Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level, 60918-60920 [2015-25623]
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60918
Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Sara
Rothman, Office of Compliance, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
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‘‘Adverse Event Reporting for
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act.’’ On November 27, 2013,
President Obama signed the Drug
Quality and Security Act (DQSA) into
law (Pub. L. 113–54). The DQSA added
a new section, 503B, to the FD&C Act
(21 U.S.C. 353b). Under section 503B(b),
a compounder can register as an
outsourcing facility with FDA. Section
503B(d)(4) of the FD&C Act defines an
outsourcing facility, in part, as a facility
that complies with all of the
requirements of section 503B, including
registering with FDA as an outsourcing
facility and paying associated fees. If the
conditions outlined in section 503B(a)
of the FD&C Act are satisfied, a drug
compounded by or under the direct
supervision of a licensed pharmacist in
an outsourcing facility is exempt from
certain sections of the FD&C Act,
including section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of
drugs with adequate directions for use)
and section 505 (21 U.S.C. 355)
(concerning the approval of human drug
products under new drug applications
(NDAs) or abbreviated new drug
applications (ANDAs)). Drugs
compounded in outsourcing facilities
are not exempt from the requirements of
section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice for drugs).
Under section 503B(b)(5), an
outsourcing facility must submit
adverse event reports to FDA in
accordance with the content and format
requirements established through
guidance or regulation under 21 CFR
310.305 (or any successor regulations).
This guidance explains how FDA
intends to implement § 310.305 with
respect to outsourcing facilities.
In the Federal Register of February
19, 2015 (80 FR 8872), FDA issued a
notice announcing the availability of the
draft version of this guidance. The
comment period on the draft guidance
ended on May 20, 2015. FDA received
seven comments on the draft guidance.
In response to received comments or
on its own initiative, FDA made several
changes to clarify particular points and
to provide updated information.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
any rights for any person and is not
binding on FDA or the public. An
alternative approach can be used if such
approach satisfies the requirements of
the applicable statutes and regulations.
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II. Paperwork Reduction Act
This guidance contains collections of
information that are subject to review by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501–3520). The
collections of information have been
approved under OMB control number
0910–0800.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25622 Filed 10–7–15; 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;
Submission for Office of Management
and Budget Review; 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 November
9, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
E:\FR\FM\08OCN1.SGM
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Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations .gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0248 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Submission for Office of
Management and Budget Review;
Guidance for Industry on Formal
Dispute Resolution; Appeals Above the
Division Level.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
VerDate Sep<11>2014
18:42 Oct 07, 2015
Jkt 238001
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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.
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: 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
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60919
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 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
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Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
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
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.
In the Federal Register of June 2, 2015
(80 FR 31386), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
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
Number of
responses per
respondent
Number of
respondents
Requests for formal dispute resolution
Average
burden per
response
Total annual
responses
Total hours
CDER ...............................................................
CBER ...............................................................
8
1
2
1
31
1
8
8
248
8
Total ..........................................................
............................
............................
............................
............................
256
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25623 Filed 10–7–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
E:\FR\FM\08OCN1.SGM
08OCN1
]]>Agencies
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60918-60920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25623]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0248]
Agency Information Collection Activities; Proposed Collection;
Submission for Office of Management and Budget Review; 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
November 9, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your
[[Page 60919]]
comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations .gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0248 for ``Agency Information Collection Activities;
Proposed Collection; Submission for Office of Management and Budget
Review; Guidance for Industry on Formal Dispute Resolution; Appeals
Above the Division Level.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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.
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: 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 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
[[Page 60920]]
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 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.
In the Federal Register of June 2, 2015 (80 FR 31386), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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
Requests for formal dispute resolution Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25623 Filed 10-7-15; 8:45 am]
BILLING CODE 4164-01-P
