[Federal Register Volume 67, Number 138 (Thursday, July 18, 2002)]
[Notices]
[Pages 47385-47387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0303]


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 written or electronic comments on the collection of 
information by September 16, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
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: Karen Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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

[[Page 47386]]

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 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 (Secs. 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, expires September 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 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.
    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

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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.

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


    Dated: July 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18121 Filed 7-17-02; 8:45 am]
BILLING CODE 4160-01-S