Product-Specific Guidance Meetings Between the Food and Drug Administration and Abbreviated New Drug Applicants Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability, 10523-10525 [2023-03517]

Download as PDF Federal Register / Vol. 88, No. 34 / Tuesday, February 21, 2023 / Notices Silver Spring, MD 20993–0002, 240– 402–4078, Alexandria.Fujisaki@ fda.hhs.gov. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. TOPAMAX (topiramate) sprinkle capsules, 50 mg, is the subject of NDA 020844, held by Janssen Pharmaceuticals, Inc., and initially approved on October 26, 1998. TOPAMAX is indicated for epilepsy (initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older) and preventive treatment of migraine in patients 12 years of age and older. lotter on DSK11XQN23PROD with NOTICES1 SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:54 Feb 17, 2023 Jkt 259001 Janssen Pharmaceuticals, Inc., has never marketed TOPAMAX (topiramate) sprinkle capsules, 50 mg. In previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996), the Agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated August 17, 2022 (Docket No. FDA– 2022–P–1939), under 21 CFR 10.30, requesting that the Agency determine whether TOPAMAX (topiramate) sprinkle capsules, 50 mg, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that TOPAMAX (topiramate) sprinkle capsules, 50 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that TOPAMAX (topiramate) sprinkle capsules, 50 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of TOPAMAX (topiramate) sprinkle capsules, 50 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list TOPAMAX (topiramate) sprinkle capsules, 50 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to TOPAMAX (topiramate) sprinkle capsules, 50 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: February 15, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–03516 Filed 2–17–23; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 10523 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–0044] Product-Specific Guidance Meetings Between the Food and Drug Administration and Abbreviated New Drug Applicants Under the Generic Drug User Fee Act; Draft 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 draft guidance for industry entitled ‘‘ProductSpecific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.’’ This draft guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, this draft guidance provides information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as contemplated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027 (GDUFA III commitment letter). This draft guidance is intended to provide procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter. SUMMARY: Submit either electronic or written comments on the draft guidance by April 24, 2023 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: DATES: 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:// E:\FR\FM\21FEN1.SGM 21FEN1 10524 Federal Register / Vol. 88, No. 34 / Tuesday, February 21, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 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– 2023–D–0044 for ‘‘Product-Specific Guidance 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, 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 VerDate Sep<11>2014 17:54 Feb 17, 2023 Jkt 259001 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 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: David Coppersmith, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring MD 20993–0002, 301– 796–9193. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.’’ The Generic Drug User Fee Amendments (GDUFA I) amended the FD&C Act to authorize FDA to assess and collect user fees to provide the Agency with resources to help ensure patients have access to quality, affordable, safe, and effective generic drugs. GDUFA fee resources bring greater predictability and timeliness to PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 the review of generic drug applications. GDUFA must be reauthorized every 5 years to continue FDA’s ability to assess and collect GDUFA fees and this user fee program has been reauthorized two times since GDUFA I, most recently in the Generic Drug User Fee Amendments of 2022 (GDUFA III). As described in the GDUFA III commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals and program enhancements regarding aspects of the generic drug assessment program that build on previous authorizations of GDUFA. 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 ANDAs and facilitating timely access to generic medicines for American patients. To receive approval for an ANDA submitted under section 505(j) of the FD&C Act, an applicant generally must demonstrate, among other things, that its proposed drug product is bioequivalent to the reference listed drug (RLD). As noted in 21 CFR 320.24, in vivo and/or in vitro methods can be used to establish bioequivalence (BE). FDA recommends that applicants consult published PSGs when considering an appropriate BE study and/or other studies for a proposed drug product. PSGs provide recommendations for developing generic drug products and describe FDA’s current thinking on the evidence needed to demonstrate that an ANDA is therapeutically equivalent to the specific RLD product. As described in the GDUFA III commitment letter, FDA agreed to certain time frames and procedures for scheduling and conducting: (1) PSG teleconferences to provide feedback on the potential impact of a new or revised PSG on the applicant’s development program and (2) pre-submission PSG meetings and post-submission PSG meetings to provide a forum in which the applicant can discuss the scientific rationale for an approach other than the approach recommended in the PSG to ensure that the approach complies with the relevant statutes and regulations. 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 ‘‘Product-Specific Guidance 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 E:\FR\FM\21FEN1.SGM 21FEN1 Federal Register / Vol. 88, No. 34 / Tuesday, February 21, 2023 / Notices it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collection of information are subject to review by OMB under the PRA. The collections of information pertaining to the submissions of controlled correspondence, GDUFA III commitment letter, and meetings related to generic drug development have been approved under OMB control number 0910–0797. The collections of information pertaining to the Generic Drug User Fee Program have been approved under OMB control number 0910–0727. 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 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: February 15, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–03517 Filed 2–17–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–P–2438] Determination That ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. lotter on DSK11XQN23PROD with NOTICES1 ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means SUMMARY: VerDate Sep<11>2014 17:54 Feb 17, 2023 Jkt 259001 that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Donna Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993–0002, 301–796–3600, Donna.Tran@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. ASACOL HD (Mesalamine) DelayedRelease Tablet, 800 mg, is the subject of NDA 021830, held by Allergan Pharmaceuticals International Ltd., and initially approved on May 29, 2008. ASACOL HD is indicated for the PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 10525 treatment of moderately active ulcerative colitis in adults. In a letter dated May 13, 2022, Allergan Pharmaceuticals International Ltd. notified FDA that ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 mg, was being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Aurobindo Pharma USA, Inc., submitted a citizen petition dated October 4, 2022 (Docket No. FDA–2022– P–2438), under 21 CFR 10.30, requesting that the Agency determine whether ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 mg, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ASACOL HD (Mesalamine) DelayedRelease Tablet, 800 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10523-10525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03517]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0044]

Product-Specific Guidance Meetings Between the Food and Drug
Administration and Abbreviated New Drug Applicants Under the Generic
Drug User Fee Act; Draft 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 draft guidance for industry entitled ``Product-
Specific Guidance Meetings Between FDA and ANDA Applicants Under
GDUFA.'' This draft guidance provides recommendations to industry on
product-specific guidance (PSG) meetings between FDA and a prospective
applicant preparing to submit to FDA or an applicant that has submitted
to FDA an abbreviated new drug application (ANDA) under the Federal
Food, Drug and Cosmetic Act (FD&C Act). Specifically, this draft
guidance provides information on requesting and conducting PSG meetings
with FDA (PSG teleconferences, pre-submission PSG meetings, and post-
submission PSG meetings), as contemplated in the Generic Drug User Fee
Amendments (GDUFA) Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This
draft guidance is intended to provide procedures that will promote
well-managed PSG meetings and help ensure that such meetings are
scheduled and conducted in accordance with the time frames set forth in
the GDUFA III commitment letter.

DATES: Submit either electronic or written comments on the draft
guidance by April 24, 2023 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://

[[Page 10524]]

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-2023-D-0044 for ``Product-Specific Guidance 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, 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 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: David Coppersmith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring MD 20993-0002, 301-
796-9193.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Product-Specific Guidance Meetings Between FDA and ANDA
Applicants Under GDUFA.'' The Generic Drug User Fee Amendments (GDUFA
I) amended the FD&C Act to authorize FDA to assess and collect user
fees to provide the Agency with resources to help ensure patients have
access to quality, affordable, safe, and effective generic drugs. GDUFA
fee resources bring greater predictability and timeliness to the review
of generic drug applications. GDUFA must be reauthorized every 5 years
to continue FDA's ability to assess and collect GDUFA fees and this
user fee program has been reauthorized two times since GDUFA I, most
recently in the Generic Drug User Fee Amendments of 2022 (GDUFA III).
As described in the GDUFA III commitment letter applicable to this
latest reauthorization, FDA has agreed to performance goals and program
enhancements regarding aspects of the generic drug assessment program
that build on previous authorizations of GDUFA. 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 ANDAs and facilitating timely access to generic medicines
for American patients.
To receive approval for an ANDA submitted under section 505(j) of
the FD&C Act, an applicant generally must demonstrate, among other
things, that its proposed drug product is bioequivalent to the
reference listed drug (RLD). As noted in 21 CFR 320.24, in vivo and/or
in vitro methods can be used to establish bioequivalence (BE). FDA
recommends that applicants consult published PSGs when considering an
appropriate BE study and/or other studies for a proposed drug product.
PSGs provide recommendations for developing generic drug products and
describe FDA's current thinking on the evidence needed to demonstrate
that an ANDA is therapeutically equivalent to the specific RLD product.
As described in the GDUFA III commitment letter, FDA agreed to
certain time frames and procedures for scheduling and conducting: (1)
PSG teleconferences to provide feedback on the potential impact of a
new or revised PSG on the applicant's development program and (2) pre-
submission PSG meetings and post-submission PSG meetings to provide a
forum in which the applicant can discuss the scientific rationale for
an approach other than the approach recommended in the PSG to ensure
that the approach complies with the relevant statutes and regulations.
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 ``Product-
Specific Guidance 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

[[Page 10525]]

it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collection of
information are subject to review by OMB under the PRA. The collections
of information pertaining to the submissions of controlled
correspondence, GDUFA III commitment letter, and meetings related to
generic drug development have been approved under OMB control number
0910-0797. The collections of information pertaining to the Generic
Drug User Fee Program have been approved under OMB control number 0910-
0727. 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 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: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03517 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P

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