Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief; Draft Guidance for Industry; Availability, 26475-26477 [2018-12217]
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26475
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and Date
O. Physical Medicine
16–202 ...............
RESNA Standard for Wheelchairs Volume 4: Wheelchairs and Transportation ......................
RESNA WC–4:2017.
P. Radiology
No new entries at this time
Q. Software/Informatics
13–104 ...............
Software Cybersecurity for Network-Connectable Products, Part 2–1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems.
ANSI/UL 2900–2–1, First Edition September 1, 2017.
R. Sterility
No new entries at this time
S. Tissue Engineering
15–53 .................
15–54 .................
1 All
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular
Therapies.
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model.
ASTM F3207–17.
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA
Recognized Consensus Standards in a
searchable database that may be
accessed at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will be incorporating the modifications
and revisions described in this notice
into the database and, upon publication
in the Federal Register, this recognition
of consensus standards will be effective.
FDA will be announcing additional
modifications and revisions to the list of
recognized consensus standards, as
needed, in the Federal Register once a
year, or more often if necessary.
Beginning with recognition list 049,
FDA will no longer include in the
database the CDRH Office and Division
associated with recognized standards,
Devices Affected, and Processes
Affected. Beginning with recognition
list 049 FDA will automatically
incorporate, upon publication, a U.S.
parallel adoption of an existing
recognized international standard.
sradovich on DSK3GMQ082PROD with NOTICES
ASTM F3206 –17.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
be considered, such recommendations
should contain, at a minimum, the
following information available at
https://www.fda.gov/MedicalDevices/
VerDate Sep<11>2014
17:19 Jun 06, 2018
Jkt 244001
DeviceRegulationandGuidance/
Standards/ucm123739.htm.
Dated: May 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12222 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1635]
Prescription Drug User Fee Act
Waivers for Fixed-Combination
Antiretroviral Drugs for the President’s
Emergency Plan for AIDS Relief; 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
‘‘Prescription Drug User Fee Act
Waivers for Fixed-Combination
Antiretroviral Drugs for the President’s
Emergency Plan for AIDS Relief.’’ This
draft guidance describes circumstances
under which an applicant may be
eligible for a barrier-to-innovation
waiver for some new drug applications
(NDAs) for fixed-combination versions
and single-entity versions of previously
approved antiretroviral therapies for the
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
treatment of human immunodeficiency
virus (HIV).
DATES: Submit either electronic or
written comments on the guidance
August 6, 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
E:\FR\FM\07JNN1.SGM
07JNN1
26476
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
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–
2018–D–1635 for ‘‘Prescription Drug
User Fee Act Waivers for FixedCombination Antiretroviral Drugs for
the President’s Emergency Plan for
AIDS Relief.’’ 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.
VerDate Sep<11>2014
17:19 Jun 06, 2018
Jkt 244001
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: Ted
Palat, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10001 New Hampshire
Ave., Rm. 2185, Silver Spring, MD
20993, 240–402–8739, Ted.Palat@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Prescription Drug User Fee Act
Waivers for Fixed-Combination
Antiretroviral Drugs for the President’s
Emergency Plan for AIDS Relief.’’ The
draft guidance describes the
circumstances under which certain
applications for fixed-combination and
single-entity versions of previously
approved antiretroviral therapies for the
treatment of HIV under the President’s
Emergency Plan for AIDS Relief
(PEPFAR) may be eligible for a barrierto-innovation waiver.
In October 2006, to encourage
applicants to submit applications for
HIV combination therapies that can be
used in PEPFAR, FDA issued a final
guidance entitled ‘‘Fixed Dose
Combinations, Co-Packaged Drug
Products, and Single-Entity Versions of
Previously Approved Antiretrovirals for
the Treatment of HIV’’ (fixedcombination guidance). Attachments to
the fixed-combination guidance
describe some scenarios for approval of
fixed-combination for the treatment of
HIV and provide examples of drug
combinations considered acceptable as
fixed combinations and examples of
those not considered acceptable as fixed
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
combinations. Although the 2006 fixedcombination guidance focuses on fixed
combinations, the scientific principles
outlined in the guidance also apply to
single ingredient versions of
antiretroviral drugs that are components
of regimens listed in Attachment B. The
guidance also explains that the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) provides for certain circumstances
in which FDA may grant a waiver or
reduction in user fees.
This draft guidance is a revision of the
guidance for industry entitled ‘‘User Fee
Waivers for FDC and Co-Packaged HIV
Drugs for PEPFAR,’’ issued February
2007. In this guidance, FDA provides
information about the circumstances
under which certain applications for
fixed-combination and single-entity
versions of previously approved
antiretroviral therapies for the treatment
of HIV under PEPFAR may be eligible
for a barrier-to-innovation waiver.
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 ‘‘Prescription Drug User Fee Act
Waivers for Fixed-Combination
Antiretroviral Drugs for the President’s
Emergency Plan for AIDS Relief.’’ 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 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 burden of
information collection associated with
requesting waivers of user fees
(including PEPFAR waivers) was
previously approved under OMB
control number 0910–0693. The burden
for completing and submitting Form
FDA 3397 (Prescription Drug User Fee
Coversheet) is not included in this
analysis as the burden is already
approved under OMB control number
0910–0297. The collections of
information associated with submission
of a new drug application or biologics
license application are approved under
OMB control numbers 0910–0001 and
0910–0338, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
E:\FR\FM\07JNN1.SGM
07JNN1
26477
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12217 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0781]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
Claim
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by July 9,
2018.
DATES:
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 0910–0428. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
ADDRESSES:
Record Retention Requirements for the
Soy Protein and Risk of Coronary Heart
Disease Health Claim—21 CFR 101.82
OMB Control Number 0910–0428—
Extension
Section 403(r)(3)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
343(r)(3)(A)) provides for the use of food
label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health-related
condition only where that statement
meets the requirements of the
regulations issued by the Secretary of
Health and Human Services to authorize
the use of such a health claim. Section
101.82 (21 CFR 101.82) of our
regulations authorizes a health claim for
food labels about soy protein and the
risk of coronary heart disease.
Accordingly, FDA established the
previously referenced information
collection in support of the regulation.
In the Federal Register of October 31,
2017 (82 FR 50324), we published a
proposed rule to revoke the underlying
regulation found at § 101.82. We are
taking this action based on our review
of the totality of publicly available
scientific evidence currently available
and our tentative conclusion that such
evidence does not support our previous
determination that there is significant
scientific agreement among qualified
experts for a health claim regarding the
relationship between soy protein and
reduced risk of coronary heart disease.
Upon finalization of the proposed rule,
the associated information collection
requirements under this OMB control
number will be revoked. Until such time
and in accordance with the PRA, we
retain our currently approved burden
estimate for the information collection
displayed in table 1 of this notice.
In the Federal Register of March 8,
2018 (83 FR 9856), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
101.82(c)(2)(ii)(B) .................................................................
sradovich on DSK3GMQ082PROD with NOTICES
1 There
Number of
records per
recordkeeper
25
Total
annual
records
Average
burden per
recordkeeping
1
25
Total
hours
1
25
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our current experience with
the use of health claims, we estimate 25
firms market products bearing a soy
protein/coronary heart disease health
claim and that perhaps one of each
firm’s products might contain non-soy
sources of protein along with soy
protein. The records currently required
to be retained under § 101.82(c)(2)(ii)(B)
are the records, e.g., the formulation or
recipe, that a manufacturer has and
maintains as a normal course of its
doing business. Thus, the burden to the
food manufacturer is limited to
assembling and retaining the records,
which we estimate will take 1 hour
annually.
VerDate Sep<11>2014
17:19 Jun 06, 2018
Jkt 244001
Dated: May 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12216 Filed 6–6–18; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2012–N–0961]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
SUMMARY:
Frm 00068
Fmt 4703
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07JNN1
]]>Agencies
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26475-26477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12217]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1635]
Prescription Drug User Fee Act Waivers for Fixed-Combination
Antiretroviral Drugs for the President's Emergency Plan for AIDS
Relief; 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
``Prescription Drug User Fee Act Waivers for Fixed-Combination
Antiretroviral Drugs for the President's Emergency Plan for AIDS
Relief.'' This draft guidance describes circumstances under which an
applicant may be eligible for a barrier-to-innovation waiver for some
new drug applications (NDAs) for fixed-combination versions and single-
entity versions of previously approved antiretroviral therapies for the
treatment of human immunodeficiency virus (HIV).
DATES: Submit either electronic or written comments on the guidance
August 6, 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
[[Page 26476]]
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-2018-D-1635 for ``Prescription Drug User Fee Act Waivers for Fixed-
Combination Antiretroviral Drugs for the President's Emergency Plan for
AIDS Relief.'' 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: Ted Palat, Center for Drug Evaluation
and Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Rm. 2185, Silver Spring, MD 20993, 240-402-8739, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Prescription Drug User Fee Act Waivers for Fixed-Combination
Antiretroviral Drugs for the President's Emergency Plan for AIDS
Relief.'' The draft guidance describes the circumstances under which
certain applications for fixed-combination and single-entity versions
of previously approved antiretroviral therapies for the treatment of
HIV under the President's Emergency Plan for AIDS Relief (PEPFAR) may
be eligible for a barrier-to-innovation waiver.
In October 2006, to encourage applicants to submit applications for
HIV combination therapies that can be used in PEPFAR, FDA issued a
final guidance entitled ``Fixed Dose Combinations, Co-Packaged Drug
Products, and Single-Entity Versions of Previously Approved
Antiretrovirals for the Treatment of HIV'' (fixed-combination
guidance). Attachments to the fixed-combination guidance describe some
scenarios for approval of fixed-combination for the treatment of HIV
and provide examples of drug combinations considered acceptable as
fixed combinations and examples of those not considered acceptable as
fixed combinations. Although the 2006 fixed-combination guidance
focuses on fixed combinations, the scientific principles outlined in
the guidance also apply to single ingredient versions of antiretroviral
drugs that are components of regimens listed in Attachment B. The
guidance also explains that the Federal Food, Drug, and Cosmetic Act
(FD&C Act) provides for certain circumstances in which FDA may grant a
waiver or reduction in user fees.
This draft guidance is a revision of the guidance for industry
entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for
PEPFAR,'' issued February 2007. In this guidance, FDA provides
information about the circumstances under which certain applications
for fixed-combination and single-entity versions of previously approved
antiretroviral therapies for the treatment of HIV under PEPFAR may be
eligible for a barrier-to-innovation waiver.
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 ``Prescription
Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs
for the President's Emergency Plan for AIDS Relief.'' 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 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
burden of information collection associated with requesting waivers of
user fees (including PEPFAR waivers) was previously approved under OMB
control number 0910-0693. The burden for completing and submitting Form
FDA 3397 (Prescription Drug User Fee Coversheet) is not included in
this analysis as the burden is already approved under OMB control
number 0910-0297. The collections of information associated with
submission of a new drug application or biologics license application
are approved under OMB control numbers 0910-0001 and 0910-0338,
respectively.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/
[[Page 26477]]
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12217 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P
