[Federal Register: November 3, 2008 (Volume 73, Number 213)]
[Notices]
[Page 65385-65386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no08-50]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0565]
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.
-----------------------------------------------------------------------
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 January 2, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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 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 these topics: (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) 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
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(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
[[Page 65386]]
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
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 the 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.
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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Dated: October 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26095 Filed 10-31-08; 8:45 am]
BILLING CODE 4160-01-S