Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms, 50382-50383 [2018-21682]
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Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices
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defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Title of Information Collection:
Electronic Visit Verification Compliance
Survey; Type of Information Collection
Request: New collection (request for a
new OMB control number); Use: This
collection entails an electronic webbased survey that will allow states to
self-report their progress in
implementing electronic visit
verification (EVV) for personal care
services (PCS) and home health care
services (HHCS), as required by section
1903(l) of the Social Security Act. CMS
will use the survey data to assess states’
compliance with section 1903(l) of the
Act and levy Federal Medical
Assistance Percentage (FMAP)
reductions where necessary as required
by 1903(l) of the Act. Data collection
will begin in November 2019 and will
end when all states have fully
implemented EVV systems according to
the requirements specified at section
1903(l) of the Act.
The survey will be disseminated to all
51 state Medicaid agencies (including
the District of Columbia) and the
Medicaid agencies of five US territories.
States will be required to complete the
survey in order to demonstrate that they
are complaint with Section 1903(l) of
the Act by reporting on their EVV
implementation status for PCS provided
under sections 1905(a)(24), 1915(c),
1915(i), 1915(j), 1915(k), and Section
1115 of the Act; and HHCS provided
under 1905(a)(7) of the Act or under a
demonstration project or waiver (e.g.,
1915(c) or 1115 of the Act).
The survey will be a live form,
meaning states will have the ability to
update their 1903(l) compliance status
on a continuous basis. As FMAP
reductions are assigned quarterly per
1903(l) of the Act, states who are not in
compliance will be asked to review their
survey information on a quarterly basis
to ensure it is up-to-date and to update
their survey responses as needed until
they come into compliance. Form
Number: CMS–10680 (OMB control
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number: 0938–New); Frequency: On
occasion; Affected Public: State, Local,
or Tribal Governments; Number of
Respondents: 56; Number of Responses:
336; Total Annual Hours: 1,344. (For
questions regarding this collection
contact Ryan Shannahan at 410–786–
0295.)
Dated: October 2, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–21754 Filed 10–4–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3464]
Food and Drug Administration,
HHS.
Notice of availability;
correction.
ACTION:
The Food and Drug
Administration (FDA or we) is
correcting a document that appeared in
the Federal Register of September 7,
2018 (83 FR 45454). The document
announced the draft guidance for
industry entitled ‘‘Policy Regarding
Quantitative Labeling of Dietary
Supplements Containing Live
Microbials.’’ The notice inadvertently
contained the wrong docket number.
This document corrects that error.
SUMMARY:
This notice is applicable October
5, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Steven Tave, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2878.
In the
Federal Register of Friday, September 7,
2018, appearing on page 45454 in FR.
Doc. 2018–19367, the following
corrections are made:
On page 45454, in the docket heading
in column 1, the docket number
appearing in square brackets is
corrected to be FDA–2018–D–3464.
On page 45454, in the ‘‘Instructions,’’
in column 2, the Docket No. is corrected
to be FDA–2018–D–3464.
SUPPLEMENTARY INFORMATION:
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[FR Doc. 2018–21677 Filed 10–4–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–1837]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic User
Fee Payment Request Forms
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.
DATES: Fax written comments on the
collection of information by November
5, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0805. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Policy Regarding Quantitative Labeling
of Dietary Supplements Containing
Live Microbials; Draft Guidance for
Industry; Availability; Correction
AGENCY:
Dated: October 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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.
Electronic User Fee Payment Request
Forms—Form FDA 3913 and Form FDA
3914
OMB Control Number 0910–0805—
Extension
Form FDA 3913, User Fee Payment
Refund Request, is designed to provide
the minimum necessary information for
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Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices
FDA to review and process a user fee
payment refund. The information
collected includes the organization,
contact, and payment information. The
information is used to determine the
reason for the refund, the refund
amount, and who to contact if there are
any questions regarding the refund
request. A submission of the User Fee
Payment Refund Request form does not
guarantee that a refund will be issued.
FDA estimates an average of 0.40 hours
per response, including the time to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete and review the
collection of information. The estimated
hours are based on past FDA experience
with user fee payment refund requests.
In fiscal year 2017, approximately
1,657 user fee refunds were processed
for cover sheets and invoices including
12 for Animal Drug User Fee Act, 2 for
Animal Generic Drug User Fee Act, 13
for Biosimilar Drug User Fee Act, 68 for
Export Certificate Program, 14 for
Freedom of Information Act requests,
227 for Generic Drug User Fee
Amendments, 1,021 for Medical Device
User Fee Amendments, 227 for
mammography inspection fees, 67 for
Prescription Drug User Fee Act, and 6
for tobacco product fees.
Form FDA 3914, User Fee Payment
Transfer Request, is designed to provide
the minimum information necessary for
FDA to review and process a user fee
payment transfer request. The
information collected includes payment
and organization information. The
information is used to determine the
reason for the transfer, how the transfer
should be performed, and who to
contact if there are any questions
regarding the transfer request. A
submission of the User Fee Payment
Transfer Request form does not
guarantee that a transfer will be
performed. FDA estimates an average of
0.25 hours per response, including the
time to review instructions, search
existing data sources, gather and
maintain the data needed, and complete
and review the collection of
information. FDA estimated hours are
based on past FDA experience with user
fee payment transfer requests.
In fiscal year 2017, approximately 871
user fee payment transfers were
processed for cover sheets and invoices
including 8 for Animal Drug User Fee
Act, 1 for Animal Generic Drug User Fee
Act, 1 for Biosimilar Drug User Fee Act,
163 for Generic Drug User Fee
Amendments, 692 for Medical Device
User Fee Amendments, and 6 for
Prescription Drug User Fee Act.
Respondents for the electronic request
forms include domestic and foreign
firms (including pharmaceutical,
medical device, etc.). Specifically,
refund request forms target respondents
50383
who submitted a duplicate payment or
overpayment for a user fee cover sheet
or invoice. Respondents may also
include firms that withdrew an
application or submission. Transfer
request forms target respondents who
submitted payment for a user fee cover
sheet or invoice and need that payment
to be reapplied to another cover sheet or
invoice (transfer of funds).
The electronic user fee payment
request forms will streamline the refund
and transfer processes, facilitate
processing, and improve the tracking of
requests. The burden for this collection
of information is the same for all
customers (small and large
organizations). The information being
requested or required has been held to
the absolute minimum required for the
intended use of the data. Customers will
be able to request a user fee payment
refund and transfer online at https://
www.fda.gov/forindustry/userfees/
default.htm. This electronic submission
is intended to reduce the burden for
customers to submit user fee payment
refund and transfer requests.
In the Federal Register of May 15,
2018 (83 FR 22493), FDA published a
60-day 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 REPORTING BURDEN 1
FDA Form
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
User Fee Payment Refund Request—Form FDA 3913 ........
User Fee Payment Transfer Request—Form FDA 3914 ......
Total ................................................................................
1,657
871
....................
1
1
........................
1,657
871
....................
0.40 (24 minutes) ....
0.25 (15 minutes) ....
.................................
663
218
881
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
daltland on DSKBBV9HB2PROD with NOTICES
We have adjusted our burden
estimate, which has resulted in a
decrease to the currently approved
burden. New information technology
applications have more accurately
calculated the number of registrants of
drug facilities/food facilities/medical
device facilities/medicated feed
facilities, and we have therefore revised
the number of respondents to the
information collection.
Dated: October 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21682 Filed 10–4–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Applications in Lung Disease.
Date: October 30–31, 2018.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: George M. Barnas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4220,
MSC 7818, Bethesda, MD 20892, 301–435–
0696, barnasg@csr.nih.gov.
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]]>Agencies
[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50382-50383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21682]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1837]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic User Fee
Payment Request Forms
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Fax written comments on the collection of information by
November 5, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0805.
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,
[email protected].
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.
Electronic User Fee Payment Request Forms--Form FDA 3913 and Form FDA
3914
OMB Control Number 0910-0805--Extension
Form FDA 3913, User Fee Payment Refund Request, is designed to
provide the minimum necessary information for
[[Page 50383]]
FDA to review and process a user fee payment refund. The information
collected includes the organization, contact, and payment information.
The information is used to determine the reason for the refund, the
refund amount, and who to contact if there are any questions regarding
the refund request. A submission of the User Fee Payment Refund Request
form does not guarantee that a refund will be issued. FDA estimates an
average of 0.40 hours per response, including the time to review
instructions, search existing data sources, gather and maintain the
data needed, and complete and review the collection of information. The
estimated hours are based on past FDA experience with user fee payment
refund requests.
In fiscal year 2017, approximately 1,657 user fee refunds were
processed for cover sheets and invoices including 12 for Animal Drug
User Fee Act, 2 for Animal Generic Drug User Fee Act, 13 for Biosimilar
Drug User Fee Act, 68 for Export Certificate Program, 14 for Freedom of
Information Act requests, 227 for Generic Drug User Fee Amendments,
1,021 for Medical Device User Fee Amendments, 227 for mammography
inspection fees, 67 for Prescription Drug User Fee Act, and 6 for
tobacco product fees.
Form FDA 3914, User Fee Payment Transfer Request, is designed to
provide the minimum information necessary for FDA to review and process
a user fee payment transfer request. The information collected includes
payment and organization information. The information is used to
determine the reason for the transfer, how the transfer should be
performed, and who to contact if there are any questions regarding the
transfer request. A submission of the User Fee Payment Transfer Request
form does not guarantee that a transfer will be performed. FDA
estimates an average of 0.25 hours per response, including the time to
review instructions, search existing data sources, gather and maintain
the data needed, and complete and review the collection of information.
FDA estimated hours are based on past FDA experience with user fee
payment transfer requests.
In fiscal year 2017, approximately 871 user fee payment transfers
were processed for cover sheets and invoices including 8 for Animal
Drug User Fee Act, 1 for Animal Generic Drug User Fee Act, 1 for
Biosimilar Drug User Fee Act, 163 for Generic Drug User Fee Amendments,
692 for Medical Device User Fee Amendments, and 6 for Prescription Drug
User Fee Act.
Respondents for the electronic request forms include domestic and
foreign firms (including pharmaceutical, medical device, etc.).
Specifically, refund request forms target respondents who submitted a
duplicate payment or overpayment for a user fee cover sheet or invoice.
Respondents may also include firms that withdrew an application or
submission. Transfer request forms target respondents who submitted
payment for a user fee cover sheet or invoice and need that payment to
be reapplied to another cover sheet or invoice (transfer of funds).
The electronic user fee payment request forms will streamline the
refund and transfer processes, facilitate processing, and improve the
tracking of requests. The burden for this collection of information is
the same for all customers (small and large organizations). The
information being requested or required has been held to the absolute
minimum required for the intended use of the data. Customers will be
able to request a user fee payment refund and transfer online at
https://www.fda.gov/forindustry/userfees/default.htm. This electronic
submission is intended to reduce the burden for customers to submit
user fee payment refund and transfer requests.
In the Federal Register of May 15, 2018 (83 FR 22493), FDA
published a 60-day 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 Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
FDA Form Number of responses per annual Average burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
User Fee Payment Refund 1,657 1 1,657 0.40 (24 minutes)......... 663
Request--Form FDA 3913.
User Fee Payment Transfer 871 1 871 0.25 (15 minutes)......... 218
Request--Form FDA 3914.
Total.................... ........... .............. ........... .......................... 881
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. New information technology
applications have more accurately calculated the number of registrants
of drug facilities/food facilities/medical device facilities/medicated
feed facilities, and we have therefore revised the number of
respondents to the information collection.
Dated: October 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21682 Filed 10-4-18; 8:45 am]
BILLING CODE 4164-01-P
