United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2015-06-05 article Notices D09002ee1c7f78376 D09002ee1c7f783ff United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food. The draft guidance describes VQIP, which provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the program. The draft guidance describes the eligibility criteria for, and benefits of, participation in VQIP. The draft guidance also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported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. We are issuing the draft guidance in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). 80 FR 32136 https://www.govinfo.gov/app/details/FR-2015-06-05/2015-13706 2015-13706 fr05jn15-87 4164-01-P Docket No. FDA-2011-N-0144 https://www.govinfo.gov/app/details/FR-2015-06-05/2015-13706 https://www.govinfo.gov/content/pkg/FR-2015-06-05/html/2015-13706.htm https://www.govinfo.gov/content/pkg/FR-2015-06-05/pdf/2015-13706.pdf 5 p. 32136 32140 80 FR 32136 Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers and Guidelines in Consideration of the Burden of the Voluntary Qualified Importer Program Fee Amounts on Small Business; Availability; Federal Register Vol. 80, Issue NOTICE 2015-13706 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2011-N-0144 4164-01-P 2015-13706 Notice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food. The draft guidance describes VQIP, which provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the program. The draft guidance describes the eligibility criteria for, and benefits of, participation in VQIP. The draft 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. We are issuing the draft guidance in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Although you may comment on any guidance at any time (21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it completes a final version of the guidance, submit either electronic or written comments on the draft guidance by August 19, 2015. Submit either electronic or written comments on the proposed collection of information by August 4, 2015. With regard to this draft guidance: Domenic Veneziano, 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. Guidance: Voluntary Qualified Importer Program for Food Importers and Guidelines in Consideration of the Burden of the Voluntary Qualified Importer Program Fee Amounts on Small Business , PRAStaff@fda.hhs.gov http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm http://www.regulations.gov Vol. 80, no. 108 Office of the Federal Register, National Archives and Records Administration 2015-06-05 continuing daily deposited born digital 304 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-06-05 P0b002ee18c9cf41d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05jn15 https://www.govinfo.gov/app/details/FR-2015-06-05 https://www.govinfo.gov/content/pkg/FR-2015-06-05/pdf/FR-2015-06-05.pdf https://www.govinfo.gov/content/pkg/FR-2015-06-05/xml/FR-2015-06-05.xml fdlp 31971 32265 DGPO 2015-06-05 2024-06-02 FR-2015-06-05 machine generated eng FR FR-2015-06-05 80 108