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, 19225-19226 [E9-9632]
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Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Linda
Wisniewski, Office of Clinical Research
Training and Medical Education,
Clinical Center, Building 10, Room:
1N252B, 9000 Rockville Pike, Bethesda,
MD 20892, or call 301–496–9425 or
E-mail your request, including your
address to: wisniewskil@cc.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: April 16, 2009.
Laura Lee,
Project Clearance Liaison, Warren Grant
Magnuson Clinical Center, National Institutes
of Health.
[FR Doc. E9–9688 Filed 4–27–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0565]
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.
erowe on PROD1PC64 with NOTICES
ACTION:
Notice.
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 May 28,
2009.
VerDate Nov<24>2008
15:33 Apr 27, 2009
Jkt 217001
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: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0396. Also
include the FDA 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Guidance for Industry on Formal
Dispute Resolution; Appeals Above the
Division Level—(OMB Control Number
0910–0396)—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 (§ 10.75) and dispute
resolution during the investigational
new drug (IND) process (§ 312.48) and
the new drug application/abbreviated
new drug application (NDA/ANDA)
process (§ 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
PO 00000
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Fmt 4703
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19225
(§ 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 (§§ 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
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
E:\FR\FM\28APN1.SGM
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19226
Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices
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 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 184 hours
will be spent per year by respondents
requesting formal dispute resolution
under the guidance.
In the Federal Register of November
3, 2008 (73 FR 65385), 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 BURDEN 1
Requests for Formal Dispute
Resolution
No. of
Respondents
No. of Responses
per Respondent
Total Annual
Responses
Hours Per
Response
Total Hours
CDER
13
1.7
22
8
176
CBER
1
1
1
8
8
Total
1 There
184
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 21, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9632 Filed 4–27–09; 8:45 am]
ACTION:
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
erowe on PROD1PC64 with NOTICES
[Docket No. FDA–2009–N–0664]
Cellular, Tissue and Gene Therapies
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
VerDate Nov<24>2008
15:33 Apr 27, 2009
Jkt 217001
Notice.
Name of Committee: Cellular, Tissue and
Gene Therapies Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on May 14, 2009, from 8 a.m. to
approximately 6 p.m. and on May 15, 2009,
from 8 a.m. to approximately 1 pm.
Location: Hilton Hotel, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Gail Dapolito or Danielle
Cubbage, Food and Drug Administration,
PO 00000
Frm 00034
Fmt 4703
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1401 Rockville Pike (HFM–71), Rockville,
MD, 301–827–0314, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 3014512389. Please call the
Information Line for up-to-date information
on this meeting. A notice in the Federal
Register about last minute modifications that
impact a previously announced advisory
committee meeting cannot always be
published quickly enough to provide timely
notice. Therefore, you should always check
the agency’s Web site and call the
appropriate advisory committee hot line/
phone line to learn about possible
modifications before coming to the meeting.
Agenda: On May 14 in the morning, in
open session, the Committee will discuss the
potential for Chlamydia trachomatis and
Neisseria gonorrhea transmission by human
cells, tissues, and cellular and tissue-based
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19225-19226]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9632]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0565]
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.
-----------------------------------------------------------------------
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 May 28,
2009.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0396.
Also include the FDA 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: 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 0910-0396)--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 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
[[Page 19226]]
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 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 184 hours will be spent per year by respondents requesting formal
dispute resolution under the guidance.
In the Federal Register of November 3, 2008 (73 FR 65385), 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 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.
Dated: April 21, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9632 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S
