Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability, 47531-47533 [2017-22049]
Download as PDF
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
pharmacists) are not clearly
communicated in REMS documents.
Stakeholders have reported spending
excessive time trying to locate,
understand, and comply with REMS
requirements.
To address the stakeholders’ feedback,
FDA is revising the 2009 draft guidance
on the format and content of a REMS to
include information to assist applicants
in drafting clear, informative, and
standardized REMS documents. This
revised draft guidance provides updated
recommendations on the format and
content of a REMS document and
supersedes the 2009 draft guidance.
Additional and more detailed
information is provided in the template
appended to this guidance.
The new format of the REMS
document, as described in this revised
draft guidance and appended template,
contains substantially the same content
as described in the 2009 draft guidance;
however, the information has been
reorganized. In the old format, the
REMS requirements were organized by
the elements described in the statute. In
the new format, requirements are
organized to describe who is responsible
for implementing the requirement,
when the requirement is to be
implemented, what the required action
is, and with what REMS material(s).
Additionally, the new format supports
submission of REMS documents in
Structured Product Labeling (SPL)
format.
Certain information included in the
2009 draft guidance has been revised
and included in other guidances
subsequently published and therefore
has been omitted from this revised draft
guidance. For example:
• Information on how FDA
determines when a REMS is necessary
to ensure that the benefits of a drug
outweigh its risks can be found in the
draft guidance for industry, ‘‘FDA’s
Application of Statutory Factors in
Determining When a REMS Is
Necessary’’ (at: https://www.fda.gov/
ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/
ucm521504.pdf).
• Information on REMS modifications
can be found in the guidance for
industry, ‘‘Risk Evaluation and
Mitigation Strategies: Modifications and
Revisions’’ (at: https://www.fda.gov/
downloads/drugs/guidancecompliance
regulatoryinformation/guidances/
ucm441226.pdf).
This revised guidance and appended
template are being reissued in draft form
to enable the public to review and
comment before finalization.
This revised draft guidance is being
issued consistent with FDA’s good
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on the format
and content of a REMS document. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
II. The Paperwork Reduction Act of
1995
This revised draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in the guidance was
approved under OMB control numbers
0910–0001 and 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22050 Filed 10–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5868]
Requests for Reconsideration at the
Division Level Under the Generic Drug
User Fee Act; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Requests
for Reconsideration at the Division
Level Under GDUFA.’’ This guidance
provides recommendations for industry
on the procedures for resolving
scientific and/or regulatory issues or
matters between FDA and applicants of
abbreviated new drug applications
SUMMARY:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
47531
(ANDAs) that wish to pursue a request
for reconsideration within the review
discipline at the division level or
original signatory authority. This
guidance also provides information for
applicants to consider before pursuing a
request for reconsideration, procedures
for submitting a request for
reconsideration, and the Agency’s
process for responding to those requests.
DATES: Submit either electronic or
written comments on the draft guidance
by December 11, 2017 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
E:\FR\FM\12OCN1.SGM
12OCN1
47532
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
2017–D–5868 for ‘‘Requests for
Reconsideration at the Division Level
Under GDUFA; Draft Guidance for
Industry; Availability.’’ 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 Dockets Management Staff
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
your requests. See the SUPPLEMENTARY
section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lisa
Bercu, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1611, Silver Spring,
MD 20993–0002, 240–402–6902.
SUPPLEMENTARY INFORMATION:
INFORMATION
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Requests for Reconsideration at the
Division Level Under GDUFA.’’ This
guidance provides recommendations for
industry on the procedures for resolving
scientific and/or regulatory issues or
matters between FDA and applicants of
THIS DOCUMENT CONTAINS CONFIDENTIAL
ANDAs that wish to pursue a request for
INFORMATION. The Agency will review
reconsideration within the review
this copy, including the claimed
discipline at the division level or
confidential information, in its
original signatory authority. In
consideration of comments. The second accordance with ‘‘GDUFA
copy, which will have the claimed
Reauthorization Performance Goals and
confidential information redacted/
Program Enhancements Fiscal Years
blacked out, will be available for public 2018–2022’’ (GDUFA II Goals Letter or
viewing and posted on https://
GDUFA II Commitment Letter; https://
www.regulations.gov. Submit both
www.fda.gov/downloads/ForIndustry/
copies to the Dockets Management Staff. UserFees/GenericDrugUserFees/
If you do not wish your name and
UCM525234.pdf), FDA agreed to certain
contact information to be made publicly review goals and procedures for the
available, you can provide this
review of requests for reconsideration
information on the cover sheet and not
received on or after October 1, 2017.1
in the body of your comments and you
As agreed to by FDA and industry in
must identify this information as
the GDUFA II Commitment Letter,
‘‘confidential.’’ Any information marked applicants may pursue a request for
as ‘‘confidential’’ will not be disclosed
reconsideration within the review
except in accordance with 21 CFR 10.20 discipline at the division level. In
and other applicable disclosure law. For addition, if an applicant requests a
more information about FDA’s posting
teleconference as part of its request to
of comments to public dockets, see 80
reclassify a major amendment or
FR 56469, September 18, 2015, or access standard review status, FDA will
the information at: https://www.gpo.gov/ schedule and conduct the
fdsys/pkg/FR-2015-09-18/pdf/2015teleconference and decide 90 percent of
23389.pdf.
such reclassification requests within 30
Docket: For access to the docket to
days of the date of FDA’s receipt of the
read background documents or the
request for a teleconference. As stated in
electronic and written/paper comments
the GDUFA II Commitment Letter, this
received, go to https://
goal only applies when the applicant
www.regulations.gov and insert the
accepts the first scheduled
docket number, found in brackets in the
teleconference date offered by FDA.
heading of this document, into the
This guidance provides additional
‘‘Search’’ box and follow the prompts
details and recommendations
and/or go to the Dockets Management
concerning considerations for
Staff, 5630 Fishers Lane, Rm. 1061,
applicants before pursuing a request for
Rockville, MD 20852.
reconsideration and procedures for
You may submit comments on any
submitting a request for reconsideration
guidance at any time (see 21 CFR
and the Agency’s process for responding
10.115(g)(5)).
to those requests.
Submit written requests for single
This draft guidance is being issued
copies of the draft guidance to the
Division of Drug Information, Center for consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
Drug Evaluation and Research, Food
The draft guidance, when finalized, will
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
1 The FDA Reauthorization Act of 2017 (Pub. L.
4th Floor, Silver Spring, MD 20993–
115–52) included the reauthorization of generic
0002. Send one self-addressed adhesive user fees as Title III, Generic Drug User
Amendments of 2017 (GDUFA II).
label to assist that office in processing
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
represent the current thinking of FDA
on ‘‘Requests for Reconsideration at the
Division Level Under GDUFA.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3520),
Federal Agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on 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.
Applications for FDA Approval To
Market a New Drug
OMB Control Number 0910–0001—
Revision
The information collection request
supports the Agency’s draft guidance
entitled, ‘‘Requests for Reconsideration
at the Division Level Under GDUFA.’’
As discussed in section I of this notice,
this guidance provides information to
respondents regarding procedures for
E:\FR\FM\12OCN1.SGM
12OCN1
47533
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
submitting requests for reconsideration,
including details on the content and
format of the submission. Respondents
to the collection of information are
applicants of ANDAs. Based on
available data with regard to similar
information collections, FDA’s Center
for Drug Evaluation and Research will
receive approximately 150 requests for
reconsideration annually from 75
respondents. Because we estimate it will
take 5 hours to prepare a request for
reconsideration, we estimate it will take
an average of 750 total hours annually
for respondents to prepare and submit
requests for reconsideration. The burden
of the information collection, therefore,
is estimated as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance recommendation
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
Section IV: Procedures for Submitting and Responding to
a Request for Reconsideration ........................................
75
2
150
5
750
1 There
are no capital or operating and maintenance costs associated with the collection of information.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://www.regulations
.gov.
Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22049 Filed 10–11–17; 8:45 am]
BILLING CODE 4164–01–P
Ila
Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10–12M, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7729, 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.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0424]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Temporary
Marketing Permit Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Fax written comments on the
collection of information by November
13, 2017.
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 0910–0133. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
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.
SUMMARY:
Temporary Marketing Permit
Applications—21 CFR 130.17(c) and (i)
OMB Control Number 0910–0133—
Extension
This information collection supports
Agency regulations. Specifically, section
401 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
341) directs FDA to issue regulations
establishing definitions and standards of
identity for food ‘‘whenever . . . such
action will promote honesty and fair
dealing in the interest of consumers
. . . .’’ Under section 403(g) of the
FD&C Act (21 U.S.C. 343(g)), a food that
is subject to a definition and standard of
identity prescribed by regulation is
misbranded if it does not conform to
such definition and standard of identity.
Section 130.17 (21 CFR 130.17) provides
for the issuance by FDA of temporary
marketing permits that enable the food
industry to test consumer acceptance
and measure the technological and
commercial feasibility in interstate
commerce of experimental packs of food
that deviate from applicable definitions
and standards of identity. Section
130.17(c) enables the Agency to monitor
the manufacture, labeling, and
distribution of experimental packs of
food that deviate from applicable
definitions and standards of identity.
The information so obtained can be
used in support of a petition to establish
or amend the applicable definition or
standard of identity to provide for the
variations. Section 130.17(i) specifies
the information that a firm must submit
to FDA to obtain an extension of a
temporary marketing permit.
In the Federal Register of June 15,
2017 (82 FR 27489), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
We therefore estimate the burden of
this collection of information as follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
Total hours
130.17(c)—Request for temporary marketing permit ..........
130.17(i)—Request to extend marketing permit ..................
13
1
2
2
26
2
25
2
650
4
Total ..............................................................................
........................
........................
........................
........................
654
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
E:\FR\FM\12OCN1.SGM
12OCN1
Agencies
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47531-47533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22049]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5868]
Requests for Reconsideration at the Division Level Under the
Generic Drug User Fee Act; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Requests
for Reconsideration at the Division Level Under GDUFA.'' This guidance
provides recommendations for industry on the procedures for resolving
scientific and/or regulatory issues or matters between FDA and
applicants of abbreviated new drug applications (ANDAs) that wish to
pursue a request for reconsideration within the review discipline at
the division level or original signatory authority. This guidance also
provides information for applicants to consider before pursuing a
request for reconsideration, procedures for submitting a request for
reconsideration, and the Agency's process for responding to those
requests.
DATES: Submit either electronic or written comments on the draft
guidance by December 11, 2017 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-
[[Page 47532]]
2017-D-5868 for ``Requests for Reconsideration at the Division Level
Under GDUFA; Draft Guidance for Industry; Availability.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft 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 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lisa Bercu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 240-402-6902.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Requests for Reconsideration at the Division Level Under
GDUFA.'' This guidance provides recommendations for industry on the
procedures for resolving scientific and/or regulatory issues or matters
between FDA and applicants of ANDAs that wish to pursue a request for
reconsideration within the review discipline at the division level or
original signatory authority. In accordance with ``GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2018-2022'' (GDUFA II Goals Letter or GDUFA II Commitment Letter;
https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf), FDA agreed to certain review goals and procedures for
the review of requests for reconsideration received on or after October
1, 2017.\1\
---------------------------------------------------------------------------
\1\ The FDA Reauthorization Act of 2017 (Pub. L. 115-52)
included the reauthorization of generic user fees as Title III,
Generic Drug User Amendments of 2017 (GDUFA II).
---------------------------------------------------------------------------
As agreed to by FDA and industry in the GDUFA II Commitment Letter,
applicants may pursue a request for reconsideration within the review
discipline at the division level. In addition, if an applicant requests
a teleconference as part of its request to reclassify a major amendment
or standard review status, FDA will schedule and conduct the
teleconference and decide 90 percent of such reclassification requests
within 30 days of the date of FDA's receipt of the request for a
teleconference. As stated in the GDUFA II Commitment Letter, this goal
only applies when the applicant accepts the first scheduled
teleconference date offered by FDA. This guidance provides additional
details and recommendations concerning considerations for applicants
before pursuing a request for reconsideration and procedures for
submitting a request for reconsideration and the Agency's process for
responding to those requests.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Requests for
Reconsideration at the Division Level Under GDUFA.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information, including each proposed extension of an
existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
With respect to the following collection of information, FDA
invites comments on 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.
Applications for FDA Approval To Market a New Drug
OMB Control Number 0910-0001--Revision
The information collection request supports the Agency's draft
guidance entitled, ``Requests for Reconsideration at the Division Level
Under GDUFA.'' As discussed in section I of this notice, this guidance
provides information to respondents regarding procedures for
[[Page 47533]]
submitting requests for reconsideration, including details on the
content and format of the submission. Respondents to the collection of
information are applicants of ANDAs. Based on available data with
regard to similar information collections, FDA's Center for Drug
Evaluation and Research will receive approximately 150 requests for
reconsideration annually from 75 respondents. Because we estimate it
will take 5 hours to prepare a request for reconsideration, we estimate
it will take an average of 750 total hours annually for respondents to
prepare and submit requests for reconsideration. The burden of the
information collection, therefore, is estimated as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Guidance recommendation Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section IV: Procedures for Submitting and Responding to a Request 75 2 150 5 750
for Reconsideration...............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the collection of information.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22049 Filed 10-11-17; 8:45 am]
BILLING CODE 4164-01-P