Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Guidance for Industry; Availability, 19564-19565 [2018-09366]
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19564
Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Child Care and Development
Fund, Annual Aggregate Report (ACF–
800).
OMB No.: 0970–0150.
Description: Section 658K of the Child
Care and Development Block Grant
(CCDBG) Act (42 U.S.C. 9858, as
amended by Pub. L. 113–186) requires
that States and Territories submit
annual aggregate data on the children
and families receiving direct services
under the Child Care and Development
Fund (CCDF). The implementing
regulations for the statutorily required
reporting are at 45 CFR 98.70 and 98.71.
Annual aggregate reports include data
elements represented in the ACF–800
reflecting the scope, type, and methods
of child care delivery. This provides
ACF with the information necessary to
make reports to Congress, address
national child care needs, offer
technical assistance to grantees, meet
performance measures, and conduct
research. Consistent with the statute and
regulations, ACF requests extension of
the ACF–800 without changes.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Marianna Islands.
ANNUAL BURDEN ESTIMATES
sradovich on DSK3GMQ082PROD with NOTICES
ACF–800 ..................................................................................
Estimated Total Annual Burden
Hours: 2,352.
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
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–09384 Filed 5–2–18; 8:45 am]
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Number of
responses
per respondent
Number of
respondents
Instrument
56
1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5913]
Assessing User Fees Under the
Prescription Drug User Fee
Amendments of 2017; 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 final
guidance for industry entitled
‘‘Assessing User Fees Under the
Prescription Drug User Fee
Amendments of 2017.’’ This guidance
concerns FDA’s implementation of the
Prescription Drug User Fee
Amendments of 2017 (PDUFA VI) and
certain changes in policies and
procedures surrounding its application.
DATES: The announcement of the
guidance is published in the Federal
Register on May 3, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Average
burden hours
per response
Total burden
hours
42
2,352
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–5913 for ‘‘Assessing User Fees
Under the Prescription Drug User Fee
Amendments of 2017; Guidance for
Industry.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
E:\FR\FM\03MYN1.SGM
03MYN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Notices
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 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; or to 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,
Silver Spring, MD 20993–0002. Send
VerDate Sep<11>2014
17:29 May 02, 2018
Jkt 244001
one self-addressed adhesive label to
assist the office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Peter Chen, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Building, Rm. 2112,
Silver Spring, MD 20993, 240–402–
8605, Peter.Chen@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave, Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Assessing User Fees Under the
Prescription Drug User Fee
Amendments of 2017.’’ This guidance
concerns the implementation of the
PDUFA VI and certain changes in
policies and procedures surrounding its
application. Because PDUFA VI created
significant changes to the user fee
program, this guidance serves to provide
an explanation about the new fee
structure and types of fees for which
applicants are responsible.
PDUFA VI provides two different fee
types that applicants pay: Application
and program fees. This guidance
describes when these fees are incurred
and the process by which applicants can
submit payments. The guidance also
provides information on consequences
of failing to pay PDUFA VI fees as well
as the process for submitting a
reconsideration and appeals request.
In the Federal Register of October 13,
2017 (82 FR 47748), FDA announced the
availability of a draft version of this
guidance and provided interested
parties an opportunity to submit
comments. We have reviewed the
comments submitted to the docket and
determined that they did not raise any
relevant issues. This guidance does not
include any substantive changes from
the draft guidance.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on assessing user fees
under PDUFA VI. 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.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
19565
II. Electronic Access
Persons with access to the internet
may obtain the 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: April 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–09366 Filed 5–2–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Pain Management Best
Practices Inter-Agency Task Force
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the Pain Management Best Practices
Inter-Agency Task Force (Task Force).
The meeting will be open to the public;
public comment sessions will be held
during the meeting.
DATES: The inaugural meeting will be
held on Wednesday, May 30, 2018, from
9:30 a.m. to 5:00 p.m. Eastern Time and
Thursday, May 31, 2018, from 9:00 a.m.
to 3:30 p.m. Eastern Time The agenda
will be posted on the Task Force
website at https://www.hhs.gov/ash/
advisory-committees/pain/.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW, Washington,
DC 20201.
FOR FURTHER INFORMATION CONTACT:
Alicia Richmond Scott, Designated
Federal Officer, Pain Management Best
Practices Inter-Agency Task Force, U.S.
Department of Health and Human
Services, Office of the Assistant
Secretary for Health, 200 Independence
Avenue SW, Room 736E, Washington,
DC 20201. Email: paintaskforce@
hhs.gov.
SUMMARY:
Section
101 of the Comprehensive Addiction
and Recovery Act of 2016 (CARA)
authorizes the Secretary of Health and
Human Services, in cooperation with
SUPPLEMENTARY INFORMATION:
E:\FR\FM\03MYN1.SGM
03MYN1
Agencies
[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Notices]
[Pages 19564-19565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09366]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5913]
Assessing User Fees Under the Prescription Drug User Fee
Amendments of 2017; 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 final guidance for industry entitled ``Assessing
User Fees Under the Prescription Drug User Fee Amendments of 2017.''
This guidance concerns FDA's implementation of the Prescription Drug
User Fee Amendments of 2017 (PDUFA VI) and certain changes in policies
and procedures surrounding its application.
DATES: The announcement of the guidance is published in the Federal
Register on May 3, 2018.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-5913 for ``Assessing User Fees Under the Prescription Drug
User Fee Amendments of 2017; Guidance for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential
[[Page 19565]]
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 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; or to 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, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Peter Chen, Center for Drug Evaluation
and Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, Rm. 2112, Silver Spring, MD 20993, 240-402-8605,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Assessing User Fees Under the Prescription Drug User Fee
Amendments of 2017.'' This guidance concerns the implementation of the
PDUFA VI and certain changes in policies and procedures surrounding its
application. Because PDUFA VI created significant changes to the user
fee program, this guidance serves to provide an explanation about the
new fee structure and types of fees for which applicants are
responsible.
PDUFA VI provides two different fee types that applicants pay:
Application and program fees. This guidance describes when these fees
are incurred and the process by which applicants can submit payments.
The guidance also provides information on consequences of failing to
pay PDUFA VI fees as well as the process for submitting a
reconsideration and appeals request.
In the Federal Register of October 13, 2017 (82 FR 47748), FDA
announced the availability of a draft version of this guidance and
provided interested parties an opportunity to submit comments. We have
reviewed the comments submitted to the docket and determined that they
did not raise any relevant issues. This guidance does not include any
substantive changes from the draft guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on assessing user fees under PDUFA VI. 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. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: April 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09366 Filed 5-2-18; 8:45 am]
BILLING CODE 4164-01-P