FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting, 13643-13645 [2011-5942]

Download as PDF Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices plan to continue this activity in 2011 in three different locations. In March 2011, the meeting will be held in Dallas, TX. After this meeting, CDRH will host one more this year in the San Francisco, CA, area. II. Public Meeting The objective of this public meeting is to engage in a dialogue about issues that are of importance to the public. The public meeting will open with an introduction of CDRH senior staff in attendance. Following introductions, Dr. Jeffrey Shuren, the Director of CDRH, will describe CDRH’s strategic priorities for 2011. Members of the public will then be given the opportunity to present comments to CDRH senior staff followed by a question and answer session during which any member of the public may ask questions of the CDRH senior staff on any topic of interest. In advance of the meeting, additional information, including a meeting agenda with a speakers’ schedule, will be made available on the Internet. This information will be placed on file in the public docket (docket number found in brackets in the heading of this document), which is available at https://www.regulations.gov. This information will also be available at https://www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm (select the appropriate meeting from the list). III. Transcripts mstockstill on DSKH9S0YB1PROD with NOTICES Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI–35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857. Dated: March 4, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–5735 Filed 3–11–11; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:20 Mar 11, 2011 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2011–N–0134, FDA– 2011–N–0143, FDA–2011–N–0144, FDA– 2011–N–0145, and FDA–2011–N–0146] FDA Food Safety Modernization Act: Title III—A New Paradigm for Importers; Public Meeting AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comment. ACTION: The Food and Drug Administration (FDA) is announcing a public meeting entitled ‘‘FDA Food Safety Modernization Act: Title III—A New Paradigm for Importers.’’ The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of the import safety provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is seeking information on importer verification, the Voluntary Qualified Importer Program, import certifications for food, and third-party accreditation. In a separate notice published elsewhere in this issue of the Federal Register, FDA is announcing a public hearing to provide stakeholders the opportunity to discuss FDA’s use of international comparability assessments as a mechanism to enhance the safety of imported foods and animal feed and lessons learned through equivalence determinations. The public hearing will include a separate discussion of FDA’s efforts to gather information from regulators in other countries regarding the regulatory policies, practices, and programs they currently use to ensure the safety of foods and animal feed imported into their countries. DATES: See ‘‘How to Participate in the Meeting’’ in the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: Patricia M. Kuntze, Office of External Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5322, Silver Spring, MD 20993, 301–796–8641, Patricia.Kuntze@fda.hhs.gov. SUMMARY: SUPPLEMENTARY INFORMATION: I. Background FSMA (Pub. L. 111–353) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation for a modernized, prevention-based food safety system that emphasizes accountability for PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 13643 domestic and foreign food and animal feed firms in the supply chain from farm to U.S. table. In particular, title III of FSMA significantly enhances FDA’s authority for oversight of the millions of food products that enter the United States each year and, among other things, requires FDA to develop regulations, guidance, and to otherwise implement the following provisions: Section 301. Foreign Supplier Verification Program (FSVP) requires importers to conduct risk-based foreign supplier verification activities to verify that imported food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342) or misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (relating to allergens) and is produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable. Facilities in compliance with FDA’s seafood, juice, or low-acid canned food products requirements are exempted in whole or in part from the FSVP requirements. The statute directs FDA to exempt, by notice in the Federal Register, importers of food imported into the United States in small quantities for research uses or for personal consumption. The statute further directs FDA to issue implementing regulations and guidance on FSVPs. Section 302. Voluntary qualified importer program (VQIP) requires FDA to establish a voluntary, user-fee funded program to expedite entry into the United States of imported food from eligible, qualified importers. To be eligible to participate in VQIP, an importer must offer food for importation from a facility that has a certification by an accredited third party. FDA will qualify eligible importers to participate in VQIP based on risk considerations. The statute directs FDA to issue guidance on participation in and compliance with VQIP. Section 303. Authority to require import certifications for food authorizes FDA, based on risk considerations, to require an article of food offered for import into the United States to be accompanied by certifications or other assurances that the food complies with relevant provisions of the FD&C Act. Certifications may be issued by designated foreign governments or accredited third parties. Section 307. Accreditation of thirdparty auditors directs FDA to establish a system for the recognition of accreditation bodies that accredit thirdparty auditors to issue certifications for purposes of the import certification for food and VQIP provisions described previously in this document. Foreign E:\FR\FM\14MRN1.SGM 14MRN1 13644 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices governments, foreign cooperatives, and any other third parties (including private entities) are eligible to be considered for accreditation as thirdparty auditors. The statute further provides that if FDA has not, within a specified timeframe, identified and recognized an accreditation body to meet the requirements of this provision, FDA may directly accredit third-party auditors. The statute directs FDA to issue implementing regulations, including provisions on conflicts of interest, financial ties, and unannounced audits, as well as model accreditation standards, including requirements for regulatory audit reports. In a separate notice published elsewhere in this issue of the Federal Register, FDA is announcing a public hearing March 30 and 31, 2011, to provide stakeholders the opportunity to discuss FDA’s use of international comparability assessments as a mechanism to enhance the safety of imported foods and animal feed and lessons learned through equivalence determinations. In addition, there will be a separate discussion of FDA’s efforts to gather information from regulators in other countries regarding the regulatory policies, practices, and programs they currently use to ensure the safety of foods and animal feed imported into their countries. II. Purpose and Format of the Meeting If you wish to attend and/or present at the meeting scheduled for March 29, 2011, please register by e-mail to https:// www.blsmeetings.net/FDAImportSafety by March 22, 2011. FDA is holding the public meeting on the FSMA imports provisions to receive input from the public to inform the development of the regulations and guidance identified previously in this document. In general, the meeting format will include introductory presentations by FDA. Listening to our stakeholders is the primary purpose of this meeting. In order to meet this goal, FDA will provide multiple opportunities for individuals to actively express their views by making presentations at the meeting, participating in break-out sessions on the provisions discussed at the meeting, and submitting written comments to the docket(s) (see table 2 of this document for a list of docket numbers and corresponding sections of FSMA) within 30 days after this meeting. There will be an interactive webcast; see section III of this document, ‘‘How to Participate in the Meeting.’’ III. How To Participate in the Meeting Stakeholders will have an opportunity to provide oral comments. Due to limited space and time, FDA encourages all persons who wish to attend the meeting, including those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting, to register in advance and to provide the specific topic or issue to be addressed and the approximate desired length of their presentation. Depending on the number of requests for such oral presentations, there may be a need to limit the time of each oral presentation (e.g., 3 minutes each). If time permits, individuals or organizations that did not register in advance may be granted the opportunity for such an oral presentation. FDA would like to maximize the number of stakeholders who make a presentation at the meeting and will do our best to accommodate all persons who wish to make a presentation or express their views at the meeting. FDA anticipates that there will be several opportunities to speak in break-out sessions and an interactive webcast will also be available for stakeholders who are not onsite. FDA encourages persons and groups who have similar interests to consolidate their information for presentation through a single representative. After reviewing the presentation requests, FDA will notify each participant before the meeting of the amount of time available and the approximate time their presentation is scheduled to begin. There is no fee to register for the public meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Table 1 of this document provides information on participating in the meeting and on submitting comments to the docket (see table 2 of this document for a list of docket numbers and corresponding sections of FSMA). TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS Electronic address Address (non-electronic) Date of Public Meeting. March 29, 2011, 9 a.m. to 5 p.m. ................................................ Webcast ......... March 29, 2011, 9 a.m. to 5 p.m. https://collaboration.fda.gov/ foodsafety/. FDA White Oak Campus, The Great Room, Bldg. 31, rm. 1503, 10903 New Hampshire Ave., Silver Spring, MD 20993. ................................................ Advance Registration. mstockstill on DSKH9S0YB1PROD with NOTICES Date By March 22, 2011. https://www.blsmeetings.net/ FDAImportSafety. ................................................ Request special accommodations due to disability. By March 22, 2011. ................................................ Patricia M. Kuntze, 301–796– 8641, email: Patricia. Kuntze@fda.hhs.gov. VerDate Mar<15>2010 17:44 Mar 11, 2011 Jkt 223001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Other information Registration begins at 7:30 a.m. • If you have never attended a ConnectPRO meeting: Test your connection: https:// collaboration.fda.gov/common/help/en/ support/meeting_test.htm Get a quick overview: https://www.adobe.com/go/connectpro_overview 1 • The webcast will provide closed captioning. Registration to attend the meeting will also be accepted onsite on the day of the meeting, as space permits. Registration information may be posted without change to https://www.regulations.gov, including any personal information provided. E:\FR\FM\14MRN1.SGM 14MRN1 13645 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS—Continued Date Electronic address Address (non-electronic) Other information Requests made on the day of the meeting to make an oral presentation may be granted as time permits. Information on requests to make an oral presentation may be posted without change to https:// www.regulations.gov, including any personal information provided. Written material associated with an oral presentation should be submitted in Microsoft PowerPoint, Microsoft Word, or Adobe Portable Document Format (PDF) and may be posted without change to https:// www.regulations.gov, including any personal information provided. Make a request for oral presentation. By March 22, 2011. https://www.blsmeetings.net/ FDAImportSafety. ................................................ Provide a brief description of the oral presentation and any written material for the presentation. Submit electronic or written comments. By March 22, 2011. https://www.blsmeetings.net/ FDAImportSafety. ................................................ Submit comments by April 29, 2011. Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. FAX: 301–827–6870. Mail/ Hand delivery/Courier (for paper, disk, or CD–ROM submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments must include the Agency name and the docket number corresponding with the section of FSMA on which you are commenting (see table 2 of this document for a list of docket numbers and corresponding sections of FSMA). All received comments may be posted without change to https://www.regulations.gov, including any personal information provided. FDA encourages the submission of electronic comments by using the Federal eRulemaking Portal. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. 1 Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries. IV. Comments Regardless of attendance at the public meeting, interested persons may submit to the Division of Dockets Management (see table 1 of this document) either electronic or written comments for consideration at or after the meeting in addition to, or in place of, a request for an opportunity to make an oral presentation. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Because multiple docket numbers are associated with this document, please include with your comments the docket number(s) that corresponds with the section of FSMA on which you are commenting (see table 2 of this document for a list of docket numbers and corresponding sections of FSMA). TABLE 2 Section of FSMA 301 302 303 307 Topic .................................................... .................................................... .................................................... .................................................... Foreign supplier verification program ....................................................................... Voluntary qualified importer program ....................................................................... Authority to require import certifications for food ..................................................... Accreditation of third-party auditors ......................................................................... mstockstill on DSKH9S0YB1PROD with NOTICES Comments that address more than one docket must be filed with each docket to ensure consideration. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Transcripts Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov and https://www.fda.gov/Food/ FoodSafety/FSMA/default.htm. It may be viewed at the Division of Dockets VerDate Mar<15>2010 16:20 Mar 11, 2011 Docket No. Jkt 223001 Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI–35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857. PO 00000 Frm 00049 Fmt 4703 Sfmt 9990 FDA–2011–N–0143 FDA–2011–N–0144 FDA–2011–N–0145 FDA–2011–N–0146 Dated: March 9, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–5942 Filed 3–10–11; 4:15 pm] BILLING CODE 4160–01–P E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13643-13645]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5942]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-N-0144, FDA-
2011-N-0145, and FDA-2011-N-0146]

FDA Food Safety Modernization Act: Title III--A New Paradigm for
Importers; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``FDA Food Safety Modernization Act: Title III--A New
Paradigm for Importers.'' The purpose of the public meeting is to
provide interested persons an opportunity to discuss implementation of
the import safety provisions of the recently enacted FDA Food Safety
Modernization Act (FSMA). FDA is seeking information on importer
verification, the Voluntary Qualified Importer Program, import
certifications for food, and third-party accreditation. In a separate
notice published elsewhere in this issue of the Federal Register, FDA
is announcing a public hearing to provide stakeholders the opportunity
to discuss FDA's use of international comparability assessments as a
mechanism to enhance the safety of imported foods and animal feed and
lessons learned through equivalence determinations. The public hearing
will include a separate discussion of FDA's efforts to gather
information from regulators in other countries regarding the regulatory
policies, practices, and programs they currently use to ensure the
safety of foods and animal feed imported into their countries.

DATES: See ``How to Participate in the Meeting'' in the SUPPLEMENTARY
INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Patricia M. Kuntze, Office of External
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, rm. 5322, Silver Spring, MD 20993, 301-796-8641,
Patricia.Kuntze@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FSMA (Pub. L. 111-353) amends the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to establish the foundation for a modernized,
prevention-based food safety system that emphasizes accountability for
domestic and foreign food and animal feed firms in the supply chain
from farm to U.S. table. In particular, title III of FSMA significantly
enhances FDA's authority for oversight of the millions of food products
that enter the United States each year and, among other things,
requires FDA to develop regulations, guidance, and to otherwise
implement the following provisions:
Section 301. Foreign Supplier Verification Program (FSVP) requires
importers to conduct risk-based foreign supplier verification
activities to verify that imported food is not adulterated under
section 402 of the FD&C Act (21 U.S.C. 342) or misbranded under section
403(w) of the FD&C Act (21 U.S.C. 343(w)) (relating to allergens) and
is produced in compliance with FDA's preventive controls requirements
and produce safety standards, where applicable. Facilities in
compliance with FDA's seafood, juice, or low-acid canned food products
requirements are exempted in whole or in part from the FSVP
requirements. The statute directs FDA to exempt, by notice in the
Federal Register, importers of food imported into the United States in
small quantities for research uses or for personal consumption. The
statute further directs FDA to issue implementing regulations and
guidance on FSVPs.
Section 302. Voluntary qualified importer program (VQIP) requires
FDA to establish a voluntary, user-fee funded program to expedite entry
into the United States of imported food from eligible, qualified
importers. To be eligible to participate in VQIP, an importer must
offer food for importation from a facility that has a certification by
an accredited third party. FDA will qualify eligible importers to
participate in VQIP based on risk considerations. The statute directs
FDA to issue guidance on participation in and compliance with VQIP.
Section 303. Authority to require import certifications for food
authorizes FDA, based on risk considerations, to require an article of
food offered for import into the United States to be accompanied by
certifications or other assurances that the food complies with relevant
provisions of the FD&C Act. Certifications may be issued by designated
foreign governments or accredited third parties.
Section 307. Accreditation of third-party auditors directs FDA to
establish a system for the recognition of accreditation bodies that
accredit third-party auditors to issue certifications for purposes of
the import certification for food and VQIP provisions described
previously in this document. Foreign

[[Page 13644]]

governments, foreign cooperatives, and any other third parties
(including private entities) are eligible to be considered for
accreditation as third-party auditors. The statute further provides
that if FDA has not, within a specified timeframe, identified and
recognized an accreditation body to meet the requirements of this
provision, FDA may directly accredit third-party auditors. The statute
directs FDA to issue implementing regulations, including provisions on
conflicts of interest, financial ties, and unannounced audits, as well
as model accreditation standards, including requirements for regulatory
audit reports.
In a separate notice published elsewhere in this issue of the
Federal Register, FDA is announcing a public hearing March 30 and 31,
2011, to provide stakeholders the opportunity to discuss FDA's use of
international comparability assessments as a mechanism to enhance the
safety of imported foods and animal feed and lessons learned through
equivalence determinations. In addition, there will be a separate
discussion of FDA's efforts to gather information from regulators in
other countries regarding the regulatory policies, practices, and
programs they currently use to ensure the safety of foods and animal
feed imported into their countries.

II. Purpose and Format of the Meeting

If you wish to attend and/or present at the meeting scheduled for
March 29, 2011, please register by e-mail to https://www.blsmeetings.net/FDAImportSafety by March 22, 2011. FDA is holding
the public meeting on the FSMA imports provisions to receive input from
the public to inform the development of the regulations and guidance
identified previously in this document. In general, the meeting format
will include introductory presentations by FDA. Listening to our
stakeholders is the primary purpose of this meeting. In order to meet
this goal, FDA will provide multiple opportunities for individuals to
actively express their views by making presentations at the meeting,
participating in break-out sessions on the provisions discussed at the
meeting, and submitting written comments to the docket(s) (see table 2
of this document for a list of docket numbers and corresponding
sections of FSMA) within 30 days after this meeting. There will be an
interactive webcast; see section III of this document, ``How to
Participate in the Meeting.''

III. How To Participate in the Meeting

Stakeholders will have an opportunity to provide oral comments. Due
to limited space and time, FDA encourages all persons who wish to
attend the meeting, including those requesting an opportunity to make
an oral presentation during the time allotted for public comment at the
meeting, to register in advance and to provide the specific topic or
issue to be addressed and the approximate desired length of their
presentation. Depending on the number of requests for such oral
presentations, there may be a need to limit the time of each oral
presentation (e.g., 3 minutes each). If time permits, individuals or
organizations that did not register in advance may be granted the
opportunity for such an oral presentation. FDA would like to maximize
the number of stakeholders who make a presentation at the meeting and
will do our best to accommodate all persons who wish to make a
presentation or express their views at the meeting. FDA anticipates
that there will be several opportunities to speak in break-out sessions
and an interactive webcast will also be available for stakeholders who
are not onsite. FDA encourages persons and groups who have similar
interests to consolidate their information for presentation through a
single representative. After reviewing the presentation requests, FDA
will notify each participant before the meeting of the amount of time
available and the approximate time their presentation is scheduled to
begin.
There is no fee to register for the public meeting and registration
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited.
Table 1 of this document provides information on participating in
the meeting and on submitting comments to the docket (see table 2 of
this document for a list of docket numbers and corresponding sections
of FSMA).

Table 1--Information on Participation in the Meeting and on Submitting Comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date Electronic address Address (non-electronic) Other information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date of Public Meeting............. March 29, 2011, 9 .......................... FDA White Oak Campus, The Registration begins at 7:30 a.m.
a.m. to 5 p.m. Great Room, Bldg. 31, rm.
1503, 10903 New Hampshire
Ave., Silver Spring, MD
20993.
Webcast............................ March 29, 2011, 9 https:// .......................... If you have never attended
a.m. to 5 p.m. collaboration.fda.gov/ a ConnectPRO meeting: Test your
foodsafety/. connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm Get a
quick overview: https://www.adobe.com/go/connectpro_overview overview \1\
The webcast will provide
closed captioning.
Advance Registration............... By March 22, 2011.... https://www.blsmeetings.net/ .......................... Registration to attend the meeting
FDAImportSafety. will also be accepted onsite on the
day of the meeting, as space
permits. Registration information
may be posted without change to
https://www.regulations.gov,
including any personal information
provided.
Request special accommodations due By March 22, 2011.... .......................... Patricia M. Kuntze, 301- ....................................
to disability. 796-8641, email:
Patricia.Kuntze@fda.hhs.gov.

[[Page 13645]]

Make a request for oral By March 22, 2011.... https://www.blsmeetings.net/ .......................... Requests made on the day of the
presentation. FDAImportSafety. meeting to make an oral
presentation may be granted as time
permits. Information on requests to
make an oral presentation may be
posted without change to https://www.regulations.gov, including any
personal information provided.
Provide a brief description of the By March 22, 2011.... https://www.blsmeetings.net/ .......................... Written material associated with an
oral presentation and any written FDAImportSafety. oral presentation should be
material for the presentation. submitted in Microsoft PowerPoint,
Microsoft Word, or Adobe Portable
Document Format (PDF) and may be
posted without change to https://www.regulations.gov, including any
personal information provided.
Submit electronic or written Submit comments by Federal eRulemaking FAX: 301-827-6870. Mail/ All comments must include the Agency
comments. April 29, 2011. Portal: https:// Hand delivery/Courier name and the docket number
www.regulations.gov. (for paper, disk, or CD- corresponding with the section of
Follow the instructions ROM submissions): FSMA on which you are commenting
for submitting comments. Division of Dockets (see table 2 of this document for a
Management (HFA-305), list of docket numbers and
Food and Drug corresponding sections of FSMA).
Administration, 5630 All received comments may be posted
Fishers Lane, rm. 1061, without change to https://
Rockville, MD 20852. www.regulations.gov, including any
personal information provided. FDA
encourages the submission of
electronic comments by using the
Federal eRulemaking Portal. For
additional information on
submitting comments, see the
``Comments'' heading of the
SUPPLEMENTARY INFORMATION section
of this document.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States
and/or other countries.

IV. Comments

Regardless of attendance at the public meeting, interested persons
may submit to the Division of Dockets Management (see table 1 of this
document) either electronic or written comments for consideration at or
after the meeting in addition to, or in place of, a request for an
opportunity to make an oral presentation. It is only necessary to send
one set of comments. It is no longer necessary to send two copies of
mailed comments. Because multiple docket numbers are associated with
this document, please include with your comments the docket number(s)
that corresponds with the section of FSMA on which you are commenting
(see table 2 of this document for a list of docket numbers and
corresponding sections of FSMA).

Table 2
----------------------------------------------------------------------------------------------------------------
Section of FSMA Topic Docket No.
----------------------------------------------------------------------------------------------------------------
301..................................... Foreign supplier verification FDA-2011-N-0143
program.
302..................................... Voluntary qualified importer FDA-2011-N-0144
program.
303..................................... Authority to require import FDA-2011-N-0145
certifications for food.
307..................................... Accreditation of third-party FDA-2011-N-0146
auditors.
----------------------------------------------------------------------------------------------------------------

Comments that address more than one docket must be filed with each
docket to ensure consideration. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

V. Transcripts

Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov and https://www.fda.gov/Food/FoodSafety/FSMA/default.htm. It may be viewed at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.

Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5942 Filed 3-10-11; 4:15 pm]
BILLING CODE 4160-01-P

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