Agency Information Collection Request. 60-Day Public Comment Request, 46679-46680 [2020-16815]
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Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices
biologic are required to register in the
Blood Establishment Registration (BER)
system. FDA’s Center for Biologics
Evaluation and Research (CBER) will
send establishment registration fee
invoices annually to these companies.
khammond on DSKJM1Z7X2PROD with NOTICES
A. Submit a DFUF Order With a PIN
From FDA Before Registering or
Submitting Payment
To submit a DFUF Order, you must
create or have previously created a user
account and password for the user fee
website listed previously in this section.
After creating a user name and
password, log into the Establishment
Registration User Fee FY 2021 store.
Complete the DFUF order by entering
the number of establishments you are
registering that require payment. When
you are satisfied that the information in
the order is accurate, electronically
transmit that data to FDA according to
instructions on the screen. Print a copy
of the final DFUF order and note the
unique PIN located in the upper righthand corner of the printed order.
B. Pay For Your DFUF Order
Unless paying by U.S. credit card, all
payments must be in U.S. currency and
drawn on a U.S. bank.
1. If paying by credit card or
electronic check (ACH or eCheck):
The DFUF order will include payment
information, including details on how
you can pay online using a credit card
or electronic check. Follow the
instructions provided to make an
electronic payment.
2. If paying with a paper check:
The check must be in U.S. currency
and drawn on a U.S. bank, and mailed
to: Food and Drug Administration, P.O.
Box 979108, St. Louis, MO 63197–9000.
(Note: This address is different from the
address for payments of application and
annual report fees and is to be used only
for payment of annual establishment
registration fees.)
If a check is sent by a courier that
requests a street address, the courier can
deliver the check 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. 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.)
Please make sure that both of the
following are written on your check: (1)
The FDA post office box number (P.O.
Box 979108) and (2) the PIN that is
printed on your order. Include a copy of
your printed order when you mail your
check.
3. If paying with a wire transfer:
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Wire transfers may also be used to pay
annual establishment registration fees.
To send a wire transfer, please read and
comply with the following information:
Include your order’s unique PIN (in
the upper right-hand corner of your
completed DFUF order) in your wire
transfer. Without the PIN, your payment
may not be applied to your facility and
your registration may be delayed.
The originating financial institution
may charge a wire transfer fee. If the
financial institution charges a wire
transfer fee, it is required that you add
that amount to the payment to ensure
that the invoice is paid in full. Use the
following account information when
sending a wire transfer: U.S. Dept. of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.
75060099, Routing No. 021030004,
SWIFT: FRNYUS33. If needed, FDA’s
tax identification number is 53–
0196965.
This email address and this telephone
number are for assistance with
establishment registration only; they are
not to be used for questions related to
other aspects of medical device user
fees.) Problems with the BER system
should be directed to https://
www.accessdata.fda.gov/scripts/email/
cber/bldregcontact.cfm or call 240–402–
8360.
C. Complete the Information Online to
Update Your Establishment’s Annual
Registration for FY 2021, or To Register
a New Establishment for FY 2021
Go to the Center for Devices and
Radiological Health’s website at https://
www.fda.gov/medical-devices/howstudy-and-market-your-device/deviceregistration-and-listing and click the
‘‘Access Electronic Registration’’ link on
the left side of the page. This opens up
a new page with important information
about the FDA Unified Registration and
Listing System (FURLS). After reading
this information, click on the ‘‘Access
Electronic Registration’’ link in the
middle of the page. This link takes you
to an FDA Industry Systems page with
tutorials that demonstrate how to create
a new FURLS user account, if your
establishment did not create an account
in FY 2020. Manufacturers of licensed
biologics should register in the Biologics
Establishment Registration (BER) system
at https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-establishment-registration.
Enter your existing account ID and
password to log into FURLS. From the
FURLS/FDA Industry Systems menu,
click on the Device Registration and
Listing Module (DRLM) of FURLS
button. New establishments will need to
register and existing establishments will
update their annual registration using
choices on the DRLM menu. When you
choose to register or update your annual
registration, the system will prompt you
through the entry of information about
your establishment and your devices. If
you have any problems with this
process, email: reglist@cdrh.fda.gov or
call 301–796–7400 for assistance. (Note:
Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
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D. Enter Your DFUF Order PIN and PCN
After completing your annual or
initial registration and device listing,
you will be prompted to enter your
DFUF order PIN and PCN, when
applicable. This process does not apply
to establishments engaged only in the
manufacture, preparation, propagation,
compounding, or processing of licensed
biologic devices. CBER will send
invoices for payment of the
establishment registration fee to such
establishments.
[FR Doc. 2020–16793 Filed 7–29–20; 4:15 pm]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–0025]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before October 2, 2020.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990-New-60D,
and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
SUMMARY:
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46680
Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Commissioned
Corps of the U.S. Public Health Service
Application.
Type of Collection: Revision.
OMB No. 0937–0025—Office Within
OS—Specific Program Collecting the
Data Is Commissioned Corps
Headquarters
Abstract: The principal purpose of
this revision is a result of the
Coronavirus Aid, Relief, and Economic
Security (CARES) Act that was signed
into law on March 27, 202. The Public
Health Service Act was amended to
provide for a Ready Reserve corps in
times of public health emergencies, in
addition to national emergencies.
Collecting the information is to permit
HHS to determine eligibility for
appointment of applicants into the
Regular Corps and Ready Reserve Corps
of the Commissioned Corps of the U.S.
Public Health Service Corps (Corps).
The Corps is one of the seven
Uniformed Services of the United States
(37 U.S.C. 101(3), and appointments in
the Corps are made pursuant to 42
U.S.C. 204 et seq. and 42 CFR 21.58.
Type of respondent: Candidates/
Applicants to the Regular and Ready
Reserve Corps of the Commissioned
Corps of the U.S. Public Health Service.
ANNUALIZED BURDEN HOUR TABLE
Number of
Reserve Corps
respondents
Prequalification Questionnaire.
Form .....................................
PHS–50 ................................
Form PHS–1813 ...................
6,000
1,000
1
10/60
1,167
3,000
500
1
15/60
875
3,000
500
1
15/60
875
Addendum: Commissioned
Corps Personal Statement.
3,000
500
1
15/60
875
...............................................
........................
........................
........................
........................
3,792
Form name
Interested Health Professionals.
Health Professionals .............
References (college professors/teachers).
Health Professionals .............
Total ...............................
Dated: July 29, 2020.
Sherrettte A. Funn,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2020–16815 Filed 7–31–20; 8:45 am]
BILLING CODE 4150–49–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
VerDate Sep<11>2014
20:39 Jul 31, 2020
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Emphasis Panel Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS-CoV–2) and
Coronavirus Disease 2019 (COVID–19) (R21,
R01 Clinical Trials Not Allowed)
Date: August 17, 2020.
Time: 10:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E71B,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Lee G. Klinkenberg, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3E71B, Bethesda, MD
20892–9834, 301–761–7749,
lee.klinkenberg@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 28, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–16802 Filed 7–31–20; 8:45 am]
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No response
per respondent
Average
burden per
responses
(in hours)
Number of
Regular Corps
respondents
Type of respondent
Total burden
hours
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel: Mechanism for TimeSensitive Research Opportunities in
Environmental Health Sciences.
Date: August 11, 2020.
Time: 11:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
E:\FR\FM\03AUN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46679-46680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16815]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0937-0025]
Agency Information Collection Request. 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before October 2,
2020.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-New-60D, and
project title for reference, to Sherrette Funn, the Reports Clearance
Officer, [email protected], or call 202-795-7714.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and
[[Page 46680]]
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Title of the Collection: Commissioned Corps of the U.S. Public
Health Service Application.
Type of Collection: Revision.
OMB No. 0937-0025--Office Within OS--Specific Program Collecting the
Data Is Commissioned Corps Headquarters
Abstract: The principal purpose of this revision is a result of the
Coronavirus Aid, Relief, and Economic Security (CARES) Act that was
signed into law on March 27, 202. The Public Health Service Act was
amended to provide for a Ready Reserve corps in times of public health
emergencies, in addition to national emergencies. Collecting the
information is to permit HHS to determine eligibility for appointment
of applicants into the Regular Corps and Ready Reserve Corps of the
Commissioned Corps of the U.S. Public Health Service Corps (Corps). The
Corps is one of the seven Uniformed Services of the United States (37
U.S.C. 101(3), and appointments in the Corps are made pursuant to 42
U.S.C. 204 et seq. and 42 CFR 21.58.
Type of respondent: Candidates/Applicants to the Regular and Ready
Reserve Corps of the Commissioned Corps of the U.S. Public Health
Service.
Annualized Burden Hour Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of Average burden Total
Type of respondent Form name Regular Corps Reserve Corps No response per responses burden
respondents respondents per respondent (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interested Health Professionals............ Prequalification Questionnaire 6,000 1,000 1 10/60 1,167
Health Professionals....................... Form.......................... 3,000 500 1 15/60 875
PHS-50........................
References (college professors/teachers)... Form PHS-1813................. 3,000 500 1 15/60 875
Health Professionals....................... Addendum: Commissioned Corps 3,000 500 1 15/60 875
Personal Statement.
----------------------------------------------------------------------------
Total.................................. .............................. .............. .............. .............. .............. 3,792
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: July 29, 2020.
Sherrettte A. Funn,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2020-16815 Filed 7-31-20; 8:45 am]
BILLING CODE 4150-49-P
