[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Pages 42127-42130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 process for formally resolving 
scientific and procedural disputes in the Center for Drug Evaluation 
and Research (CDER) and the Center for Biologics Evaluation and 
Research (CBER) that cannot be resolved at the division level.

DATES: Submit either electronic or written comments on the collection 
of information by October 19, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 19, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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'').

[[Page 42128]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2012-N-0248 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry on Formal 
Dispute Resolution; Appeals Above the Division Level.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Guidance for Industry on Formal Dispute Resolution; Appeals Above the 
Division Level

OMB Control Number 0910-0430--Extension

    This information collection approval request is for FDA guidance on 
the process for formally resolving scientific and procedural disputes 
in FDA's CDER and 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.
    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

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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) (21 CFR 
312.23(a)(11) and (d), 314.50 (21 CFR 314.50), 314.94 (21 CFR 314.94), 
and 601.2 (21 CFR 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 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 one 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.
    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.


[[Page 42130]]

    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. We attribute this adjustment to a decrease in 
the number of requests received over the last few years.

    Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17860 Filed 8-17-18; 8:45 am]
 BILLING CODE 4164-01-P