[Federal Register Volume 67, Number 200 (Wednesday, October 16, 2002)]
[Notices]
[Pages 63929-63931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0303]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Guidance for Industry on Formal Dispute 
Resolution; Appeals Above the Division Level

AGENCY: Food and Drug Administration, HHS.

[[Page 63930]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 15, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 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 (21 CFR 
10.75) and dispute resolution during the investigational new drug 
application (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 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 parts 312 (OMB control number 
0910-0014), 314 (OMB control number 0910-0001), and part 601 (21 CFR 
part 601) (OMB control number 0910-0315), 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.
    FDA's 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 November 30, 2002; and FDA Form 
356h, OMB control number 0910-0001, expires March 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 the following 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 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 act 
or section 351 of the Public Health Service Act who requests formal 
resolution of a scientific or procedural dispute.

[[Page 63931]]

    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 seven 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 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 96 hours will be spent per year by respondents requesting formal 
dispute resolution under the guidance.
    In the Federal Register of July 18, 2002 (67 FR 47385), the agency 
requested comments on the proposed collections of information. No 
comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      No. of
Request for Formal Dispute        No. of        [chyph]Respondents    Total Annual       Hours per       Total
     [chyph]Resolution      [chyph]Respondents          per         [chyph]Responses  [chyph]Response    Hours
                                                  [chyph]Response
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CDER                                    7                 1.4                 10                8            80
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CBER                                    1                   2                  2                8            16
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Total                                                                                                        96
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 9, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26326 Filed 10-15-02; 8:45 am]
BILLING CODE 4160-01-S