Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products), 43243-43244 [2017-19492]
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Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices
submission by the sponsor of an IND
describing an investigation that FDA
determines is intended to support a
biosimilar biological product
application.
The application fee for a biosimilar
biological product is due upon
submission of the application (see
section 744H(a)(2)(C) of the FD&C Act).
To make a payment of the initial BPD,
reactivation, or application fee,
complete the Biosimilar User Fee Cover
Sheet, available on FDA’s Web site
(https://www.fda.gov/bsufa) and generate
a user fee identification (ID) number.
Payment must be made in U.S. currency
by electronic check, check, bank draft,
U.S. postal money order, or wire
transfer. The preferred payment method
is online using electronic check
(Automated Clearing House (ACH) also
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
Express). Secure electronic payments
can be submitted using the User Fees
Payment Portal at https://
userfees.fda.gov/pay (Note: Only full
payments are accepted. No partial
payments can be made online). Once
you search for your invoice, click ‘‘Pay
Now’’ to be redirected to Pay.gov.
Electronic payment options are based on
the balance due. Payment by credit card
is available for balances that are less
than $25,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be made using
U.S. bank accounts as well as U.S. credit
cards.
FDA has partnered with the U.S.
Department of the Treasury to use
https://www.pay.gov, a web-based
payment application, for online
electronic payment. The Pay.gov feature
is available on FDA’s Web site after
completing the Biosimilar User Fee
Cover Sheet and generating the user fee
ID number.
Please include the user fee ID number
on your check, bank draft, or postal
money order, and make it payable to the
Food and Drug Administration. Your
payment can be mailed to: Food and
Drug Administration, P.O. Box 979108,
St. Louis, MO 63197–9000. To send a
check by a courier such as Federal
Express or United Parcel Service, the
courier must deliver the check and
printed copy of the cover sheet to: U.S.
Bank, ATTN: Government Lockbox
979108, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only.
Contact U.S. Bank at 314–418–4013 if
you have any questions concerning
courier delivery.) Please make sure that
the FDA post office box number (P.O.
Box 979108) is written on the check,
bank draft, or postal money order.
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If paying by wire transfer, please
reference your unique user fee ID
number when completing the transfer.
The originating financial institution
may charge a wire transfer fee. Please
ask your financial institution about the
fee and include it with your payment to
ensure that your fee is fully paid. The
account information for wire transfers is
as follows: U.S. Department of Treasury,
TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No.: 75060099, Routing
No.: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Rd.,
14th Floor, Silver Spring, MD 20993–
0002. If needed, FDA’s tax identification
number is 53–0196965.
B. Annual BPD and Program Fees
FDA will issue invoices for annual
BPD and program fees for FY 2018
under the new fee schedule in
September 2017. Payment instructions
will be included in the invoices,
including payment due dates. If
sponsors join the BPD program after the
annual BPD invoices have been issued
in September 2017, FDA will issue
invoices in December 2017 to firms
subject to fees for FY 2018 that qualify
for the annual BPD fee after the
September 2017 billing. FDA will issue
invoices in December 2017 for any
annual program fees for FY 2018 that
qualify for fee assessments and were not
issued in September 2017.
Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–19493 Filed 9–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0594]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All Food and Drug
Administration-Regulated Products)
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.
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
43243
Fax written comments on the
collection of information by October 16,
2017.
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 0910–0497. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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. Focus Groups as
Used by the Food and Drug
Administration (All FDA-Regulated
Products), OMB Control Number 0910–
0497.
FDA conducts voluntary focus group
interviews on a variety of topics
involving FDA-regulated products,
including drugs, biologics, devices,
food, tobacco, and veterinary medicine.
Focus groups provide an important
role in gathering information because
they allow for a more in-depth
understanding of patients’ and
consumers’ attitudes, beliefs,
motivations, and feelings than do
quantitative studies. Focus groups serve
the narrowly defined need for direct and
informal opinion on a specific topic and
as a qualitative research tool have three
major purposes:
• To obtain patient and consumer
information that is useful for developing
variables and measures for quantitative
studies,
• To better understand patients’ and
consumers’ attitudes and emotions in
response to topics and concepts, and
• To further explore findings
obtained from quantitative studies.
FDA will use focus group findings to
test and refine their ideas, but will
generally conduct further research
before making important decisions such
as adopting new policies and allocating
or redirecting significant resources to
support these policies.
In the Federal Register of April 21,
2017 (82 FR 18763), FDA published a
60-day notice requesting public
comment on the proposed collection of
DATES:
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14SEN1
43244
Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
Focus Group Interviews .......................................................
8,800
1
8,800
1.75
15,400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–19492 Filed 9–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0007]
Prescription Drug User Fee Rates for
Fiscal Year 2018
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates for prescription drug user fees for
fiscal year (FY) 2018. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Prescription Drug
User Fee Amendments of 2017 (PDUFA
VI), authorizes FDA to collect
application fees for certain applications
for the review of human drug and
biological products, and prescription
drug program fees for certain approved
products. This notice establishes the fee
rates for FY 2018.
FOR FURTHER INFORMATION CONTACT:
Robert J. Marcarelli, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14202F, Silver Spring, MD
20993–0002, 301–796–7223.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Sections 735 and 736 of the FD&C Act
(21 U.S.C. 379g and 379h, respectively)
establish two different kinds of user
fees. Fees are assessed on the following:
(1) Application fees are assessed on
certain types of applications for the
review of human drug and biological
products; and (2) prescription drug
program fees are assessed on certain
approved products (section 736(a) of the
FD&C Act). When specific conditions
are met, FDA may waive or reduce fees
(section 736(d) of the FD&C Act).
For FY 2018 through FY 2022, the
base revenue amounts for the total
revenues from all PDUFA fees are
established by PDUFA VI. The base
revenue amount for FY 2018 is
$878,590,000. The FY 2018 base
revenue amount is to be adjusted for
inflation and for the resource capacity
needs for the process for the review of
human drug applications (the capacity
planning adjustment). An additional
dollar amount specified in the statute
(see section 736(b)(1)(F) of the FD&C
Act) is then added to provide for
additional full-time equivalent (FTE)
positions to support PDUFA VI
initiatives. The FY 2018 revenue
amount may be adjusted further, if
necessary, to provide for sufficient
operating reserves of carryover user fees.
Finally, the amount is adjusted to
provide for additional direct costs to
fund PDUFA VI initiatives. Fee amounts
are to be established each year so that
revenues from application fees provide
20 percent of the total revenue, and
prescription drug program fees provide
80 percent of the total revenue.
This document provides fee rates for
FY 2018 for an application requiring
clinical data ($2,421,495), for an
application not requiring clinical data
($1,210,748), and for the prescription
drug program fee ($304,162). These fees
are effective on October 1, 2017, and
will remain in effect through September
30, 2018. For applications that are
submitted on or after October 1, 2017,
the new fee schedule must be used.
II. Fee Revenue Amount for FY 2018
The base revenue amount for FY 2018
is $878,590,000 prior to adjustments for
inflation, capacity planning, additional
FTE, operating reserve, and additional
direct costs (see section 736(b)(1) of the
FD&C Act).
A. FY 2018 Statutory Fee Revenue
Adjustments for Inflation
PDUFA VI specifies that the
$878,590,000 is to be adjusted for
inflation increases for FY 2018 using
two separate adjustments—one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (see
section 736(c)(1) of the FD&C Act).
The component of the inflation
adjustment for payroll costs shall be one
plus the average annual percent change
in the cost of all PC&B paid per FTE
positions at FDA for the first three of the
preceding four FYs, multiplied by the
proportion of PC&B costs to total FDA
costs of the process for the review of
human drug applications for the first
three of the preceding four FYs (see
section 736(c)(1)(A) and (c)(1)(B) of the
FD&C Act).
Table 1 summarizes the actual cost
and FTE data for the specified FYs and
provides the percent changes from the
previous FYs and the average percent
changes over the first three of the four
FYs preceding FY 2018. The 3-year
average is 2.2354 percent.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES
Fiscal year
2014
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent Change From Previous Year .....................................
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$2,054,937,000
14,555
$141,184
2.3451
Fmt 4703
Sfmt 4703
2015
$2,232,304,000
15,484
$144,168
2.1136
E:\FR\FM\14SEN1.SGM
2016
$2,414,728,159
16,381
$147,408
2.2474
14SEN1
3-year
average
2.2354
]]>Agencies
[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43243-43244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19492]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0594]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Focus Groups as Used
by the Food and Drug Administration (All Food and Drug Administration-
Regulated Products)
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 October
16, 2017.
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 0910-0497.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
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. Focus Groups as Used by the Food and Drug
Administration (All FDA-Regulated Products), OMB Control Number 0910-
0497.
FDA conducts voluntary focus group interviews on a variety of
topics involving FDA-regulated products, including drugs, biologics,
devices, food, tobacco, and veterinary medicine.
Focus groups provide an important role in gathering information
because they allow for a more in-depth understanding of patients' and
consumers' attitudes, beliefs, motivations, and feelings than do
quantitative studies. Focus groups serve the narrowly defined need for
direct and informal opinion on a specific topic and as a qualitative
research tool have three major purposes:
To obtain patient and consumer information that is useful
for developing variables and measures for quantitative studies,
To better understand patients' and consumers' attitudes
and emotions in response to topics and concepts, and
To further explore findings obtained from quantitative
studies.
FDA will use focus group findings to test and refine their ideas,
but will generally conduct further research before making important
decisions such as adopting new policies and allocating or redirecting
significant resources to support these policies.
In the Federal Register of April 21, 2017 (82 FR 18763), FDA
published a 60-day notice requesting public comment on the proposed
collection of
[[Page 43244]]
information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Activity Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Interviews............................................. 8,800 1 8,800 1.75 15,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19492 Filed 9-13-17; 8:45 am]
BILLING CODE 4164-01-P
