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 2016_register executive 2016-05-14 article Proposed Rules D09002ee1c7f62f8c D09002ee1c7f63023 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Agency or Subagency The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled "Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)." This draft guidance explains our current thinking on how to determine whether a business is a "qualified facility" that is subject to modified requirements under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" (the Preventive Controls for Human Food Rule) or under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals" (the Preventive Controls for Animal Food Rule). This draft guidance also explains our current thinking on how a business would submit Form FDA 3942a attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule and how a business would submit Form FDA 3942b attesting to its status as a qualified facility under the Preventive Controls for Animal Food Rule. We also are announcing an opportunity for public comment on the proposed collection of information embodied in Forms FDA 3942a and 3942b. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and allow 60 days for public comment in response to the notice. 81 FR 30219 https://www.govinfo.gov/app/details/FR-2016-05-16/2016-11439 2016-11439 fr16my16-29 4164-01-P Docket No. FDA-2016-D-1164 https://www.govinfo.gov/app/details/FR-2016-05-16/2016-11439 https://www.govinfo.gov/content/pkg/FR-2016-05-16/html/2016-11439.htm https://www.govinfo.gov/content/pkg/FR-2016-05-16/pdf/2016-11439.pdf 3 p. 30219 30221 81 FR 30219 Title 21 Part 117 21 CFR Part 117 Title 21 Part 507 21 CFR Part 507 Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food); Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Federal Register Vol. 81, Issue PRORULE 2016-11439 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-D-1164 4164-01-P 2016-11439 Notification of availability.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled "Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)." This draft guidance explains our current thinking on how to determine whether a business is a "qualified facility" that is subject to modified requirements under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" (the Preventive Controls for Human Food Rule) or under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals" (the Preventive Controls for Animal Food Rule). This draft guidance also explains our current thinking on how a business would submit Form FDA 3942a attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule and how a business would submit Form FDA 3942b attesting to its status as a qualified facility under the Preventive Controls for Animal Food Rule. We also are announcing an opportunity for public comment on the proposed collection of information embodied in Forms FDA 3942a and 3942b. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and allow 60 days for public comment in response to the notice.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments by November 14, 2016. Submit either electronic or written comments on the proposed collection of information by July 15, 2016. With regard to this draft guidance for human food facility: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166. Draft Guidance for Industry: Qualified Facility Attestation , PRAstaff@fda.hhs.gov http://www.fda.gov/FoodGuidances http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 94 Office of the Federal Register, National Archives and Records Administration 2016-05-16 continuing daily deposited born digital 335 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-05-16 P0b002ee18f74885b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16my16 https://www.govinfo.gov/app/details/FR-2016-05-16 https://www.govinfo.gov/content/pkg/FR-2016-05-16/pdf/FR-2016-05-16.pdf https://www.govinfo.gov/content/pkg/FR-2016-05-16/xml/FR-2016-05-16.xml fdlp 30157 30481 DGPO 2016-05-14 2024-06-01 FR-2016-05-16 machine generated eng FR FR-2016-05-16 81 94