[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Notices]
[Pages 46397-46399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0297]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Draft Guidance for Industry on Formal Dispute 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 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 (the PRA).

DATES: Submit written comments on the collection of information by 
September 24, 1999.
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: 
Wendy Taylor, 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 section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

    Title: Draft Guidance for Industry on Formal Dispute Resolution; 
Appeals Above the Division Level
    Description: FDA is issuing a draft guidance on the process for 
formally resolving scientific and procedural disputes in the Center for 
Drug Evaluation and Research (CDER) and the Center for Biological 
Evaluation and Research (CBER) that cannot be resolved at the division 
level. The draft guidance describes procedures for formally appealing 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 The draft guidance provides information on how the agency 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 (NDA)/
abbreviated new drug application (ANDA) process (21 CFR 314.103). In 
addition, the draft guidance provides information on how the agency 
will interpret and apply the specific Prescription Drug User Fee Act of 
1992 (PDUFA) (Public Law 102-571) 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. 
0910-0001), 314 (OMB Control No. 0910-0014), and part 601 (21 CFR part 
601) (OMB Control No. 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 requester in the appeal 
would facilitate timely resolution of the dispute. The draft 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 
IND's, and Form FDA 356h must accompany submissions under NDA's, 
ANDA's, and BLA's. Both forms have valid OMB control numbers as 
follows: Form FDA 1571, OMB Control No. 0910-0014, expires December 31, 
1999; and Form FDA 356h, OMB Control No. 0910-0338, expires April 30, 
2000.
    In the draft guidance, 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

[[Page 46398]]

tracking data bases. Use of the information in the agency's tracking 
data bases 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 draft 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:
     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;
      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;
      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
      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) documents previously submitted to FDA under an OMB approved 
collection of information (see previous discussion).
    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 biologic 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: Table 1 of this document provides an estimate of 
the annual reporting burden for requests for dispute resolution. In 
fiscal year (FY) 1998, 39 sponsors and applicants (respondents) 
submitted requests for formal dispute resolution to CDER and 12 
respondents submitted requests for formal dispute resolution to CBER . 
Although the procedures for requesting formal dispute resolution that 
are set forth in the draft guidance were not in place in FY 1998, FDA 
estimates that the number of respondents who would submit requests for 
dispute resolution under the guidance would remain the same. 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. In FY 1998, CDER received 
approximately 49 requests and CBER received approximately 15 requests. 
The agency estimates that the total annual responses will remain the 
same, averaging to 1.26 responses per respondent. 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 draft 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 512 hours will be 
spent per year by respondents requesting formal dispute resolution 
under the guidance.
    On Friday, March 9, 1999, FDA invited comments on this analysis of 
information collection burdens. FDA received one comment regarding the 
agency's estimate of the paperwork burden. The comment stated that 
FDA's estimate is a relatively accurate accounting of time used in 
administrative preparation of information for requests for dispute 
resolution of procedural matters. The comment stated that FDA 
underestimated the time required for creative writing and editing tasks 
associated with preparation of paperwork to resolve disputes of a 
scientific or technical nature.
    The agency's estimates are based in part on the expectation that 
respondents will have already compiled for submission to the agency 
most of the data and information that is described in the guidance 
document. The agency anticipates that respondents will have submitted 
the information as part of the underlying product application. 
Therefore, the bulk of the paperwork burden is related to 
administrative tasks (i.e., gathering and copying brief statements 
describing the issue from the perspective of the person with the 
dispute and brief statements describing the history of the matter).

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      No. of
   Results for Formal Dispute         No. of       Responses per   Total Annual      Hours per      Total Hours
           Resolution               Respondents     Respondent       Responses       Response
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CDER                                   39               1.26           49               8             392
CBER                                   12               1.25           15               8             120
Total                                                                                                 512
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 46399]]

    Dated: August 18, 1999.
 William K. Hubbard,
 Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-21965 Filed 8-24-99; 8:45 am]
BILLING CODE 4160-01-F