[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Proposed Rules]
[Pages 49025-49027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19632]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / 
Proposed Rules  

[[Page 49025]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2014-N-1168]


Generic Drug User Fee Amendments of 2012; Public Hearing on 
Policy Development; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing to solicit public comment on certain topics related to 
implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), 
and the GDUFA Commitment Letter that accompanies the legislation. The 
public hearing also will provide an opportunity for public input on 
future policy priorities. FDA is seeking participation in the public 
hearing and written comments from all interested parties, including, 
but not limited to, regulated industry, consumers, patients, 
caregivers, health care professionals, and patient groups.

DATES: The public hearing will be held on September 17, 2014, from 9 
a.m. to 5 p.m. The public hearing may be extended or may end early 
depending on the level of public participation. Submit electronic or 
written requests to make oral presentations at the hearing by September 
3, 2014. Electronic or written comments will be accepted after the 
hearing until October 13, 2014.

ADDRESSES: The public hearing will be held at the College Park Marriott 
Hotel and Conference Center, 3501 University Blvd., East, Hyattsville, 
MD 20783.
    Submit electronic comments to http://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. Identify all comments with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Shaniece Bowens, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1611, 240-402-7923, email: 
[email protected]; or Connie Wisner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1674, 240-402-7946, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Public Law 98-417) (the Hatch-Waxman Amendments) amended the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act). The Hatch-Waxman 
Amendments created section 505(j) of the FD&C Act (21 U.S.C. 355(j)). 
Section 505(j) of the FD&C Act established the abbreviated new drug 
application (ANDA) approval pathway, which allows lower-priced generic 
versions of previously approved innovator drugs to be approved and 
marketed.
    On July 9, 2012, GDUFA was signed into law by the President to help 
speed the delivery of safe and effective generic drugs to the public 
and to reduce costs to industry. Under GDUFA, FDA agreed to certain 
obligations as laid out in the GDUFA Commitment Letter that accompanies 
the legislation.\1\ To support these obligations, FDA is developing 
numerous guidance documents. Thus far, FDA has developed the following 
draft guidances for industry: \2\
---------------------------------------------------------------------------

    \1\ See Generic Drug User Fee Act Program Performance Goals and 
Procedures (GDUFA Commitment Letter) for fiscal years 2013 through 
2017, available at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf).
    \2\ The draft guidance documents referenced in this document are 
available on the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

 ANDA Submissions--Content and Format of ANDAs
 ANDA Submissions--Refuse to Receive for Lack of Proper 
Justification of Impurity Limits
 ANDA Submissions--Amendments and Easily Correctable 
Deficiencies Under GDUFA
 ANDA Submissions--Prior Approval Supplements Under GDUFA
 Controlled Correspondence Related to Generic Drug Development

II. Purpose and Scope of the Public Hearing

A. GDUFA Implementation: Draft Guidance Documents

    The purpose of this public hearing is to (1) solicit public comment 
on the five draft guidance documents described in section I that FDA 
has issued to facilitate implementation of GDUFA and (2) recommend 
future policy priorities, including recommendations for additional 
guidance topics to facilitate GDUFA implementation. We are soliciting 
comments from interested members of the public, including industry, 
consumers, patient groups, caregivers, and health care professionals, 
on the following topics related to GDUFA implementation guidances:
    1. Are there comments on the five draft guidances described in 
section I?
    2. Are there GDUFA implementation issues related to the five draft 
guidances described in section I that have not been addressed?
    3. What other GDUFA implementation topics need the development of 
guidance?
    4. Are there any topics or issues related to generic drug 
development other than those related to GDUFA implementation that need 
the development of guidance?

B. GDUFA Implementation Related to Generic Drug Exclusivity

    Another purpose of this hearing is also to solicit feedback on 
issues that may arise in FDA's consideration of 180-day exclusivity 
provided for in section 505(j)(5)(B)(iv) of the FD&C Act.
    Timing of ANDA approval is directly affected by an applicant's 
eligibility for 180-day exclusivity, and thus FDA's consideration of 
any issues related to 180-day exclusivity is a component of approval 
actions. FDA decisions regarding 180-day exclusivity are fact-specific, 
and the facts that have the potential to determine eligibility for 
exclusivity may shift up to the time when an ANDA that is eligible for 
180-day exclusivity, or another ANDA

[[Page 49026]]

referencing the same listed drug, is ready for approval.
    With the enactment of GDUFA, FDA will take actions on pending 
applications consistent with the timeframes agreed upon in the GDUFA 
Commitment Letter. In this hearing, we are seeking input on possible 
processes FDA might introduce under GDUFA for making determinations on 
180-day exclusivity, as described in the following questions. When 
submitting input on the questions provided in this document, we 
encourage commenters to consider FDA's statutory and regulatory 
authorities, including any restrictions on FDA's authority to disclose 
certain information related to unapproved ANDAs. We are seeking comment 
on the following topics:
    1. Should FDA's consideration of eligibility for 180-day 
exclusivity for a specific drug product be a public process, including 
consideration of whether a first applicant has forfeited its 
eligibility for exclusivity under section 505(j)(5)(D) of the FD&C Act? 
If a public process is advisable, would it be so in all instances, or 
is there a subset of circumstances in which the process should be 
public? Also, what administrative mechanisms would best facilitate such 
a process?
    2. Legal challenges to FDA's decisions on 180-day exclusivity often 
must be resolved on an expedited basis which can be inconvenient for 
the parties and the court. What legal or regulatory mechanisms, if any, 
are available to better facilitate FDA's determination of and orderly 
resolution of sponsors' challenges to 180-day exclusivity 
determinations?
    3. Are there other topics related to 180-day exclusivity on which 
you would like to comment?
    4. Are there topics related to 180-day exclusivity that would 
benefit from FDA guidance?

C. GDUFA Implementation and Potential First Generics

    The GDUFA Commitment Letter also provides that certain ANDAs may be 
identified at the date of submission for expedited review, including 
ANDAs for ``first generic products for which there are no blocking 
patents or exclusivities on the reference listed drug.'' \3\ Subsequent 
to GDUFA's enactment, FDA has received numerous individual stakeholder 
comments on what should qualify as a first generic ANDA for the 
purposes of expedited review. These comments reflect a range of 
options, for example, from a broad definition that would prioritize 
review of all ANDAs for each strength of a Reference Listed Drug 
submitted for which there is not already an approved ANDA at the time 
of submission, to a more narrow definition under which only ANDAs that 
contain a paragraph IV certification and qualify as a ``first 
applicant'' under section 505(j)(5)(B)(iv)(II)(bb) of the FD&C Act 
would be designated as a first generic eligible for expedited review. 
In addition, several stakeholders have indicated that depending on the 
criteria FDA applies, first generic status could or should change over 
time based on other external factors, for example, withdrawal or 
rescission of approval of another applicant's ANDA, or shifts in the 
patent or exclusivity landscape (for example, an unsuccessful patent 
challenge).
---------------------------------------------------------------------------

    \3\ GDUFA Commitment Letter, at 15.
---------------------------------------------------------------------------

    In order to meet the goals in the GDUFA Commitment letter with 
respect to expedited ANDA review, we will be prioritizing ANDA review 
consistent with the recently issued Manual of Policies and Procedures 
(MAPP) 5240.3 Rev. 1: 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.\4\ In order to meet the goals of the GDUFA Commitment 
Letter related to first generics in particular, in a manner that best 
effectuates the intent of the negotiators, we are seeking comment on 
the following questions:
---------------------------------------------------------------------------

    \4\ http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/.
---------------------------------------------------------------------------

    1. What specific criteria should FDA apply to identify an ANDA as a 
first generic eligible for expedited ANDA review?
    2. Are there other topics related to first generics eligible for 
expedited review on which you would like to comment?

III. Attendance, Registration, and Presentations

    Attendance is free and on a first-come, first-served basis. We 
recommend that you register early because seating is limited.
    If you wish to attend the hearing and/or make an oral presentation 
at the hearing, please register and/or send a request for oral 
presentation by email to [email protected] by September 3, 
2014. The email should contain complete contact information for each 
attendee, including name, title, affiliation, address, email address, 
and telephone number. Those without email access may register by 
contacting Shaniece Bowens or Connie Wisner by September 3, 2014 (see 
FOR FURTHER INFORMATION CONTACT).
    Individuals and organizations with common interests should 
consolidate or coordinate their presentations and request time for a 
joint presentation. FDA will do its best to accommodate requests to 
speak and will determine the amount of time allotted for each oral 
presentation, and the approximate time that each oral presentation is 
scheduled to begin. These individuals should identify the section and 
the number of each question they wish to address (see section II) in 
their presentation to help FDA organize the presentations.
    FDA will notify registered presenters of their scheduled 
presentation times, and make available an agenda at http://www.fda.gov/Drugs/NewsEvents/ucm265628.htm approximately 2 weeks before the public 
hearing. Once FDA notifies registered presenters of their scheduled 
times, presenters should submit an electronic copy of their 
presentation to [email protected] by September 9, 2014. 
Persons registered to make an oral presentation should check in before 
the hearing and are encouraged to arrive early to ensure the designated 
order of presentation times.
    If you need special accommodations because of a disability, please 
contact Shaniece Bowens or Connie Wisner (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days before the hearing.

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
hearing will be conducted by a presiding officer, who will be 
accompanied by FDA senior management from the Office of Generic Drugs 
and other relevant Agency components. Under Sec.  15.30(f), the hearing 
is informal and the rules of evidence do not apply. No participant may 
interrupt the presentation of another participant. Only the presiding 
officer and panel members may question any person during or at the 
conclusion of each presentation (Sec.  15.30(e)). Public hearings under 
part 15 are subject to FDA's policy and procedures for electronic media 
coverage of FDA's public administrative proceedings (21 CFR part 10, 
subpart C) (Sec.  10.203(a)). Under Sec.  10.205, representatives of 
the electronic media may be permitted, subject to certain limitations, 
to videotape, film, or otherwise record FDA's public administrative 
proceedings, including presentations by participants. The hearing will 
be transcribed as stipulated in Sec.  15.30(b).

[[Page 49027]]

(See section VI for more details.) To the extent that the conditions 
for the hearing as described in this document conflict with any 
provisions set out in part 15, this notice acts as a waiver of those 
provisions as specified in Sec.  15.30(h).

V. Request for Comments

    Regardless of attendance at the public hearing, interested persons 
may submit either electronic comments 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. To ensure consideration, submit comments by (see DATES). 
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.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (see ADDRESSES). A transcript will 
also be available in either hard copy or on CD-ROM, after submission of 
a Freedom of Information request. Written requests are to be sent to 
the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: August 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19632 Filed 8-15-14; 8:45 am]
BILLING CODE 4164-01-P