Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level, 31386-31388 [2015-13386]
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Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
• facilitate, identify, and prioritize
technical assistance and development
needs, develop strategic and project
plans, and allocate resources to
coordinate FDA training program
components for U.S. teachers actively
incorporating FDA’s food safety and
nutrition curriculum in their
classrooms, as specified in the various
training components of this proposed
cooperative agreement.
C. Eligibility Information
The following organization is eligible
to apply: Graduate School USA.
• Step 6: Register With Electronic
Research Administration (eRA)
Commons
Steps 1 through 5, in detail, can be
found at https://www07.grants.gov/
applicants/organization_
registration.jsp. Step 6, in detail, can be
found at https://commons.era.nih.gov/
commons/registration/
registrationInstructions.jsp. After you
have followed these steps, submit
electronic applications to: https://
www.grants.gov.
II. Award Information/Funds Available
Dated: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
A. Award Amount
[FR Doc. 2015–13330 Filed 6–1–15; 8:45 am]
The number of awards is contingent
upon FDA appropriations and the
submission of a sufficient number of
meritorious applications. Future year
amounts will depend on annual
appropriations, availability of funding
and awardee performance.
FDA/CFSAN intends to fund up to
$452,700.00 for fiscal year 2015 in
support of this grant program.
Application budgets need to reflect the
actual needs of the proposed project and
should not exceed the following in total
costs (direct and indirect):
YR 1: $452,700
YR 2: $500,000
YR 3: $500,000
YR 4: $500,000
YR 5: $500,000
BILLING CODE 4164–01–P
B. Length of Support
The scope of the proposed project
should determine the project period.
The maximum project period is 5 years.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
III. Electronic Application,
Registration, and Submission
Only electronic applications will be
accepted. To submit an electronic
application in response to this FOA,
applicants should first review the full
announcement located at https://
www.grants.gov. Search by Funding
Opportunity Number: RFA–FD–15–011.
(FDA has verified the Web site
addresses throughout this document,
but FDA is not responsible for any
subsequent changes to the Web sites
after this document publishes in the
Federal Register.) For all electronically
submitted applications, the following
steps are required.
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With System for
Award Management (SAM)
• Step 3: Obtain Username & Password
• Step 4: Authorized Organization
Representative (AOR) Authorization
• Step 5: Track AOR Status
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Dated: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–13337 Filed 6–1–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0248]
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2015–N–1805]
Retrospective Review of Premarket
Approval Application Devices; Striking
the Balance Between Premarket and
Postmarket Data Collection; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for comments;
correction.
ACTION:
The Food and Drug
Administration is correcting a notice
entitled ‘‘Retrospective Review of
Premarket Approval Application
Devices; Striking the Balance Between
Premarket and Postmarket Data
Collection’’ that appeared in the Federal
Register of April 29, 2015 (80 FR
23798). The document announced the
progress of the Center for Devices and
Radiological Health on its 2014–2015
Strategic Priority ‘‘Strike the Right
Balance Between Premarket and
Postmarket Data Collection.’’ The
document was published with the
incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
3330, Silver Spring, MD 20993–0002,
301–796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 29, 2015, in
FR Doc. 2015–09884, on page 23798, the
following correction is made:
1. On page 23798, in the first column,
in the headings section of the document,
‘‘[Docket No. FDA–2014–D–0090]’’ is
corrected to read ‘‘[Docket No. FDA–
2015–N–1805]’’.
SUMMARY:
PO 00000
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Notice.
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 either electronic or
written comments on the collection of
information by August 3, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
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Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
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‘‘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 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
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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 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 (§§ 312.23(a)(11)
and (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,
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31387
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,
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
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31388
Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
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 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 eight sponsors and
applicants (respondents) submit
requests for formal dispute resolution to
CDER annually and approximately one
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 8 hours
will be spent per year by respondents
requesting formal dispute resolution
under the guidance.
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 31 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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Requests for formal dispute resolution
Total annual
responses
Average
burden per
response
Total hours
CDER ...................................................................................
CBER ...................................................................................
8
1
2
1
31
1
8
8
248
8
Total ..............................................................................
........................
........................
........................
........................
256
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–13386 Filed 6–1–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0748]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Generic Drug User Fee
Cover Sheet; Form FDA 3794
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
concerning collection of information
using Form FDA 3794 entitled ‘‘Generic
Drug User Fee Cover Sheet.’’
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SUMMARY:
VerDate Sep<11>2014
17:26 Jun 01, 2015
Jkt 235001
Submit either electronic or
written comments on the collection of
information by August 3, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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,
DATES:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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.
Generic Drug User Fee Cover Sheet;
Form FDA 3794
OMB Control Number 0910–0727—
Extension
On July 9, 2012, the Generic Drug
User Fee Act (GDUFA) (Pub. L. 112–
144, Title 111) was signed into law by
the President. GDUFA, designed to
speed the delivery of safe and effective
generic drugs to the public and reduce
costs to industry, requires that generic
drug manufacturers pay user fees to
finance critical and measurable program
enhancements. The user fees required
E:\FR\FM\02JNN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31386-31388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13386]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0248]
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 either electronic or written comments on the collection
of information by August 3, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
[[Page 31387]]
``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 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 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 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(a)(11) and (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 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
[[Page 31388]]
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 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 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 31 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 8 hours will be spent per year by respondents requesting formal
dispute resolution under the guidance.
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Requests for formal dispute Number of responses per Total annual burden per Total hours
resolution respondents respondent responses response
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CDER............................ 8 2 31 8 248
CBER............................ 1 1 1 8 8
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Total....................... .............. .............. .............. .............. 256
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13386 Filed 6-1-15; 8:45 am]
BILLING CODE 4164-01-P
