Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 35398-35399 [2019-15626]
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35398
Federal Register / Vol. 84, No. 141 / Tuesday, July 23, 2019 / Notices
When paying by wire transfer, it is
TABLE 4—ESTIMATED FEE RATES FOR
OTHER FEE CATEGORIES UNDER required that the invoice number is
THE FSMA THIRD-PARTY CERTIFI- included; without the invoice number
the payment may not be applied. The
CATION PROGRAM—Continued
originating financial institution may
charge a wire transfer fee. If the
financial institution charges a wire
Fee category
transfer fee, it is required to add that
amount to the payment to ensure that
the invoice is paid in full. For
Annual fee for certification body
directly accredited by FDA ....
19,720 international wire transfers, please
inquire with the financial institutions
prior to submitting the payment. Use the
V. How must the fee be paid?
following account information when
Accreditation bodies seeking initial
sending a wire transfer: U.S. Department
recognition must submit the application of the Treasury, TREAS NYC, 33 Liberty
fee with the application.
St., New York, NY 10045, Account
For recognized accreditation bodies
Name: Food and Drug Administration,
and accredited certification bodies, an
Account No.: 75060099, Routing No.:
invoice will be sent annually. Payment
021030004, Swift No.: FRNYUS33.
must be made within 30 days of the
To send a check by a courier such as
receipt date. The payment must be made
Federal Express, the courier must
in U.S. currency from a U.S. bank by
deliver the check and printed copy of
one of the following methods: Wire
the cover sheet to: U.S. Bank, Attn:
transfer, electronically, check, bank
Government Lockbox 979108, 1005
draft, or U.S. postal money order made
Convention Plaza, St. Louis, MO 63101.
payable to the Food and Drug
(Note: This address is for courier
Administration. The preferred payment
delivery only. If you have any questions
method is online using an electronic
concerning courier delivery, contact
check (Automated Clearing House
U.S. Bank at 314–418–4013. This phone
(ACH), also known as eCheck) or credit
number is only for questions about
card (Discover, VISA, MasterCard,
courier delivery.)
American Express). Secure electronic
The tax identification number of FDA
payments can be submitted using the
is 53–0196965. (Note: In no case should
User Fees Payment Portal at https://
the payment for the fee be submitted to
userfees.fda.gov/pay or the Pay.gov
payment option is available to you after FDA with the invoice.)
you submit a cover sheet. (Note: Only
VI. What are the consequences of not
full payments are accepted. No partial
paying this fee?
payments can be made online.) Once
The consequences of not paying these
you have found your invoice, select
fees are outlined in 21 CFR 1.725. If
‘‘Pay Now’’ to be redirected to Pay.gov.
Electronic payment options are based on FDA does not receive an application fee
the balance due. Payment by credit card with an application for recognition, the
application will be considered
is available only for balances less than
incomplete and FDA will not review the
$25,000. If the balance exceeds this
application. If a recognized
amount, only the ACH option is
available. Payments must be made using accreditation body fails to submit its
U.S. bank accounts as well as U.S. credit annual user fee within 30 days of the
due date, we will suspend its
cards.
When paying by check, bank draft, or
recognition. If the recognized
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the invoice number. Also write the FDA annual user fee within 90 days of the
post office box number (P.O. Box
due date, we will revoke its recognition.
979108) on the enclosed check, bank
If an accredited certification body fails
draft, or money order. Mail the payment to pay its annual fee within 30 days of
and a copy of the invoice to: Food and
the due date, we will suspend its
Drug Administration, P.O. Box 979108,
accreditation. If the accredited
St. Louis, MO 63197–9000.
certification body fails to pay its annual
Estimated
fee
rates for FY
2020
fee within 90 days of the due date, we
will withdraw its accreditation.
Dated: July 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15622 Filed 7–22–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–3138; FDA–
2009–N–0232; FDA–2018–N–4465; FDA–
2018–N–4206; FDA–2018–N–3758; FDA–
2015–D–1163; FDA–2012–N–0559; FDA–
2015–N–3815; FDA–2018–N–3353; and
FDA–2018–N–2973]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
jspears on DSK30JT082PROD with NOTICES
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Experimental Study of an Accelerated Approval Disclosure ...................................................................................
Interstate Shellfish Dealer’s Certificate ...................................................................................................................
Administrative Detention and Banned Medical Devices .........................................................................................
Medical Device User Fee Small Business Qualifications and Certifications ..........................................................
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0910–0872
0910–0021
0910–0114
0910–0508
Date
approval
expires
6/30/2020
5/31/2022
5/31/2022
5/31/2022
Federal Register / Vol. 84, No. 141 / Tuesday, July 23, 2019 / Notices
35399
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control
No.
Title of collection
Individual Patient Expanded Access Applications ...................................................................................................
Electronic Forma for Submissions; Promotional labeling and Advertising Materials for Human Prescription
Drugs ....................................................................................................................................................................
Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation .........................................
Electronic Submission of Medical Device Registration and Listing ........................................................................
Antimicrobial Animal Drug Distribution Reports and Recordkeeping ......................................................................
Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products
Under Section 503B of the Federal Food, Drug, and Cosmetic Act ...................................................................
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15626 Filed 7–22–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0424]
Final Guidance for Industry and FDA
Staff on Postmarketing Safety
Reporting for Combination Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a final guidance for
industry and FDA staff entitled
‘‘Postmarketing Safety Reporting for
Combination Products Guidance for
Industry and FDA Staff.’’ The guidance
describes and explains the final rule on
postmarketing safety reporting (PMSR)
for combination products, issued on
December 20, 2016, and provides
recommendations for complying with
the PMSR requirements as well as
hypothetical scenarios that illustrate
how to comply with certain PMSR
requirements.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on July 23, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
jspears on DSK30JT082PROD with NOTICES
DATES:
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,
VerDate Sep<11>2014
16:43 Jul 22, 2019
Jkt 247001
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 below (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–
2008–N–0424 for ‘‘Postmarketing Safety
Reporting for Combination Products
Guidance for Industry and FDA Staff.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
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.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Date
approval
expires
0910–0814
5/31/2022
0910–0870
0910–0456
0910–0625
0910–0659
5/31/2022
6/30/2022
6/30/2022
6/30/2022
0910–0871
6/30/2022
• 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 a single hard copy of the guidance
document entitled ‘‘Postmarketing
Safety Reporting for Combination
E:\FR\FM\23JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35398-35399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15626]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-3138; FDA-2009-N-0232; FDA-2018-N-4465; FDA-
2018-N-4206; FDA-2018-N-3758; FDA-2015-D-1163; FDA-2012-N-0559; FDA-
2015-N-3815; FDA-2018-N-3353; and FDA-2018-N-2973]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Experimental Study of an Accelerated 0910-0872 6/30/2020
Approval Disclosure....................
Interstate Shellfish Dealer's 0910-0021 5/31/2022
Certificate............................
Administrative Detention and Banned 0910-0114 5/31/2022
Medical Devices........................
Medical Device User Fee Small Business 0910-0508 5/31/2022
Qualifications and Certifications......
[[Page 35399]]
Individual Patient Expanded Access 0910-0814 5/31/2022
Applications...........................
Electronic Forma for Submissions; 0910-0870 5/31/2022
Promotional labeling and Advertising
Materials for Human Prescription Drugs.
Public Health Service Guideline on 0910-0456 6/30/2022
Infectious Disease Issues in
Xenotransplantation....................
Electronic Submission of Medical Device 0910-0625 6/30/2022
Registration and Listing...............
Antimicrobial Animal Drug Distribution 0910-0659 6/30/2022
Reports and Recordkeeping..............
Obtaining Information for Evaluating 0910-0871 6/30/2022
Nominated Bulk Drug Substances for Use
in Compounding Drug Products Under
Section 503B of the Federal Food, Drug,
and Cosmetic Act.......................
------------------------------------------------------------------------
Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15626 Filed 7-22-19; 8:45 am]
BILLING CODE 4164-01-P
