
[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16237-16239]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6690]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 information collection 
contained in the guidance for industry on formal dispute resolution.

DATES: Submit either electronic or written comments on the collection 
of information by May 21, 2012.

[[Page 16238]]


ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. All comments should be identified with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
Juanmanuel.vilela@fda.hhs.gov.

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 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), 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 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(11)(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 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

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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 (42 U.S.C. 262) (Pub. L. 99-660) who requests formal 
resolution of a scientific or procedural dispute.
    Burden Estimate: Provided below 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 nine 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 18 
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 152 
hours will be spent per year by respondents requesting formal dispute 
resolution under the guidance.

                                   Table 1--Estimated Annual Reporting Burden
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                                                     Number of                        Average
   Requests for formal dispute       Number of     responses per   Total annual     burden per      Total hours
           resolution               respondents     respondent       responses       response
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CDER............................               9               2              18               8             144
CBER............................               1               1               1               8               8
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    Total.......................  ..............  ..............  ..............  ..............             152
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    Dated: March 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6690 Filed 3-19-12; 8:45 am]
BILLING CODE 4160-01-P


