[Federal Register Volume 71, Number 15 (Tuesday, January 24, 2006)]
[Notices]
[Pages 3854-3856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-763]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0396]


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.

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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 
February 23, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail,

[[Page 3855]]

including first class and express mail, and messenger deliveries are 
not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (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 
(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 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(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, expires January 31, 2006; and FDA 
Form 356h, OMB Control No. 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 
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 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 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 8 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.

[[Page 3856]]

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 88 hours will be spent per year by 
respondents requesting formal dispute resolution under the guidance.
    In the Federal Register of October 24, 2005, (70 FR 61453), FDA 
announced the availability of the draft guidance and requested comments 
for 60 days on the information collection. No comments were received on 
this information collection.

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


    Dated: January 13, 2006.
Jeffrey Shuren,
Assistant Commssioner for Policy.
[FR Doc. E6-763 Filed 1-23-06; 8:45 am]
BILLING CODE 4160-01-S