[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Notices]
[Pages 6004-6005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03193]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0248]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Formal Dispute Resolution; Appeals Above the Division Level

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
27, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0430. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Formal Dispute Resolution; Appeals Above the Division Level; OMB 
Control Number 0910-0430--Extension

    This approval request is for information collection found in the 
FDA guidance document entitled, ``Formal Dispute Resolution: Sponsor 
Appeals Above the Division Level Guidance for Industry and Review 
Staff.'' The guidance document discusses the process for formally 
resolving scientific and procedural disputes in FDA's Center for Drug 
Evaluation and Research (CDER) and Center for Biologics Evaluation and 
Research (CBER) that cannot be resolved at the division level. The 
guidance document describes procedures for formally appealing such 
disputes to the office or center level and for submitting information 
to assist center officials in resolving the issue or issues presented. 
The guidance document provides information on how the Agency will 
interpret and apply provisions of the existing regulations regarding 
internal Agency review of decisions (Sec.  10.75 (21 CFR 10.75)) and 
dispute resolution during the investigational new drug (IND) process 
(Sec.  312.48 (21 CFR 312.48)) and the new drug application/abbreviated 
new drug application (NDA/ANDA) process (Sec.  314.103 (21 CFR 
314.103)). In addition, the guidance document provides information on 
how the Agency will interpret and apply the specific Prescription Drug 
User Fee Act (PDUFA) goals for major dispute resolution associated with 
the development and review of PDUFA products. The guidance document is 
available on our website at: https://www.fda.gov/downloads/drugs/guidances/ucm343101.pdf.
    Existing regulations, which appear primarily in parts 10, 312, and 
314 (21 CFR parts 10, 312, and 314), establish procedures for the 
resolution of scientific and procedural disputes between interested 
persons and the Agency, CDER, and CBER. All Agency decisions on such 
matters are based on information in the administrative file (Sec.  
10.75(d)). In general, the information in an administrative file is 
collected under existing regulations in part 312 (OMB control number 
0910-0014), part 314 (OMB control number 0910-0001), and part 601 (21 
CFR part 601) (OMB control number 0910-0338), which specify the 
information manufacturers must submit so that FDA may properly evaluate 
the safety and effectiveness of drugs and biological products. This 
information is usually submitted as part of an IND, NDA, or biologics 
license application (BLA), or as a supplement to an approved 
application. Although FDA already possesses in the administrative file 
the information that would form the basis of a decision on a matter in 
dispute resolution, the submission of information regarding the request 
itself and the data and information that the requestor relies on in the 
appeal would facilitate timely resolution of the dispute. The guidance 
document describes the following collections of information not 
expressly specified under existing regulations: The submission of the 
request for dispute resolution as an amendment to the application for 
the underlying product, including the submission of supporting 
information with the request for dispute resolution.
    Agency regulations (Sec. Sec.  312.23(a)(11) and (d), 314.50, 
314.94, and 601.2) state that information provided to the Agency as 
part of an IND, NDA, ANDA, or BLA must be submitted in triplicate and 
with an appropriate cover form. Form FDA 1571 must accompany 
submissions under INDs and Form FDA 356h must accompany submissions 
under NDAs, ANDAs, and BLAs. Both forms have valid OMB control numbers 
as follows: Form FDA 1571 (OMB control number 0910-0014) and Form FDA 
356h (OMB control number 0910-0338).
    In the guidance document, CDER and CBER ask that a request for 
formal dispute resolution be submitted as an amendment to the 
application for the underlying product and that it be submitted to the 
Agency in triplicate with the appropriate form attached, either Form 
FDA 1571 or Form FDA 356h. The Agency recommends that a request be 
submitted as an amendment in this manner for two reasons: (1) To ensure 
that each request is kept in the administrative file with the entire 
underlying application; and (2) to ensure that pertinent information 
about the request is entered into the appropriate tracking databases. 
Use of the information in the Agency's tracking databases enables the 
appropriate Agency official to monitor progress on the resolution of 
the dispute and to ensure that appropriate steps will be taken in a 
timely manner.
    CDER and CBER have determined and the guidance document recommends 
that the following information should be submitted to the appropriate 
center with each request for dispute resolution so that the center may 
quickly and efficiently respond to the request: (1) A brief but 
comprehensive statement of each issue to be resolved, including a 
description of the issue, the nature of the issue (i.e., scientific, 
procedural, or both), possible solutions based on information in the 
administrative file, whether informal dispute resolution was sought 
prior to the formal appeal, whether advisory committee review is 
sought, and the expected outcome; (2) a statement identifying the 
review division/office that issued the original decision on the matter 
and, if applicable, the last Agency official that attempted to formally 
resolve the matter; (3) a list of documents in the administrative file 
or additional copies of such documents that are deemed necessary for 
resolution of the issue or issues; and (4) a statement that the 
previous supervisory level has already

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had the opportunity to review all of the material relied on for dispute 
resolution. The information the Agency suggests submitting with a 
formal request for dispute resolution consists of: (1) Statements 
describing the issue from the perspective of the person with a dispute; 
(2) brief statements describing the history of the matter; and (3) the 
documents previously submitted to FDA under an OMB approved collection 
of information.
    Based on FDA's experience with dispute resolution, the Agency 
expects that most persons seeking formal dispute resolution will have 
gathered the materials listed previously when identifying the existence 
of a dispute with the Agency. Consequently, FDA anticipates that the 
collection of information attributed solely to the guidance document 
will be minimal.
    Provided in this document is an estimate of the annual reporting 
burden for requests for dispute resolution. Based on data collected 
from review divisions and offices within CDER and CBER, FDA estimates 
that approximately 12 sponsors and applicants (respondents) will submit 
requests for formal dispute resolution to CDER annually and 
approximately 1 respondent will submit requests for formal dispute 
resolution to CBER annually.
    The total annual responses are the total number of requests 
submitted to CDER and CBER in 1 year, including requests for dispute 
resolution that a single respondent submits more than one time. FDA 
estimates that CDER receives approximately 17 requests annually and 
CBER receives approximately 1 request annually. The hours per response 
is the estimated number of hours that a respondent would spend 
preparing the information to be submitted with a request for formal 
dispute resolution in accordance with the guidance document, including 
the time it takes to gather and copy brief statements describing the 
issue from the perspective of the person with the dispute, brief 
statements describing the history of the matter, and supporting 
information that has already been submitted to the Agency. Based on 
experience, FDA estimates that approximately 8 hours, on average, would 
be needed per response. Therefore, FDA estimates that 8 hours will be 
spent per year by respondents requesting formal dispute resolution in 
accordance with the guidance document.
    In the Federal Register of August 20, 2018 (83 FR 42127), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
   Requests for formal dispute       Number of     responses per   Total annual   Average burden    Total hours
           resolution               respondents     respondent       responses     per response
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CDER............................              12            1.42              17               8             136
CBER............................               1               1               1               8               8
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    Total.......................  ..............  ..............  ..............  ..............             144
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden for this information collection has changed since the 
last OMB approval. Our burden estimate reflects a decrease in burden by 
14 records and 112 hours. This adjustment corresponds to a decrease in 
the number of requests received over the last few years.

    Dated: February 19, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03193 Filed 2-22-19; 8:45 am]
BILLING CODE 4164-01-P