Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process, 22984-22985 [2018-10551]
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22984
Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
2018. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
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conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 31, 2018.
Persons attending FDA’s advisory
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meetings and will make every effort to
accommodate persons with disabilities.
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disability, please contact Artair Mallett
at Artair.Mallett@fda.hhs.gov or 301–
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AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10552 Filed 5–16–18; 8:45 am]
BILLING CODE 4164–01–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 Certificate
Application Process
AGENCY:
Food and Drug Administration,
HHS.
daltland on DSKBBV9HB2PROD with NOTICES
ACTION:
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:
VerDate Sep<11>2014
18:36 May 16, 2018
Jkt 244001
Fax written comments on the
collection of information by June 18,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 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, 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.
DATES:
Food and Cosmetic Export Certificate
Application Process
OMB Control Number 0910–0793—
Revision
This information collection supports
FDA’s Center for Food Safety and
Applied Nutrition’s (CFSAN) export
certificate application process. 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.
Interested persons may request a
certificate from CFSAN electronically
via the Certificate Application Process
(CAP), a component of FDA Industry
Systems, or by contacting CFSAN for
assistance. To facilitate the application
process we have eliminated paper-based
forms. For food products, we have
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
expanded the electronic options for
providing facility and product
information. Respondents will now be
able to identify facilities based on a food
facility registration number, FDA
Establishment Identification number, or
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. Respondents can also
upload product information via a
spreadsheet, which reduces the time
needed to enter product information,
particularly for applications that
include multiple products. All
information is entered using electronic
Forms FDA 3613d, 3613e, 3613g, and
3613l and used to evaluate certificate
requests.
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 Form FDA 3613d
are available online at https://
www.fda.gov/cosmetics/
internationalactivities/exporters/
ucm353912.htm and instructions for
Form FDA 3613e are available online at
https://www.fda.gov/Food/
GuidanceRegulation/ImportsExports/
Exporting/ucm260280.htm. Draft
screenshots of Form FDA 3613g and
3613l are available for comment online
at https://www.fda.gov/Food/
GuidanceRegulation/ImportsExports/
Exporting/default.htm.
Description of Respondents: The
respondents to this collection of
information are firms interested in
exporting U.S.-manufactured food and
cosmetic products to foreign countries
that require export certificates.
In the Federal Register of January 2,
2018 (83 FR 133), we published a notice
soliciting public comment of the
information collection. Two comments
were received in support of the
information collection. One comment
included technical suggestions as well
regarding respondents’ ability to review
and edit data that might have been
entered improperly. We appreciate this
comment and continue to seek ways to
utilize improved information collection
E:\FR\FM\17MYN1.SGM
17MYN1
Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
technologies as our resources permit.
FDA notes section 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
381) also provides that FDA may charge
a fee of up to $175 if the Agency issues
a certificate within 20 days of receipt of
a complete request for such a certificate.
This fee may vary depending on the
22985
product type, but it will not exceed
$175.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Average burden per
response
(in hours)
Total annual
responses
Type of respondent
FDA Form No.2
Cosmetics .....................
Food .............................
3613d ..........................
3613e, 3613g, 3613l ...
270
881
3
5
810
4,405
0.5 (30 minutes) ..........
0.5 (30 minutes) ..........
405
2,203
Total ......................
.....................................
........................
........................
........................
.....................................
2,608
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 CAP.
daltland on DSKBBV9HB2PROD with NOTICES
This estimate reflects a revision
resulting from the elimination of paperbased forms. Specifically, and based on
our experience with the information
collection, we have reduced the
estimated time to prepare a submission
from 1.5 hours to 0.5 hour. The previous
estimate was based on the time
necessary to prepare a paper
submission, but all firms requesting
export certificates now provide
submissions electronically via CAP. We
believe that the time to prepare an
electronic submission is under 0.25
hour, but are estimating 0.5 hour as a
conservative approach to address all
scenarios. We base our estimates of the
total annual responses on our
experience with certificate applications
received in the past 3 fiscal years.
We expect that most firms requesting
export certificates in the next 3 years
will choose to take advantage of the
option of electronic submission via
CAP. If a firm is unable to submit their
information via CAP, they may contact
CFSAN and request assistance. CFSAN
will assist firms in entering their
information into the electronic system
so that the firm may receive their export
certificates in a timely manner. Our
burden estimates in table 1 are based on
the expectation of 100 percent
participation in the electronic
submission process. Providing the
opportunity to submit the information
in electronic format has reduced our
previous estimates for the time to
prepare each submission.
Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10551 Filed 5–16–18; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:36 May 16, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request. 30-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 June 18, 2018.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
SUMMARY:
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
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: Evaluation of
the Assisted Outpatient Treatment Grant
Program for Individuals with Serious
Mental Illness.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Type of Collection: New.
Abstract: The Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) at the U.S. Department of Health
and Human Services (HHS) is
requesting Office of Management and
Budget (OMB) approval for data
collection activities to support the
evaluation of the Substance Abuse and
Mental Health Services
Administration’s (SAMHSA’s) Assisted
Outpatient Treatment (AOT) Grant
Program for Individuals with Serious
Mental Illness (SM–16–011). Enacted
into law on April 1, 2014, Section 224
of the Protecting Access to Medicare Act
(PAMA) (Pub. L. 113–93) mandated a 4year pilot program of grants to
implement AOT programs nationwide.
Section 224(e) required a program
evaluation to examine the impact of
AOT on cost savings and public health
outcomes, incarceration, homelessness,
and patient and family satisfaction with
program participation.
Focusing specifically on six of the 17
sites, the in-depth implementation and
outcome evaluation of the SAMHSA
AOT Grant Program for Individuals with
Serious Mental Illness is being carried
out by RTI International, in partnership
with Duke University and Policy
Research Associates. The completed
implementation evaluation, conducted
from November 2016 to August 2017,
gathered information related to the
processes and practices of AOT across
the six in-depth sites. The information
to be collected for the outcome
evaluation will allow ASPE and
partners SAMHSA and NIMH to assess
which elements of AOT programs
influence health and social outcomes for
people under AOT orders, as well as the
use of services, associated costs, and
patient and family satisfaction with the
AOT process.
Need and Proposed Use of the
Information: Section 224(e) of PAMA
requires annual reports to Congress that
include evaluation of: Cost savings and
E:\FR\FM\17MYN1.SGM
17MYN1
]]>Agencies
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22984-22985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10551]
-----------------------------------------------------------------------
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 Certificate Application Process
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: Fax written comments on the collection of information by June
18, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 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 Certificate Application Process
OMB Control Number 0910-0793--Revision
This information collection supports FDA's Center for Food Safety
and Applied Nutrition's (CFSAN) export certificate application process.
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.
Interested persons may request a certificate from CFSAN
electronically via the Certificate Application Process (CAP), a
component of FDA Industry Systems, or by contacting CFSAN for
assistance. To facilitate the application process we have eliminated
paper-based forms. For food products, we have expanded the electronic
options for providing facility and product information. Respondents
will now be able to identify facilities based on a food facility
registration number, FDA Establishment Identification number, or 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. Respondents can also upload product
information via a spreadsheet, which reduces the time needed to enter
product information, particularly for applications that include
multiple products. All information is entered using electronic Forms
FDA 3613d, 3613e, 3613g, and 3613l and used to evaluate certificate
requests.
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 Form FDA 3613d are available online at
https://www.fda.gov/cosmetics/internationalactivities/exporters/ucm353912.htm and instructions for Form FDA 3613e are available online
at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm260280.htm. Draft screenshots of Form FDA 3613g and 3613l
are available for comment online at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm.
Description of Respondents: The respondents to this collection of
information are firms interested in exporting U.S.-manufactured food
and cosmetic products to foreign countries that require export
certificates.
In the Federal Register of January 2, 2018 (83 FR 133), we
published a notice soliciting public comment of the information
collection. Two comments were received in support of the information
collection. One comment included technical suggestions as well
regarding respondents' ability to review and edit data that might have
been entered improperly. We appreciate this comment and continue to
seek ways to utilize improved information collection
[[Page 22985]]
technologies as our resources permit. FDA notes section 801 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) also provides that
FDA may charge a fee of up to $175 if the Agency issues a certificate
within 20 days of receipt of a complete request for such a certificate.
This fee may vary depending on the product type, but it will not exceed
$175.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent FDA Form No.\2\ Number of responses per Total annual Average burden per Total hours
respondents respondent responses response (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cosmetics............................ 3613d................... 270 3 810 0.5 (30 minutes)....... 405
Food................................. 3613e, 3613g, 3613l..... 881 5 4,405 0.5 (30 minutes)....... 2,203
----------------------------------------------------------------------------------------
Total............................ ........................ .............. .............. .............. ....................... 2,608
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ All forms are submitted electronically via CAP.
This estimate reflects a revision resulting from the elimination of
paper-based forms. Specifically, and based on our experience with the
information collection, we have reduced the estimated time to prepare a
submission from 1.5 hours to 0.5 hour. The previous estimate was based
on the time necessary to prepare a paper submission, but all firms
requesting export certificates now provide submissions electronically
via CAP. We believe that the time to prepare an electronic submission
is under 0.25 hour, but are estimating 0.5 hour as a conservative
approach to address all scenarios. We base our estimates of the total
annual responses on our experience with certificate applications
received in the past 3 fiscal years.
We expect that most firms requesting export certificates in the
next 3 years will choose to take advantage of the option of electronic
submission via CAP. If a firm is unable to submit their information via
CAP, they may contact CFSAN and request assistance. CFSAN will assist
firms in entering their information into the electronic system so that
the firm may receive their export certificates in a timely manner. Our
burden estimates in table 1 are based on the expectation of 100 percent
participation in the electronic submission process. Providing the
opportunity to submit the information in electronic format has reduced
our previous estimates for the time to prepare each submission.
Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10551 Filed 5-16-18; 8:45 am]
BILLING CODE 4164-01-P
