Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level, 61453-61455 [05-21156]
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Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
except where FDA determines that the
submission and premarket review of a
food additive petition (FAP) under
section 409(b) of the act is necessary to
provide adequate assurance of safety or
where FDA and the manufacturer or
supplier agree that an FAP should be
submitted. Section 409(h)(1) of the act
requires that a notification include
information on the identity and the
intended use of the food contact
substance and the basis for the
manufacturer’s or supplier’s
determination that the food contact
substance is safe under the intended
conditions of use.
Sections 170.101 and 170.106 of
FDA’s regulations (21 CFR 170.101 and
170.106) require that a food contact
notification (FCN) include FDA Form
3480 entitled ‘‘Notification for New Use
of a Food Contact Substance’’ and that
a notification for a food contact
substance formulation include FDA
Form 3479 entitled ‘‘Notification for a
Food Contact Substance Formulation.’’
These forms will serve to summarize
pertinent information in the
notification. FDA believes that these
forms will facilitate both preparation
and review of notifications because the
forms will serve to organize information
necessary to support the safety of the
use of the food contact substance. The
burden of filling out the appropriate
form has been included in the burden
estimate for the notification.
Description of Respondents:
Manufacturers of food contact
substances.
In the Federal Register of June 7, 2005
(70 FR 33180), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of Respondents
Form
Annual Frequency per
Response
Total Annual
Responses
Hours per Response
Total Hours
170.1062
(Category A)
5
FDA 3479
1
5
2
10
170.1013,7
(Category B)
5
FDA 3480
1
5
25
125
170.1014,7
(Category C)
5
FDA 3480
2
10
120
1,200
170.1015,7
(Category D)
33
FDA 3480
2
66
150
9,900
170.1016,7
(Category E)
30
FDA 3480
1
30
150
4,500
Total
15,735
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
for food contact substance formulations and food contact articles. These notifications require the submission of FDA form 3479
(‘‘Notification for a Food Contact Substance Formulation’’) only.
3 Duplicate notifications for uses of food contact substances.
4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
5 Notifications for uses that are the subject of moderately complex food additive petitions.
6 Notifications for uses that are the subject of very complex food additive petitions.
7 These notifications require the submission of FDA Form 3480.
2 Notifications
These estimates are based on FDA’s
experience with the food contact
substances notification system.
• Based on input from industry
sources, FDA estimates that the agency
will receive approximately five
notifications annually for food contact
substance formulations.
• FDA also has included five
expected duplicate submissions in the
second row of table 1 of this document.
FDA expects that the burden for
preparing these notifications primarily
will consist of the manufacturer or
supplier filling out FDA Form 3480,
verifying that a previous notification is
effective, and preparing necessary
documentation.
• Based on the submissions received,
FDA identified three other tiers of FCNs
that represent escalating levels of
burden required to collect information
(the third, fourth and fifth rows of table
1 of this document).
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• FDA estimated the median number
of hours necessary for collecting
information for each type of notification
within each of the three tiers based on
input from industry sources.
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21155 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0396]
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
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Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
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 for appeals above the
division level.
DATES: Submit written or electronic
comments on the collection of
information by December 23, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857.
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: (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
VerDate Aug<31>2005
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Jkt 208001
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 (21 CFR 10.75), 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
(§ 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 0910–0338), 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
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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 (§§ 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 January 31, 2006;
and FDA Form 356h, OMB control
number 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,
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Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
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
agency suggests submitting the
following information with a formal
request for dispute resolution: (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.
Respondents are expected to be
sponsors, applicants, or manufacturers
of drug or biological products regulated
by the agency under section 505 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the
Public Health Service Act (42 U.S.C.
262) who request formal resolution of a
scientific or procedural dispute.
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 eight
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 are
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Requests for Formal Dispute
Resolution
No. of
Respondents
Number of Responses
per Respondent
CDER
8
1.25
CBER
1
Total Annual
Responses
1
Hours per
Response
Total Hours
10
8
80
1
8
8
Total
88
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21156 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2004N–0516]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
2005 Food Safety Survey
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘2005 Food Safety Survey’’ has been
approved by the Office of Management
SUMMARY:
VerDate Aug<31>2005
15:19 Oct 21, 2005
Jkt 208001
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In the
Federal Register of May 24, 2005 (70 FR
29768), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0345. The
approval expires on February 30, 2008.
A copy of the supporting statement
for this information collection is
available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
PO 00000
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Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21157 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0216]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
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]]>Agencies
[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Notices]
[Pages 61453-61455]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21156]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0396]
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
[[Page 61454]]
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 for appeals above the division level.
DATES: Submit written or electronic comments on the collection of
information by December 23, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857.
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: (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 (21 CFR 10.75), 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 number
0910-0014), 314 (OMB control number 0910-0001), and part 601 (21 CFR
part 601) (OMB control number 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 number 0910-0014, expires January 31, 2006; and
FDA Form 356h, OMB control number 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,
[[Page 61455]]
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 agency suggests submitting the following information
with a formal request for dispute resolution: (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.
Respondents are expected to be sponsors, applicants, or
manufacturers of drug or biological products regulated by the agency
under section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C.
262) who request formal resolution of a scientific or procedural
dispute.
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 eight 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 are 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Number of Responses Total Annual Hours per
Requests for Formal Dispute Resolution Respondents per Respondent Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER 8 1.25 10 8 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER 1 1 1 8 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 88
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21156 Filed 10-21-05; 8:45 am]
BILLING CODE 4160-01-S
