82 FR 18915 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 77 (April 24, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 77 (April 24, 2017)
| Page Range | 18915-18916 | |
| FR Document | 2017-08181 |
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)] [Notices] [Pages 18915-18916] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices 18915
DEPARTMENT OF HEALTH AND the European Council states that • list of products presently shipped to
HUMAN SERVICES products of animal origin may only be the EU and those intended to be
imported from establishments that shipped within the next 2 years;
Food and Drug Administration appear on a list of establishments for • name and address of the
which the competent authority of the manufacturing and processing plant for
[Docket No. FDA–2016–N–2976]
exporting country has guaranteed each product (manufacturer type for
Agency Information Collection compliance with applicable regulatory primary producer);
Activities; Submission for Office of requirements and that shipments of • names and affiliations of any
Management and Budget Review; these products must be accompanied by Federal, State, and local governmental
Comment Request; Information From documents that certify the products’ Agencies that inspect the plant,
United States Firms and Processors compliance with applicable regulatory government assigned plant identifier
That Export to the European Union standards. Section 801(e) of the Federal such as plant number and last date of
Food, Drug, and Cosmetic Act (21 U.S.C. inspection; and
AGENCY: Food and Drug Administration, 381(e)) authorizes FDA to provide the • a copy of the most recent (within 1
HHS. certification described in Regulation year of the date of application)
ACTION: Notice. (EC) No. 854/2004. As stated in the inspection report issued by a State,
notice published in the Federal Register local, or Federal public health
SUMMARY: The Food and Drug regulatory Agency and a copy of a
of April 4, 1996 (61 FR 15077), we
Administration (FDA or we) is recent laboratory analysis as required by
established a list of U.S. firms and
announcing that a proposed collection the EU of the finished product
processors eligible to export shell eggs,
of information has been submitted to the including: Total aerobic bacteria,
dairy products, and game meat and
Office of Management and Budget coliforms (30 degrees C), coliforms (44.5
game meat products to the EU. In
(OMB) for review and clearance under degrees C), anaerobic sulphite-reducing
response to changing EU requirements,
the Paperwork Reduction Act of 1995. bacteria (no gas production),
we revised this information collection
DATES: Fax written comments on the Clostridium perfringens,
and lists of eligible exporters in order to
collection of information by May 24, Staphylococcus aureus, Salmonella,
facilitate U.S. exports of gelatin and
2017. arsenic, lead, cadmium, mercury,
collagen to the EU. In 2001, we revised
ADDRESSES: To ensure that comments on
chromium, copper, zinc, moisture (105
this collection to include firms and
the information collection are received, degrees C), ash (550 degrees C), sulfur
processors intending to export gelatin
OMB recommends that written dioxide, and hydrogen peroxide.
products to the EU (66 FR 12802, We use the information to maintain
comments be faxed to the Office of February 28, 2001) and in 2010, we lists of firms and processors that have
Information and Regulatory Affairs, revised the collection again to include demonstrated current compliance with
OMB, Attn: FDA Desk Officer, FAX: firms and processors intending to export U.S. requirements. We make the lists
202–395–7285, or emailed to oira_ collagen products to the EU (75 FR available on our Web site. We include
submission@omb.eop.gov. All 51077, August 18, 2010). on the lists only firms and processors
comments should be identified with the We request the following information that are not the subject of an unresolved
OMB control number 0910–0320. Also from each firm or processor seeking to regulatory enforcement action or
include the FDA docket number found be included on the lists of eligible unresolved warning letter. If a listed
in brackets in the heading of this exporters for shell eggs, and game meat firm or processor subsequently becomes
document. and game meat products (dairy products the subject of a regulatory enforcement
FOR FURTHER INFORMATION CONTACT: Ila will be covered under OMB control action or an unresolved warning letter,
S. Mizrachi, Office of Operations, Food number 0910–0509): we will view such a circumstance as
and Drug Administration, Three White • Business name and address; evidence that the firm or processor is no
Flint North, 10A63, 11601 Landsdown • name and telephone number of longer in compliance with applicable
St., North Bethesda, MD 20852, 301– person designated as business contact; U.S. laws and regulations. Should this
796–7726. • lists of products presently being occur, we will take steps to remove that
SUPPLEMENTARY INFORMATION: In shipped to the EU and those intended firm or processor from the list and send
compliance with 44 U.S.C. 3507, FDA to be shipped in the next 6 months; a revised list to the EU authorities,
has submitted the following proposed • name and address of manufacturing usually within 48 to 72 hours after the
collection of information to OMB for plants for each product; and relevant regulatory enforcement action.
review and clearance. • names and affiliations of any If a firm or processor has been delisted
Federal, State, or local governmental as a result of a regulatory enforcement
Information From U.S. Firms and action or unresolved warning letter, the
Processors That Export to the EU OMB Agencies that inspect the plant,
government-assigned plant identifier firm or processor will have to reapply
Control Number 0910–0320—Extension for inclusion on the list once the
such as plant number, and last date of
The European Union (EU) is a group regulatory action has been resolved.
inspection.
of 28 European countries that have We update quarterly the lists of firms
agreed to harmonize their commodity We request the following information and processors eligible to export
requirements to facilitate commerce from each firm or processor seeking to products of animal origin to the EU.
among member States. For certain food be included on the list of eligible Firms and processors placed on lists of
products, including those listed in this exporters for gelatin and collagen eligible exporters are subject to audit by
jstallworth on DSK7TPTVN1PROD with NOTICES
document, EU legislation requires products: FDA and EU officials. Complete
assurances from the responsible • Food Facility Registration Number requests for inclusion on the lists of
authority of the country of origin that and Pin Number (if applicable); eligible exporters, which is voluntary,
the processor of the food is in • business name and address; must be submitted 12 months to remain
compliance with applicable regulatory • name, telephone number, fax on the list of firms and processors
requirements. Regulation (EC) No. 854/ number, and email address of main eligible to export products of animal
2004 of the European Parliament and of business contact person; origin to the EU. However, products of
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![18916 Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
animal origin from firms or processors information include U.S. producers of comment which was not PRA-related,
not on lists of eligible exporters for shell eggs, game meat and game meat and therefore is not addressed in this
these products are not eligible for export products, gelatin, and collagen. supporting statement.
certificates for these products, and these In the Federal Register of October 4,
FDA estimates the burden of this
products may be detained at EU ports of 2016 (81 FR 68424), FDA published a
60-day notice requesting public collection of information as follows:
entry.
Description of Respondents: The comment on the proposed collection of
respondents to this collection of information. FDA received one
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
Number of Total annual Average burden
Products responses per Total hours
respondents responses per response
respondent
Shell Eggs ..................................................... 10 1 10 .25 (15 minutes) ................... 3
Game Meat and Game Meat Products ........ 5 1 5 .25 (15 minutes) ................... 1
Gelatin ........................................................... 7 1 7 .25 (15 minutes) ................... 2
Collagen ........................................................ 18 1 18 .25 (15 minutes) ................... 5
Total ....................................................... ........................ ........................ ........................ ............................................... 11
1There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates of the number for a total of seven annual responses. ACTION: Notice.
of respondents and total annual Each submission is estimated to take
responses on the submissions that we 0.25 hour per response for a total of 1.75 SUMMARY: The Food and Drug
have received in the past 3 years for hours, rounded to 2 hours. We estimate Administration (FDA) is withdrawing
each product type. To calculate the that we will receive 1 submission from approval of two new drug applications
estimate for the hours per response 18 collagen producers annually, for a (NDAs) held by Guerbet Group. Guerbet
values, we assumed that the information total of 18 annual responses. Each Group notified the Agency in writing
requested is readily available to the submission is estimated to take 0.25 that the drug products were no longer
submitter. We expect that the submitter hour per response for a total of 4.5 marketed and requested that the
will need to gather information from hours, rounded to 5 hours. The approval of the applications be
appropriate persons in the submitter’s estimated burden for collagen producers
company and to prepare this withdrawn.
includes animal casings, which have
information for submission. We believe been listed separately in previous DATES: Withdrawal of approval is
that this effort should take no longer notices. Therefore, the proposed annual effective May 24, 2017.
than 15 minutes (0.25 hour) per burden for this information collection is
response. We estimate that we will 11 hours. FOR FURTHER INFORMATION CONTACT:
receive 1 submission from 10 shell egg Florine P. Purdie, Center for Drug
Dated: April 17, 2017.
producers annually, for a total of 10 Evaluation and Research, Food and
Anna K. Abram,
annual responses. Each submission is Drug Administration, 10903 New
estimated to take 0.25 hour per response Deputy Commissioner for Policy, Planning, Hampshire Ave., Bldg. 51, Rm. 6248,
Legislation, and Analysis.
for a total of 2.5 hours, rounded to 3 Silver Spring, MD 20993–0002, 301–
hours. This collection has previously [FR Doc. 2017–08181 Filed 4–21–17; 8:45 am]
796–3601.
covered information collected to BILLING CODE 4164–01–P
maintain lists of eligible exporters of SUPPLEMENTARY INFORMATION: The
dairy products; dairy products will be applications listed in table 1 in this
covered under OMB control number DEPARTMENT OF HEALTH AND document are no longer marketed, and
0910–0509, so the estimated burden has HUMAN SERVICES Guerbet Group has requested that FDA
been removed from this collection. We withdraw approval of the applications
Food and Drug Administration
estimate that we will receive one pursuant to the process in § 314.150(c)
submission from five game meat and (21 CFR 314.150(c)). The company has
[Docket No. FDA–2017–N–1748]
game meat product producers annually, also, by its request, waived its
for a total of five annual responses. Each Guerbet Group; Withdrawal of opportunity for a hearing. Withdrawal
submission is estimated to take 0.25 Approval of Two New Drug of approval of an application or
hour per response for a total of 1.25 Applications abbreviated application under
hours, rounded to 1 hour. We estimate § 314.150(c) is without prejudice to
that we will receive one submission AGENCY: Food and Drug Administration, refiling.
from seven gelatin producers annually, HHS.
TABLE 1
jstallworth on DSK7TPTVN1PROD with NOTICES
Application No. Drug Applicant
NDA 018905 .......... Hexabrix (ioxaglate meglumine and ioxaglate sodium) Injection Guerbet Group, 821 Alexander Rd., Suite 204, Princeton,
USP, 39.3%/19.6%. NJ 08540.
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Document Created: 2017-04-22 00:11:31
Document Modified: 2017-04-22 00:11:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 24, 2017. | |
| 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. | |
| FR Citation | 82 FR 18915 |
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