Abbreviated New Drug Application Submissions-Prior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability, 71511-71513 [2016-25037]

Download as PDF jstallworth on DSK7TPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Audrey Thomas, Office of Regulatory Science and Innovation, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993–0002, 301–796–3520, Audrey.Thomas@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to provide an opportunity for stakeholders, including scientists from government, academia, and industry, patient advocacy groups, clinicians, pharmacists, and the general public to discuss marketed generic drugs. Generic drugs account for 88 percent of prescriptions in the United States. In light of the significant contributions of generic drugs to public health, it is important that tools are developed to monitor marketed generic drugs to ensure that they have the same safety and effectiveness as their reference listed drug. Specifically, this workshop will include presentations on: (1) Current generic drug surveillance practices at FDA and in industry, (2) public perception of generic drug quality and effectiveness, (3) generic drug substitution studies in patients, and (4) development of methods and tools to conduct postmarket surveillance of generic drugs. The workshop will include four panel sessions for interaction and discussion among the speakers and attendees. Agenda: The agenda is available at https://www.fda.gov/scienceresearch/ specialtopics/regulatoryscience/ ucm521545.htm. Registration: There is no registration fee to attend this public workshop. Seats are limited and registration will be on a first-come, first-served basis. Advance registration is required and is online only at https://www.fda.gov/ scienceresearch/specialtopics/ regulatoryscience/ucm521545.htm. There will be no day-of, onsite registration. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. There is no registration fee for access to the workshop via the Webcast, but registration is still required. Information regarding registration and access to the Webcast link is available at https://www.fda.gov/ scienceresearch/specialtopics/ regulatoryscience/ucm521545.htm. If VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. (FDA has verified these Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Accommodations: Attendees are responsible for their own hotel accommodations. If you need special accommodations while at FDA’s White Oak Campus due to a disability, please contact Shari Solomon at Shari.Solomon@fda.hhs.gov at least 7 days in advance. Dated: October 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25004 Filed 10–14–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0229] Food and Drug Administration, HHS. ACTION: Dated: October 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–24947 Filed 10–14–16; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Notice. [Docket No. FDA–2014–D–0901] The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that EXONDYS 51 (eteplirsen), manufactured by Sarepta Therapeutics, meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Larry Bauer, Rare Diseases Program, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4842, FAX: 301–796–9858, email: larry.bauer@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. SUMMARY: PO 00000 Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that EXONDYS 51 (eteplirsen), manufactured by Sarepta Therapeutics, meets the criteria for a priority review voucher. EXONDYS 51 (eteplirsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about EXONDYS 51 (eteplirsen) go to the ‘‘Drugs@FDA’’ Web site at https://www.accessdata.fda.gov/ scripts/cder/drugsatfda/index.cfm. BILLING CODE 4164–01–P Issuance of Priority Review Voucher; Rare Pediatric Disease Product AGENCY: 71511 Frm 00037 Fmt 4703 Sfmt 4703 Abbreviated New Drug Application Submissions—Prior Approval Supplements Under Generic Drug User Fee Amendments; 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 guidance for industry entitled ‘‘ANDA Submissions—Prior Approval 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 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 SUMMARY: E:\FR\FM\17OCN1.SGM 17OCN1 71512 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices and amendments to a PAS for an ANDA subject to GDUFA performance metric goals. This guidance finalizes the draft guidance issued on July 11, 2014. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments 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’’). jstallworth on DSK7TPTVN1PROD with NOTICES Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2014–D–0901 for ‘‘ANDA Submissions—Prior Approval Supplements 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 Division of Dockets VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 Management 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 Division of Dockets Management. 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.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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; or to 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 guidance document. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Tamara R. Coley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 240–402–6903 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a 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, affordable 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 period from the date of submission for receipts in fiscal years 2015 to 2017. The percentage of PASs that FDA has committed to review and act on increases with each fiscal year, and the deadlines for review depend on whether a PAS requires an inspection. This guidance describes the performance metric goals to which FDA agreed 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 guidance only apply to ANDA applicants who electronically 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 supplements and annual report filings to NDAs, BLAs, or ANDAs. This guidance finalizes the draft guidance that was issued under the same title on July 11, 2014 (79 FR 40112), and reflects FDA’s consideration of public comments on the draft guidance. Generally, FDA revised the E:\FR\FM\17OCN1.SGM 17OCN1 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices draft guidance to provide clarifying and explanatory information that will assist human generic drug manufacturers with PAS submissions. Changes from the draft guidance include clarification on the point at which a PAS is deemed submitted to FDA and a description of the process through which applicants may request FDA reconsider its supplement reporting category determination. The draft guidance and related public comments are publicly available in Docket No. FDA–2014–D– 0901. 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 ‘‘ANDA Submissions—Prior Approval Supplements 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 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 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. jstallworth on DSK7TPTVN1PROD with NOTICES III. Electronic Access Persons with access to the Internet may obtain the guidance 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: October 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25037 Filed 10–14–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 14:22 Oct 14, 2016 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0598] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for manufacturers of Type A medicated articles. SUMMARY: Submit either electronic or written comments on the collection of information by December 16, 2016. ADDRESSES: You may submit comments 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:// 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 71513 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2010–N–0598] for ‘‘[Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles].’’ 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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/ E:\FR\FM\17OCN1.SGM 17OCN1

Agencies

[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71511-71513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25037]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Abbreviated New Drug Application Submissions--Prior Approval 
Supplements 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 guidance for industry entitled ``ANDA 
Submissions--Prior Approval 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 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

[[Page 71512]]

and amendments to a PAS for an ANDA subject to GDUFA performance metric 
goals. This guidance finalizes the draft guidance issued on July 11, 
2014.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2014-D-0901 for ``ANDA Submissions--Prior Approval Supplements 
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 Division of Dockets 
Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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; or to 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Tamara R. Coley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20903, 240-402-6903 or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a 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, affordable 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 
period from the date of submission for receipts in fiscal years 2015 to 
2017. The percentage of PASs that FDA has committed to review and act 
on increases with each fiscal year, and the deadlines for review depend 
on whether a PAS requires an inspection.
    This guidance describes the performance metric goals to which FDA 
agreed 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 guidance 
only apply to ANDA applicants who electronically 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 
supplements and annual report filings to NDAs, BLAs, or ANDAs.
    This guidance finalizes the draft guidance that was issued under 
the same title on July 11, 2014 (79 FR 40112), and reflects FDA's 
consideration of public comments on the draft guidance. Generally, FDA 
revised the

[[Page 71513]]

draft guidance to provide clarifying and explanatory information that 
will assist human generic drug manufacturers with PAS submissions. 
Changes from the draft guidance include clarification on the point at 
which a PAS is deemed submitted to FDA and a description of the process 
through which applicants may request FDA reconsider its supplement 
reporting category determination. The draft guidance and related public 
comments are publicly available in Docket No. FDA-2014-D-0901.
    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 ``ANDA Submissions--Prior Approval 
Supplements 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 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 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. Electronic Access

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

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25037 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.