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, 42501-42502 [2012-17556]
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Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Notices
Promotion’’ 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 0910–0714. The
approval expires on July 31, 2015. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–17554 Filed 7–18–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0248]
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.
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 August 20,
2012.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0430. Also
include the FDA docket number found
in brackets in the heading of this
document.
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
VerDate Mar<15>2010
15:07 Jul 18, 2012
Jkt 226001
796–7651,
juanmanuel.vilela@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 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 (21 CFR 10.75)) and
dispute resolution during the
investigational new drug (IND) process
(§ 312.48 (21 CFR 312.48)) and the new
drug application/abbreviated new drug
application (NDA/ANDA) process
(§ 314.103 (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 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 part 312 (OMB
control number 0910–0014), part 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
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
42501
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 number
0910–0014, and FDA Form 356h—OMB
control number 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
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
E:\FR\FM\19JYN1.SGM
19JYN1
42502
Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Notices
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 (42
U.S.C. 262) (Pub. L. 99–660) who
requests formal resolution of a scientific
or procedural dispute.
Burden Estimate: Provided in 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 nine 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 18 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 152 hours
will be spent per year by respondents
requesting formal dispute resolution
under the guidance.
In the Federal Register of March 20,
2012 (77 FR 16237), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments on the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
responses per
respondent
Number of
respondents
Requests for formal dispute resolution
Total annual
responses
Average
burden
per response
Total hours
CDER ...................................................................................
CBER ...................................................................................
9
1
2
1
18
1
8
8
144
8
Total ..............................................................................
........................
........................
........................
........................
152
Dated: July 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
ACTION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with NOTICES
[Docket No. FDA–2011–N–0766]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Survey of ‘‘Health Care Providers’
Responses to Medical Device
Labeling’’
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
17:10 Jul 18, 2012
Jkt 226001
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
Survey of ‘‘Health Care Providers’
Responses to Medical Device Labeling’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March
8, 2012, the Agency submitted a
proposed collection of information
entitled Survey of ‘‘Health Care
Providers’ Responses to Medical Device
SUMMARY:
[FR Doc. 2012–17556 Filed 7–18–12; 8:45 am]
AGENCY:
Notice.
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
Labeling’’ 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 0910–0715. The
approval expires on July 31, 2015. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–17555 Filed 7–18–12; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 77, Number 139 (Thursday, July 19, 2012)]
[Notices]
[Pages 42501-42502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17556]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0248]
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 August
20, 2012.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0430.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
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 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 (Sec. 312.48 (21 CFR 312.48)) and the new drug
application/abbreviated new drug application (NDA/ANDA) process (Sec.
314.103 (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 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 part 312 (OMB control number 0910-0014), part 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(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 number 0910-0014, and FDA Form 356h--OMB control
number 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 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
[[Page 42502]]
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 (42 U.S.C. 262) (Pub. L. 99-660) who requests formal
resolution of a scientific or procedural dispute.
Burden Estimate: Provided in 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 nine 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 18 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 152 hours will be spent per year by respondents requesting formal
dispute resolution under the guidance.
In the Federal Register of March 20, 2012 (77 FR 16237), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments on the information
collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Requests for formal dispute Number of responses per Total annual burden per Total hours
resolution respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
CDER............................ 9 2 18 8 144
CBER............................ 1 1 1 8 8
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 152
----------------------------------------------------------------------------------------------------------------
Dated: July 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17556 Filed 7-18-12; 8:45 am]
BILLING CODE 4160-01-P
