to clarify identified deficiencies. Other issues, including questions requiring further Agency review, disputes about classification of complete response amendments, or new information submitted by the applicant, will not be addressed in a post-CRL meeting. This guidance finalizes the draft guidance announced in the Federal Register on October 16, 2017 (82 FR 48093). The Agency considered comments on the draft guidance while finalizing the guidance. Generally, we revised the draft guidance to provide clarifying information on the process for submitting post-CRL meeting requests and the criteria for granting post-CRL meeting requests. Changes from the draft guidance include information on the process for an abbreviated new drug application (ANDA) applicant to change the list of meeting participants and clarification on when a post-CRL meeting request may be denied. 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 ``Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.'' 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. III. Electronic Access Persons with access to the internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: November 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26285 Filed 12-3-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices 62589
Cumulatively, the total estimated comment will be made public, you are both copies to the Dockets Management
burden is 12,086 annual hours, which solely responsible for ensuring that your Staff. If you do not wish your name and
reflects a significant decrease. We base comment does not include any contact information to be made publicly
this adjustment on our experience with confidential information that you or a available, you can provide this
the information collection since its third party may not wish to be posted, information on the cover sheet and not
establishment and implementation. such as medical information, your or in the body of your comments and you
Dated: November 28, 2018. anyone else’s Social Security number, or must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
Leslie Kux,
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy.
that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2018–26295 Filed 12–3–18; 8:45 am] information, or other information that and other applicable disclosure law. For
BILLING CODE 4164–01–P identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND • If you want to submit a comment the information at: https://www.gpo.gov/
HUMAN SERVICES with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration public, submit the comment as a Docket: For access to the docket to
[Docket No. FDA–2017–D–5928] written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Post-Complete Response Letter Submissions’’ and ‘‘Instructions’’). received, go to https://
Meetings Between the Food and Drug www.regulations.gov and insert the
Administration and Abbreviated New Written/Paper Submissions
docket number, found in brackets in the
Drug Application Applicants Under Submit written/paper submissions as heading of this document, into the
Generic Drug User Fee Amendments; follows: ‘‘Search’’ box and follow the prompts
Guidance for Industry; Availability • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and Rockville, MD 20852.
HHS. Drug Administration, 5630 Fishers You may submit comments on any
ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
• For written/paper comments 10.115(g)(5)).
SUMMARY: The Food and Drug submitted to the Dockets Management Submit written requests for single
Administration (FDA or Agency) is Staff, FDA will post your comment, as copies of this guidance to the Division
announcing the availability of a final well as any attachments, except for of Drug Information, Center for Drug
guidance for industry entitled ‘‘Post- information submitted, marked and Evaluation and Research, Food and
Complete Response Letter Meetings identified, as confidential, if submitted Drug Administration, 10001 New
Between FDA and ANDA Applicants as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
Under GDUFA.’’ This guidance is Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
intended to clarify the criteria for must include the Docket No. FDA– 0002. Send one self-addressed adhesive
granting post-complete response letter 2017–D–5928 for ‘‘Post-Complete label to assist that office in processing
(CRL) meeting requests and the scope of Response Letter Meetings Between FDA your requests. See the SUPPLEMENTARY
discussions for granted meeting and ANDA Applicants Under GDUFA.’’ INFORMATION section for electronic
requests. This guidance provides Received comments will be placed in access to the guidance document.
procedures that will promote well- the docket and, except for those FOR FURTHER INFORMATION CONTACT: Lisa
managed post-CRL meetings and help submitted as ‘‘Confidential Bercu, Center for Drug Evaluation and
ensure that such meetings are scheduled Submissions,’’ publicly viewable at Research, Food and Drug
and conducted in accordance with the https://www.regulations.gov or at the Administration, 10903 New Hampshire
commitments made by FDA in Dockets Management Staff between 9 Ave., Silver Spring, MD 20993–0002,
connection with the reauthorization of a.m. and 4 p.m., Monday through 240–402–6902.
the Generic Drug User Fee Amendments Friday. SUPPLEMENTARY INFORMATION:
for Fiscal Years 2018–2022 (GDUFA II). • Confidential Submissions—To
DATES: The announcement of the submit a comment with confidential I. Background
guidance is published in the Federal information that you do not wish to be FDA is announcing the availability of
Register on December 4, 2018. made publicly available, submit your a guidance for industry entitled ‘‘Post-
ADDRESSES: You may submit either comments only as a written/paper Complete Response Letter Meetings
electronic or written comments on submission. You should submit two Between FDA and ANDA Applicants
Agency guidances at any time as copies total. One copy will include the Under GDUFA.’’ GDUFA was
follows: information you claim to be confidential reauthorized (GDUFA II) on August 18,
with a heading or cover note that states 2017, in order to facilitate timely access
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS to high quality, affordable generic
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The medicines. In accordance with the
following way: Agency will review this copy, including GDUFA Reauthorization Performance
• Federal eRulemaking Portal: the claimed confidential information, in Goals and Program Enhancements Fiscal
https://www.regulations.gov. Follow the its consideration of comments. The Years 2018–2022 (GDUFA II Goals or
instructions for submitting comments. second copy, which will have the Commitment Letter) that accompanied
Comments submitted electronically, claimed confidential information the legislation, FDA committed to
including attachments, to https:// redacted/blacked out, will be available schedule and conduct 90 percent of
www.regulations.gov will be posted to for public viewing and posted on post-CRL meetings within prescribed
the docket unchanged. Because your https://www.regulations.gov. Submit time frames.
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![62590 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
As described in the GDUFA II Guidances/default.htm or https:// Electronic Submissions
Commitment Letter, post-CRL meetings www.regulations.gov. Submit electronic comments in the
will be used by applicants ‘‘to seek Dated: November 28, 2018. following way:
clarification concerning deficiencies • Federal eRulemaking Portal:
Leslie Kux,
identified in a CRL.’’ Under GDUFA II, https://www.regulations.gov. Follow the
Associate Commissioner for Policy.
post-CRL meetings are available for both instructions for submitting comments.
major and minor CRLs and for first and [FR Doc. 2018–26285 Filed 12–3–18; 8:45 am]
Comments submitted electronically,
subsequent review cycles. FDA will BILLING CODE 4164–01–P
including attachments, to https://
grant any complete post-CRL meeting www.regulations.gov will be posted to
request that satisfies the criteria the docket unchanged. Because your
outlined in section IV of this guidance. DEPARTMENT OF HEALTH AND
HUMAN SERVICES comment will be made public, you are
FDA will only grant post-CRL meeting
solely responsible for ensuring that your
requests that pose questions to clarify
Food and Drug Administration comment does not include any
identified deficiencies. Other issues,
confidential information that you or a
including questions requiring further
[Docket No. FDA–2017–E–4282] third party may not wish to be posted,
Agency review, disputes about
such as medical information, your or
classification of complete response
Determination of Regulatory Review anyone else’s Social Security number, or
amendments, or new information
Period for Purposes of Patent confidential business information, such
submitted by the applicant, will not be
Extension; TRULANCE as a manufacturing process. Please note
addressed in a post-CRL meeting.
This guidance finalizes the draft that if you include your name, contact
guidance announced in the Federal AGENCY: Food and Drug Administration, information, or other information that
Register on October 16, 2017 (82 FR HHS. identifies you in the body of your
48093). The Agency considered comments, that information will be
ACTION: Notice.
comments on the draft guidance while posted on https://www.regulations.gov.
finalizing the guidance. Generally, we • If you want to submit a comment
SUMMARY: The Food and Drug with confidential information that you
revised the draft guidance to provide Administration (FDA or the Agency) has
clarifying information on the process for do not wish to be made available to the
determined the regulatory review period public, submit the comment as a
submitting post-CRL meeting requests for TRULANCE and is publishing this
and the criteria for granting post-CRL written/paper submission and in the
notice of that determination as required manner detailed (see ‘‘Written/Paper
meeting requests. Changes from the by law. FDA has made the
draft guidance include information on Submissions’’ and ‘‘Instructions’’).
determination because of the
the process for an abbreviated new drug submission of an application to the Written/Paper Submissions
application (ANDA) applicant to change Director of the U.S. Patent and
the list of meeting participants and Submit written/paper submissions as
Trademark Office (USPTO), Department follows:
clarification on when a post-CRL of Commerce, for the extension of a • Mail/Hand delivery/Courier (for
meeting request may be denied. patent which claims that human drug
This guidance is being issued written/paper submissions): Dockets
product. Management Staff (HFA–305), Food and
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any
The guidance represents the current Lane, Rm. 1061, Rockville, MD 20852.
of the dates as published (see the
thinking of FDA on ‘‘Post-Complete • For written/paper comments
SUPPLEMENTARY INFORMATION section) are
Response Letter Meetings Between FDA submitted to the Dockets Management
incorrect may submit either electronic
and ANDA Applicants Under GDUFA.’’ Staff, FDA will post your comment, as
or written comments and ask for a
It does not establish any rights for any well as any attachments, except for
redetermination by February 4, 2019.
person and is not binding on FDA or the information submitted, marked and
Furthermore, any interested person may
public. You can use an alternative identified, as confidential, if submitted
petition FDA for a determination
approach if it satisfies the requirements as detailed in ‘‘Instructions.’’
regarding whether the applicant for
of the applicable statutes and Instructions: All submissions received
extension acted with due diligence
regulations. This guidance is not subject must include the Docket No. FDA–
during the regulatory review period by
to Executive Order 12866. 2017–E–4282 for ‘‘Determination of
June 3, 2019. See ‘‘Petitions’’ in the
Regulatory Review Period for Purposes
SUPPLEMENTARY INFORMATION section for
II. Paperwork Reduction Act of 1995 of Patent Extension; TRULANCE.’’
more information.
This guidance refers to previously Received comments, those filed in a
approved collections of information ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be
found in FDA regulations. These as follows. Please note that late, placed in the docket and, except for
collections of information are subject to untimely filed comments will not be those submitted as ‘‘Confidential
review by the Office of Management and considered. Electronic comments must Submissions,’’ publicly viewable at
Budget (OMB) under the Paperwork be submitted on or before February 4, https://www.regulations.gov or at the
Reduction Act of 1995 (44 U.S.C. 3501– 2019. The https://www.regulations.gov Dockets Management Staff between 9
3520). The collections of information in electronic filing system will accept a.m. and 4 p.m., Monday through
21 CFR part 314 have been approved comments until 11:59 p.m. Eastern Time Friday.
under OMB control number 0910–0001. at the end of February 4, 2019. • Confidential Submissions—To
Comments received by mail/hand submit a comment with confidential
III. Electronic Access delivery/courier (for written/paper information that you do not wish to be
Persons with access to the internet submissions) will be considered timely made publicly available, submit your
may obtain the guidance at either http:// if they are postmarked or the delivery comments only as a written/paper
www.fda.gov/Drugs/Guidance service acceptance receipt is on or submission. You should submit two
ComplianceRegulatoryInformation/ before that date. copies total. One copy will include the
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Document Created: 2018-12-04 00:43:12
Document Modified: 2018-12-04 00:43:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on December 4, 2018. | |
| Contact | Lisa Bercu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6902. | |
| FR Citation | 83 FR 62589 |
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