Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates, 83091-83092 [2020-28064]
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83091
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
collection, changes compared to before
COVID–19 began, and what has been
challenging or worked well. The study
will use surveys and interviews with
center directors, FCC providers, and
Number of
respondents
(total over request period)
Instrument
Coach Survey (Instrument 1) ........................................................................
Center Director Survey (Instrument 2) ..........................................................
FCC Provider Survey (Instrument 3) .............................................................
Coach Interview (Instrument 4) .....................................................................
Center Director Interview (Instrument 5) .......................................................
FCC Provider Interview (Instrument 6): FCC providers ................................
Estimated Total Annual Burden
Hours: 104.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 9858(a)(5), 42 U.S.C.
9835, and 42 U.S.C. 9844.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–28043 Filed 12–18–20; 8:45 am]
BILLING CODE 4184–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2010–N–0161]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Food and
Drug Administration-Regulated
Products: Export Certificates
AGENCY:
ACTION:
Food and Drug Administration,
Number of
responses per
respondent
(total over request period)
Average
Burden per response (in
hours)
1
1
1
1
1
1
.33
.33
.33
.75
.75
.75
100
66
38
12
24
12
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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:
Submit written comments
(including recommendations) on the
collection of information by January 20,
2021.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0498. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
Annual Burden Estimates
Data collection will be completed
within a 1-year period.
coaches. The sample frame will be
comprised of respondents to the 2019
survey.
Respondents: ECE center directors,
coaches, and FCC providers who
responded to 2019 SCOPE surveys.
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
22:33 Dec 18, 2020
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22
13
9
18
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Export of Food and Drug
Administration-Regulated Products:
Export Certificates
OMB Control Number 0910–0498—
Extension
Sections 801(e) and 802 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 381(e) and 382) pertain
to the export of FDA-regulated products
and are intended to ease restrictions on
exportation. The provisions also require
the Agency to issue written export
certifications within 20 days of any
request. In January 2011, section
801(e)(4)(A) was amended by the FDA
Food Safety Modernization Act (Pub. L.
111–353) to provide authorization for
export certification for food and animal
feed, as well as certain unapproved
products. To offset Agency resource
expenditures for processing
certifications requests, the statute
provides that FDA may charge firms a
fee not to exceed $175.
There are four FDA forms (Form FDA
3613, 3613a, 3613b, and 3613c) related
to exporting FDA-regulated products. A
description of each form is provided
below. To obtain a fillable PDF file of
each form, visit https://www.fda.gov/
vaccines-blood-biologics/exporting-cberregulated-products/fda-formscertificates-exporting. To learn more
about how to complete these forms, visit
https://www.fda.gov/vaccines-bloodbiologics/exporting-cber-regulatedproducts/how-complete-fda-exportcertificate-forms.
HHS.
VerDate Sep<11>2014
Total/Annual
burden (in
hours)
E:\FR\FM\21DEN1.SGM
21DEN1
83092
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
TABLE 1—CERTIFICATES AND USES
Type of certificate
Use
‘‘Supplementary Information Certificate to Foreign Government Requests‘‘.
‘‘Exporter’s Certification Statement Certificate to Foreign Government‘‘.
‘‘Exporter’s Certification Statement Certificate to Foreign Government
(For Human Tissue Intended for Transplantation)‘‘..
‘‘Supplementary Information Certificate of Exportability Requests‘‘ ........
Exporter’s Certification Statement Certificate of Exportability‘‘. ...............
‘‘Supplementary Information Certificate of a Pharmaceutical Product‘‘ ...
‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical
Product‘‘.
‘‘Supplementary Information Non-Clinical Research Use Only Certificate‘‘.
‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)‘‘
Appropriate centers within FDA
review product information submitted
by firms in support of the firms’
certificate requests. We rely on
respondents to certify their compliance
with all applicable requirements of the
FD&C Act both at the time the
certification request is submitted to FDA
and at the time the certification is
submitted to the respective foreign
government. Information regarding
FDA’s Export Certificates may be found
on our website at https://www.fda.gov/
For the export of products legally marketed in the United States.
For the export of products not approved for marketing in the United
States (unapproved products) that meet the requirements of sections
801(e) or 802 of the FD&C Act.
Conforms to the format established by the World Health Organization
and is intended for use by the importing country when the product in
question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or
reviewing a license.
For the export of a non-clinical research use only product, material, or
component that is not intended for human use and which may be
marketed in, and legally exported from the United States under the
FD&C Act.
regulatory-information/search-fdaguidance-documents/fda-exportcertificates.
On September 16, 2020, we submitted
an information collection request to the
Office of Management and Budget
(OMB) to revise certain data elements as
may be applicable under the
Coronavirus Aid, Relief, and Economic
Security Act (CARES Act). Because
Section 3856 of the CARES Act
contained immediately effective
provisions obligating FDA to review and
process certification requests, we
requested emergency processing by
OMB under 5 CFR 1320.13 for the
respective information collection. Our
information collection request was
granted by OMB on September 29, 2020.
Therefore, in accordance with 5 CFR
1320.8(d)(1), we invite comment on the
burden we attribute to the information
collection, which we estimate as
follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
Respondents
FDA center
Center
Center
Center
Center
1
for
for
for
for
Number of
Responses
per Respondent
Total Anual
responses
Average burden per
response
Total hours
Biologics Evaluation and Research ....................
Devices and Radiological Health .......................
Drug Evaluation and Research ..........................
Veterinary Medicine ............................................
2,651
11,175
3,680
1,925
1
1
1
1
2,651
11,175
3,680
1,925
1
2
1
1
2,651
22,350
3,680
1,925
Total ..............................................................................
........................
........................
........................
........................
30,606
There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our current evaluation of the
information collection, we have made
no adjustments since our last request for
OMB review and approval.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[Docket No. FDA–2020–N–2217]
[FR Doc. 2020–28064 Filed 12–18–20; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drugs
for Investigational Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
VerDate Sep<11>2014
22:33 Dec 18, 2020
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certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the reporting and
recordkeeping requirements of our
regulations concerning new animal
drugs for investigational use.
Submit either electronic or
written comments on the collection of
information by February 19, 2021.
DATES:
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83091-83092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28064]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0161]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export of Food and
Drug Administration-Regulated Products: Export Certificates
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by January 20, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0498. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Export of Food and Drug Administration-Regulated Products: Export
Certificates
OMB Control Number 0910-0498--Extension
Sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 381(e) and 382) pertain to the export of FDA-
regulated products and are intended to ease restrictions on
exportation. The provisions also require the Agency to issue written
export certifications within 20 days of any request. In January 2011,
section 801(e)(4)(A) was amended by the FDA Food Safety Modernization
Act (Pub. L. 111-353) to provide authorization for export certification
for food and animal feed, as well as certain unapproved products. To
offset Agency resource expenditures for processing certifications
requests, the statute provides that FDA may charge firms a fee not to
exceed $175.
There are four FDA forms (Form FDA 3613, 3613a, 3613b, and 3613c)
related to exporting FDA-regulated products. A description of each form
is provided below. To obtain a fillable PDF file of each form, visit
https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/fda-forms-certificates-exporting. To learn more about how to
complete these forms, visit https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/how-complete-fda-export-certificate-forms.
[[Page 83092]]
Table 1--Certificates and Uses
------------------------------------------------------------------------
Type of certificate Use
------------------------------------------------------------------------
``Supplementary Information Certificate For the export of products
to Foreign Government Requests``. legally marketed in the United
``Exporter's Certification Statement States.
Certificate to Foreign Government``..
``Exporter's Certification Statement
Certificate to Foreign Government (For
Human Tissue Intended for
Transplantation)``..
``Supplementary Information Certificate For the export of products not
of Exportability Requests``. approved for marketing in the
Exporter's Certification Statement United States (unapproved
Certificate of Exportability``.. products) that meet the
requirements of sections
801(e) or 802 of the FD&C Act.
``Supplementary Information Certificate Conforms to the format
of a Pharmaceutical Product``. established by the World
``Exporter's Certification Statement Health Organization and is
Certificate of a Pharmaceutical intended for use by the
Product``. importing country when the
product in question is under
consideration for a product
license that will authorize
its importation and sale or
for renewal, extension,
amending, or reviewing a
license.
``Supplementary Information Non- For the export of a non-
Clinical Research Use Only clinical research use only
Certificate``. product, material, or
``Exporter's Certification Statement component that is not intended
(Non-Clinical Research Use Only)``. for human use and which may be
marketed in, and legally
exported from the United
States under the FD&C Act.
------------------------------------------------------------------------
Appropriate centers within FDA review product information submitted
by firms in support of the firms' certificate requests. We rely on
respondents to certify their compliance with all applicable
requirements of the FD&C Act both at the time the certification request
is submitted to FDA and at the time the certification is submitted to
the respective foreign government. Information regarding FDA's Export
Certificates may be found on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates.
On September 16, 2020, we submitted an information collection
request to the Office of Management and Budget (OMB) to revise certain
data elements as may be applicable under the Coronavirus Aid, Relief,
and Economic Security Act (CARES Act). Because Section 3856 of the
CARES Act contained immediately effective provisions obligating FDA to
review and process certification requests, we requested emergency
processing by OMB under 5 CFR 1320.13 for the respective information
collection. Our information collection request was granted by OMB on
September 29, 2020. Therefore, in accordance with 5 CFR 1320.8(d)(1),
we invite comment on the burden we attribute to the information
collection, which we estimate as follows:
Table 2--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Number of
FDA center Number of Responses per Total Anual Average burden Total hours
Respondents Respondent responses per response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation 2,651 1 2,651 1 2,651
and Research...................
Center for Devices and 11,175 1 11,175 2 22,350
Radiological Health............
Center for Drug Evaluation and 3,680 1 3,680 1 3,680
Research.......................
Center for Veterinary Medicine.. 1,925 1 1,925 1 1,925
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 30,606
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on our current evaluation of the information collection, we
have made no adjustments since our last request for OMB review and
approval.
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28064 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P
