[Federal Register: October 24, 2005 (Volume 70, Number 204)]
[Page 61453-61455]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0396]

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.


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

[[Page 61454]]

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 for appeals above the division level.

DATES: Submit written or electronic comments on the collection of 
information by December 23, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(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: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857.

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: (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 an 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 (21 CFR 10.75), dispute 
resolution during the investigational new drug (IND) process (21 CFR 
312.48), and the new drug application/abbreviated new drug application 
(NDA/ANDA) process (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 
    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 parts 312 (OMB control number 
0910-0014), 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(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, expires January 31, 2006; and 
FDA Form 356h, OMB control number 0910-0338, expires August 31, 2005.
    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 

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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 agency suggests submitting the following information 
with a formal request for dispute resolution: (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 
    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 
    Respondents are expected to be sponsors, applicants, or 
manufacturers of drug or biological products regulated by the agency 
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 
262) who request formal resolution of a scientific or procedural 
    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 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 10 
requests annually and CBER receives approximately 1 request annually. 
The hours per response are 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 88 
hours will be spent per year by respondents requesting formal dispute 
resolution under the guidance.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                             No. of        Number of Responses      Total Annual        Hours per
        Requests for Formal Dispute Resolution            Respondents         per Respondent         Responses           Response         Total Hours
CDER                                                                   8                   1.25                 10                  8                 80
CBER                                                                   1                   1                     1                  8                  8
Total                                                                                                                                                 88
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21156 Filed 10-21-05; 8:45 am]