81 FR 79502 - Voluntary Qualified Importer Program; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 219 (November 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 219 (November 14, 2016)
| Page Range | 79502-79504 | |
| FR Document | 2016-27252 |
[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)] [Notices] [Pages 79502-79504] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27252] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![79502 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices
August 29, 2016, a notice proposing to provides services in any capacity to a under VQIP, the VQIP user fee,
permanently debar him from providing person with an approved or pending conditions that might result in the
services in any capacity to a person that drug product application during his revocation of VQIP eligibility, and
has an approved or pending drug period of debarment he will be subject criteria for reinstatement of eligibility.
product application. The proposal was to civil money penalties (section DATES: Submit either electronic or
based on a finding, under section 307(a)(7) of the FD&C Act). In addition, written comments on FDA guidances at
306(a)(2)(B) of the FD&C Act, that Mr. FDA will not accept or review any any time.
Manookian was convicted of felonies abbreviated new drug applications from
ADDRESSES: You may submit comments
under Federal law for conduct relating Edward Manookian during his period of
as follows:
to the regulation of a drug product debarment (section 306(c)(1)(B) of the
under the FD&C Act. FDA determined FD&C Act). Electronic Submissions
that Mr. Manookian’s felony convictions Any application by Mr. Manookian
Submit electronic comments in the
were related to the regulation of drug for special termination of debarment
following way:
products because the conduct under section 306(d)(4) of the FD&C Act
• Federal eRulemaking Portal: http://
underlying his convictions undermined should be identified with Docket No.
www.regulations.gov. Follow the
FDA’s regulatory oversight over drug FDA–2015–N–4169 and sent to the
instructions for submitting comments.
products marketed in the United Division of Dockets Management (see
Comments submitted electronically,
States—Mr. Manookian knowingly sold ADDRESSES). All such submissions are to
including attachments, to http://
unapproved drugs and put patients at be filed in four copies. The public
www.regulations.gov will be posted to
risk. The proposal also offered Mr. availability of information in these
the docket unchanged. Because your
Manookian an opportunity to request a submissions is governed by 21 CFR
comment will be made public, you are
hearing, providing him 30 days from the 10.20.
Publicly available submissions will be solely responsible for ensuring that your
date of receipt of the letter in which to
placed in the docket, and will be comment does not include any
file the request, and advised him that
viewable at http://www.regulations.gov confidential information that you or a
failure to request a hearing constituted
or at the Division of Dockets third party may not wish to be posted,
a waiver of the opportunity for a hearing
and of any contentions concerning this Management (see ADDRESSES) between 9 such as medical information, your or
action. The proposal was received on a.m. and 4 p.m., Monday through anyone else’s Social Security number, or
September 2, 2016. Mr. Manookian did Friday. confidential business information, such
not request a hearing and has, therefore, as a manufacturing process. Please note
Dated: November 7, 2016. that if you include your name, contact
waived his opportunity for a hearing Armando Zamora,
and any contentions concerning his information, or other information that
Deputy Director, Office of Enforcement and identifies you in the body of your
debarment (21 CFR part 12). Import Operations, Office of Regulatory comments, that information will be
II. Findings and Order Affairs. posted on http://www.regulations.gov.
Therefore, the Director, Office of [FR Doc. 2016–27244 Filed 11–10–16; 8:45 am] • If you want to submit a comment
Enforcement and Import Operations, BILLING CODE 4164–01–P with confidential information that you
Office of Regulatory Affairs, under do not wish to be made available to the
section 306(a)(2)(B) of the FD&C Act, public, submit the comment as a
DEPARTMENT OF HEALTH AND written/paper submission and in the
under authority delegated to him (Staff
HUMAN SERVICES manner detailed below (see ‘‘Written/
Manual Guide 1410.35), finds that
Edward Manookian has been convicted Food and Drug Administration Paper Submissions’’ and
of felonies under Federal law for ‘‘Instructions’’).
conduct relating to the regulation of a [Docket No. FDA–2011–N–0144]
Written/Paper Submissions
drug product under the FD&C Act.
Section 306(c)(2)(A)(ii) of the FD&C Act Voluntary Qualified Importer Program; Submit written/paper submissions as
requires that Mr. Manookian’s Guidance for Industry; Availability follows:
debarment be permanent. AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
As a result of the foregoing finding, HHS. written/paper submissions): Division of
Edward Manookian is permanently ACTION: Notice of availability. Dockets Management (HFA–305), Food
debarred from providing services in any and Drug Administration, 5630 Fishers
capacity to a person with an approved SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
or pending drug product application Administration (FDA or we) is • For written/paper comments
under section 505, 512, or 802 of the announcing the availability of a submitted to the Division of Dockets
FD&C Act (21 U.S.C. 355, 360b, or 382), guidance for industry entitled ‘‘FDA’s Management, FDA will post your
or under section 351 of the Public Voluntary Qualified Importer Program.’’ comment, as well as any attachments,
Health Service Act (42 U.S.C. 262), The guidance describes the Voluntary except for information submitted,
effective (see DATES) (see sections Qualified Importer Program (VQIP), marked and identified, as confidential,
201(dd) (21 U.S.C. 321(dd), 306(c)(1)(B), which provides for expedited review if submitted as detailed in
and (c)(2)(A)(ii) of the FD&C Act). Any and importation of food offered for ‘‘Instructions.’’
person with an approved or pending importation by importers who Instructions: All submissions received
drug product application who voluntarily agree to participate in the must include the Docket No. FDA–
mstockstill on DSK3G9T082PROD with NOTICES
knowingly employs or retains as a program. The guidance describes the 2011–N–0144 for ‘‘FDA’s Voluntary
consultant or contractor, or otherwise eligibility criteria for, and benefits of, Qualified Importer Program.’’ Received
uses the services of Edward Manookian, participation in VQIP. The guidance comments will be placed in the docket
in any capacity during his debarment, also provides information on submitting and, except for those submitted as
will be subject to civil money penalties an application for VQIP participation, ‘‘Confidential Submissions,’’ publicly
(section 307(a)(6) of the FD&C Act (21 obtaining a facility certification for the viewable at http://www.regulations.gov
U.S.C. 335b(a)(6))). If Mr. Manookian foreign supplier of a food imported or at the Division of Dockets
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![79504 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices
Agency may not conduct or sponsor, consideration of the burden of user fee SUPPLEMENTARY INFORMATION: In
and a person is not required to respond amounts on small businesses in the compliance with 44 U.S.C. 3507, FDA
to, a collection of information unless it Federal Register of June 5, 2015 (80 FR has submitted the following proposed
displays a currently valid OMB control 32136), which also announced the draft collection of information to OMB for
number. FDA is issuing this final guidance for industry on VQIP. We are review and clearance.
guidance subject to OMB approval of considering comments we received on Biological Products: Reporting of
the collection of information. Before the the VQIP user fee. We will publish the Biological Product Deviations and
Agency begins collecting information actual fee in a Federal Register notice Human Cells, Tissues, and Cellular and
for the VQIP program, FDA will publish in accordance with section 743(b)(1) of Tissue-Based Product Deviations in
a notice in the Federal Register the FD&C Act prior to the fiscal year Manufacturing; Forms FDA 3486 and
announcing OMB’s decision to approve, when we begin program benefits. 3486A.
modify, or disapprove the information Dated: November 7, 2016. OMB Control Number 0910–0458—
collection provisions in the guidance. Extension
The guidance also refers to previously Leslie Kux,
approved collections of information Associate Commissioner for Policy. Under section 351 of the Public
found in FDA regulations. The [FR Doc. 2016–27252 Filed 11–10–16; 8:45 am] Health Service Act (PHS Act) (42 U.S.C.
collections of information regarding BILLING CODE 4164–01–P 262), all biological products, including
food labeling have been approved under human blood and blood components,
OMB control number 0910–0381; the offered for sale in interstate commerce
collections of information regarding DEPARTMENT OF HEALTH AND must be licensed and meet standards,
Low Acid Canned Food have been HUMAN SERVICES including those prescribed in FDA
approved under OMB control number regulations, designed to ensure the
0910–0037; the collections of Food and Drug Administration continued safety, purity, and potency of
information regarding Third-Party such products. In addition under
[Docket No. FDA–2013–N–0579]
Certification Bodies to Conduct Food section 361 of the PHS Act (42 U.S.C.
Safety Audits and to Issue Certifications Agency Information Collection 264), FDA may issue and enforce
have been approved under OMB control Activities; Submission for Office of regulations necessary to prevent the
number 0910–0750; the collections of Management and Budget Review; introduction, transmission, or spread of
information regarding Current Good Comment Request; Biological communicable diseases between the
Manufacturing Practice and Hazard Products: Reporting of Biological States or possessions or from foreign
Analysis and Risk-Based Preventive Product Deviations and Human Cells, countries into the States or possessions.
Controls for Human Food have been Tissues, and Cellular and Tissue- Further, section 501 of the Federal
approved under OMB control number Based Deviations in Manufacturing Food, Drug, and Cosmetic Act (the
0910–0751; the collections of FD&C Act) (21 U.S.C. 351) provides that
information regarding Current Good AGENCY: Food and Drug Administration, drugs and devices (including human
Manufacturing Practice and Hazard HHS. blood and blood components) are
Analysis and Risk-Based Preventive ACTION: Notice. adulterated if they do not conform with
Controls for Food for Animals have been current good manufacturing practice
approved under OMB control number SUMMARY: The Food and Drug (CGMP) assuring that they meet the
0910–0789; the collections of Administration (FDA or we) is requirements of the FD&C Act.
information regarding the Foreign announcing that a proposed collection Establishments manufacturing
Supplier Verification Program have of information has been submitted to the biological products, including human
been approved under OMB control Office of Management and Budget blood and blood components, must
number 0910–0752; the collections of (OMB) for review and clearance under comply with the applicable CGMP
information regarding the Sanitary the Paperwork Reduction Act of 1995 regulations (21 CFR parts 211, 606, and
Transportation of Human and Animal (the PRA). 820)) and current good tissue practice
Food have been approved under OMB DATES: Fax written comments on the (CGTP) regulations (part 1271 (21 CFR
control number 0910–0773; and the collection of information by December part 1271)) as appropriate. FDA regards
collections of information regarding 14, 2016. biological product deviation (BPD)
Focused Mitigation Strategies to Protect reporting and human cells, tissues, and
ADDRESSES: To ensure that comments on
Food Against Intentional Adulteration cellular and tissue-based product (HCT/
the information collection are received,
have been approved under OMB control P) deviation reporting to be an essential
OMB recommends that written
number 0910–0812. tool in its directive to protect public
comments be faxed to the Office of
health by establishing and maintaining
III. Electronic Access Information and Regulatory Affairs,
surveillance programs that provide
OMB, Attn: FDA Desk Officer, FAX:
Persons with access to the Internet timely and useful information.
202–395–7285, or emailed to oira_ Section 600.14 (21 CFR 600.14), in
may obtain the guidance at either http:// submission@omb.eop.gov. All
www.fda.gov/RegulatoryInformation/ brief, requires the manufacturer who
comments should be identified with the holds the biological product license, for
Guidances or http:// OMB control number 0910–0458. Also
www.regulations.gov. Use the FDA Web other than human blood and blood
include the FDA docket number found components, and who had control over
site listed in the previous sentence to in brackets in the heading of this a distributed product when the
mstockstill on DSK3G9T082PROD with NOTICES
find the most current version of the document.
guidance. deviation occurred, to report to the
FOR FURTHER INFORMATION CONTACT: FDA Center for Biologics Evaluation and
IV. Other Issues for Consideration PRA Staff, Office of Operations, Food Research (CBER) or to the Center for
FSMA directs FDA to collect user fees and Drug Administration, Three White Drugs Evaluation and Research (CDER)
to fund VQIP. Consistent with section Flint North, 10A63, 11601 Landsdown as soon as possible but at a date not to
743(b)(2)(B)(iii) of the FD&C Act, we set St., North Bethesda, MD 20852, exceed 45 calendar days after acquiring
forth a proposed set of guidelines in PRAStaff@fda.hhs.gov. information reasonably suggesting that a
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Document Created: 2018-10-24 10:45:34
Document Modified: 2018-10-24 10:45:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 79502 |
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