Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificates, 36282-36283 [2021-14650]
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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
for-profit institutions); Number of
Respondents: 20,000; Total Annual
Responses: 4,589,433; Total Annual
Hours: 351,046. (For policy questions
regarding this collection contact
Michael Forman at 410–786–2666.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Administrative
Requirements for Section 6071 of the
Deficit Reduction Act; Use: State
Operational Protocols should provide
enough information such that: the CMS
Project Officer and other federal officials
may use it to understand the operation
of the demonstration, prepare for
potential site visits without needing
additional information, or both; the
State Project Director can use it as the
manual for program implementation;
and external stakeholders may use it to
understand the operation of the
demonstration. The financial
information collection is used in our
financial statements and shared with the
auditors who validate CMS’ financial
position. The Money Follows the Person
Rebalancing Demonstration (MFP)
Finders File, MFP Program Participation
Data file, and MFP Services File are
used by the national evaluation
contractor to assess program outcomes
while we use the information to monitor
program implementation. The MFP
Quality of Life data is used by the
national evaluation contractor to assess
program outcomes. The evaluation is
used to determine how participants’
quality of life changes after transitioning
to the community. The semi-annual
progress report is used by the national
evaluation contractor and CMS to
monitor program implementation at the
grantee level. The revisions aim to
reduce the reporting burden by
presenting a substantially revised and
shorted version of the semi-annual
progress report. The budget workbook
has also been revised to combine two
earlier reporting forms. Form Number:
CMS–10249 (OMB control number:
0938–1053); Frequency: Yearly,
quarterly, and semi-annually; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
42; Total Annual Responses: 336; Total
Annual Hours: 2,604. (For policy
questions regarding this collection
contact Todd Wilson at 410–786–3409.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Section 1115
Demonstration Projects Regulations at
42 CFR 431.408, 431.412, 431.420,
431.424, and 431.428; Use: This
collection is necessary to ensure that
states comply with regulatory and
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statutory requirements related to the
development, implementation and
evaluation of demonstration projects.
States seeking waiver authority under
Section 1115 are required to meet
certain requirements for public notice,
the evaluation of demonstration
projects, and reports to the Secretary on
the implementation of approved
demonstrations. Form Number: CMS–
10341 (OMB control number: 0938–
1162); Frequency: Yearly and quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
37; Total Annual Responses: 372; Total
Annual Hours: 27,914. (For policy
questions regarding this collection
contact Tonya Moore at 410–786–0019.)
Dated: July 6, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–14671 Filed 7–8–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2347]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and
Cosmetic Export Certificates
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA 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 August 9,
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 0910–0793. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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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, 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.
Food and Cosmetic Export Certificates
OMB Control Number 0910–0793—
Extension
Some countries may require
manufacturers of FDA-regulated
products to provide certificates for
products they wish to export to that
country. Accordingly, firms exporting
products from the United States often
ask FDA to provide such a ‘‘certificate.’’
In many cases, foreign governments are
seeking official assurance that products
exported to their countries can be
marketed in the United States, or that
they meet specific U.S. requirements. In
some cases, review of an FDA export
certificate may be required as part of the
process to register or import a product
into another country. An export
certificate generally indicates that the
particular product is marketed in the
United States or otherwise eligible for
export and that the particular
manufacturer has no unresolved
enforcement actions pending before, or
taken by, FDA.
FDA’s Center for Food Safety and
Applied Nutrition (CFSAN) issues
export certificates for human food and
cosmetic products. Interested persons
may request a certificate electronically
via the CFSAN Export Certification
Application and Tracking System
(CFSAN eCATS) or Certificate
Application Process (CAP), components
of the FDA Industry Systems, or by
contacting CFSAN for assistance. Health
certificates are the exception and are
requested via email. To facilitate the
application process, we have eliminated
paper-based forms. For food products,
respondents are able to identify
facilities using their Food Facility
Registration, an FDA Establishment
Identifier number, or a Data Universal
Numbering System number. The system
uses these identifiers to locate and autopopulate name and address information,
eliminating the need for users to
manually enter this information and
reducing the time to complete the
application. For some applications,
respondents can also upload product
information via a spreadsheet, which
reduces the time needed to enter
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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
product information, particularly for
applications that include multiple
products.
All information is entered using
electronic Forms FDA 3613d, 3613e,
and 3613k and used to evaluate
certificate requests. The eCATS Module
is Form FDA 3613k, where Form FDA
3613e is the Certificate of Free Sale
(https://www.fda.gov/food/food-exportcertificates/online-applications-exportcertificates-food). All ‘‘forms’’ are
electronic and part of the eCATS or CAP
portal accessed via https://
www.access.fda.gov. To view
representations of the forms, you have
to download the instructions, which are
accessible from the following links:
https://www.fda.gov/cosmetics/
cosmetics-exporters/onlineapplications-export-certificatescosmetics and https://www.fda.gov/
food/food-export-certificates/onlineapplications-export-certificates-food.
While burden associated with
information collection activities for
export certificates issued for other FDAregulated products is approved under
OMB control number 0910–0498, this
collection specifically supports export
certificates issued by CFSAN. Also,
because we have eliminated paperbased forms, respondents who require
assistance with completing export
certificate applications online may
contact CFSAN directly by email
(CFSANExportCertification@
fda.hhs.gov) or telephone (240–402–
2307). Instructions for requesting export
certificates for cosmetics (Form FDA
3613d) are available online at https://
www.fda.gov/cosmetics/cosmeticsexporters/online-applications-exportcertificates-cosmetics and instructions
for requesting export certificates for
food (Forms FDA 3613e and 3613k) are
available online at https://www.fda.gov/
food/food-export-certificates/onlineapplications-export-certificates-food.
Description of Respondents: The
respondents to this collection of
information are firms interested in
36283
exporting U.S.-manufactured human
food and cosmetic products to foreign
countries that require export certificates.
In the Federal Register of March 16,
2021 (86 FR 14452), we published a 60day notice requesting public comment
on the proposed collection of
information. We received one comment
offering general support for our
cosmetic export certificate program. The
comment also recommended FDA
consider providing certificates that
allow exporters to use an exemption
from requirements in China for animal
testing for certain imported cosmetic
products. We appreciate the comment
and continue to seek ways to increase
the utility of the information collection
as our limited resources permit. At the
same time, the comment did not suggest
we revise the burden we attribute to the
associated information collection
activity.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
(in hours)
Type of respondent
Form No. 2
Cosmetics .....................
Food .............................
FDA 3613d ..................
FDA 3613e, 3613k ......
113
468
3
9
339
4,212
0.5 (30 minutes) ..........
0.5 (30 minutes) ..........
170
2,106
Total ......................
.....................................
........................
........................
........................
.....................................
2,276
Total hours
1 There
2 All
are no capital costs or operating and maintenance costs associated with this collection of information.
forms are submitted electronically via FDA Industry Systems.
Based on a review of the information
collection since our last OMB approval,
we have reduced our burden estimate.
The burden estimate has been lowered
due to a reduced number of
respondents. We base our estimates on
our experience with certificate
applications received in the past 3 fiscal
years.
Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14650 Filed 7–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–Z–0025]
Requests for Proposals for Insulin
Reimportation and Personal
Prescription Drug Importation;
Withdrawal
Food and Drug Administration
(FDA), Department of Health and
Human Services (HHS).
ACTION: Notice; withdrawal.
AGENCY:
The Department of Health and
Human Services (Department or HHS) is
announcing the withdrawal of a notice
published in the Federal Register on
January 21, 2021, entitled ‘‘Requests for
Proposals for Insulin Reimportation and
Personal Prescription Drug
Importation.’’ HHS also withdraws the
requests for proposals issued on its
website on September 24, 2020, and
revised on January 13, 2021, and ends
the period for submission of proposals
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SUMMARY:
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in response to the requests for
proposals.
DATES: The notice published in the
Federal Register on January 21, 2021, at
86 FR 6343, is withdrawn as of July 9,
2021.
FOR FURTHER INFORMATION CONTACT:
Katelyn Mineo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6222,
Silver Spring, MD 20993, 301–796–
1054.
SUPPLEMENTARY INFORMATION: On
September 24, 2020, HHS issued two
requests for proposals for the
reimportation of insulin and the
personal importation of prescription
drugs (collectively, the RFPs) and
posted related ‘‘Frequently Asked
Questions’’ documents (FAQs) on its
website. On January 21, 2021, HHS
published a notice in the Federal
Register entitled ‘‘Requests for
Proposals for Insulin Reimportation and
Personal Prescription Drug Importation’’
(the HHS Notice) (86 FR 6343). The
HHS Notice referred to revised versions
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]]>Agencies
[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36282-36283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14650]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2347]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Cosmetic
Export Certificates
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA 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 August 9, 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 0910-0793. 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.
Food and Cosmetic Export Certificates
OMB Control Number 0910-0793--Extension
Some countries may require manufacturers of FDA-regulated products
to provide certificates for products they wish to export to that
country. Accordingly, firms exporting products from the United States
often ask FDA to provide such a ``certificate.'' In many cases, foreign
governments are seeking official assurance that products exported to
their countries can be marketed in the United States, or that they meet
specific U.S. requirements. In some cases, review of an FDA export
certificate may be required as part of the process to register or
import a product into another country. An export certificate generally
indicates that the particular product is marketed in the United States
or otherwise eligible for export and that the particular manufacturer
has no unresolved enforcement actions pending before, or taken by, FDA.
FDA's Center for Food Safety and Applied Nutrition (CFSAN) issues
export certificates for human food and cosmetic products. Interested
persons may request a certificate electronically via the CFSAN Export
Certification Application and Tracking System (CFSAN eCATS) or
Certificate Application Process (CAP), components of the FDA Industry
Systems, or by contacting CFSAN for assistance. Health certificates are
the exception and are requested via email. To facilitate the
application process, we have eliminated paper-based forms. For food
products, respondents are able to identify facilities using their Food
Facility Registration, an FDA Establishment Identifier number, or a
Data Universal Numbering System number. The system uses these
identifiers to locate and auto-populate name and address information,
eliminating the need for users to manually enter this information and
reducing the time to complete the application. For some applications,
respondents can also upload product information via a spreadsheet,
which reduces the time needed to enter
[[Page 36283]]
product information, particularly for applications that include
multiple products.
All information is entered using electronic Forms FDA 3613d, 3613e,
and 3613k and used to evaluate certificate requests. The eCATS Module
is Form FDA 3613k, where Form FDA 3613e is the Certificate of Free Sale
(https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food). All ``forms'' are electronic and part of the
eCATS or CAP portal accessed via https://www.access.fda.gov. To view
representations of the forms, you have to download the instructions,
which are accessible from the following links: https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics and https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food.
While burden associated with information collection activities for
export certificates issued for other FDA-regulated products is approved
under OMB control number 0910-0498, this collection specifically
supports export certificates issued by CFSAN. Also, because we have
eliminated paper-based forms, respondents who require assistance with
completing export certificate applications online may contact CFSAN
directly by email ([email protected]) or telephone
(240-402-2307). Instructions for requesting export certificates for
cosmetics (Form FDA 3613d) are available online at https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics and instructions for requesting export certificates for food
(Forms FDA 3613e and 3613k) are available online at https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food.
Description of Respondents: The respondents to this collection of
information are firms interested in exporting U.S.-manufactured human
food and cosmetic products to foreign countries that require export
certificates.
In the Federal Register of March 16, 2021 (86 FR 14452), we
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment offering general
support for our cosmetic export certificate program. The comment also
recommended FDA consider providing certificates that allow exporters to
use an exemption from requirements in China for animal testing for
certain imported cosmetic products. We appreciate the comment and
continue to seek ways to increase the utility of the information
collection as our limited resources permit. At the same time, the
comment did not suggest we revise the burden we attribute to the
associated information collection activity.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Form No. \2\ Number of responses per Total annual Average burden per Total hours
respondents respondent responses response (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cosmetics............................ FDA 3613d............... 113 3 339 0.5 (30 minutes)....... 170
Food................................. FDA 3613e, 3613k........ 468 9 4,212 0.5 (30 minutes)....... 2,106
----------------------------------------------------------------------------------------
Total............................ ........................ .............. .............. .............. ....................... 2,276
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ All forms are submitted electronically via FDA Industry Systems.
Based on a review of the information collection since our last OMB
approval, we have reduced our burden estimate. The burden estimate has
been lowered due to a reduced number of respondents. We base our
estimates on our experience with certificate applications received in
the past 3 fiscal years.
Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14650 Filed 7-8-21; 8:45 am]
BILLING CODE 4164-01-P
