[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Pages 79502-79504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0144]


Voluntary Qualified Importer Program; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``FDA's Voluntary 
Qualified Importer Program.'' The guidance describes the Voluntary 
Qualified Importer Program (VQIP), which provides for expedited review 
and importation of food offered for importation by importers who 
voluntarily agree to participate in the program. The guidance describes 
the eligibility criteria for, and benefits of, participation in VQIP. 
The guidance also provides information on submitting an application for 
VQIP participation, obtaining a facility certification for the foreign 
supplier of a food imported under VQIP, the VQIP user fee, conditions 
that might result in the revocation of VQIP eligibility, and criteria 
for reinstatement of eligibility.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed below (see ``Written/Paper Submissions'' and 
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0144 for ``FDA's Voluntary Qualified Importer Program.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets

[[Page 79503]]

Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for a single hard copy of the guidance to 
the Office of Enforcement and Import Operations (ELEM-3108), Office of 
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., 
Element Bldg., Rockville, MD 20857. Send two self-addressed adhesive 
labels to assist that office in processing your request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Office of 
Enforcement and Import Operations (ELEM-3108), Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857, 301-796-0356.
    Regarding the information collection: FDA PRA Staff, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
11601 Landsdown St., 10A-12M, North Bethesda, MD 20852, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 302 of the FDA Food Safety Modernization Act (FSMA) (Pub. 
L. 111-353) amended the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) by adding section 806, Voluntary Qualified Importer Program (21 
U.S.C. 384b). Section 806(a)(1) of the FD&C Act directs FDA to 
establish a voluntary program for the expedited review and importation 
of food, and to establish a process for the issuance of a facility 
certification to accompany food offered for importation by importers 
participating in VQIP. Section 806(a)(2) of the FD&C Act directs FDA to 
issue a guidance document related to participation in, revocation of 
such participation in, reinstatement in, and compliance with VQIP.
    We are announcing the availability of a guidance for industry 
entitled ``FDA's Voluntary Qualified Importer Program.'' We are issuing 
this guidance consistent with our good guidance practices regulation 
(21 CFR 10.115). The guidance represents the current thinking of FDA on 
this topic. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.
    In the Federal Register of June 5, 2015 (80 FR 32136), we made 
available a draft guidance for industry on VQIP for importers of human 
or animal food and gave interested parties an opportunity to submit 
comments by August 19, 2015, for us to consider before beginning work 
on the final version of the guidance. We received numerous comments on 
the draft guidance and have modified the final guidance where 
appropriate. Changes to the guidance include:
     Clarifying that, during the VQIP fiscal year, a VQIP 
importer may add additional food from a foreign supplier from which the 
importer already imports food under VQIP;
     clarifying that VQIP applicants will not be required to 
upload food labels for foods included in the VQIP application, but FDA 
may request a copy of food labels for the foods included in the 
application to determine if there are labeling violations relating to 
the risk of the food during a VQIP inspection or audit examinations;
     providing examples of how to ensure that the Foreign 
Supplier Verification Program (FSVP) or the Hazard Analysis and 
Critical Control Point (HACCP) importer of the food (when it is not the 
VQIP applicant) is in compliance with the applicable FSVP or HACCP 
regulations; and
     revising the `3-year import history' eligibility criteria 
to provide for use of shared importation history of previous or parent 
companies.
    We also made editorial changes and changes to improve clarity. The 
guidance announced in this notice finalizes the draft guidance dated 
June 2015.
    VQIP begins on January 1, 2018, which is the first date FDA will 
begin accepting applications to participate in VQIP for the fiscal year 
2019 beginning October 1, 2018. We encourage food importers with robust 
supplier verification programs to apply for participation in VQIP. We 
anticipate that VQIP will allow FDA to focus its resources on food 
shipments that pose a higher risk to public health and will facilitate 
risk-based admissibility practices. We anticipate that we will approve 
approximately 200 applications for the first year of the program. We 
established this limit based on consideration of the demands on Agency 
resources necessary to establish and implement VQIP. We will review 
applications in the order that we receive them.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Under the 
PRA, Federal Agencies must obtain approval from OMB for each collection 
of information they conduct or sponsor. ``Collection of information'' 
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
Agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information before submitting the 
collection to OMB for approval. To comply with this requirement, in the 
Federal Register of June 5, 2015, we gave interested persons 60 days to 
comment on the information collection provisions in the draft guidance 
(80 FR 32136 at 32138).
    Currently FDA is finalizing the VQIP application and will be 
submitting the proposed collection for OMB review and clearance under 
44 U.S.C. 3507. An

[[Page 79504]]

Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. FDA is issuing this final guidance subject to 
OMB approval of the collection of information. Before the Agency begins 
collecting information for the VQIP program, FDA will publish a notice 
in the Federal Register announcing OMB's decision to approve, modify, 
or disapprove the information collection provisions in the guidance.
    The guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information 
regarding food labeling have been approved under OMB control number 
0910-0381; the collections of information regarding Low Acid Canned 
Food have been approved under OMB control number 0910-0037; the 
collections of information regarding Third-Party Certification Bodies 
to Conduct Food Safety Audits and to Issue Certifications have been 
approved under OMB control number 0910-0750; the collections of 
information regarding Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Human Food have been 
approved under OMB control number 0910-0751; the collections of 
information regarding Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Food for Animals have 
been approved under OMB control number 0910-0789; the collections of 
information regarding the Foreign Supplier Verification Program have 
been approved under OMB control number 0910-0752; the collections of 
information regarding the Sanitary Transportation of Human and Animal 
Food have been approved under OMB control number 0910-0773; and the 
collections of information regarding Focused Mitigation Strategies to 
Protect Food Against Intentional Adulteration have been approved under 
OMB control number 0910-0812.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/RegulatoryInformation/Guidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

IV. Other Issues for Consideration

    FSMA directs FDA to collect user fees to fund VQIP. Consistent with 
section 743(b)(2)(B)(iii) of the FD&C Act, we set forth a proposed set 
of guidelines in consideration of the burden of user fee amounts on 
small businesses in the Federal Register of June 5, 2015 (80 FR 32136), 
which also announced the draft guidance for industry on VQIP. We are 
considering comments we received on the VQIP user fee. We will publish 
the actual fee in a Federal Register notice in accordance with section 
743(b)(1) of the FD&C Act prior to the fiscal year when we begin 
program benefits.

    Dated: November 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27252 Filed 11-10-16; 8:45 am]
 BILLING CODE 4164-01-P