[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60918-60920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25623]


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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; 
Submission for Office of Management and Budget Review; 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) 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 
November 9, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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

[[Page 60919]]

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 http://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-2012-N-0248 for ``Agency Information Collection Activities; 
Proposed Collection; Submission for Office of Management and Budget 
Review; Guidance for Industry on Formal Dispute Resolution; Appeals 
Above the Division Level.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://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 http://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: http://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 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 and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

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 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. The guidance 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(s) presented. The guidance 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 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 that 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. While 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 particular information regarding 
the request itself and the data and information relied on by the 
requestor in the appeal would facilitate timely resolution of the 
dispute. The guidance describes the following collection 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 is to be submitted in triplicate and 
with

[[Page 60920]]

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: 
FDA Form 1571--OMB control number 0910-0014, and FDA Form 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: To ensure 
that each request is kept in the administrative file with the entire 
underlying application and 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 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(s); 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 that 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 will be 
minimal.
    Description of Respondents: A sponsor, applicant, or manufacturer 
of a drug or biological product regulated by the Agency under the 
Federal Food, Drug, and Cosmetic Act or section 351 of the Public 
Health Service Act who requests formal resolution of a scientific or 
procedural dispute.
    In the Federal Register of June 2, 2015 (80 FR 31386), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Burden Estimate: 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 eight sponsors and applicants 
(respondents) submit requests for formal dispute resolution to CDER 
annually and approximately one respondent submits 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 31 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 this guidance, 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 under the guidance.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Number of
            Requests for formal dispute resolution                  Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
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CDER..........................................................                 8                 2                31                 8               248
CBER..........................................................                 1                 1                 1                 8                 8
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    Total.....................................................  ................  ................  ................  ................               256
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25623 Filed 10-7-15; 8:45 am]
BILLING CODE 4164-01-P