Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability, 50142-50144 [2017-23526]
Download as PDF
<![CDATA[
50142
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
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.
Postmarketing Safety Reports for
Human Drug and Biological Products:
Waivers From Electronic Submission
Requirements—OMB Control Number
0910–0770—Extension
This information collection supports
FDA regulations. In the Federal Register
of June 10, 2014 (79 FR 33072), FDA
published a final rule entitled
‘‘Postmarketing Safety Reports for
Human Drug and Biological Products:
Electronic Submission Requirements.’’
The final rule amended FDA’s
postmarketing safety reporting
regulations for human drug and
biological products under 21 CFR parts
310, 314, and 600 and added part 329
to require that persons subject to
mandatory reporting requirements
submit safety reports in an electronic
format that FDA can process, review,
and archive. Specifically, this includes:
• manufacturers; packers;
distributors; applicants with approved
new drug applications, abbreviated new
drug applications, and biologics
licensing applications (BLAs); and those
that market prescription drugs for
human use without an approved
application must submit postmarketing
safety reports to the Agency (§§ 310.305,
314.80, 314.98, and 600.80);
• manufacturers, packers, or
distributors whose name appears on the
label of nonprescription human drug
products marketed without an approved
application must report serious adverse
events associated with their products
(section 760 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 379aa)); and
• applicants with approved BLAs
must submit biological lot distribution
reports to the Agency (§ 600.81).
Under §§ 310.305(e)(2), 314.80(g)(2),
329.100(c)(2), 600.80(h)(2), and
600.81(b)(2), those who are subject to
these postmarketing safety reporting
requirements may request a waiver from
the electronic format requirement.
While FDA currently has OMB approval
for the collection of postmarketing
safety reports,1 this information
collection supports respondents seeking
waivers from submitting those reports in
electronic format as required by the
regulations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
310.305(e)(2) .......................................................................
314.80(g)(2) .........................................................................
329.100(c)(2) ........................................................................
600.80(h)(2) .........................................................................
600.81(b)(2) .........................................................................
1
5
1
5
1
1
1
1
1
1
1
5
1
5
1
1
1
1
1
1
1
5
1
5
1
Total ..............................................................................
........................
........................
........................
........................
13
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital or operating and maintenance costs associated with this collection of information.
In table 1 of this document, we
estimate the burden associated with the
submission of waiver requests for
postmarketing safety reports in
electronic format under §§ 310.305(e)(2),
314.80(g)(2), 329.100(c)(2), 600.80(h)(2),
and 600.81(b)(2). We expect few waiver
requests. We estimate that
approximately one manufacturer will
request a waiver annually under
§§ 310.305(e)(2), 329.100(c)(2), and
600.81(b)(2), and approximately five
manufacturers will request a waiver
annually under §§ 314.80(g)(2) and
600.80(h)(2). We estimate that each
waiver request will take approximately
1 hour to prepare and submit.
Dated: October 24, 2017.
Lauren Silvis,
Chief of Staff.
1 FDA currently has OMB approval for
submission of postmarketing safety reports under
parts 310, 314, and 600. The information collection
for parts 310 and 314 is approved under OMB
control numbers 0910–0291 and 0910–0230. The
information collection for part 600 is approved
under OMB control numbers 0910–0291 and 0910–
0308. Submissions required by section 760 of the
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–23518 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2012–D–0880]
Assessing User Fees Under the
Generic Drug User Fee Amendments of
2017; 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
SUMMARY:
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
FD&C Act have been approved under OMB control
number 0910–0636.
E:\FR\FM\30OCN1.SGM
30OCN1
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
guidance for industry entitled
‘‘Assessing User Fees Under the Generic
Drug User Fee Amendments of 2017.’’
This draft guidance provides
stakeholders information regarding the
implementation of the Generic Drug
User Fee Amendments of 2017 (GDUFA
II) and policies and procedures
surrounding its application.
DATES: Submit either electronic or
written comments on the guidance
December 29, 2017 to ensure that the
Agency considers your comment on this
draft 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’’).
sradovich on DSK3GMQ082PROD with NOTICES
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–
2012–D–0880 for ‘‘Assessing User Fees
Under the Generic Drug User Fee
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
Amendments of 2017.’’ 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 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/201523389.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
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
50143
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Mehrban Iranshad, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Rm. 4145, Silver
Spring, MD 20993, 301–796–7900,
CDERCollections@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Assessing User Fees Under the Generic
Drug User Fee Amendments of 2017.’’
GDUFA II (Pub. L. 115–52, Title III) was
signed into law by the President on
August 18, 2017. GDUFA II continues
FDA’s and industry’s goal to improve
the public’s access to safe and effective
generic drugs and to improve upon the
predictability of the review process.
GDUFA II extends FDA’s authority to
collect user fees from fiscal year (FY)
2018 to FY 2022 and introduces a
number of technical revisions that affect
what fees are collected and how some
fees are collected. GDUFA II authorizes
fees for abbreviated new drug
applications (ANDAs), drug master files
(DMFs), annual facility fees, a one-time
fee for original ANDAs pending with
FDA on October 1, 2012 (backlog fees),
and the Generic Drug Applicant
Program Fee (GDUFA Program Fee).
The draft guidance announced in this
notice addresses changes in user fee
assessments from GDUFA I, user fees
incurred by industry under GDUFA II,
payment procedures, reconsideration
and appeals, and other additional
information to assist industry in
complying with GDUFA II. FDA will
issue separate guidance documents
regarding GDUFA II non-user fee
requirements and processes.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Assessing User Fees Under the
Generic Drug User Fee Amendments of
2017.’’ 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
This 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–
E:\FR\FM\30OCN1.SGM
30OCN1
50144
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
3520). The guidance refers to collections
of information for filling out and
submitting Form FDA 3913 (User Fee
Payment Refund Request), previously
approved under OMB control number
0910–0805, and Form FDA 3914 (User
Fee Payment Transfer Request),
previously approved under OMB
control number 0910–0805.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23526 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0689]
De Novo Classification Process
(Evaluation of Automatic Class III
Designation); Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation).’’ The
purpose of this document is to provide
guidance on the process for the
submission and review of a De Novo
classification request (hereafter a ‘‘De
Novo request’’) under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
also known as the De Novo
classification process. FDA is issuing
this guidance to also provide updated
recommendations for interactions with
FDA related to the De Novo
classification process, including what
information to submit when seeking a
path to market via the De Novo
classification process. This guidance
replaces ‘‘New Section 513(f)(2)—
Evaluation of Automatic Class III
Designation, Guidance for Industry and
CDRH Staff,’’ dated February 19, 1998.
DATES: The announcement of the
guidance is published in the Federal
Register on October 30, 2017.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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–
2011–D–0689 for ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation);
Guidance for Industry and Food and
Drug Administration Staff;
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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/201523389.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)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002 or the
Office of Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
E:\FR\FM\30OCN1.SGM
30OCN1
]]>Agencies
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50142-50144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23526]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0880]
Assessing User Fees Under the Generic Drug User Fee Amendments of
2017; 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
[[Page 50143]]
guidance for industry entitled ``Assessing User Fees Under the Generic
Drug User Fee Amendments of 2017.'' This draft guidance provides
stakeholders information regarding the implementation of the Generic
Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures
surrounding its application.
DATES: Submit either electronic or written comments on the guidance
December 29, 2017 to ensure that the Agency considers your comment on
this draft 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-2012-D-0880 for ``Assessing User Fees Under the Generic Drug User
Fee Amendments of 2017.'' 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 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: Mehrban Iranshad, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 4145, Silver Spring, MD 20993, 301-796-7900,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Assessing User Fees Under the Generic Drug User Fee
Amendments of 2017.'' GDUFA II (Pub. L. 115-52, Title III) was signed
into law by the President on August 18, 2017. GDUFA II continues FDA's
and industry's goal to improve the public's access to safe and
effective generic drugs and to improve upon the predictability of the
review process. GDUFA II extends FDA's authority to collect user fees
from fiscal year (FY) 2018 to FY 2022 and introduces a number of
technical revisions that affect what fees are collected and how some
fees are collected. GDUFA II authorizes fees for abbreviated new drug
applications (ANDAs), drug master files (DMFs), annual facility fees, a
one-time fee for original ANDAs pending with FDA on October 1, 2012
(backlog fees), and the Generic Drug Applicant Program Fee (GDUFA
Program Fee).
The draft guidance announced in this notice addresses changes in
user fee assessments from GDUFA I, user fees incurred by industry under
GDUFA II, payment procedures, reconsideration and appeals, and other
additional information to assist industry in complying with GDUFA II.
FDA will issue separate guidance documents regarding GDUFA II non-user
fee requirements and processes.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance, when finalized,
will represent the Agency's current thinking on ``Assessing User Fees
Under the Generic Drug User Fee Amendments of 2017.'' 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
This 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-
[[Page 50144]]
3520). The guidance refers to collections of information for filling
out and submitting Form FDA 3913 (User Fee Payment Refund Request),
previously approved under OMB control number 0910-0805, and Form FDA
3914 (User Fee Payment Transfer Request), previously approved under OMB
control number 0910-0805.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: October 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23526 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P
