Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
Submit either electronic or written comments on the collection of information by June 18, 2019.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 18, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 18, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
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”).
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-2013-N-0065 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” Received comments, those filed in a timely manner (see ADDRESSES), 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 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 Start Printed Page 16520second 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.
Start Further Info
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
End Further Info
Start Supplemental Information
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (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(c) 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, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Registration of Food Facilities
OMB Control Number 0910-0502—Extension
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which, among other things, requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. Sections 1.230 to 1.235 of our regulations (21 CFR 1.230 to 1.235) set forth the requirements for the registration of food facilities. Information provided to us under these regulations helps us to notify quickly the facilities that might be affected by a deliberate or accidental contamination of the food supply. In addition, data collected through registration is used to support FDA enforcement activities and to screen imported food shipments.
Advance notice of imported food allows FDA, with the support of the Bureau of Customs and Border Protection, to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies. If a facility is not registered or the registration for a facility is not updated when necessary, we may not be able to contact the facility and may not be able to target import inspections effectively in case of a known or potential threat to the food supply or other food-related emergency, putting consumers at risk of consuming hazardous food products that could cause serious adverse health consequences or death.
To assist respondents of the information collection we developed the following forms. Each facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with FDA using Form FDA 3537 entitled “Food Facility Registration” (§ 1.231), unless exempt under 21 CFR 1.226 from the requirement to register. To cancel a registration, respondents must use Form FDA 3537a entitled “Cancellation of Food Facility Registration” (§ 1.235). The terms “Form FDA 3537” and “Form FDA 3537a” refer to both the paper version of each form and the electronic system known as the Food Facility Registration Module, which is available at https://www.access.fda.gov. Beginning in January 2020, registrations, updates, and cancellations will be required to be submitted electronically. Domestic facilities are required to register whether or not food from the facility enters interstate commerce. Foreign facilities that manufacture, process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility outside the United States. However, if the further manufacturing/processing conducted by the subsequent facility consists of adding labeling or any similar activity of a de minimis nature, the former facility is required to register.
In addition to the initial registration requirements, a facility is required to submit timely updates within 60 days of a change to any required information on its registration form, using Form FDA 3537 (§ 1.234), and to cancel its registration when the facility ceases to operate or is sold to new owners or ceases to manufacture, process, pack, or hold food for consumption in the United States, using Form FDA 3537a (§ 1.235).
Registration is one of several tools under the Bioterrorism Act that enables us to act quickly in responding to a threatened or actual bioterrorist attack on the U.S. food supply or other food-related emergency. Further, in the event of an outbreak of foodborne illness, the information provided helps us determine the source and cause of the event and enables us to quickly notify food facilities that might be affected by an outbreak, terrorist attack, or other emergency. Finally, the registration requirements enable us to quickly identify and remove from commerce an article of food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.
Description of Respondents: Respondents to this collection of information are owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, Start Printed Page 16521pack, or hold food for human or animal consumption in the United States.
We estimate the burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden 1
|Activity; 21 CFR section||FDA Form No.2||Number of respondents||Number of responses per
respondent||Total annual responses||Average burden per
|New domestic facility registration; 1.230-1.233||3537||9,795||1||9,795||2.7||26,447|
|New foreign facility registration; 1.230-1.233||3537||13,697||1||13,697||8.7||119,164|
|Biennial renewals; 1.235||3537||97,883||1||97,883||0.38 (23 minutes)||37,196|
|3rd party registration verification||3537||41,256||1||41,256||0.25 (15 minutes)||10,314|
|U.S. Agent verification||3537||57,070||1||57,070||0.25 (15 minutes)||14,268|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
|2 Forms FDA 3537 and FDA 3537a refer to both the paper version of the form and the electronic system known as the Food Facility Registration Module, which is available at https://www.access.fda.gov.|
These burden figures are based on currently available data and reflect an overall decrease to the information collection by 174,395 and 31,370 hours. The decrease results from the realization of burden associated with implementing measures on newly established electronic registration requirements.
End Supplemental Information
Dated: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07839 Filed 4-18-19; 8:45 am]
BILLING CODE 4164-01-P