81 FR 9761 - The Food and Drug Administration Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation; Public Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 38 (February 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 38 (February 26, 2016)
| Page Range | 9761-9763 | |
| FR Document | 2016-04127 |
[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)] [Rules and Regulations] [Pages 9761-9763] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04127] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 11, 16, and 111 [Docket No. FDA-2015-N-0797] RIN 0910-AG64 and 0910-AG66 The Food and Drug Administration Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation.'' The public meeting will provide importers and other interested persons an opportunity to discuss import safety regulations and programs, including final rules for foreign supplier verification programs (FSVPs) for importers of food for humans and animals (the FSVP final rule) and accreditation of third-party certification bodies (the third- party certification final rule). Participants will also be briefed on the status of FDA's Voluntary Qualified Importer Program (VQIP), which is still in development. Additionally, the public meeting will provide importers and other interested persons an opportunity to discuss FDA's comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act implementation relating to import safety programs, which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance. DATES: See section III, ``How to Participate in the Public Meeting'' in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the public meeting, closing dates for advance registration, and requesting special accommodations due to disability. ADDRESSES: See section III, ``How to Participate in the Public Meeting'' in the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: For questions about registering for the meeting, or to register by phone: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email: [email protected]. For general questions about the meeting or for special accommodations due to a disability: Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1731, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background The FDA Food Safety Modernization Act (FSMA) (Pub. L.111-353), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. Among other things, FSMA directs FDA to issue regulations requiring preventive controls for human food and animal food, setting standards for produce safety, and requiring importers to perform certain activities to help ensure that the food they bring into the United States is produced in a manner consistent with U.S. safety standards. In the Federal Register of November 27, 2015, we published the FSVP final rule (80 FR 74225) and the third-party certification final rule (80 FR 74569). The FSVP final rule requires importers of food to verify that their foreign suppliers use processes and procedures that provide the same level of public health protection as the preventive controls and produce safety regulations, where applicable, and also to verify that the food they import is not adulterated and is not misbranded with respect to food allergen labeling. The third-party certification final rule adopts regulations to provide for accreditation of third-party certification bodies to conduct food safety audits of foreign entities, including registered foreign food facilities, and to issue food and facility certifications under FSMA. Certification will be required to establish VQIP eligibility. To prevent potentially harmful food from reaching U.S. consumers, in specific circumstances FDA also may require a food offered for import to be accompanied by a certification. On June 5, 2015, we published a notice of availability of a draft guidance for industry on VQIP for importers of human or animal food (80 FR 32136). The draft guidance describes and answers questions about VQIP. To ensure that we consider comments on the draft guidance before we complete a final version of the guidance, we invited electronic or written comments on the draft guidance by August 19, 2015. The FSVP and third-party certification final rules and related fact sheets are available on FDA's FSMA Web page located at http://www.fda.gov/FSMA. The FSVP and third-party certification final rules are two of several final rules that will establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in FSMA. II. Purpose and Format of the Public Meeting FDA is holding the public meeting on FSMA's prevention-oriented import system to brief participants on the key components of the FSVP and third-party certification final rules; brief participants on the status of the VQIP; discuss the plans for guidance documents related to import safety, as well as training, education, and technical assistance; provide an update on the development of a risk-based industry oversight framework that are at the core of FSMA; and answer questions about these import programs. The public meeting is an opportunity for FDA to share its current thinking on implementation plans for programs related to import safety. We encourage interested persons to provide feedback during the meeting on any ideas that we present at the public meeting related to the operational aspects of FSMA [[Page 9762]] implementation. The agenda and other documents will be accessible on our FSMA Web site at http://www.fda.gov/FSMA before the public meeting. There will be an opportunity for stakeholders who are unable to participate in person to join the meeting via Webcast. (See section III for more information on the Webcast option.) Following the public meeting, FDA plans to continue dialogue on implementation of these import safety programs with a series of regional meetings across the United States. III. How To Participate in the Public Meeting We are holding the public meeting on March 21, 2016, from 8:30 a.m. until 5 p.m., at FDA's Center for Food Safety and Applied Nutrition, Wiley Auditorium, 5100 Paint Branch Parkway, College Park, MD 20740. Due to limited space and time, we encourage all persons who wish to attend the meeting to register in advance. 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. Onsite registration will be accepted, as space permits, after all preregistered attendees are seated. Those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting are asked to focus their remarks on the implementation or operational aspects of the import safety programs. To make such a presentation, please submit a request and provide the specific topic or issue to be addressed. Due to the anticipated high level of interest in presenting public comment and the limited time available, we are allocating 3 minutes to each speaker to make an oral presentation. Speakers will be limited to making oral remarks; there will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. If time permits, individuals or organizations that did not register in advance may be granted the opportunity to make an oral presentation. We would like to maximize the number of individuals 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 opinions at the meeting. We encourage persons and groups who have similar interests to consolidate their information for presentation by a single representative. After reviewing the presentation requests, we will notify each participant before the meeting of the approximate time their presentation is scheduled to begin, and remind them of the presentation format (i.e., 3-minute oral presentation without visual media). We encourage interested persons to provide feedback on any ideas that we present at the public meeting related to the operational aspects of FSMA implementation. Table 1 provides information on participation in the public meeting. Table 1--Information on Participation in the Meeting ---------------------------------------------------------------------------------------------------------------- Other Date Electronic address Address Information ---------------------------------------------------------------------------------------------------------------- Attend public meeting......... March 21, 2016, Please preregister at FDA Center for Food Registration from 8:30 a.m. http://www.fda.gov/ Safety and Applied check-in begins to 5 p.m. ET. Food/NewsEvents/ Nutrition, Wiley at 8 a.m. WorkshopsMeetingsCon Auditorium, 5100 ferences/default.htm. Paint Branch Parkway, College Park, MD 20740. View Webcast.................. March 21, 2016, Individuals who wish ..................... The Webcast will from 8:30 a.m. to participate by have closed to 5 p.m. ET. Webcast are asked to captioning. preregister at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Preregister................... Register by Individuals who wish We encourage the use There is no March 14, 2016. to participate in of electronic registration person are asked to registration, if fee for the preregister at http:/ possible\1\. public meeting. /www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsCon ferences/default.htm. Request to make a public Request by March Individuals who wish ..................... ................ comment. 7, 2016. to make a public comment during the Open Public Comment and Q&A Session are asked to submit request at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Request special accommodations Request by March Juanita Yates, email: See FOR FURTHER ................ due to a disability 7, 2016. [email protected] INFORMATION CONTACT. s.gov. Submit electronic questions ................ Submit questions to ..................... For more about the FSMA final rules. the FDA FSMA information Technical Assistance about the FDA Network at http:// FSMA Technical www.fda.gov/Food/ Assistance GuidanceRegulation/ Network, visit FSMA/ucm459719.htm. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm. ---------------------------------------------------------------------------------------------------------------- \1\ You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration information and send to: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email: [email protected]. [[Page 9763]] IV. Transcripts and Recorded Video Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov and at FDA's FSMA Web site at: http://www.fda.gov/FSMA. You may also view the transcript 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. The Freedom of Information office address is available on FDA's Web site at http://www.fda.gov. Additionally, we will be video recording the public meeting. Once the recorded video is available, it will be accessible at FDA's FSMA Web site at http://www.fda.gov/FSMA. Dated: February 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04127 Filed 2-25-16; 8:45 am] BILLING CODE 4164-01-P
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(3) For service information identified in persons an opportunity to discuss FDA’s foreign suppliers use processes and
this AD, contact Boeing Commercial comprehensive planning effort for the procedures that provide the same level
Airplanes, Attention: Data & Services next phase of the FDA Food Safety of public health protection as the
Management, P. O. Box 3707, MC 2H–65, Modernization Act implementation preventive controls and produce safety
Seattle, WA 98124–2207; telephone 206–
544–5000, extension 1; fax 206–766–5680; relating to import safety programs, regulations, where applicable, and also
Internet https://www.myboeingfleet.com. which includes establishing the to verify that the food they import is not
(4) You may view this service information operational framework for these adulterated and is not misbranded with
at FAA, Transport Airplane Directorate, 1601 programs and plans for guidance respect to food allergen labeling.
Lind Avenue SW., Renton, WA. For documents, training, education, and The third-party certification final rule
information on the availability of this technical assistance. adopts regulations to provide for
material at the FAA, call 425–227–1221. DATES: See section III, ‘‘How to accreditation of third-party certification
(5) You may view this service information bodies to conduct food safety audits of
that is incorporated by reference at the
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of foreign entities, including registered
National Archives and Records
Administration (NARA). For information on this document for dates and times of the foreign food facilities, and to issue food
the availability of this material at NARA, call public meeting, closing dates for and facility certifications under FSMA.
202–741–6030, or go to: http:// advance registration, and requesting Certification will be required to
www.archives.gov/federal-register/cfr/ibr- special accommodations due to establish VQIP eligibility. To prevent
locations.html. disability. potentially harmful food from reaching
Issued in Renton, Washington, on February U.S. consumers, in specific
ADDRESSES: See section III, ‘‘How to
8, 2016. circumstances FDA also may require a
Participate in the Public Meeting’’ in the
Michael Kaszycki,
food offered for import to be
SUPPLEMENTARY INFORMATION section of
accompanied by a certification.
Acting Manager, Transport Airplane this document. On June 5, 2015, we published a
Directorate, Aircraft Certification Service. FOR FURTHER INFORMATION CONTACT: For notice of availability of a draft guidance
[FR Doc. 2016–03459 Filed 2–25–16; 8:45 am] questions about registering for the for industry on VQIP for importers of
BILLING CODE 4910–13–P meeting, or to register by phone: human or animal food (80 FR 32136).
Courtney Treece, Planning Professionals The draft guidance describes and
Ltd., 1210 West McDermott St., Suite answers questions about VQIP. To
DEPARTMENT OF HEALTH AND 111, Allen, TX 75013, 704–258–4983, ensure that we consider comments on
HUMAN SERVICES FAX: 469–854–6992, email: ctreece@ the draft guidance before we complete a
planningprofessionals.com. final version of the guidance, we invited
Food and Drug Administration For general questions about the electronic or written comments on the
meeting or for special accommodations draft guidance by August 19, 2015.
21 CFR Parts 1, 11, 16, and 111 due to a disability: Juanita Yates, Center The FSVP and third-party
[Docket No. FDA–2015–N–0797]
for Food Safety and Applied Nutrition certification final rules and related fact
(HFS–009), Food and Drug sheets are available on FDA’s FSMA
RIN 0910–AG64 and 0910–AG66 Administration, 5100 Paint Branch Web page located at http://www.fda.gov/
Pkwy., College Park, MD 20740, 240– FSMA.
The Food and Drug Administration 402–1731, email: Juanita.yates@
Food Safety Modernization Act: The FSVP and third-party
fda.hhs.gov. certification final rules are two of
Prevention-Oriented Import System
Regulations and Implementation; SUPPLEMENTARY INFORMATION: several final rules that will establish the
Public Meeting foundation of, and central framework
I. Background for, the modern food safety system
AGENCY: Food and Drug Administration, The FDA Food Safety Modernization envisioned by Congress in FSMA.
HHS. Act (FSMA) (Pub. L.111–353), signed
into law by President Obama on January II. Purpose and Format of the Public
ACTION: Notification of public meeting. Meeting
4, 2011, enables FDA to better protect
SUMMARY: The Food and Drug public health by helping to ensure the FDA is holding the public meeting on
Administration (FDA or we) is safety and security of the food supply. FSMA’s prevention-oriented import
announcing a public meeting entitled FSMA amends the Federal Food, Drug, system to brief participants on the key
‘‘FDA Food Safety Modernization Act: and Cosmetic Act (the FD&C Act) to components of the FSVP and third-party
Prevention-Oriented Import System establish the foundation of a certification final rules; brief
Regulations and Implementation.’’ The modernized, prevention-based food participants on the status of the VQIP;
public meeting will provide importers safety system. Among other things, discuss the plans for guidance
and other interested persons an FSMA directs FDA to issue regulations documents related to import safety, as
opportunity to discuss import safety requiring preventive controls for human well as training, education, and
regulations and programs, including food and animal food, setting standards technical assistance; provide an update
final rules for foreign supplier for produce safety, and requiring on the development of a risk-based
verification programs (FSVPs) for importers to perform certain activities to industry oversight framework that are at
importers of food for humans and help ensure that the food they bring into the core of FSMA; and answer questions
animals (the FSVP final rule) and the United States is produced in a about these import programs.
accreditation of third-party certification manner consistent with U.S. safety The public meeting is an opportunity
mstockstill on DSK4VPTVN1PROD with RULES
bodies (the third-party certification final standards. for FDA to share its current thinking on
rule). Participants will also be briefed In the Federal Register of November implementation plans for programs
on the status of FDA’s Voluntary 27, 2015, we published the FSVP final related to import safety. We encourage
Qualified Importer Program (VQIP), rule (80 FR 74225) and the third-party interested persons to provide feedback
which is still in development. certification final rule (80 FR 74569). during the meeting on any ideas that we
Additionally, the public meeting will The FSVP final rule requires present at the public meeting related to
provide importers and other interested importers of food to verify that their the operational aspects of FSMA
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IV. Transcripts and Recorded Video Diversion Control, Drug Enforcement Attorney General finds it consistent
Please be advised that as soon as a Administration; Mailing Address: 8701 with the public health and safety
transcript is available, it will be Morrissette Drive, Springfield, Virginia pursuant to 21 U.S.C. 822(d). The
accessible at 22152, Telephone: (202) 598–6812. Attorney General delegated this
http://www.regulations.gov and at SUPPLEMENTARY INFORMATION: authority to the Administrator of the
FDA’s FSMA Web site at: http:// DEA, 28 CFR 0.100(b), who in turn
Legal Authority
www.fda.gov/FSMA. You may also view redelegated that authority to the Deputy
the transcript at the Division of Dockets The Drug Enforcement Assistant Administrator of the DEA
Management (HFA–305), Food and Drug Administration (DEA) implements and Office of Diversion Control (‘‘Deputy
Administration, 5630 Fishers Lane, Rm. enforces Titles II and III of the Assistant Administrator’’). 28 CFR part
Comprehensive Drug Abuse Prevention 0, subpart R, App. section 7.
1061, Rockville, MD 20852. A transcript
and Control Act of 1970, as amended. 21
will also be available in either hardcopy Background
U.S.C. 801–971. Titles II and III are
or on CD–ROM, after submission of a
referred to as the ‘‘Controlled
Freedom of Information request. The On November 25, 2014, the DEA
Substances Act’’ and the ‘‘Controlled
Freedom of Information office address is published an interim final rule (IFR)
Substances Import and Export Act,’’
available on FDA’s Web site at http:// exempting from registration persons
respectively, and are collectively
www.fda.gov. Additionally, we will be authorized under Nuclear Regulatory
referred to as the ‘‘Controlled
video recording the public meeting. Commission (NRC) or Agreement State
Substances Act’’ or the ‘‘CSA’’ for the
Once the recorded video is available, it Medical Use Licenses or permits and
purpose of this action. The DEA
will be accessible at FDA’s FSMA Web publishes the implementing regulations administering the drug product DaTscan
site at http://www.fda.gov/FSMA. for these statutes in title 21 of the Code directly to patients for diagnostic
Dated: February 23, 2016. of Federal Regulations (CFR), chapter II. purposes. 79 FR 70085. The IFR was
Leslie Kux, The CSA and its implementing intended to alleviate the regulatory
Associate Commissioner for Policy. regulations are designed to prevent, burdens on those administering the drug
[FR Doc. 2016–04127 Filed 2–25–16; 8:45 am] detect, and eliminate the diversion of product DaTscan, to allow more patients
BILLING CODE 4164–01–P controlled substances and listed to receive important diagnostic testing.
chemicals into the illicit market while Additionally, because persons who
providing for the legitimate medical, administer DaTscan are subject to strict
scientific, research, and industrial needs NRC/Agreement State requirements, the
DEPARTMENT OF JUSTICE
of the United States. Controlled DEA determined in the IFR that the
Drug Enforcement Administration substances have the potential for abuse waiver from registration of persons who
and dependence and are controlled to administer DaTscan was consistent with
21 CFR Part 1301 protect the public health and safety. the public health and safety. The IFR
Under the CSA, each controlled provided an opportunity for interested
[Docket No. DEA–394F] substance is classified into one of five persons to submit written comments on
RIN 1117–AB38 schedules based upon its potential for the rulemaking on or before January 26,
abuse, its currently accepted medical 2015.
Removal of Exemption From use in treatment in the United States, However, effective September 11,
Registration for Persons Authorized and the degree of dependence the 2015, the DEA removed [123I]ioflupane
Under U.S. Nuclear Regulatory substance may cause. 21 U.S.C. 812. The from the schedules of controlled
Commission or Agreement State initial schedules of controlled substances. 80 FR 54715. [123I]Ioflupane
Medical Use Licenses or Permits and substances established by Congress are is the active pharmaceutical ingredient
Administering the Drug Product found at 21 U.S.C. 812(c), and pursuant in DaTscan. Accordingly, a registration
DaTscan to 21 U.S.C. 812 (a) and (b), the current exemption is no longer necessary for
list of all scheduled substances is persons who administer the drug
AGENCY: Drug Enforcement published at 21 CFR part 1308.
Administration, Department of Justice. product DaTscan. As the DEA explained
Pursuant to 21 U.S.C. 822(a)(1), every
ACTION: Final rule. in the final rule removing
person who manufactures or distributes
[123I]ioflupane from the schedules of
SUMMARY: On November 25, 2014, the any controlled substance or list I
chemical, or who proposes to engage in controlled substances, all of the
Drug Enforcement Administration administrative, civil, and criminal
the manufacture or distribution of any
published the interim final rule titled sanctions applicable to controlled
controlled substance or list I chemical,
‘‘Exemption from Registration for substances no longer apply to those
shall obtain annually a registration
Persons Authorized Under U.S. Nuclear persons who handle [123I]ioflupane, or
issued by the Attorney General in
Regulatory Commission or Agreement any drug products that contain
accordance with the rules and
State Medical Use Licenses or Permits [123I]ioflupane, on or after September
regulations promulgated by the Attorney
and Administering the Drug Product 11, 2015.
General. Further, pursuant to 21 U.S.C.
DaTscan.’’ The Drug Enforcement Because the decontrol of
822(a)(2), every person who dispenses,
Administration is hereby removing this [123I]ioflupane supersedes the
or who proposes to dispense, any
interim final rule as it is no longer registration exemption provided in the
controlled substance, shall obtain from
needed, as a result of the removal of IFR, the DEA hereby finalizes the
the Attorney General a registration
mstockstill on DSK4VPTVN1PROD with RULES
[123I]ioflupane from the schedules of rulemaking procedure that was initiated
issued in accordance with the rules and
controlled substances effective with the November 25, 2014, IFR (79 FR
regulations promulgated by the Attorney
September 11, 2015. 70085) by publishing this final rule
General.
DATES: Effective Date: February 26, The Attorney General however may, removing that regulation. Below the
2016. by regulation, waive the requirement for DEA has provided a discussion of
FOR FURTHER INFORMATION CONTACT: registration of certain manufacturers, comments received in response to the
Barbara J. Boockholdt, Office of distributors, or dispensers if the IFR. 79 FR 70085.
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Document Created: 2018-02-02 14:36:51
Document Modified: 2018-02-02 14:36:51
| 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 | Rules and Regulations | |
| Action | Notification of public meeting. | |
| Dates | See section III, ``How to Participate in the Public Meeting'' in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the public meeting, closing dates for advance registration, and requesting special accommodations due to disability. | |
| Contact | For questions about registering for the meeting, or to register by phone: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email: [email protected] | |
| FR Citation | 81 FR 9761 | |
| RIN Number | 0910-AG64 and 0910-AG66 | |
| CFR Citation | 21
CFR
1 21 CFR 11 21 CFR 111 21 CFR 16 |
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