[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Pages 19225-19226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9632]



Food and Drug Administration

[Docket No. FDA-2008-N-0565]

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.


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 May 28, 

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: 202-395-6974, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0396. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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 0910-0396)--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 (Sec.  10.75) and dispute 
resolution during the investigational new drug (IND) process (Sec.  
312.48) and the new drug application/abbreviated new drug application 
(NDA/ANDA) process (Sec.  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 No. 
0910-0014), 314 (OMB Control No. 0910-0001), and part 601 (21 CFR part 
601) (OMB Control No. 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 No. 0910-0014, and FDA Form 356h--OMB Control 
No. 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

[[Page 19226]]

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 
    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.
    Burden Estimate: Provided in table 1 of 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 13 sponsors and 
applicants (respondents) submit requests for formal dispute resolution 
to CDER annually and approximately 1 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 22 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 184 hours will be spent per year by respondents requesting formal 
dispute resolution under the guidance.
    In the Federal Register of November 3, 2008 (73 FR 65385), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden \1\
                                                           No. of        No. of Responses  per      Total Annual        Hours Per
       Requests for Formal Dispute Resolution           Respondents            Respondent            Responses           Response         Total Hours
CDER                                                                13                      1.7                 22                  8                176
CBER                                                                 1                        1                  1                  8                  8
Total                                                                                                                                                184
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: April 21, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9632 Filed 4-27-09; 8:45 am]