Notice To Announce Supplemental Awards To Support Technical Assistance To Address the HIV Epidemic, 37901-37902 [2019-16585]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices
approval under section 571 of the FD&C
Act for the same product and paid an
application fee at the time they applied
for conditional approval, provided the
sponsor has submitted the application
under section 512(b)(1) of the FD&C Act
within the timeframe specified in
section 571(h) of the FD&C Act.
jbell on DSK3GLQ082PROD with NOTICES
IX. Procedures for Paying the FY 2020
Fees
A. Application Fees and Payment
Instructions
The appropriate application fee
established in the new fee schedule
must be paid for an animal drug
application or supplement subject to
fees under ADUFA IV that is submitted
on or after October 1, 2019. The
payment must be made in U.S. currency
by one of the following methods: Wire
transfer, electronic check, bank draft, or
U.S. postal money order made payable
to FDA. 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, or the Pay.gov
payment option is available after you
submit a cover sheet. (Note: Only full
payments are accepted. No partial
payments can be made online.) Once
you search for and find your invoice,
select ‘‘Pay Now’’ to be redirected to
https://www.pay.gov/. Electronic
payment options are based on the
balance due. Payment by credit card is
available only 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.
When paying by check, bank draft, or
U.S. postal money order, please write
your application’s unique Payment
Identification Number (PIN), beginning
with the letters AD, on the upper righthand corner of your completed Animal
Drug User Fee Cover Sheet. Also write
the FDA post office box number (P.O.
Box 979033) on the enclosed check,
bank draft, or money order. Mail the
payment and a copy of the completed
Animal Drug User Fee Cover Sheet to:
Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197–9000.
When paying by wire transfer, the
invoice number needs to be included.
Without the invoice number, the
payment may not be applied. If the
payment amount is not applied, the
invoice amount would be referred to
collections. The originating financial
VerDate Sep<11>2014
18:02 Aug 01, 2019
Jkt 247001
institution may charge a wire transfer
fee. If the financial institution charges a
wire transfer fee, it is required to add
that amount to the payment to ensure
that the invoice is paid in full.
Use the following account
information when sending a payment by
wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, FDA deposit
account number: 75060099, U.S.
Department of the Treasury routing/
transit number: 021030004, SWIFT
number: FRNYUS33.
To send a check by a courier such as
Federal Express, the courier must
deliver the check and printed copy of
the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier
delivery only. If you have any questions
concerning courier delivery, contact
U.S. Bank at 314–418–4013. This
telephone number is only for questions
about courier delivery.)
It is important that the fee arrives at
the bank at least a day or two before the
application arrives at CVM. FDA records
the official application receipt date as
the later of the following: The date the
application was received by CVM, or the
date U.S. Bank notifies FDA that your
payment in the full amount has been
received, or when the U.S. Treasury
notifies FDA of receipt of an electronic
or wire transfer payment. U.S. Bank and
the U.S. Treasury are required to notify
FDA within 1 working day, using the
PIN described previously.
FDA’s tax identification number is
53–0196965. (Note: In no case should
the payment for the fee be submitted to
FDA with the application.)
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log on to the ADUFA website
at https://www.fda.gov/industry/animaldrug-user-fee-act-adufa/animal-druguser-fee-cover-sheet and, under
Application Submission Information,
click ‘‘Create ADUFA User Fee Cover
Sheet.’’ For security reasons, each firm
submitting an application will be
assigned an organization identification
number, and each user will also be
required to set up a user account and
password the first time they use this
site. Online instructions will walk you
through this process.
Step Two—Create an Animal Drug
User Fee Cover Sheet, transmit it to
FDA, and print a copy. After logging
into your account with user name and
password, complete the steps required
to create an Animal Drug User Fee
Cover Sheet. One cover sheet is needed
for each animal drug application or
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
37901
supplement. Once you are satisfied that
the data on the cover sheet are accurate
and you have finalized the cover sheet,
you will be able to transmit it
electronically to FDA and you will be
able to print a copy of your cover sheet
showing your unique PIN.
Step Three—Send the payment for
your application as described in section
IX.A of this document.
Step Four—Please submit your
application and a copy of the completed
Animal Drug User Fee Cover Sheet to
the following address: Food and Drug
Administration, Center for Veterinary
Medicine, Document Control Unit
(HFV–199), 7500 Standish Pl.,
Rockville, MD 20855.
C. Product, Establishment, and Sponsor
Fees
By December 31, 2019, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2020 using this fee schedule.
Payment will be due by January 31,
2020. FDA will issue invoices in
November 2020 for any products,
establishments, and sponsors subject to
fees for FY 2020 that qualify for fees
after the December 2019 billing.
Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16434 Filed 8–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice To Announce Supplemental
Awards To Support Technical
Assistance To Address the HIV
Epidemic
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice to announce
supplemental awards to support
technical assistance to address the HIV
epidemic.
AGENCY:
HRSA provided supplemental
grant funds to two currently funded
National Training and Technical
Assistance Cooperative Agreement
award recipients to support ending the
HIV epidemic by providing critical
expertise and resources to health centers
in geographic locations identified in
Ending the HIV Epidemic: A Plan for
America.
FOR FURTHER INFORMATION CONTACT:
Tracey Orloff, Strategic Partnerships
SUMMARY:
E:\FR\FM\02AUN1.SGM
02AUN1
37902
Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices
Authority: Section 330(l) of the Public
Health Service Act, as amended.
Justification: The award recipients
will provide specialized training and
technical assistance (T/TA) to health
centers in geographic areas with the
highest HIV burden, which include 48
counties; Washington, DC; San Juan;
Puerto Rico; as well as seven states that
have a substantial rural HIV burden. JSI
Research and Training Institute, Inc.
will provide T/TA focused on the use of
data in HIV outreach, in-reach, and
prevention efforts. Fenway Community
Division Director in the Office of
Quality Improvement, at TOrloff@
hrsa.gov or (301) 443–3197.
SUPPLEMENTARY INFORMATION:
Recipients: Two current National
Training and Technical Assistance
Cooperative Agreement award
recipients, as listed in Table 1.
Amount of Non-Competitive Awards:
Two awards with a combined total of
$249,000.
Period of Supplemental Funding:
Fiscal year 2019.
CFDA Number: 93.129.
Health Center will provide T/TA
focused on expanding the use of preexposure prophylaxis and addressing
barriers to patients seeking HIV
prevention care. Supplemental funds
are necessary to support timely
implementation of critical T/TA to
health centers in geographic locations
identified by the Ending the HIV
Epidemic initiative. The award
recipients have the demonstrated
expertise and scalable experience
required to swiftly address these timesensitive T/TA needs.
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Award recipient name
U30CS29366 ............................................
U30CS22742 ............................................
JSI Research and Training Institute, Inc .....................................................................
Fenway Community Health Center ..............................................................................
Dated: July 30, 2019.
George Sigounas,
Administrator.
[FR Doc. 2019–16585 Filed 8–1–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
COBRA Fees To Be Adjusted for
Inflation in Fiscal Year 2020 CBP Dec.
19–08
U.S. Customs and Border
Protection, Department of Homeland
Security.
AGENCY:
ACTION:
General notice.
This document announces
that U.S. Customs and Border Protection
(CBP) is adjusting certain customs user
fees and corresponding limitations
established by the Consolidated
Omnibus Budget Reconciliation Act
(COBRA) for Fiscal Year 2020 in
accordance with the Fixing America’s
Surface Transportation Act (FAST Act)
as implemented by CBP regulations.
SUMMARY:
The adjusted amounts of
customs COBRA user fees and their
corresponding limitations set forth in
this notice for Fiscal Year 2020 are
required as of October 1, 2019.
DATES:
jbell on DSK3GLQ082PROD with NOTICES
Award
amount
($)
Grant No.
Tina
Ghiladi, Director—Office of Finance,
202–344–3722, UserFeeNotices@
cbp.dhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:02 Aug 01, 2019
Jkt 247001
Background
On December 4, 2015, the Fixing
America’s Surface Transportation Act
(FAST Act, Pub. L. 114–94) was signed
into law. Section 32201 of the FAST Act
amended section 13031 of the
Consolidated Omnibus Budget
Reconciliation Act (COBRA) of 1985 (19
U.S.C. 58c) by requiring certain customs
COBRA user fees and corresponding
limitations to be adjusted by the
Secretary of the Treasury (Secretary) to
reflect certain increases in inflation.
Sections 24.22 and 24.23 of title 19 of
the Code of Federal Regulations (19 CFR
24.22 and 24.23) describe the
procedures that implement the
requirements of the FAST Act.
Specifically, paragraph (k) in section
24.22 (19 CFR 24.22(k)) sets forth the
methodology to determine the change in
inflation as well as the factor by which
the fees and limitations will be adjusted,
if necessary. The fees and limitations
subject to adjustment, which are set
forth in Appendix A and Appendix B of
part 24, include the commercial vessel
arrival fees, commercial truck arrival
fees, railroad car arrival fees, private
vessel arrival fees, private aircraft
arrival fees, commercial aircraft and
vessel passenger arrival fees, dutiable
mail fees, customs broker permit user
fees, barges and other bulk carriers
arrival fees, and merchandise processing
fees, as well as the corresponding
limitations.
Determination of Whether an
Adjustment Is Necessary for Fiscal Year
2020
In accordance with 19 CFR 24.22, CBP
must determine annually whether the
fees and limitations must be adjusted to
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
130,000
119,000
reflect inflation. For fiscal year 2020,
CBP is making this determination by
comparing the average of the Consumer
Price Index—All Urban Consumers, U.S.
All items, 1982–84 (CPI–U) for the
current year (June 2018–May 2019) with
the average of the CPI–U for the
comparison year (June 2017–May 2018)
to determine the change in inflation, if
any. If there is an increase in the CPI of
greater than one (1) percent, CBP must
adjust the customs COBRA user fees and
corresponding limitations using the
methodology set forth in 19 CFR
24.22(k). Following the steps provided
in paragraph (k)(2) of section 24.22, CBP
has determined that the increase in the
CPI between the most recent June to
May 12-month period (June 2018–May
2019) and the comparison year (June
2017–May 2018) is 2.02 1 percent. As
the increase in the CPI is greater than
one (1) percent, the customs COBRA
user fees and corresponding limitations
must be adjusted for Fiscal Year 2020.
Determination of the Adjusted Fees and
Limitations
Using the methodology set forth in
section 24.22(k)(2) of the CBP
regulations (19 CFR 24.22(k)), CBP has
determined that the factor by which the
base fees and limitations will be
adjusted is 7.167 percent (base fees and
limitations can be found in Appendix A
and B to part 24 of title 19). In reaching
this determination, CBP calculated the
values for each variable found in
1 The figures provided in this notice may be
rounded for publication purposes only. The
calculations for the adjusted fees and limitations
were made using unrounded figures, unless
otherwise noted.
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37901-37902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16585]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice To Announce Supplemental Awards To Support Technical
Assistance To Address the HIV Epidemic
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice to announce supplemental awards to support technical
assistance to address the HIV epidemic.
-----------------------------------------------------------------------
SUMMARY: HRSA provided supplemental grant funds to two currently funded
National Training and Technical Assistance Cooperative Agreement award
recipients to support ending the HIV epidemic by providing critical
expertise and resources to health centers in geographic locations
identified in Ending the HIV Epidemic: A Plan for America.
FOR FURTHER INFORMATION CONTACT: Tracey Orloff, Strategic Partnerships
[[Page 37902]]
Division Director in the Office of Quality Improvement, at
[email protected] or (301) 443-3197.
SUPPLEMENTARY INFORMATION:
Recipients: Two current National Training and Technical Assistance
Cooperative Agreement award recipients, as listed in Table 1.
Amount of Non-Competitive Awards: Two awards with a combined total
of $249,000.
Period of Supplemental Funding: Fiscal year 2019.
CFDA Number: 93.129.
Authority: Section 330(l) of the Public Health Service Act, as
amended.
Justification: The award recipients will provide specialized
training and technical assistance (T/TA) to health centers in
geographic areas with the highest HIV burden, which include 48
counties; Washington, DC; San Juan; Puerto Rico; as well as seven
states that have a substantial rural HIV burden. JSI Research and
Training Institute, Inc. will provide T/TA focused on the use of data
in HIV outreach, in-reach, and prevention efforts. Fenway Community
Health Center will provide T/TA focused on expanding the use of pre-
exposure prophylaxis and addressing barriers to patients seeking HIV
prevention care. Supplemental funds are necessary to support timely
implementation of critical T/TA to health centers in geographic
locations identified by the Ending the HIV Epidemic initiative. The
award recipients have the demonstrated expertise and scalable
experience required to swiftly address these time-sensitive T/TA needs.
Table 1--Recipients and Award Amounts
------------------------------------------------------------------------
Award amount
Grant No. Award recipient name ($)
------------------------------------------------------------------------
U30CS29366..................... JSI Research and 130,000
Training Institute,
Inc.
U30CS22742..................... Fenway Community Health 119,000
Center.
------------------------------------------------------------------------
Dated: July 30, 2019.
George Sigounas,
Administrator.
[FR Doc. 2019-16585 Filed 8-1-19; 8:45 am]
BILLING CODE 4165-15-P
