Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information From United States Firms and Processors That Export to the European Union, 18915-18916 [2017-08181]
Download as PDF
Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2976]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Information From
United States Firms and Processors
That Export to the European Union
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Fax written comments on the
collection of information by May 24,
2017.
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 0910–0320. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726.
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.
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
Information From U.S. Firms and
Processors That Export to the EU OMB
Control Number 0910–0320—Extension
The European Union (EU) is a group
of 28 European countries that have
agreed to harmonize their commodity
requirements to facilitate commerce
among member States. For certain food
products, including those listed in this
document, EU legislation requires
assurances from the responsible
authority of the country of origin that
the processor of the food is in
compliance with applicable regulatory
requirements. Regulation (EC) No. 854/
2004 of the European Parliament and of
VerDate Sep<11>2014
13:48 Apr 21, 2017
Jkt 241001
the European Council states that
products of animal origin may only be
imported from establishments that
appear on a list of establishments for
which the competent authority of the
exporting country has guaranteed
compliance with applicable regulatory
requirements and that shipments of
these products must be accompanied by
documents that certify the products’
compliance with applicable regulatory
standards. Section 801(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
381(e)) authorizes FDA to provide the
certification described in Regulation
(EC) No. 854/2004. As stated in the
notice published in the Federal Register
of April 4, 1996 (61 FR 15077), we
established a list of U.S. firms and
processors eligible to export shell eggs,
dairy products, and game meat and
game meat products to the EU. In
response to changing EU requirements,
we revised this information collection
and lists of eligible exporters in order to
facilitate U.S. exports of gelatin and
collagen to the EU. In 2001, we revised
this collection to include firms and
processors intending to export gelatin
products to the EU (66 FR 12802,
February 28, 2001) and in 2010, we
revised the collection again to include
firms and processors intending to export
collagen products to the EU (75 FR
51077, August 18, 2010).
We request the following information
from each firm or processor seeking to
be included on the lists of eligible
exporters for shell eggs, and game meat
and game meat products (dairy products
will be covered under OMB control
number 0910–0509):
• Business name and address;
• name and telephone number of
person designated as business contact;
• lists of products presently being
shipped to the EU and those intended
to be shipped in the next 6 months;
• name and address of manufacturing
plants for each product; and
• names and affiliations of any
Federal, State, or local governmental
Agencies that inspect the plant,
government-assigned plant identifier
such as plant number, and last date of
inspection.
We request the following information
from each firm or processor seeking to
be included on the list of eligible
exporters for gelatin and collagen
products:
• Food Facility Registration Number
and Pin Number (if applicable);
• business name and address;
• name, telephone number, fax
number, and email address of main
business contact person;
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
18915
• list of products presently shipped to
the EU and those intended to be
shipped within the next 2 years;
• name and address of the
manufacturing and processing plant for
each product (manufacturer type for
primary producer);
• names and affiliations of any
Federal, State, and local governmental
Agencies that inspect the plant,
government assigned plant identifier
such as plant number and last date of
inspection; and
• a copy of the most recent (within 1
year of the date of application)
inspection report issued by a State,
local, or Federal public health
regulatory Agency and a copy of a
recent laboratory analysis as required by
the EU of the finished product
including: Total aerobic bacteria,
coliforms (30 degrees C), coliforms (44.5
degrees C), anaerobic sulphite-reducing
bacteria (no gas production),
Clostridium perfringens,
Staphylococcus aureus, Salmonella,
arsenic, lead, cadmium, mercury,
chromium, copper, zinc, moisture (105
degrees C), ash (550 degrees C), sulfur
dioxide, and hydrogen peroxide.
We use the information to maintain
lists of firms and processors that have
demonstrated current compliance with
U.S. requirements. We make the lists
available on our Web site. We include
on the lists only firms and processors
that are not the subject of an unresolved
regulatory enforcement action or
unresolved warning letter. If a listed
firm or processor subsequently becomes
the subject of a regulatory enforcement
action or an unresolved warning letter,
we will view such a circumstance as
evidence that the firm or processor is no
longer in compliance with applicable
U.S. laws and regulations. Should this
occur, we will take steps to remove that
firm or processor from the list and send
a revised list to the EU authorities,
usually within 48 to 72 hours after the
relevant regulatory enforcement action.
If a firm or processor has been delisted
as a result of a regulatory enforcement
action or unresolved warning letter, the
firm or processor will have to reapply
for inclusion on the list once the
regulatory action has been resolved.
We update quarterly the lists of firms
and processors eligible to export
products of animal origin to the EU.
Firms and processors placed on lists of
eligible exporters are subject to audit by
FDA and EU officials. Complete
requests for inclusion on the lists of
eligible exporters, which is voluntary,
must be submitted 12 months to remain
on the list of firms and processors
eligible to export products of animal
origin to the EU. However, products of
E:\FR\FM\24APN1.SGM
24APN1
18916
Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
animal origin from firms or processors
not on lists of eligible exporters for
these products are not eligible for export
certificates for these products, and these
products may be detained at EU ports of
entry.
Description of Respondents: The
respondents to this collection of
information include U.S. producers of
shell eggs, game meat and game meat
products, gelatin, and collagen.
In the Federal Register of October 4,
2016 (81 FR 68424), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment which was not PRA-related,
and therefore is not addressed in this
supporting statement.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Products
Number of
responses per
respondent
Total annual
responses
Shell Eggs .....................................................
Game Meat and Game Meat Products ........
Gelatin ...........................................................
Collagen ........................................................
10
5
7
18
1
1
1
1
10
5
7
18
Total .......................................................
........................
........................
........................
1There
.25
.25
.25
.25
(15
(15
(15
(15
minutes)
minutes)
minutes)
minutes)
Total hours
...................
...................
...................
...................
3
1
2
5
...............................................
11
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates of the number
of respondents and total annual
responses on the submissions that we
have received in the past 3 years for
each product type. To calculate the
estimate for the hours per response
values, we assumed that the information
requested is readily available to the
submitter. We expect that the submitter
will need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for submission. We believe
that this effort should take no longer
than 15 minutes (0.25 hour) per
response. We estimate that we will
receive 1 submission from 10 shell egg
producers annually, for a total of 10
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 2.5 hours, rounded to 3
hours. This collection has previously
covered information collected to
maintain lists of eligible exporters of
dairy products; dairy products will be
covered under OMB control number
0910–0509, so the estimated burden has
been removed from this collection. We
estimate that we will receive one
submission from five game meat and
game meat product producers annually,
for a total of five annual responses. Each
submission is estimated to take 0.25
hour per response for a total of 1.25
hours, rounded to 1 hour. We estimate
that we will receive one submission
from seven gelatin producers annually,
jstallworth on DSK7TPTVN1PROD with NOTICES
Average burden
per response
for a total of seven annual responses.
Each submission is estimated to take
0.25 hour per response for a total of 1.75
hours, rounded to 2 hours. We estimate
that we will receive 1 submission from
18 collagen producers annually, for a
total of 18 annual responses. Each
submission is estimated to take 0.25
hour per response for a total of 4.5
hours, rounded to 5 hours. The
estimated burden for collagen producers
includes animal casings, which have
been listed separately in previous
notices. Therefore, the proposed annual
burden for this information collection is
11 hours.
Dated: April 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08181 Filed 4–21–17; 8:45 am]
BILLING CODE 4164–01–P
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of two new drug applications
(NDAs) held by Guerbet Group. Guerbet
Group notified the Agency in writing
that the drug products were no longer
marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
Withdrawal of approval is
effective May 24, 2017.
DATES:
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
applications listed in table 1 in this
document are no longer marketed, and
Guerbet Group has requested that FDA
withdraw approval of the applications
pursuant to the process in § 314.150(c)
(21 CFR 314.150(c)). The company has
also, by its request, waived its
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1748]
Guerbet Group; Withdrawal of
Approval of Two New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1
Application No.
Drug
Applicant
NDA 018905 ..........
Hexabrix (ioxaglate meglumine and ioxaglate sodium) Injection
USP, 39.3%/19.6%.
Guerbet Group, 821 Alexander Rd., Suite 204, Princeton,
NJ 08540.
VerDate Sep<11>2014
17:25 Apr 21, 2017
Jkt 241001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
E:\FR\FM\24APN1.SGM
24APN1
Agencies
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18915-18916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08181]
[[Page 18915]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2976]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Information From
United States Firms and Processors That Export to the European Union
AGENCY: Food and Drug Administration, 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: Fax written comments on the collection of information by May 24,
2017.
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 0910-0320.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726.
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.
Information From U.S. Firms and Processors That Export to the EU OMB
Control Number 0910-0320--Extension
The European Union (EU) is a group of 28 European countries that
have agreed to harmonize their commodity requirements to facilitate
commerce among member States. For certain food products, including
those listed in this document, EU legislation requires assurances from
the responsible authority of the country of origin that the processor
of the food is in compliance with applicable regulatory requirements.
Regulation (EC) No. 854/2004 of the European Parliament and of the
European Council states that products of animal origin may only be
imported from establishments that appear on a list of establishments
for which the competent authority of the exporting country has
guaranteed compliance with applicable regulatory requirements and that
shipments of these products must be accompanied by documents that
certify the products' compliance with applicable regulatory standards.
Section 801(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(e)) authorizes FDA to provide the certification described in
Regulation (EC) No. 854/2004. As stated in the notice published in the
Federal Register of April 4, 1996 (61 FR 15077), we established a list
of U.S. firms and processors eligible to export shell eggs, dairy
products, and game meat and game meat products to the EU. In response
to changing EU requirements, we revised this information collection and
lists of eligible exporters in order to facilitate U.S. exports of
gelatin and collagen to the EU. In 2001, we revised this collection to
include firms and processors intending to export gelatin products to
the EU (66 FR 12802, February 28, 2001) and in 2010, we revised the
collection again to include firms and processors intending to export
collagen products to the EU (75 FR 51077, August 18, 2010).
We request the following information from each firm or processor
seeking to be included on the lists of eligible exporters for shell
eggs, and game meat and game meat products (dairy products will be
covered under OMB control number 0910-0509):
Business name and address;
name and telephone number of person designated as business
contact;
lists of products presently being shipped to the EU and
those intended to be shipped in the next 6 months;
name and address of manufacturing plants for each product;
and
names and affiliations of any Federal, State, or local
governmental Agencies that inspect the plant, government-assigned plant
identifier such as plant number, and last date of inspection.
We request the following information from each firm or processor
seeking to be included on the list of eligible exporters for gelatin
and collagen products:
Food Facility Registration Number and Pin Number (if
applicable);
business name and address;
name, telephone number, fax number, and email address of
main business contact person;
list of products presently shipped to the EU and those
intended to be shipped within the next 2 years;
name and address of the manufacturing and processing plant
for each product (manufacturer type for primary producer);
names and affiliations of any Federal, State, and local
governmental Agencies that inspect the plant, government assigned plant
identifier such as plant number and last date of inspection; and
a copy of the most recent (within 1 year of the date of
application) inspection report issued by a State, local, or Federal
public health regulatory Agency and a copy of a recent laboratory
analysis as required by the EU of the finished product including: Total
aerobic bacteria, coliforms (30 degrees C), coliforms (44.5 degrees C),
anaerobic sulphite-reducing bacteria (no gas production), Clostridium
perfringens, Staphylococcus aureus, Salmonella, arsenic, lead, cadmium,
mercury, chromium, copper, zinc, moisture (105 degrees C), ash (550
degrees C), sulfur dioxide, and hydrogen peroxide.
We use the information to maintain lists of firms and processors
that have demonstrated current compliance with U.S. requirements. We
make the lists available on our Web site. We include on the lists only
firms and processors that are not the subject of an unresolved
regulatory enforcement action or unresolved warning letter. If a listed
firm or processor subsequently becomes the subject of a regulatory
enforcement action or an unresolved warning letter, we will view such a
circumstance as evidence that the firm or processor is no longer in
compliance with applicable U.S. laws and regulations. Should this
occur, we will take steps to remove that firm or processor from the
list and send a revised list to the EU authorities, usually within 48
to 72 hours after the relevant regulatory enforcement action. If a firm
or processor has been delisted as a result of a regulatory enforcement
action or unresolved warning letter, the firm or processor will have to
reapply for inclusion on the list once the regulatory action has been
resolved.
We update quarterly the lists of firms and processors eligible to
export products of animal origin to the EU. Firms and processors placed
on lists of eligible exporters are subject to audit by FDA and EU
officials. Complete requests for inclusion on the lists of eligible
exporters, which is voluntary, must be submitted 12 months to remain on
the list of firms and processors eligible to export products of animal
origin to the EU. However, products of
[[Page 18916]]
animal origin from firms or processors not on lists of eligible
exporters for these products are not eligible for export certificates
for these products, and these products may be detained at EU ports of
entry.
Description of Respondents: The respondents to this collection of
information include U.S. producers of shell eggs, game meat and game
meat products, gelatin, and collagen.
In the Federal Register of October 4, 2016 (81 FR 68424), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment which was not PRA-
related, and therefore is not addressed in this supporting statement.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of
Products Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Shell Eggs.................... 10 1 10 .25 (15 minutes) 3
Game Meat and Game Meat 5 1 5 .25 (15 minutes) 1
Products.
Gelatin....................... 7 1 7 .25 (15 minutes) 2
Collagen...................... 18 1 18 .25 (15 minutes) 5
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 11
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates of the number of respondents and total annual
responses on the submissions that we have received in the past 3 years
for each product type. To calculate the estimate for the hours per
response values, we assumed that the information requested is readily
available to the submitter. We expect that the submitter will need to
gather information from appropriate persons in the submitter's company
and to prepare this information for submission. We believe that this
effort should take no longer than 15 minutes (0.25 hour) per response.
We estimate that we will receive 1 submission from 10 shell egg
producers annually, for a total of 10 annual responses. Each submission
is estimated to take 0.25 hour per response for a total of 2.5 hours,
rounded to 3 hours. This collection has previously covered information
collected to maintain lists of eligible exporters of dairy products;
dairy products will be covered under OMB control number 0910-0509, so
the estimated burden has been removed from this collection. We estimate
that we will receive one submission from five game meat and game meat
product producers annually, for a total of five annual responses. Each
submission is estimated to take 0.25 hour per response for a total of
1.25 hours, rounded to 1 hour. We estimate that we will receive one
submission from seven gelatin producers annually, for a total of seven
annual responses. Each submission is estimated to take 0.25 hour per
response for a total of 1.75 hours, rounded to 2 hours. We estimate
that we will receive 1 submission from 18 collagen producers annually,
for a total of 18 annual responses. Each submission is estimated to
take 0.25 hour per response for a total of 4.5 hours, rounded to 5
hours. The estimated burden for collagen producers includes animal
casings, which have been listed separately in previous notices.
Therefore, the proposed annual burden for this information collection
is 11 hours.
Dated: April 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08181 Filed 4-21-17; 8:45 am]
BILLING CODE 4164-01-P