81 FR 28035 - The Food and Drug Administration Food Safety Modernization Act: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs; Public Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 89 (May 9, 2016)

Page Range		28035-28037
FR Document		2016-10799

The Food and Drug Administration (FDA or we) is announcing three one-day public meetings in different regions throughout the United States to provide importers and other interested persons an opportunity to have an in-depth discussion on the implementation of the FDA Food Safety Modernization Act (FSMA) import safety programs (i.e., foreign supplier verification programs (FSVPs) for importers of food for humans and animals, accreditation of third-party certification bodies, and FDA's Voluntary Qualified Importer Program (VQIP)). During these meetings, participants and key FDA subject matter experts will discuss the next phase of FSMA implementation related to import safety programs, which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance. The purpose of the regional outreach public meetings is to continue the dialogue with the importer community on FSMA and elicit ideas that will help to inform FDA and our stakeholders on how to continue to work together to successfully comply with FSMA mandates and regulations.

Federal Register, Volume 81 Issue 89 (Monday, May 9, 2016)

[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Proposed Rules]
[Pages 28035-28037]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-10799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, and 111

[Docket No. FDA-2015-N-0797]


The Food and Drug Administration Food Safety Modernization Act: 
Focus on Strategic Implementation of Prevention-Oriented Import Safety 
Programs; Public Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
three one-day public meetings in different regions throughout the 
United States to provide importers and other interested persons an 
opportunity to have an in-depth discussion on the implementation of the 
FDA Food Safety Modernization Act (FSMA) import safety programs (i.e., 
foreign supplier verification programs (FSVPs) for importers of food 
for humans and animals, accreditation of third-party certification 
bodies, and FDA's Voluntary Qualified Importer Program (VQIP)). During 
these meetings, participants and key FDA subject matter experts will 
discuss the next phase of FSMA implementation related to import safety 
programs, which includes establishing the operational framework for 
these programs and plans for guidance documents, training, education, 
and technical assistance. The purpose of the regional outreach public 
meetings is to continue the dialogue with the importer community on 
FSMA and elicit ideas that will help to inform FDA and our stakeholders 
on how to continue to work together to successfully comply with FSMA 
mandates and regulations.

DATES: See section III for dates and times of the regional outreach 
meetings, closing dates for advance registration, and requests for 
special accommodations due to disability.

ADDRESSES: See section III for meeting locations.

FOR FURTHER INFORMATION CONTACT: 

[[Page 28036]]

    For questions about registering for the meeting, or to register by 
phone: Peggy Walker, Planning Professionals Ltd., 1210 West McDermott 
St., Suite 111, Allen, TX 75013, 214-384-0667, 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

    On May 2, 2014, we released our ``Operational Strategy for 
Implementing the FDA Food Safety Modernization Act (FSMA),'' 
electronically at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm, to guide the next phase of FSMA implementation following 
the establishment of regulations and relevant programs. Within the 
``Operational Strategy for Implementing FSMA,'' there is an appendix 
that outlines guiding principles for how the operational strategy can 
be implemented with respect to food and feed facilities, produce safety 
standards, and import oversight. The guiding principles include the 
following: Expanding inspection and surveillance; administering new 
administrative enforcement tools; developing guidance, education, and 
technical assistance tools; and building a prevention-oriented import 
system.
    On April 23, 2015, FDA hosted a public meeting as an opportunity 
for interested persons to share views concerning how FDA should address 
the operational aspects of FSMA implementation as suggested by the 
guiding principles. We provided an update on current planning efforts 
and received input from the public to inform the development of 
operational work plans in the areas of produce safety, preventive 
controls for foods for humans and animals, measures to address 
intentional adulteration, FSVP, and the FDA third-party accreditation 
program. In addition, we established a docket to obtain comments on a 
range of operational issues that we might consider in our FSMA 
implementation approach.
    On March 21, 2016, FDA hosted a kick-off public meeting 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 is at the core of FSMA; and answer questions about these 
import programs. The public meeting was an opportunity for FDA to share 
its current thinking on implementation plans for programs related to 
import safety. During that public meeting, we mentioned plans to 
continue dialogue on implementation of these import safety programs 
with a series of regional meeting across the United States.
    The agendas, recordings, and transcripts for the FSMA 
implementation and prevention-oriented import system public meetings 
are accessible on our FSMA Web site at http://www.fda.gov/FSMA.

II. Purpose and Format of the Regional Outreach Meetings

    FDA plans to hold three one-day public meetings in different 
regions throughout the United States to provide importers and other 
interested persons an opportunity to have an in-depth discussion on the 
implementation of FSMA import safety programs (i.e., FSVPs for 
importers of food for humans and animals, accreditation of third-party 
certification bodies, and FDA's VQIP). We invite the public to provide 
information, share experiences, and raise issues on implementation 
topics related to import safety including (but not limited to): 
Increasing awareness/reaching the regulated community, potential 
partners on outreach and implementation, state of readiness, barriers 
to implementation, training and education for industry and regulators, 
guidance needs, promotion of best practices, technical assistance, 
compliance and enforcement issues, and long-term implementation 
success. The purpose of the regional outreach meetings is to continue 
the dialogue with the importer community and elicit ideas that will 
help to inform FDA and the regulated population on how to continue to 
work together to successfully comply with FSMA mandates and 
regulations.

III. How To Participate in the Public Meeting

    We are holding three one-day public meetings in different regions 
throughout the United States.
    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 regional outreach meetings, and registration will be on a 
first-come, first-served basis. Early registration is recommended 
because seating is very limited.
    Table 1 provides information on participation in the regional 
outreach meetings.

                                                  Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                         Special
   Regional outreach meetings           Date               Address          Preregister       Electronic address      accommodations   Other information
--------------------------------------------------------------------------------------------------------------------------------------------------------
California Regional Outreach     June 7, 2016, from  The Hilton Costa    May 26, 2016:      Please preregister at   May 25, 2016:      Registration
 Meeting.                         8:30 a.m. to 3      Mesa, 3050          Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  p.m. PDT.           Bristol Street,     Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Costa Mesa, CA                         WorkshopsMeetingsConf   accommodations
                                                      92626.                                 erences/default.htm.    due to a
                                                                                                                     disability.
New Jersey Regional Outreach     June 15, 2016,      Renaissance         June 3, 2016:      Please preregister at   June 2, 2016:      Registration
 Meeting.                         from 8:30 a.m. to   Meadowlands         Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  3 p.m. EDT.         Hotel, 801          Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Rutherford                             WorkshopsMeetingsConf   accommodations
                                                      Avenue,                                erences/default.htm.    due to a
                                                      Rutherford, NJ                                                 disability.
                                                      07070.

[[Page 28037]]

 
Michigan Regional Outreach       June 21, 2016,      Double Tree Suites  June 10, 2016:     Please preregister at   June 9, 2016:      Registration
 Meeting.                         from 8:30 a.m. to   by Hilton Hotel     Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  3 p.m. EDT.         Detroit_Downtown   Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Fort Shelby, 525                       WorkshopsMeetingsConf   accommodations
                                                      W Lafayette                            erences/default.htm.    due to a
                                                      Blvd., Detroit,                                                disability.
                                                      MI 48226.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: Peggy Walker, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 214-384-0667, FAX: 469-854-
  6992, email: [email protected].


    Dated: May 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10799 Filed 5-6-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Proposed Rules 28035

(vi) The affected fuel pumps have a Directorate, FAA, has the authority to Issued in Renton, Washington, on April 28,
combination of P/Ns 568–1–28300–001, 568– approve AMOCs for this AD, if requested 2016.
1–28300–002, and 568–1–28300–101. using the procedures found in 14 CFR 39.19. Dionne Palermo,
(2) For affected fuel pumps that have a part In accordance with 14 CFR 39.19, send your Acting Manager, Transport Airplane
number or combination of part numbers that request to your principal inspector or local Directorate, Aircraft Certification Service.
are specified in paragraphs (h)(2)(i) through Flight Standards District Office, as
(h)(2)(iii) of this AD: Do the replacement [FR Doc. 2016–10633 Filed 5–6–16; 8:45 am]
appropriate. If sending information directly
within 96 months after the effective date of BILLING CODE 4910–13–P
this AD. to the International Branch, send it to ATTN:
(i) All of the affected fuel pumps have P/ Vladimir Ulyanov, Aerospace Engineer,
N 568–1–28300–100. International Branch, ANM–116, Transport
(ii) All of the affected fuel pumps have P/ Airplane Directorate, FAA, 1601 Lind DEPARTMENT OF HEALTH AND
N 568–1–28300–101. Avenue SW., Renton, WA 98057–3356; HUMAN SERVICES
(iii) The affected fuel pumps have a telephone: 425–227–1138; fax: 425–227–
combination of P/Ns 568–1–28300–100 and 1149. Information may be emailed to: 9- Food and Drug Administration
568–1–28300–101. ANM-116-AMOC-REQUESTS@faa.gov.
(i) Definitions Before using any approved AMOC, notify 21 CFR Parts 1, 11, 16, and 111
your appropriate principal inspector, or
(1) For the purpose of this AD, an ‘‘affected [Docket No. FDA–2015–N–0797]
fuel pump’’ is defined as any pump having lacking a principal inspector, the manager of
P/N 568–1–28300–001, 568–1–28300–002, the local flight standards district office/
certificate holding district office. The AMOC
The Food and Drug Administration
568–1–28300–100, or 568–1–28300–101. Food Safety Modernization Act: Focus
(2) For the purpose of this AD, a approval letter must specifically reference
‘‘serviceable fuel pump’’ is a pump having a this AD. on Strategic Implementation of
part number not listed in paragraph (i)(1) of (2) Contacting the Manufacturer: For any Prevention-Oriented Import Safety
this AD. requirement in this AD to obtain corrective Programs; Public Meetings
(j) No Reporting Requirement actions from a manufacturer, the action must AGENCY: Food and Drug Administration,
be accomplished using a method approved HHS.
Although Airbus Service Bulletin A330–
by the Manager, International Branch, ANM–
28–3127, Revision 01, dated September 24, ACTION: Notification of public meetings.
2015; Airbus Service Bulletin A340–28–4138, 116, Transport Airplane Directorate, FAA; or
Revision 01, dated September 24, 2015; or the European Aviation Safety Agency SUMMARY: The Food and Drug
Airbus Service Bulletin A340–28–5060, (EASA); or Airbus’s EASA Design
Administration (FDA or we) is
Revision 01, dated September 24, 2015, Organization Approval (DOA). If approved by
announcing three one-day public
specifies to submit certain information to the the DOA, the approval must include the
DOA-authorized signature.
meetings in different regions throughout
manufacturer, and specifies that action as
‘‘RC’’ (Required for Compliance), this AD (3) Required for Compliance (RC): Except
the United States to provide importers
does not include that requirement. as provide by paragraph (j) of this AD, if any and other interested persons an
service information contains procedures or opportunity to have an in-depth
(k) Parts Installation Prohibition discussion on the implementation of the
tests that are identified as RC, those
After the identification of the fuel pump FDA Food Safety Modernization Act
procedures and tests must be done to comply
part numbers as required by paragraph (g) of (FSMA) import safety programs (i.e.,
this AD, comply with the prohibition with this AD; any procedures or tests that are
not identified as RC are recommended. Those foreign supplier verification programs
required by paragraph (k)(1) or (k)(2) of this
AD, as applicable. procedures and tests that are not identified (FSVPs) for importers of food for
(1) For an airplane that does not have an as RC may be deviated from using accepted humans and animals, accreditation of
affected fuel pump installed: After the methods in accordance with the operator’s third-party certification bodies, and
identification of the fuel pump part numbers maintenance or inspection program without FDA’s Voluntary Qualified Importer
as required by paragraph (g) of this AD, do obtaining approval of an AMOC, provided Program (VQIP)). During these meetings,
not install an affected fuel pump. the procedures and tests identified as RC can participants and key FDA subject matter
(2) For an airplane that has an affected fuel be done and the airplane can be put back in experts will discuss the next phase of
pump installed: After modification of an an airworthy condition. Any substitutions or FSMA implementation related to import
airplane as required by paragraph (h) of this changes to procedures or tests identified as
AD, no person may install an affected fuel safety programs, which includes
RC require approval of an AMOC. establishing the operational framework
pump on any airplane.
(n) Related Information for these programs and plans for
(l) Credit for Previous Actions guidance documents, training,
This paragraph provides credit for actions (1) Refer to Continuing Airworthiness
Information (MCAI) EASA AD 2015–0194,
education, and technical assistance. The
required by paragraphs (g) and (h) of this AD, purpose of the regional outreach public
if those actions were performed before the dated September 22, 2015, for related
information. You may examine the MCAI on meetings is to continue the dialogue
effective date of this AD using service
information included in paragraphs (l)(1), the Internet at http://www.regulations.gov by with the importer community on FSMA
(l)(2), and (l)(3) of this AD, which are not searching for and locating Docket No. FAA– and elicit ideas that will help to inform
incorporated by reference in this AD. 2016–6418. FDA and our stakeholders on how to
(1) Airbus Service Bulletin A330–28–3127 (2) For service information identified in continue to work together to
dated July 14, 2015. this AD, contact Airbus SAS, Airworthiness successfully comply with FSMA
(2) Airbus Service Bulletin A340–28–4138 Office—EAL, 1 Rond Point Maurice Bellonte, mandates and regulations.
dated July 14, 2015.
mstockstill on DSK3G9T082PROD with PROPOSALS

31707 Blagnac Cedex, France; telephone: +33 DATES: See section III for dates and
(3) Airbus Service Bulletin A340–28–5060 5 61 93 36 96; fax: +33 5 61 93 45 80; email:
dated July 14, 2015. times of the regional outreach meetings,
airworthiness.A330-A340@airbus.com; closing dates for advance registration,
(m) Other FAA AD Provisions Internet: http://www.airbus.com. You may and requests for special
The following provisions also apply to this view this service information at the FAA, accommodations due to disability.
AD: Transport Airplane Directorate, 1601 Lind
ADDRESSES: See section III for meeting
(1) Alternative Methods of Compliance Avenue SW., Renton, WA. For information
on the availability of this material at the
locations.
(AMOCs): The Manager, International
Branch, ANM–116, Transport Airplane FAA, call 425–227–1221. FOR FURTHER INFORMATION CONTACT:

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Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Proposed Rules 28037

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING—Continued
Regional outreach Special Other
Date Address Preregister Electronic address
meetings accommodations information

Michigan Regional June 21, 2016, Double Tree June 10, 2016: Please preregister at http:// June 9, 2016: Registration
Outreach Meeting. from 8:30 a.m. Suites by Hilton Closing date for www.fda.gov/Food/NewsEvents/ Closing date to check-in be-
to 3 p.m. EDT. Hotel Detroit— Registration. WorkshopsMeetingsConferences/ request special gins at 8
Downtown Fort default.htm. accommodations a.m.
Shelby, 525 W due to a dis-
Lafayette Blvd., ability.
Detroit, MI
48226.
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: Peggy Walker, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 214–384–0667, FAX: 469–854–6992, email: pwalker@
planningprofessionals.com.

Dated: May 4, 2016. ADDRESSES: Interested persons are at the HUD Headquarters building, an
Leslie Kux, invited to submit comments regarding advance appointment to review the
Associate Commissioner for Policy. this proposed rule to the Regulations public comments must be scheduled by
[FR Doc. 2016–10799 Filed 5–6–16; 8:45 am] Division, Office of General Counsel, calling the Regulations Division at 202–
BILLING CODE 4164–01–P
Department of Housing and Urban 708–3055 (this is not a toll-free
Development, 451 7th Street SW., Room number). Individuals with speech or
10276, Washington, DC 20410–0500. hearing impairments may access this
Communications must refer to the above number via TTY by calling the Federal
DEPARTMENT OF HOUSING AND docket number and title. There are two Relay Service, toll free, at 800–877–
URBAN DEVELOPMENT methods for submitting public 8339. Copies of all comments submitted
comments. All submissions must refer are available for inspection and
24 CFR Parts 1000, 1003, 1005, 1006,
to the above docket number and title. downloading at www.regulations.gov.
and 1007
1. Submission of Comments by Mail. FOR FURTHER INFORMATION CONTACT:
[Docket No. FR 5861–P–01] Comments may be submitted by mail to [Contact Name to be Inserted], Office of
the Regulations Division, Office of Native American Programs, Office of
RIN 2577–AC96 General Counsel, Department of Public and Indian Housing, Department
Housing and Urban Development, 451 of Housing and Urban Development,
Equal Access to Housing in HUD’s
7th Street SW., Room 10276, 451 7th Street SW., Room 5206,
Native American and Native Hawaiian
Washington, DC 20410–0500. Washington, DC 20410–8000; telephone
Programs—Regardless of Sexual
2. Electronic Submission of number 202–708–2333 (this is not a toll-
Orientation or Gender Identity
Comments. Interested persons may free number). Persons with hearing or
AGENCY: Office of the Assistant submit comments electronically through speech impairments may access this
Secretary for Public and Indian the Federal eRulemaking Portal at number through TTY by calling the toll-
Housing, HUD. www.regulations.gov. HUD strongly free Federal Relay Service at 800–877–
ACTION: Proposed rule. encourages commenters to submit 8339.
comments electronically. Electronic SUPPLEMENTARY INFORMATION:
SUMMARY: This proposed rule would submission of comments allows the
commenter maximum time to prepare I. Background
revise regulations for HUD’s Native
American and Native Hawaiian and submit a comment, ensures timely On February 3, 2012, HUD published
programs to incorporate existing rules receipt by HUD, and enables HUD to in the Federal Register, at 77 FR 5662,
that require HUD programs to be open make them immediately available to the a final rule titled ‘‘Equal Access to
to all eligible individuals and families public. Comments submitted Housing in HUD Programs Regardless of
regardless of sexual orientation, gender electronically through the Sexual Orientation or Gender Identity’’
identity, or marital status. Since HUD www.regulations.gov Web site can be (the Equal Access Rule) in order to
promulgated the ‘‘Equal Access to viewed by other commenters and address evidence that lesbian, gay,
Housing in HUD Programs Regardless of interested members of the public. bisexual, and transgender (LGBT)
Sexual Orientation or Gender Identity’’ Commenters should follow the individuals and families do not have
final rule in February, 2012, HUD has instructions provided on that site to equal access to housing, and to promote
required that HUD-assisted and HUD- submit comments electronically. the federal goal of providing decent
insured housing be made available in housing and a suitable living
Note: To receive consideration as public
accordance with program eligibility comments, comments must be submitted
environment for all.1 The Equal Access
requirements and without regard to through one of the two methods specified Rule requires that housing assisted or
sexual orientation, gender identity, or above. Again, all submissions must refer to insured by HUD be made available to
marital status, and has generally the docket number and title of the rule. individuals and families without regard
prohibited inquiries into sexual to actual or perceived sexual
No Facsimile Comments. Facsimile
mstockstill on DSK3G9T082PROD with PROPOSALS

orientation or gender identity. In orientation, gender identity, or marital
(fax) comments are not acceptable. status. Additionally, the rule prohibits
applying these non-discrimination Public Inspection of Public
requirements to HUD’s Native American owners and administrators of HUD-
Comments. All properly submitted assisted or HUD-insured housing,
and Native Hawaiian programs, this comments and communications
proposed rule would further the Federal approved lenders in an FHA mortgage
submitted to HUD will be available for
goal of providing decent housing and a public inspection and copying between 1 See Section 2 of the Housing Act of 1949 at 42
suitable living environment for all. 8 a.m. and 5 p.m., weekdays, at the U.S.C. 1441 (Congressional Declaration of National
DATES: Comments due: July 8, 2016. above address. Due to security measures Housing Policy).

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Document Created: 2018-02-07 14:50:32
Document Modified: 2018-02-07 14:50:32

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		Proposed Rules
Action		Notification of public meetings.
Dates		See section III for dates and times of the regional outreach meetings, closing dates for advance registration, and requests for special accommodations due to disability.
Contact		For questions about registering for the meeting, or to register by phone: Peggy Walker, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 214-384-0667, FAX: 469-854-6992, email: [email protected]
FR Citation		81 FR 28035
CFR Citation		21 CFR 1 21 CFR 11 21 CFR 111 21 CFR 16

81 FR 28035 - The Food and Drug Administration Food Safety Modernization Act: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs; Public Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 89 (May 9, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration