Document ID: FDA-2016-D-1164-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Qualified Facility Attestation
Posted Date: 2018-06-12T04:00Z

[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)]
[Notices]
[Pages 27330-27332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12615]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1164]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Qualified Facility 
Attestation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 
12, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910--NEW and 
title ``Qualified Facility Attestation.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three

[[Page 27331]]

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 301-796-5733, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Qualified Facility Attestation

OMB Control Number 0910--NEW

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
enables FDA to better protect public health by helping to ensure the 
safety and security of the food supply. It enables FDA to focus more on 
preventing food safety problems rather than relying primarily on 
reacting to problems after they occur. FSMA recognizes the important 
role industry plays in ensuring the safety of the food supply, 
including the adoption of modern systems of preventive controls in food 
production.
    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) by adding section 418 (21 U.S.C. 350g) with 
requirements for hazard analysis and risk-based preventive controls for 
facilities that produce food for humans or animals. We have established 
regulations to implement these requirements primarily within subparts C 
and G, with associated requirements in subparts A, D, E, and F, of the 
rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, 
and Risk-Based Preventive Controls for Human Food'' (Preventive 
Controls for Human Food Rule) (21 CFR part 117) and primarily within 
subparts C and E, with associated requirements in subparts A, D, and F, 
of the rule entitled ``Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Food for Animals'' 
(Preventive Controls for Animal Food Rule) (21 CFR part 507). A 
business that meets the definition of a ``qualified facility'' (see 21 
CFR 117.3 or 21 CFR 507.3) is subject to modified requirements in Sec.  
117.201 of the Preventive Controls for Human Food Rule or in Sec.  
507.7 of the Preventive Controls for Animal Food Rule. These modified 
requirements require the business to submit a form to FDA, attesting to 
its status as a qualified facility.
    Section 418(l)(2)(B)(ii) of the FD&C Act directs FDA to issue 
guidance on the documents a business is required to submit to FDA to 
show its status as a qualified facility. FDA issued a draft guidance 
for industry entitled, ``Qualified Facility Attestation Using Form FDA 
3942a (for Human Food) or Form FDA 3942b (for Animal Food): Guidance 
for Industry.'' This draft guidance explains FDA's current thinking on 
how to determine whether a business is a qualified facility, and 
describes FDA procedures regarding the submission of attestations as 
established under both the Preventive Controls for Human Food Rule and 
the Preventive Controls for Animal Food Rule. FDA has developed 
proposed Forms FDA 3942a and FDA 3942b for use by a business in 
reporting its status as a ``qualified facility'' under the applicable 
regulations.
    Description of Respondents: Respondents to the collection of 
information are owners, operators, or agents in charge of domestic or 
foreign facilities that manufacture, process, pack, or hold food for 
human or animal consumption in the United States, are required to 
register with FDA, and attest that a facility is a ``qualified 
facility'' under applicable FDA regulations.
    In the Federal Register of May 16, 2016 (81 FR 30219), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One individual submitted several comments.
    (Comment 1) One comment suggests that Forms FDA 3942a and FDA 3942b 
could be organized differently to help respondents. Specifically, the 
suggestion offered that the forms themselves should follow the 
submission type order as provided in section 2 of both forms so that 
the ``Status Change'' section is at the end of each form.
    (Response) FDA agrees and will reorganize Forms FDA 3942a and FDA 
3942b so that the ``Status Change'' section will now be section 6.
    (Comment 2) One comment recommends changing the term ``Biennial 
Submission'' to ``Biennial (Renewal) Submission'' or in some way to 
indicate that biennial submission happens in the years after the 
``Initial Submission.''
    (Response) FDA agrees and will change ``Biennial Submission'' to 
``Biennial (Renewal) Submission'' for both forms.
    (Comment 3) One comment suggests that any revisions applied to 
either the forms or instructions should be consistent between all the 
documents.
    (Response) FDA agrees and will make sure that revisions to the 
forms and instructions are consistent.
    (Comment 4) One comment suggests that, for clarity, the 
instructions direct respondents to the guidance for additional 
reference.
    (Response) FDA agrees and will include a reference to the guidance 
document in each section of the instruction document.
    (Comment 5) One comment suggests that, for clarity, Question II.A.1 
(and III.A. 1) of the guidance should advise respondents that the 
definition for ``very small business'' is forthcoming in the next 
question.
    (Response) FDA agrees, and for clarity, will revise the final 
guidance to indicate that the definition for ``very small business'' is 
provided in the next question in the guidance.
    (Comment 6) One comment suggests that Question II.A. 2 (and 
III.A.2) in the guidance should provide clarity as to the two options 
for meeting the qualified facility definition.
    (Response) FDA agrees and will revise the final guidance to provide 
clarity as to the two options for meeting the qualified facility 
definition.
    (Comment 7) One comment suggests that the guidance should provide 
more details about what other documentation FDA would accept as to 
support the first and second attestation options.
    (Response) FDA agrees and will provide more details about the types 
of documentation FDA would accept to support the first attestation 
option. FDA will also include a list of examples of documents that FDA 
would accept to support the second attestation option consistent with 
the preamble discussions for Sec. Sec.  117.201(a)(2)(ii) and 
507.7(a)(2)(ii).
    (Comment 8) One comment suggests that Question II.C.6 (and III.C.6) 
of the guidance oversimplifies the definition of farm and should 
clarify that farms that satisfy FDA's definition of ``farm'' need not 
submit Form FDA 3942a.
    (Response) FDA agrees and will revise our responses to clarify that 
farms that satisfy FDA's definition of ``farm'' need not submit Form 
FDA 3942a or Form FDA 3942b.
    (Comment 9) One comment suggests that Question II.C.7 (and III.C 7) 
of the guidance related to farm mixed-type facilities is missing 
certain information to assist farm mixed-type facilities to determine 
their level of coverage and compliance under regulations.
    (Response) FDA agrees and will revise our response to provide 
greater clarity for farm mixed-type facilities to determine their level 
of coverage and compliance under the regulations.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 27332]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
             Guidance section                  FDA form        Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section II; Human Food....................           3942a          37,134              .5          18,567  .5 (30 minutes).............           9,284
Section III; Animal Food..................           3942b           1,120              .5             560  .5 (30 minutes).............             280
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ..............  ............................           9,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Consistent with the estimates found in our Preventive Controls for 
Human Food Rule, we estimate that approximately 37,134 human food 
facilities will each spend approximately 30 minutes (0.5 hour) 
reporting their status as a qualified facility to FDA every 2 years. 
Thus, dividing this figure by two to determine the annual burden, we 
estimate there will be 18,567 responses and 9,284 burden hours 
associated with this information collection element.
    Similarly, and consistent with the estimates found in our 
Preventive Controls for Animal Food Rule, we estimate that 
approximately 1,120 animal food facilities will each spend 
approximately 30 minutes (0.5 hour) reporting their status as a 
qualified facility to FDA every 2 years. Thus, dividing this figure by 
two to determine the annual burden, we estimate there will be 560 
responses and 280 burden hours associated with this information 
collection element.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR part 117 have been approved under OMB control number 0910-
0751. The collections of information in 21 CFR part 507 have been 
approved under OMB control number 0910-0789.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12615 Filed 6-11-18; 8:45 am]
 BILLING CODE 4164-01-P