2018-20109. Determination of Status as a Qualified Facility Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of availability.

SUMMARY:

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry entitled “Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry.” This guidance explains our current thinking on how to determine whether a facility 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 guidance also explains our current thinking on how a facility 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.

DATES:

The announcement of the guidance is published in the Federal Register on September 17, 2018.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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 (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, 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-2016-D-1164 for “Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Submit written requests for single copies of the draft guidance to the Office of Food Safety (HFS-300), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:

For questions relating to the guidance as it applies to human food: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.

For questions relating to the guidance as it applies to animal food: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a guidance for industry entitled “Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). This 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. This guidance is not subject to Executive Order 12866.

In the Federal Register of May 16, 2016 (81 FR 30219), we made available a draft guidance for industry entitled “Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)” and gave interested parties an opportunity to submit comments by November 14, 2016, for us to consider before beginning work on the final version of the guidance. We received a couple of comments on the draft guidance and have modified the final guidance where appropriate. Changes to the guidance include: (1) Clarification regarding recordkeeping and FDA review of records, (2) clarification regarding how a facility can meet the definition of a “very small business,” (3) addition of new examples of calculations, and (4) explanation of a simpler method for determining whether a facility's 3-year average of food sales and food market value is below the inflation adjusted threshold for a “very small business.” In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated May 16, 2016.

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). The collections of information in 21 CFR 117.201 and 507.7 have been approved under 0910-0854.

The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in part 117 have been approved under OMB control number 0910-0751. The collections of information in part 507 have been approved under OMB control number 0910-0789.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/​FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

IV. References

The following references are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

1. FDA 2016: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food): Instructions for Submitting Your Attestation. Accessible at: https://www.fda.gov/​Food/​GuidanceRegulation/​FoodFacilityRegistration/​default.htm.

2. FDA 2017: Form FDA 3942a. Accessible at: https://www.fda.gov/​AboutFDA/​ReportsManualsForms/​Forms/​ListFormsAlphabetically/​default.htm.

3. FDA 2017: Form FDA 3942b. Accessible at: https://www.fda.gov/​AboutFDA/​ReportsManualsForms/​Forms/​ListFormsAlphabetically/​default.htm.

Dated: September 11, 2018.

Leslie Kux,

Associate Commissioner for Policy.