82_FR_46261 82 FR 46071 - Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability

82 FR 46071 - Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 190 (October 3, 2017)

Page Range46071-46072
FR Document2017-21190

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.'' This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II).

Federal Register, Volume 82 Issue 190 (Tuesday, October 3, 2017) 
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46071-46072]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21190]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5739]


Formal Meetings Between the Food and Drug Administration and 
Abbreviated New Drug Application Applicants of Complex Products Under 
Generic Drug User Fee Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Formal 
Meetings Between FDA and ANDA Applicants of Complex Products Under 
GDUFA.'' This draft guidance describes an enhanced pathway for 
discussions between FDA and a prospective applicant preparing to submit 
(or an applicant that has submitted) to FDA an abbreviated new drug 
application (ANDA) for a complex product. Specifically, this draft 
guidance provides information on requesting and conducting product 
development meetings, pre-submission meetings, and mid-review-cycle 
meetings with FDA. This draft guidance will assist applicants in 
generating and submitting a meeting request and the associated meeting 
package to FDA for complex products to be submitted under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the 
commitments made by FDA in connection with the reauthorization of the 
Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 
(GDUFA II).

DATES: Submit either electronic or written comments on the draft 
guidance by December 4, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 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-5739 for ``Formal Meetings Between FDA and ANDA Applicants 
of Complex Products Under GDUFA; Draft Guidance for Industry; 
Availability.'' 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

[[Page 46072]]

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 the draft 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 draft 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 draft guidance for industry 
entitled ``Formal Meetings Between FDA and ANDA Applicants of Complex 
Products Under GDUFA.'' This draft guidance describes an enhanced 
pathway for discussions between FDA and an applicant (or prospective 
applicant) preparing to submit an ANDA for a complex product to FDA. 
Specifically, this draft guidance provides information on requesting 
and conducting product development meetings, pre-submission meetings, 
and mid-review-cycle meetings with FDA.
    This draft guidance reflects a unified approach to all formal 
meetings between FDA and ANDA applicants or prospective ANDA applicants 
for complex products. This draft guidance is intended to assist ANDA 
applicants and prospective ANDA applicants in generating and submitting 
to FDA a meeting request and the associated meeting package for these 
complex products, as defined in this guidance, to be submitted under 
section 505(j) of the FD&C Act (21 U.S.C 355(j)) and as contemplated in 
GDUFA II.
    As part of the commitments FDA made in connection with GDUFA II, 
FDA agreed to develop a program to assist ANDA applicants and 
prospective ANDA applicants of complex products before the submission 
of an ANDA to FDA. As stated in the ``GDUFA Reauthorization Performance 
Goals and Program Enhancements Fiscal Years 2018-2022'' (GDUFA II Goals 
or Commitment Letter), this pre-ANDA program is intended to:

. . . clarify regulatory expectations for prospective applicants 
early in product development, assist applicants to develop more 
complete submissions, promote a more efficient and effective ANDA 
review process, and reduce the number of review cycles required to 
obtain ANDA approval, particularly for [complex products](GDUFA II 
Commitment Letter at 14).

    To facilitate development of complex products that may be submitted 
in an ANDA, FDA and industry agreed to a series of meetings between 
ANDA applicants and prospective ANDA applicants and FDA to discuss the 
proposed complex product and support submission of a high-quality, 
approvable ANDA.
    In addition to developing a robust pre-ANDA program, FDA agreed to 
respond to requests for and conduct meetings related to the development 
of complex products submitted on or after October 1, 2017, within 
specific timeframes.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Formal 
Meetings Between FDA and ANDA Applicants of Complex Products 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.

II. Paperwork Reduction Act of 1995

    This draft 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 
collection of information has been approved under OMB control number 
0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21190 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46071 the ‘‘Discontinued Drug Product List’’ DEPARTMENT OF HEALTH AND confidential information that you or a section of the Orange Book. HUMAN SERVICES third party may not wish to be posted, Lachman Consultant Services, Inc. such as medical information, your or Food and Drug Administration anyone else’s Social Security number, or submitted a citizen petition dated April [Docket No. FDA–2017–D–5739] confidential business information, such 21, 2017 (Docket No. FDA–2017–P– as a manufacturing process. Please note 2530), under 21 CFR 10.30, requesting Formal Meetings Between the Food that if you include your name, contact that the Agency determine whether information, or other information that and Drug Administration and SPECTAZOLE (econazole nitrate) identifies you in the body of your Abbreviated New Drug Application topical cream, 1%, was withdrawn from comments, that information will be Applicants of Complex Products Under sale for reasons of safety or Generic Drug User Fee Act; Draft posted on https://www.regulations.gov. effectiveness. Guidance for Industry; Availability • If you want to submit a comment After considering the citizen petition with confidential information that you AGENCY: Food and Drug Administration, do not wish to be made available to the and reviewing Agency records and HHS. public, submit the comment as a based on the information we have at this time, FDA has determined under ACTION: Notice of availability. written/paper submission and in the § 314.161 that SPECTAZOLE (econazole manner detailed (see ‘‘Written/Paper SUMMARY: The Food and Drug nitrate) topical cream, 1%, was not Submissions’’ and ‘‘Instructions’’). Administration (FDA or Agency) is withdrawn for reasons of safety or announcing the availability of a draft Written/Paper Submissions effectiveness. The petitioner has guidance for industry entitled ‘‘Formal Submit written/paper submissions as identified no data or other information Meetings Between FDA and ANDA follows: suggesting that SPECTAZOLE Applicants of Complex Products Under • Mail/Hand delivery/Courier (for (econazole nitrate) topical cream, 1%, GDUFA.’’ This draft guidance describes written/paper submissions): Dockets was withdrawn for reasons of safety or an enhanced pathway for discussions Management Staff (HFA–305), Food and effectiveness. We have carefully between FDA and a prospective Drug Administration, 5630 Fishers reviewed our files for records applicant preparing to submit (or an Lane, Rm. 1061, Rockville, MD 20852. concerning the withdrawal of applicant that has submitted) to FDA an • For written/paper comments SPECTAZOLE (econazole nitrate) abbreviated new drug application submitted to Dockets Management Staff, topical cream, 1%, from sale. We have (ANDA) for a complex product. FDA will post your comment, as well as also independently evaluated relevant Specifically, this draft guidance any attachments, except for information provides information on requesting and submitted, marked and identified, as literature and data for possible conducting product development confidential, if submitted as detailed in postmarketing adverse events. We have meetings, pre-submission meetings, and ‘‘Instructions.’’ reviewed the available evidence and mid-review-cycle meetings with FDA. Instructions: All submissions received determined that this drug product was This draft guidance will assist must include the Docket No. FDA– not withdrawn from sale for reasons of applicants in generating and submitting 2017–D–5739 for ‘‘Formal Meetings safety or effectiveness. a meeting request and the associated Between FDA and ANDA Applicants of Accordingly, the Agency will meeting package to FDA for complex Complex Products Under GDUFA; Draft continue to list SPECTAZOLE products to be submitted under the Guidance for Industry; Availability.’’ (econazole nitrate) topical cream, 1%, in Federal Food, Drug, and Cosmetic Act Received comments will be placed in the ‘‘Discontinued Drug Product List’’ (FD&C Act) and as contemplated in the the docket and, except for those section of the Orange Book. The commitments made by FDA in submitted as ‘‘Confidential ‘‘Discontinued Drug Product List’’ connection with the reauthorization of Submissions,’’ publicly viewable at delineates, among other items, drug the Generic Drug User Fee Amendments https://www.regulations.gov or at the products that have been discontinued for Fiscal Years (FYs) 2018–2022 Dockets Management Staff between 9 from marketing for reasons other than (GDUFA II). a.m. and 4 p.m., Monday through safety or effectiveness. FDA will not DATES: Submit either electronic or Friday. written comments on the draft guidance • Confidential Submissions—To begin procedures to withdraw approval by December 4, 2017 to ensure that the submit a comment with confidential of approved ANDAs that refer to this Agency considers your comment on this information that you do not wish to be drug product. Additional ANDAs for draft guidance before it begins work on made publicly available, submit your this drug product may also be approved comments only as a written/paper the final version of the guidance. by the Agency as long as they meet all submission. You should submit two ADDRESSES: You may submit comments other legal and regulatory requirements copies total. One copy will include the for the approval of ANDAs. If FDA on any guidance at any time as follows: information you claim to be confidential determines that labeling for this drug Electronic Submissions with a heading or cover note that states product should be revised to meet Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS current standards, the Agency will following way: CONFIDENTIAL INFORMATION.’’ The advise ANDA applicants to submit such • Federal eRulemaking Portal: Agency will review this copy, including labeling. asabaliauskas on DSKBBXCHB2PROD with NOTICES https://www.regulations.gov. Follow the the claimed confidential information, in Dated: September 27, 2017. instructions for submitting comments. its consideration of comments. The Anna K. Abram, Comments submitted electronically, second copy, which will have the including attachments, to https:// claimed confidential information Deputy Commissioner for Policy, Planning, www.regulations.gov will be posted to redacted/blacked out, will be available Legislation, and Analysis. the docket unchanged. Because your for public viewing and posted on [FR Doc. 2017–21174 Filed 10–2–17; 8:45 am] comment will be made public, you are https://www.regulations.gov. Submit BILLING CODE 4164–01–P solely responsible for ensuring that your both copies to the Dockets Management comment does not include any Staff. If you do not wish your name and VerDate Sep<11>2014 16:49 Oct 02, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1

46072 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices contact information to be made publicly This draft guidance reflects a unified These collections of information are available, you can provide this approach to all formal meetings between subject to review by the Office of information on the cover sheet and not FDA and ANDA applicants or Management and Budget (OMB) under in the body of your comments and you prospective ANDA applicants for the Paperwork Reduction Act of 1995 must identify this information as complex products. This draft guidance (44 U.S.C. 3501–3520). The collection of ‘‘confidential.’’ Any information marked is intended to assist ANDA applicants information has been approved under as ‘‘confidential’’ will not be disclosed and prospective ANDA applicants in OMB control number 0910–0797. except in accordance with 21 CFR 10.20 generating and submitting to FDA a III. Electronic Access and other applicable disclosure law. For meeting request and the associated more information about FDA’s posting meeting package for these complex Persons with access to the internet of comments to public dockets, see 80 products, as defined in this guidance, to may obtain the draft guidance at either FR 56469, September 18, 2015, or access be submitted under section 505(j) of the https://www.fda.gov/Drugs/Guidance the information at: https://www.gpo.gov/ FD&C Act (21 U.S.C 355(j)) and as ComplianceRegulatoryInformation/ fdsys/pkg/FR-2015-09-18/pdf/2015- contemplated in GDUFA II. Guidances/default.htm or https://www. 23389.pdf. As part of the commitments FDA regulations.gov. Docket: For access to the docket to made in connection with GDUFA II, Dated: September 28, 2017. read background documents or the FDA agreed to develop a program to Anna K. Abram, electronic and written/paper comments assist ANDA applicants and prospective Deputy Commissioner for Policy, Planning, received, go to https:// ANDA applicants of complex products Legislation, and Analysis. www.regulations.gov and insert the before the submission of an ANDA to [FR Doc. 2017–21190 Filed 10–2–17; 8:45 am] docket number, found in brackets in the FDA. As stated in the ‘‘GDUFA BILLING CODE 4164–01–P heading of this document, into the Reauthorization Performance Goals and ‘‘Search’’ box and follow the prompts Program Enhancements Fiscal Years and/or go to the Dockets Management 2018–2022’’ (GDUFA II Goals or DEPARTMENT OF HEALTH AND Staff, 5630 Fishers Lane, Rm. 1061, Commitment Letter), this pre-ANDA HUMAN SERVICES Rockville, MD 20852. program is intended to: You may submit comments on any . . . clarify regulatory expectations for Food and Drug Administration guidance at any time (see 21 CFR prospective applicants early in product development, assist applicants to develop [Docket No. FDA–2017–D–5846] 10.115(g)(5)). more complete submissions, promote a more Submit written requests for single efficient and effective ANDA review process, Abbreviated New Drug Applications copies of the draft guidance to the and reduce the number of review cycles Submissions—Refuse-To-Receive Division of Drug Information, Center for required to obtain ANDA approval, Standards: Questions and Answers; Drug Evaluation and Research, Food particularly for [complex products](GDUFA Draft Guidance for Industry; and Drug Administration, 10001 New II Commitment Letter at 14). Availability Hampshire Ave., Hillandale Building, To facilitate development of complex 4th Floor, Silver Spring, MD 20993– AGENCY: Food and Drug Administration, products that may be submitted in an 0002. Send one self-addressed adhesive HHS. ANDA, FDA and industry agreed to a label to assist that office in processing series of meetings between ANDA ACTION: Notice of availability. your requests. See the SUPPLEMENTARY applicants and prospective ANDA INFORMATION section for electronic SUMMARY: The Food and Drug applicants and FDA to discuss the Administration (FDA or Agency) is access to the draft guidance document. proposed complex product and support announcing the availability of a draft FOR FURTHER INFORMATION CONTACT: submission of a high-quality, guidance for industry entitled ‘‘ANDA Elizabeth Giaquinto Friedman, Center approvable ANDA. Submissions—Refuse-to-Receive for Drug Evaluation and Research, Food In addition to developing a robust Standards: Questions and Answers.’’ and Drug Administration, 10903 New pre-ANDA program, FDA agreed to This draft guidance is intended to assist Hampshire Ave., Bldg. 75, Rm. 1670, respond to requests for and conduct applicants preparing to submit Silver Spring, MD 20993–0002, 240– meetings related to the development of abbreviated new drug applications 402–7930, elizabeth.giaquinto@ complex products submitted on or after (ANDAs) and certain prior approval fda.hhs.gov. October 1, 2017, within specific supplements (PASs) to ANDAs. This timeframes. SUPPLEMENTARY INFORMATION: This draft guidance is being issued guidance provides answers to questions consistent with FDA’s good guidance we have received from applicants I. Background regarding the guidance for industry, practices regulation (21 CFR 10.115). FDA is announcing the availability of The draft guidance, when finalized, will ‘‘ANDA Submissions—Refuse-to- a draft guidance for industry entitled represent the current thinking of FDA Receive Standards’’ (RTR Standards ‘‘Formal Meetings Between FDA and on ‘‘Formal Meetings Between FDA and guidance). The questions and answers ANDA Applicants of Complex Products ANDA Applicants of Complex Products address general issues about the Under GDUFA.’’ This draft guidance Under GDUFA.’’ It does not establish organization of an ANDA, filing describes an enhanced pathway for any rights for any person and is not decisions made by FDA, the review of and deficiencies related to Drug Master asabaliauskas on DSKBBXCHB2PROD with NOTICES discussions between FDA and an binding on FDA or the public. You can applicant (or prospective applicant) use an alternative approach if it satisfies Files (DMFs), product quality, and preparing to submit an ANDA for a the requirements of the applicable bioequivalence (BE) and clinical complex product to FDA. Specifically, statutes and regulations. reviews, and are intended to clarify the this draft guidance provides information deficiencies that may cause FDA to on requesting and conducting product II. Paperwork Reduction Act of 1995 refuse to receive (RTR) an ANDA. development meetings, pre-submission This draft guidance refers to DATES: Submit either electronic or meetings, and mid-review-cycle previously approved collections of written comments on the draft guidance meetings with FDA. information found in FDA regulations. by December 4, 2017 to ensure that the VerDate Sep<11>2014 16:49 Oct 02, 2017 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1


Document Created: 2017-10-03 01:01:48
Document Modified: 2017-10-03 01:01:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactElizabeth 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]
FR Citation82 FR 46071 
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