Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process, 1422-1423 [2015-00130]
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1422
Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2347]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and
Cosmetic Export Certificate
Application Process
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice invites comments on
the information collection provisions
associated with export certificate
applications for FDA regulated food and
cosmetic products.
DATES: Submit either electronic or
written comments on the collection of
information by March 10, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
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SUMMARY:
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14:56 Jan 08, 2015
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the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Food and Cosmetic Export Certificate
Application Process (21 U.S.C. 381(e))
(OMB Control Number 0910–NEW)
Some foreign countries require
manufacturers of FDA regulated
products to provide an export certificate
for the products they wish to export to
that country. A Certificate of Free Sale
is a certificate (not pertaining to a
particular production lot or export
consignment) that indicates that the
particular product is marketed in the
United States or 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 such
certificates for food, food additives,
seafood, dietary supplements, and
cosmetics. Interested persons may
request a certificate by using the
electronic CFSAN Certificate
Application Process, which is part of
FDA Unified Registration and Listing
System, or by submitting a paper Form
FDA 3613d for cosmetic products or a
paper Form FDA 3613e for food
products. We use the information
submitted to determine whether to issue
the requested certificate.
OMB has approved the submission of
requests for export certificates on paper
Forms FDA 3613d and FDA 3613e and,
electronically, via the CFSAN Certificate
Application Process under OMB control
number 0910–0498. This notice
announces that, to ensure the efficient
review of the information collection by
OMB under the PRA, we are seeking to
obtain a new OMB control number for
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Fmt 4703
Sfmt 4703
Forms FDA 3613d and FDA 3613e and
the CFSAN Certificate Application
Process to reflect that the electronic
submission system for food and
cosmetic export certificates is separate
from the electronic submission system
associated with export certificates for
other FDA regulated products approved
under OMB control number 0910–0498.
Upon OMB approval of this information
collection request, we will adjust the
burden hours associated with Forms
FDA 3613d and FDA 3613e and the
CFSAN Certificate Application Process
approved under OMB control number
0910–0498.
We request the following information
on Form FDA 3613d and the CFSAN
Certificate Application Process, as
currently approved by OMB: The name
of and contact information for the
requester; the name of and contact
information for the exporting company
(if different from requester); a
designation of the type of certificate
requested (‘‘general’’ or ‘‘productspecific’’); if product-specific, a list of
the exact brand names of the products;
the contact person, company name and
address where the requested certificate
should be sent; and, the name and
account number (if applicable) of the
requester’s preferred carrier for delivery
of the certificate. Finally, Form FDA
3613d and the CFSAN Certificate
Application Process requires the
requester’s signature, the name and title
of the person signing the form, as well
as the date signed.
We request the following information
on Form FDA 3613e and the CFSAN
Certificate Application Process, as
currently approved by OMB: The name
of and contact information for the
manufacturer, as well as the
manufacturer’s state license or
registration number; the name of and
contact information for the exporting
company (if different from
manufacturer), as well as the exporting
company’s state license or registration
number; a description of the shipment
including the product, the common
name, the manufacturer, and a
description or additional comments; the
name of the country to which the
requester of the certificate intends to
ship the product; the contact person,
firm name and address where the
requested certificate should be sent;
and, the name and account number (if
applicable) of the requester’s preferred
carrier for delivery of the certificate.
Form FDA 3613e and the CFSAN
Certificate Application Process requires
the requestor to submit an original or
copy of the applicable product label or
labels. Finally, Form FDA 3613e and the
CFSAN Certificate Application Process
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Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices
requires the submitter’s signature, the
name and title of the person signing the
form, as well as the date signed.
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form
number 2
Type of respondent
Cosmetics ................................................
Conventional Food (Including Seafood) ..
Dietary Supplements, Food for Special
Dietary Use, Infant Formula, and Medical Foods .............................................
Food Additives and Food Contact Substances .................................................
Total ..................................................
1 There
rljohnson on DSK3VPTVN1PROD with NOTICES
2 Form
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
3613d
3613e
600
398
1
1
600
398
1.5
1.5
900
597
3613e
2,129
4
2,129
1.5
3,194
3613e
167
1
167
1.5
251
........................
........................
........................
........................
........................
4,942
are no operating and maintenance costs associated with this collection of information.
FDA 3613d and Form FDA 3613e may be submitted electronically via the Certificate Application Process.
For the purpose of this information
collection request, we are basing our
estimate of the average burden per
response in column 6 of Table 1 on the
estimates previously submitted to and
approved by OMB under control
number 0910–0498. Our estimate of the
average burden per response in column
6 of Table 1 varies according to the
product category for which the
certificate is requested. We base our
estimates of the total annual responses
in column 5 of Table 1 on our
experience with certificate applications
received in the past 2 fiscal years. Some
respondents send in requests as often as
three or four times a month while others
may submit only periodic requests.
We expect that most if not all firms
requesting export certificates in the next
3 years will choose to take advantage of
the option of electronic submission via
the CFSAN Certificate Application
Process. Thus, our burden estimates in
Table 1 are based on the expectation of
100 percent participation in the
electronic submission process. The
opportunity to provide the information
in electronic format could reduce the
Agency’s previous estimates for the time
to prepare each submission. However,
as a conservative approach for the
purpose of this analysis, we are
assuming that the opportunity to submit
the information in electronic format will
have no effect on the average time to
prepare a submission.
Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00130 Filed 1–8–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2258]
Determination That TAGAMET
(Cimetidine) Tablets and Other Drug
Products Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Amy Hopkins, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223,
Silver Spring, MD 20993–0002, 301–
796–5418, Amy.Hopkins@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
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Fmt 4703
Sfmt 4703
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
E:\FR\FM\09JAN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Pages 1422-1423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00130]
[[Page 1422]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2347]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Cosmetic Export Certificate Application
Process
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice invites comments on the information collection provisions
associated with export certificate applications for FDA regulated food
and cosmetic products.
DATES: Submit either electronic or written comments on the collection
of information by March 10, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Food and Cosmetic Export Certificate Application Process (21 U.S.C.
381(e)) (OMB Control Number 0910-NEW)
Some foreign countries require manufacturers of FDA regulated
products to provide an export certificate for the products they wish to
export to that country. A Certificate of Free Sale is a certificate
(not pertaining to a particular production lot or export consignment)
that indicates that the particular product is marketed in the United
States or 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 such
certificates for food, food additives, seafood, dietary supplements,
and cosmetics. Interested persons may request a certificate by using
the electronic CFSAN Certificate Application Process, which is part of
FDA Unified Registration and Listing System, or by submitting a paper
Form FDA 3613d for cosmetic products or a paper Form FDA 3613e for food
products. We use the information submitted to determine whether to
issue the requested certificate.
OMB has approved the submission of requests for export certificates
on paper Forms FDA 3613d and FDA 3613e and, electronically, via the
CFSAN Certificate Application Process under OMB control number 0910-
0498. This notice announces that, to ensure the efficient review of the
information collection by OMB under the PRA, we are seeking to obtain a
new OMB control number for Forms FDA 3613d and FDA 3613e and the CFSAN
Certificate Application Process to reflect that the electronic
submission system for food and cosmetic export certificates is separate
from the electronic submission system associated with export
certificates for other FDA regulated products approved under OMB
control number 0910-0498. Upon OMB approval of this information
collection request, we will adjust the burden hours associated with
Forms FDA 3613d and FDA 3613e and the CFSAN Certificate Application
Process approved under OMB control number 0910-0498.
We request the following information on Form FDA 3613d and the
CFSAN Certificate Application Process, as currently approved by OMB:
The name of and contact information for the requester; the name of and
contact information for the exporting company (if different from
requester); a designation of the type of certificate requested
(``general'' or ``product-specific''); if product-specific, a list of
the exact brand names of the products; the contact person, company name
and address where the requested certificate should be sent; and, the
name and account number (if applicable) of the requester's preferred
carrier for delivery of the certificate. Finally, Form FDA 3613d and
the CFSAN Certificate Application Process requires the requester's
signature, the name and title of the person signing the form, as well
as the date signed.
We request the following information on Form FDA 3613e and the
CFSAN Certificate Application Process, as currently approved by OMB:
The name of and contact information for the manufacturer, as well as
the manufacturer's state license or registration number; the name of
and contact information for the exporting company (if different from
manufacturer), as well as the exporting company's state license or
registration number; a description of the shipment including the
product, the common name, the manufacturer, and a description or
additional comments; the name of the country to which the requester of
the certificate intends to ship the product; the contact person, firm
name and address where the requested certificate should be sent; and,
the name and account number (if applicable) of the requester's
preferred carrier for delivery of the certificate. Form FDA 3613e and
the CFSAN Certificate Application Process requires the requestor to
submit an original or copy of the applicable product label or labels.
Finally, Form FDA 3613e and the CFSAN Certificate Application Process
[[Page 1423]]
requires the submitter's signature, the name and title of the person
signing the form, as well as the date signed.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent FDA form Number of responses per Total annual Average burden Total hours
number \2\ respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cosmetics............................................... 3613d 600 1 600 1.5 900
Conventional Food (Including Seafood)................... 3613e 398 1 398 1.5 597
Dietary Supplements, Food for Special Dietary Use, 3613e 2,129 4 2,129 1.5 3,194
Infant Formula, and Medical Foods......................
Food Additives and Food Contact Substances.............. 3613e 167 1 167 1.5 251
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 4,942
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Form FDA 3613d and Form FDA 3613e may be submitted electronically via the Certificate Application Process.
For the purpose of this information collection request, we are
basing our estimate of the average burden per response in column 6 of
Table 1 on the estimates previously submitted to and approved by OMB
under control number 0910-0498. Our estimate of the average burden per
response in column 6 of Table 1 varies according to the product
category for which the certificate is requested. We base our estimates
of the total annual responses in column 5 of Table 1 on our experience
with certificate applications received in the past 2 fiscal years. Some
respondents send in requests as often as three or four times a month
while others may submit only periodic requests.
We expect that most if not all firms requesting export certificates
in the next 3 years will choose to take advantage of the option of
electronic submission via the CFSAN Certificate Application Process.
Thus, our burden estimates in Table 1 are based on the expectation of
100 percent participation in the electronic submission process. The
opportunity to provide the information in electronic format could
reduce the Agency's previous estimates for the time to prepare each
submission. However, as a conservative approach for the purpose of this
analysis, we are assuming that the opportunity to submit the
information in electronic format will have no effect on the average
time to prepare a submission.
Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00130 Filed 1-8-15; 8:45 am]
BILLING CODE 4164-01-P
