Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability, 58615-58617 [2017-26791]
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<![CDATA[
58615
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
AFCARS ..........................................................................................................
72
2
1,786
257,184
Estimated Total Annual Burden
Hours: 257,184.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW, Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–26825 Filed 12–12–17; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Description: The information obtained
from this form will be used to: (1)
Report Child Support Enforcement
activities to the Congress as required by
law; (2) calculate incentive measures
performance and performance
indicators utilized in the program; and
(3) assist the Office of Child Support
Enforcement (OCSE) in monitoring and
evaluating State Child Support
programs.
Respondents: State, Local or Tribal
Government.
Administration for Children and
Families
[OMB No. 0970–0177]
Proposed Information Collection
Activity; Comment Request
Title: OCSE–157 Child Support
Enforcement Program Annual Data
Report.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
OCSE–157 .......................................................................................................
sradovich on DSK3GMQ082PROD with NOTICES
Instrument
54
1
7
378
Estimated Total Annual Burden
Hours: 378.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
SUMMARY:
[FR Doc. 2017–26814 Filed 12–12–17; 8:45 am]
BILLING CODE 4184–01–P
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Food and Drug Administration
[Docket No. FDA–2017–D–6554]
Refuse To File: New Drug Application
and Biologics License Application
Submissions to the Center for Drug
Evaluation and Research; 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 ‘‘Refuse
to File: NDA and BLA Submissions to
CDER.’’ The purpose of this guidance is
to clarify certain circumstances under
which FDA’s Center for Drug Evaluation
and Research (CDER) may refuse to file
a new drug application (NDA) or
E:\FR\FM\13DEN1.SGM
13DEN1
58616
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
supplemental NDA, or a biologics
license application (BLA) or
supplemental BLA submitted to CDER,
and to underscore the importance of
submitting a complete application to
minimize the chance of a refuse-to-file
(RTF) action by FDA.
DATES: Submit either electronic or
written comments on the draft guidance
by February 12, 2018 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’’).
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–
2017–D–6554 for ‘‘Refuse to File: New
Drug Application and Biologics License
Application Submissions to the Center
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
for Drug Evaluation and Research; Draft
Guidance for Industry.’’ 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/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
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INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Amalia Himaya, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6439,
Silver Spring, MD 20993–0002, 301–
796–0700.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Refuse to File: NDA and BLA
Submissions to CDER.’’ The purpose of
this guidance is to clarify certain
circumstances under which CDER may
refuse to file an NDA or supplemental
NDA, or a BLA or supplemental BLA
submitted to CDER, and to underscore
the importance of submitting a complete
application to minimize the chance of
an RTF action by FDA. Since the early
1990s, in conjunction with the
Prescription Drug User Fee Act, FDA’s
processes and timelines for reviewing
newly submitted applications have
substantially evolved. The
administrative complexity of
applications, with corresponding
determinations of completeness, has
become more challenging. The overall
goal is to efficiently and effectively
review applications, and thus it is
critical to avoid use of resources to
review an application when necessary
components are so deficient as to render
the application incomplete. FDA
exercises its RTF authority for
incomplete applications to optimize the
use of both the applicant’s and FDA’s
resources.
Incomplete applications, including
applications for which minor
components not received within 30
calendar days after receipt of the
original application, as may have been
agreed upon at a presubmission
meeting, may be refused for filing.
This guidance focuses on FDA’s
policy for refusing to file an NDA under
21 CFR 314.101(d)(3) because the NDA
is incomplete because it does not on its
face contain information required under
section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(b)) and 21 CFR 314.50. FDA
considers incompleteness to be a basis
for refusal to file for BLAs as well (21
CFR 601.2(a)).
On May 19, 2017, FDA withdrew its
previously published guidance for
industry entitled ‘‘Refusal to File’’
(issued July 12, 1993). FDA is issuing
this guidance to update and clarify
CDER’s procedures for determining
whether an application should be
E:\FR\FM\13DEN1.SGM
13DEN1
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
refused for filing because it is
incomplete. This guidance includes
procedures for certain BLAs and
supplemental BLAs, given that CDER
has regulatory responsibility for certain
therapeutic biological products subject
to licensing under the Public Health
Service Act.
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 refusal to file NDA and BLA
submissions to CDER. 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 guidance refers to previously
approved collections of information 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 collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR part 601 have
been approved under OMB control
number 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 or https://
www.regulations.gov.
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26791 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2017–N–5925]
21st Century Cures Act: Announcing
the Establishment of the Susceptibility
Test Interpretive Criteria Website
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the establishment of
SUMMARY:
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
the Susceptibility Test Interpretive
Criteria Website. The Susceptibility Test
Interpretive Criteria Website will help to
efficiently update susceptibility test
interpretive criteria for antimicrobial
drugs when necessary for public health
and may allow for more efficient
development and evaluation of
antimicrobial susceptibility test (AST)
devices. These changes may lead to
better patient care and reduce
antimicrobial resistance through
improved antibiotic stewardship. FDA
is publishing this notice in accordance
with procedures established by the 21st
Century Cures Act (Cures Act).
FOR FURTHER INFORMATION CONTACT:
Katherine Schumann, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242,
Silver Spring, MD 20993–0002, 301–
796–1182, Katherine.Schumann@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Antimicrobial susceptibility testing is
used to determine if certain
microorganisms that are isolated from a
patient with an infection are likely to be
killed or inhibited by a particular
antimicrobial drug. It is important that
the in vitro susceptibility test methods
and susceptibility test interpretive
criteria for systemic antibacterial or
antifungal drugs be reviewed on a
regular basis and updated to reflect the
most current information. The
development of new mechanisms of
resistance in bacteria or fungi may result
in decreased susceptibility to a
particular drug. Decreased susceptibility
may raise efficacy or safety concerns
when out-of-date susceptibility test
interpretive criteria are used in guiding
the treatment of patients.
Historically, susceptibility test
interpretive criteria have been contained
in the Microbiology subsection of
antimicrobial drug labeling, and there
have been significant challenges
associated with ensuring that this
information is up-to-date in individual
antimicrobial drug labels. For some
time, FDA and other stakeholders have
recognized that susceptibility test
interpretive criteria standards
established by nationally or
internationally recognized standard
development organizations (SDOs) can
be useful sources of information to
identify and update susceptibility test
interpretive criteria.
Section 511A of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360a–2), as added by section
3044 of the Cures Act (Pub. L. 114–255),
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58617
was signed into law on December 13,
2016. This provision clarifies FDA’s
authority to identify and efficiently
update susceptibility test interpretive
criteria, including through the
recognition by FDA of standards
established by SDOs. It also clarifies
that sponsors of AST devices may rely
upon listed susceptibility interpretive
criteria to support premarket
authorization of their devices, provided
they meet certain conditions, which
provides for a more streamlined process
for incorporating up-to-date information
into such devices.
II. Susceptibility Test Interpretive
Criteria Website
Section 511A of the FD&C Act
requires FDA to establish within 1 year
after the date of enactment of the Cures
Act an Interpretive Criteria Website that
contains a list of FDA-recognized
susceptibility test interpretive criteria
standards, as well as other susceptibility
test interpretive criteria identified by
FDA. FDA is announcing the
establishment of this Interpretive
Criteria Website, which can be found
here: https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
DevelopmentResources/
ucm410971.htm.
This website recognizes susceptibility
test interpretive criteria established by
an SDO that fulfills the requirements
under section 511A(b)(2)(A) of the
FD&C Act; identifies when FDA does
not recognize, in whole or in part,
susceptibility test interpretive criteria
established by an SDO; and lists
susceptibility test interpretive criteria
identified by FDA outside the SDO
process. The susceptibility test
interpretive criteria listed by FDA on
the Interpretive Criteria Website are
deemed to be recognized as a standard
under section 514(c)(1) of the FD&C Act
(21 U.S.C. 360d(c)(1)).
At least every 6 months after the
establishment of the Interpretive Criteria
Website, FDA will publish on the
Interpretive Criteria Website a notice
recognizing new or updated
susceptibility test interpretive criteria
standards, or parts of standards;
withdrawing recognition of
susceptibility test interpretive criteria
standards, or parts of standards; and
making any other necessary updates to
the lists published on the Interpretive
Criteria Website. Once a year FDA will
compile the notices from that year and
publish them in the Federal Register
and provide for public comment. If
comments are received, FDA will
review those comments and make any
updates to the recognized standards or
susceptibility test interpretive criteria as
E:\FR\FM\13DEN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58615-58617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6554]
Refuse To File: New Drug Application and Biologics License
Application Submissions to the Center for Drug Evaluation and Research;
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 ``Refuse to
File: NDA and BLA Submissions to CDER.'' The purpose of this guidance
is to clarify certain circumstances under which FDA's Center for Drug
Evaluation and Research (CDER) may refuse to file a new drug
application (NDA) or
[[Page 58616]]
supplemental NDA, or a biologics license application (BLA) or
supplemental BLA submitted to CDER, and to underscore the importance of
submitting a complete application to minimize the chance of a refuse-
to-file (RTF) action by FDA.
DATES: Submit either electronic or written comments on the draft
guidance by February 12, 2018 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-2017-D-6554 for ``Refuse to File: New Drug Application and
Biologics License Application Submissions to the Center for Drug
Evaluation and Research; Draft Guidance for Industry.'' 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: Amalia Himaya, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301-
796-0700.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Refuse to File: NDA and BLA Submissions to CDER.'' The
purpose of this guidance is to clarify certain circumstances under
which CDER may refuse to file an NDA or supplemental NDA, or a BLA or
supplemental BLA submitted to CDER, and to underscore the importance of
submitting a complete application to minimize the chance of an RTF
action by FDA. Since the early 1990s, in conjunction with the
Prescription Drug User Fee Act, FDA's processes and timelines for
reviewing newly submitted applications have substantially evolved. The
administrative complexity of applications, with corresponding
determinations of completeness, has become more challenging. The
overall goal is to efficiently and effectively review applications, and
thus it is critical to avoid use of resources to review an application
when necessary components are so deficient as to render the application
incomplete. FDA exercises its RTF authority for incomplete applications
to optimize the use of both the applicant's and FDA's resources.
Incomplete applications, including applications for which minor
components not received within 30 calendar days after receipt of the
original application, as may have been agreed upon at a presubmission
meeting, may be refused for filing.
This guidance focuses on FDA's policy for refusing to file an NDA
under 21 CFR 314.101(d)(3) because the NDA is incomplete because it
does not on its face contain information required under section 505(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and 21
CFR 314.50. FDA considers incompleteness to be a basis for refusal to
file for BLAs as well (21 CFR 601.2(a)).
On May 19, 2017, FDA withdrew its previously published guidance for
industry entitled ``Refusal to File'' (issued July 12, 1993). FDA is
issuing this guidance to update and clarify CDER's procedures for
determining whether an application should be
[[Page 58617]]
refused for filing because it is incomplete. This guidance includes
procedures for certain BLAs and supplemental BLAs, given that CDER has
regulatory responsibility for certain therapeutic biological products
subject to licensing under the Public Health Service Act.
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 refusal to
file NDA and BLA submissions to CDER. 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 guidance refers to previously approved collections of
information 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 collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR part 601 have been approved under OMB control
number 0910-0338.
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: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26791 Filed 12-12-17; 8:45 am]
BILLING CODE 4164-01-P
