Proposed Criteria for “First Generic” Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User Fee Amendments; Establishment of a Public Docket, 68891-68892 [2014-27385]

Download as PDF Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 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: Charu Mullick, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6365, Silver Spring, MD 20993–0002, 301– 796–1500. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Vaginal Microbicides: Development for the Prevention of HIV Infection.’’ This guidance addresses nonclinical development, early phases of clinical development, phase 3 trial considerations, and safety considerations in vaginal microbicide development including safety considerations in adolescent and pregnant populations. The guidance also outlines development of combination microbicide products such as drug-drug combinations, drug-device combinations, or combination products that include microbicide and are intended for multiple indications. This guidance finalizes the draft guidance issued on November 23, 2012 (77 FR 70167). The majority of public comments submitted to the docket were related to clinical trial considerations and nonclinical pharmacology/ toxicology issues. This guidance incorporates FDA responses to the public comments. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on developing vaginal microbicides for preventing HIV transmission. 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. mstockstill on DSK4VPTVN1PROD with NOTICES II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 312 have been approved under 0910–0014, and the collections of information referred to in the guidance for clinical trial VerDate Sep<11>2014 16:16 Nov 18, 2014 Jkt 235001 sponsors entitled ‘‘Establishment and Operation of Clinical Trial Data Monitoring Committees’’ have been approved under 0910–0581. II. Comments Interested persons may submit either electronic comments regarding this document to http://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 http:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: November 13, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–27287 Filed 11–18–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1741] Proposed Criteria for ‘‘First Generic’’ Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User Fee Amendments; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. Notice; establishment of public docket; request for comments. ACTION: The Food and Drug Administration (FDA or the Agency) is announcing the opening of a public docket and requesting comments on proposed criteria for ‘‘first generic’’ abbreviated new drug application (ANDA) submissions. The purpose is to facilitate FDA’s establishment of review prioritization under the Generic Drug User Fee Amendments of 2012 (GDUFA). Establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 68891 under GDUFA. Clear criteria for this category will also lead to less industry confusion and more consistent identification of ‘‘first generic’’ submissions. DATES: Submit either electronic or written comments by December 19, 2014. ADDRESSES: You may submit comments by any of the following methods: Electronic Submissions Submit electronic comments as follows: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written comments as follows: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions must include the Docket No. found in brackets in the heading of this document. All comments received may be posted without change to http:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http:// 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 or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Maryll Toufanian, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1682, Silver Spring, MD 20993–0002, 240– 402–7944. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, GDUFA (Title III of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112– 144)) was signed into law by the President. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and to reduce costs to industry. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges. An attendant E:\FR\FM\19NON1.SGM 19NON1 mstockstill on DSK4VPTVN1PROD with NOTICES 68892 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices commitment letter enumerates the performance efficiencies, metric goals, and procedures to which FDA agreed for the GDUFA program (Commitment Letter).1 In a portion of the Commitment Letter relevant to this notice, FDA agreed to: (1) Expedite review of ANDAs in the year 1 and year 2 cohorts (i.e., those ANDAs submitted in fiscal year (FY) 2013 and FY2014, respectively) that are submitted on the first day that any valid paragraph IV application for the drug in question is submitted (firstto-file ANDA); (2) strive to review and act on all first-to-file ANDAs within 30 months of submission to avoid inadvertent forfeiture of 180-day exclusivity eligibility under section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)); and (3) expedite review of ‘‘first generic’’ ANDAs for which there are no blocking patents or exclusivities. To help meet the goals in the Commitment Letter, FDA will prioritize ANDA reviews in conformance with the recently issued Manual of Policies and Procedures (MAPP) 5240.3 Rev. I: Prioritization of the Review of Original ANDAs, Amendments, and Supplements; and MAPP 5200.4: Criteria and Procedures for Managing the Review of Original ANDAs, Amendments and Supplements.2 These MAPPs contemplate FDA prioritizing its ANDA reviews in a manner consistent with the provisions of the Commitment Letter, which identify certain types of submissions, including ‘‘first generic’’ ANDA submissions, as representing public health priorities that will receive expedited review. The MAPPs also expressly describe prioritization of the ANDA types described previously. Subsequent to enactment of GDUFA, FDA has received informal comments on the Commitment Letter from several stakeholders that conveyed different understandings of the criteria for the ‘‘first generic’’ review prioritization category. For example, stakeholders have characterized a ‘‘first generic’’ as the first ANDA submitted, the first ANDA approved, the first ANDA marketed, all first-to-file ANDAs, and a company’s ‘‘top priority’’ ANDA. Without clear criteria for this category, there is the potential for confusion and inconsistent review prioritization. On September 17, 2014, FDA’s Office of Generic Drugs held a public hearing to solicit public comment on certain 1 http://www.fda.gov/downloads/ForIndustry/ UserFees/GenericDrugUserFees/UCM282505.pdf. 2 http://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ ManualofPoliciesProcedures/. VerDate Sep<11>2014 16:16 Nov 18, 2014 Jkt 235001 topics related to implementation of GDUFA.3 The hearing provided an opportunity for public input on future policy priorities. At that hearing, FDA solicited comment on the specific criteria FDA should apply to identify an ANDA as a ‘‘first generic’’ eligible for expedited review. FDA has considered comments provided at that hearing and submitted to the related public docket. Today, FDA is announcing proposed criteria for the review prioritization category of ‘‘first generic’’ ANDA submissions. II. Request for Comments and Supporting Information FDA is requesting comments and supporting information on the following criteria for a ‘‘first generic’’ ANDA for the purposes of review prioritization. A first generic application is any received ANDA 4: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product. FDA believes that these proposed criteria appropriately focus FDA’s resources on approving as quickly as possible, new safe and effective generic drug products for patient use. The Agency also believes that these criteria are consistent with the broad scope of the Commitment Letter, and generally reflect industry intent. Finally, these criteria enable FDA to prioritize review of a pending ANDA when the date on which the ANDA can be approved alters due to changes in the patent or exclusivity landscape. We note that under these proposed criteria, ‘‘first generic’’ status is predicated largely on circumstances outside Agency control, and ones that may change while the ANDA is pending, for example, developments related to the disposition of related patent litigation. Accordingly, FDA also is seeking comments and supporting information on mechanisms the Agency could put in place to facilitate ANDA sponsor submission of such relevant information in a timely manner, in addition to that already required under the regulations. We also note that as a result of such developments, ANDA submissions that originally met the criteria for a ‘‘first 3 https://www.federalregister.gov/articles/2014/ 08/19/2014-19632/generic-drug-user-feeamendments-of-2012-public-hearing-on-policydevelopment-request-for-comments#footnote-4. 4 FDA evaluates each submitted ANDA individually to determine whether the ANDA can be received. The receipt of an ANDA means that FDA made a threshold determination that the ANDA is sufficiently complete to permit a substantive review. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 generic’’ submission may no longer meet those criteria; for example, the validity of a patent may be upheld in litigation, thereby blocking approval until patent expiry. We thus are seeking comment on whether FDA should change the review prioritization for an ANDA that no longer meets the ‘‘first generic’’ criteria during its review. III. Comments Interested persons may submit either electronic comments regarding this document to http://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 http:// www.regulations.gov. Dated: November 13, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–27385 Filed 11–18–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Detection of Infectious Prion Protein by Seeded Conversion of Recombinant Prion Protein AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Amprion, Inc. located in Houston Texas, USA, to practice the inventions embodied in the following Patents and Patent Applications, each entitled ‘‘Detection of Infectious Prion Protein by Seeded Conversion of Recombinant Prion Protein’’: 1. US provisional Application 60/ 961,364 filed July 20, 2007 [HHS Ref. No. E–109–2007/0–US–01] 2. PCT/US2008/070656, filed July 21, 2008; [HHS Ref. No E–109–2007/1– PCT–01] 3. EPC application No 08796382.3 filed July 21, 2008 [HHS Ref. No E–109– 2007/1–EP–03] SUMMARY: E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68891-68892]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27385]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1741]


Proposed Criteria for ``First Generic'' Submissions for Purposes 
of Abbreviated New Drug Application Review Prioritization Under the 
Generic Drug User Fee Amendments; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the opening of a public docket and requesting comments on 
proposed criteria for ``first generic'' abbreviated new drug 
application (ANDA) submissions. The purpose is to facilitate FDA's 
establishment of review prioritization under the Generic Drug User Fee 
Amendments of 2012 (GDUFA). Establishing clear criteria for this review 
prioritization category will allow FDA to appropriately prioritize ANDA 
submissions and track them in a manner consistent with the review 
prioritization commitments FDA made under GDUFA. Clear criteria for 
this category will also lead to less industry confusion and more 
consistent identification of ``first generic'' submissions.

DATES: Submit either electronic or written comments by December 19, 
2014.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments as follows:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written comments as follows:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions must include the Docket No. found in 
brackets in the heading of this document. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://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 or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Maryll Toufanian, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1682, Silver Spring, MD 20993-0002, 240-
402-7944.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, GDUFA (Title III of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144)) was signed 
into law by the President. GDUFA is designed to speed the delivery of 
safe and effective generic drugs to the public and to reduce costs to 
industry. GDUFA is based on an agreement negotiated by FDA and 
representatives of the generic drug industry to address a growing 
number of regulatory challenges. An attendant

[[Page 68892]]

commitment letter enumerates the performance efficiencies, metric 
goals, and procedures to which FDA agreed for the GDUFA program 
(Commitment Letter).\1\ In a portion of the Commitment Letter relevant 
to this notice, FDA agreed to: (1) Expedite review of ANDAs in the year 
1 and year 2 cohorts (i.e., those ANDAs submitted in fiscal year (FY) 
2013 and FY2014, respectively) that are submitted on the first day that 
any valid paragraph IV application for the drug in question is 
submitted (first-to-file ANDA); (2) strive to review and act on all 
first-to-file ANDAs within 30 months of submission to avoid inadvertent 
forfeiture of 180-day exclusivity eligibility under section 
505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)(D)(i)(IV)); and (3) expedite review of ``first 
generic'' ANDAs for which there are no blocking patents or 
exclusivities.
---------------------------------------------------------------------------

    \1\ http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.
---------------------------------------------------------------------------

    To help meet the goals in the Commitment Letter, FDA will 
prioritize ANDA reviews in conformance with the recently issued Manual 
of Policies and Procedures (MAPP) 5240.3 Rev. I: Prioritization of the 
Review of Original ANDAs, Amendments, and Supplements; and MAPP 5200.4: 
Criteria and Procedures for Managing the Review of Original ANDAs, 
Amendments and Supplements.\2\ These MAPPs contemplate FDA prioritizing 
its ANDA reviews in a manner consistent with the provisions of the 
Commitment Letter, which identify certain types of submissions, 
including ``first generic'' ANDA submissions, as representing public 
health priorities that will receive expedited review. The MAPPs also 
expressly describe prioritization of the ANDA types described 
previously.
---------------------------------------------------------------------------

    \2\ http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/.
---------------------------------------------------------------------------

    Subsequent to enactment of GDUFA, FDA has received informal 
comments on the Commitment Letter from several stakeholders that 
conveyed different understandings of the criteria for the ``first 
generic'' review prioritization category. For example, stakeholders 
have characterized a ``first generic'' as the first ANDA submitted, the 
first ANDA approved, the first ANDA marketed, all first-to-file ANDAs, 
and a company's ``top priority'' ANDA. Without clear criteria for this 
category, there is the potential for confusion and inconsistent review 
prioritization.
    On September 17, 2014, FDA's Office of Generic Drugs held a public 
hearing to solicit public comment on certain topics related to 
implementation of GDUFA.\3\ The hearing provided an opportunity for 
public input on future policy priorities. At that hearing, FDA 
solicited comment on the specific criteria FDA should apply to identify 
an ANDA as a ``first generic'' eligible for expedited review. FDA has 
considered comments provided at that hearing and submitted to the 
related public docket. Today, FDA is announcing proposed criteria for 
the review prioritization category of ``first generic'' ANDA 
submissions.
---------------------------------------------------------------------------

    \3\ https://www.federalregister.gov/articles/2014/08/19/2014-19632/generic-drug-user-fee-amendments-of-2012-public-hearing-on-policy-development-request-for-comments#footnote-4.
---------------------------------------------------------------------------

II. Request for Comments and Supporting Information

    FDA is requesting comments and supporting information on the 
following criteria for a ``first generic'' ANDA for the purposes of 
review prioritization. A first generic application is any received ANDA 
\4\: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, 
or for which there are no blocking patents or exclusivities; and (2) 
for which there is no previously-approved ANDA for the drug product.
---------------------------------------------------------------------------

    \4\ FDA evaluates each submitted ANDA individually to determine 
whether the ANDA can be received. The receipt of an ANDA means that 
FDA made a threshold determination that the ANDA is sufficiently 
complete to permit a substantive review.
---------------------------------------------------------------------------

    FDA believes that these proposed criteria appropriately focus FDA's 
resources on approving as quickly as possible, new safe and effective 
generic drug products for patient use. The Agency also believes that 
these criteria are consistent with the broad scope of the Commitment 
Letter, and generally reflect industry intent. Finally, these criteria 
enable FDA to prioritize review of a pending ANDA when the date on 
which the ANDA can be approved alters due to changes in the patent or 
exclusivity landscape.
    We note that under these proposed criteria, ``first generic'' 
status is predicated largely on circumstances outside Agency control, 
and ones that may change while the ANDA is pending, for example, 
developments related to the disposition of related patent litigation. 
Accordingly, FDA also is seeking comments and supporting information on 
mechanisms the Agency could put in place to facilitate ANDA sponsor 
submission of such relevant information in a timely manner, in addition 
to that already required under the regulations.
    We also note that as a result of such developments, ANDA 
submissions that originally met the criteria for a ``first generic'' 
submission may no longer meet those criteria; for example, the validity 
of a patent may be upheld in litigation, thereby blocking approval 
until patent expiry.
    We thus are seeking comment on whether FDA should change the review 
prioritization for an ANDA that no longer meets the ``first generic'' 
criteria during its review.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://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 http://www.regulations.gov.

    Dated: November 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27385 Filed 11-18-14; 8:45 am]
BILLING CODE 4164-01-P