Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Prior Approval Supplements Under the Generic Drug User Fee Amendments of 2012; Availability, 40112-40113 [2014-16236]

Download as PDF 40112 Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA.’’ The guidance document is intended to assist applicants in preparing to submit to FDA amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by explaining how the Generic Drug User Fee Amendments of 2012 (GDUFA) performance metric goals apply to these submissions. When finalized, this guidance will replace the December 2001 guidance for industry entitled ‘‘Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications’’ in consideration of the new amendment review tier system and performance goals under GDUFA. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 9, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002 or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993–0002, 240– 402–7930, Elizabeth.Giaquinto@ fda.hhs.gov or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:23 Jul 10, 2014 Jkt 232001 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911, stephen.ripley@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA.’’ On July 9, 2012, GDUFA (Pub. L. 112–144, Title III) was signed into law by the President to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. Under GDUFA, FDA agreed to certain performance goals and procedures for the review of amendments submitted to original ANDAs and PASs filed on or after October 1, 2014. This draft guidance describes how FDA intends to classify major amendments, minor amendments, and easily correctable deficiencies (ECDs). Specifically, the draft guidance defines the types of amendments and describes the GDUFA performance metric goals for the amendment tiers, the process for submitting amendments, and dispute resolution procedures regarding amendment classifications. In accordance with the Commitment Letter, the GDUFA performance metrics described in the draft guidance only apply to amendments to original ANDAs and PASs submitted on or after October 1, 2014, and do not apply to amendments submitted on or after October 1, 2014, that amend original ANDAs or PASs submitted before October 1, 2014. Elsewhere in this issue of the Federal Register, FDA is announcing another draft guidance entitled ‘‘ANDA Submissions—Prior Approval Supplements Under GDUFA,’’ which describes FDA’s performance metric goals and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA. 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 Agency 02BC;s current thinking on ‘‘ANDA Submissions— Amendments and Easily Correctable Deficiencies Under GDUFA.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 collections of information in 21 CFR 314.96 have been approved under OMB control number 0910–0001. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. Dated: July 8, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–16235 Filed 7–10–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0901] Draft Guidance for Industry on Abbreviated New Drug Application Submissions—Prior Approval Supplements Under the Generic Drug User Fee Amendments of 2012; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘ANDA Submissions—Prior Approval SUMMARY: E:\FR\FM\11JYN1.SGM 11JYN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices Supplements Under GDUFA.’’ The Generic Drug User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to fund critical and measurable improvements to FDA’s generic drugs program. This draft guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA’s performance metric goals for PASs and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 9, 2014. ADDRESSES: Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002, or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, 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. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Benjamin Chacko, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993–0002, 240– 402–7924 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘ANDA Submissions—Prior Approval Supplements Under GDUFA.’’ On July VerDate Mar<15>2010 20:23 Jul 10, 2014 Jkt 232001 9, 2012, the President signed GDUFA (Pub. L. 112–144, Title III) into law. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges. GDUFA aims to ensure timely access to safe, high-quality, lowcost generic drugs. GDUFA enables FDA to assess user fees to fund critical and measurable improvements to FDA’s generic drugs program and to bring greater predictability and timeliness to the review of generic drug applications. GDUFA requires that FDA and human generic drug manufacturers meet certain commitments. In the GDUFA Commitment Letter, FDA committed to review and act on a certain percentage of PASs within a specified time period from the date of submission for receipts in fiscal years (FY) 2015–2017. The percentage of PASs that FDA has committed to review and act on varies for each fiscal year, and the deadlines for review depend on whether a PAS requires an inspection. This draft guidance describes the performance metric goals that FDA agreed to in the Commitment Letter and clarifies how FDA will review a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals. The GDUFA performance metrics described in this draft guidance only apply to ANDA applicants that submit a PAS on or after October 1, 2014. These performance metrics do not apply to new drug applications (NDAs), biologics license applications (BLAs), supplements filed for NDAs or BLAs, or changes being effected (CBE) supplements and annual report filings to NDAs, BLAs, or ANDAs. Elsewhere in this issue of the Federal Register, FDA is publishing another draft guidance entitled ‘‘ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA,’’ which explains how the GDUFA performance metric goals apply to amendments made to ANDAs and to PASs. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance, when finalized, will represent the Agency’s current thinking on how GDUFA relates to prior approval supplements for ANDAs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 40113 II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that 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 for supplements and amendments in 21 CFR part 314 have been approved under OMB control number 0910–0001. The collection of information for manufacturer registration in 21 CFR part 207 has been approved under OMB control number 0910–0045. The collection of information for manufacturer compliance with current good manufacturing practices in 21 CFR part 211 has been approved under OMB control number 0910–0139. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidance/default.htm, or https://www.regulations.gov. Dated: July 8, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–16236 Filed 7–10–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0894] 2014 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. E:\FR\FM\11JYN1.SGM 11JYN1

Agencies

[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40112-40113]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16236]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0901]

Draft Guidance for Industry on Abbreviated New Drug Application
Submissions--Prior Approval Supplements Under the Generic Drug User Fee
Amendments of 2012; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``ANDA
Submissions--Prior Approval

[[Page 40113]]

Supplements Under GDUFA.'' The Generic Drug User Fee Amendments of 2012
(GDUFA) enables FDA to assess user fees to fund critical and measurable
improvements to FDA's generic drugs program. This draft guidance is
intended to assist applicants preparing to submit to FDA prior approval
supplements (PASs) and amendments to PASs for abbreviated new drug
applications (ANDAs). It describes FDA's performance metric goals for
PASs and clarifies how FDA will handle a PAS and amendments to a PAS
for an ANDA subject to the GDUFA performance metric goals.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 9, 2014.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71,
rm. 3128, 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.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Benjamin Chacko, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 240-
402-7924 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``ANDA Submissions--Prior Approval Supplements Under GDUFA.''
On July 9, 2012, the President signed GDUFA (Pub. L. 112-144, Title
III) into law. GDUFA is based on an agreement negotiated by FDA and
representatives of the generic drug industry to address a growing
number of regulatory challenges. GDUFA aims to ensure timely access to
safe, high-quality, low-cost generic drugs. GDUFA enables FDA to assess
user fees to fund critical and measurable improvements to FDA's generic
drugs program and to bring greater predictability and timeliness to the
review of generic drug applications.
GDUFA requires that FDA and human generic drug manufacturers meet
certain commitments. In the GDUFA Commitment Letter, FDA committed to
review and act on a certain percentage of PASs within a specified time
period from the date of submission for receipts in fiscal years (FY)
2015-2017. The percentage of PASs that FDA has committed to review and
act on varies for each fiscal year, and the deadlines for review depend
on whether a PAS requires an inspection.
This draft guidance describes the performance metric goals that FDA
agreed to in the Commitment Letter and clarifies how FDA will review a
PAS and amendments to a PAS for an ANDA subject to the GDUFA
performance metric goals. The GDUFA performance metrics described in
this draft guidance only apply to ANDA applicants that submit a PAS on
or after October 1, 2014. These performance metrics do not apply to new
drug applications (NDAs), biologics license applications (BLAs),
supplements filed for NDAs or BLAs, or changes being effected (CBE)
supplements and annual report filings to NDAs, BLAs, or ANDAs.
Elsewhere in this issue of the Federal Register, FDA is publishing
another draft guidance entitled ``ANDA Submissions--Amendments and
Easily Correctable Deficiencies Under GDUFA,'' which explains how the
GDUFA performance metric goals apply to amendments made to ANDAs and to
PASs.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance, when
finalized, will represent the Agency's current thinking on how GDUFA
relates to prior approval supplements for ANDAs. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information that 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 for supplements and amendments in
21 CFR part 314 have been approved under OMB control number 0910-0001.
The collection of information for manufacturer registration in 21 CFR
part 207 has been approved under OMB control number 0910-0045. The
collection of information for manufacturer compliance with current good
manufacturing practices in 21 CFR part 211 has been approved under OMB
control number 0910-0139.

III. Comments

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidance/default.htm, or https://www.regulations.gov.

Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16236 Filed 7-10-14; 8:45 am]
BILLING CODE 4164-01-P

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