81 FR 30219 - Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food); Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 94 (May 16, 2016)

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food).'' This draft guidance explains our current thinking on how to determine whether a business is a ``qualified facility'' that is subject to modified requirements under our rule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 This draft guidance also explains our current thinking on how a business would submit Form FDA 3942a attesting to its status as a qualified facility under the Preventive Controls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.

[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)]
[Proposed Rules]
[Pages 30219-30221]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11439]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 117 and 507

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


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Food) or Form FDA 3942b (for Animal Food); Draft Guidance for Industry; 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: 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.

DATES: 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.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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

[[Page 30220]]

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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Qualified Facility Attestation Using Form FDA 
3942a (for Human Food) or Form FDA 3942b (for Animal Food).'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance and 
proposed forms to Food and Drug Administration (HFS-681), 5100 Paint 
Branch Pkwy., 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: 
    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.
    With regard to this draft guidance for animal food facility: 
Jeannette Murphy, Center for Veterinary Medicine (HFV-200), Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-
6246.
    With regard to this proposed collection of information: FDA PRA 
Staff, Office of Operations, Food and Drug Administration, 8455 
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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 within subparts C and G of 
the Preventive Controls for Human Food rule (21 CFR part 117) and 
within subparts C and E of the 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 a guidance 
related to the documents required to be submitted to FDA to show status 
as a qualified facility.
    In accordance with section 418(l)(2)(B)(ii) of the FD&C Act, we are 
announcing the availability of a draft guidance for industry on 
qualified facility attestation. Section II of this draft guidance 
explains how to determine whether your business meets the definition of 
``qualified facility'' under the Preventive Controls for Human Food 
Rule and how to submit Form FDA 3942a: Qualified Facility Attestation 
for Human Food Facility, attesting to its status as a qualified 
facility under the Preventive Controls for Human Food Rule. Section III 
of this draft guidance explains how to determine whether your business 
meets the definition of ``qualified facility'' under the Preventive 
Controls for Animal Food Rule and how to submit Form FDA 3942b: 
Qualified Facility Attestation for Animal Food Facility, attesting to 
its status as a qualified facility under the Preventive Controls for 
Animal Food Rule.
    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

[[Page 30221]]

proposed collection of information before submitting the collection to 
OMB for approval. To comply with this requirement, we also are 
publishing this notice of the proposed collection of information set 
forth in this document and seeking public comment.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on Qualified 
Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 
3942b (for Animal Food). 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.

III. Paperwork Reduction Act of 1995

    The draft guidance entitled ``Qualified Facility Attestation Using 
Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)'' 
contains information collection provisions that are subject to review 
by the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 
3501-3520). A description of these provisions is given below with an 
estimate of the associated annual reporting burden. Included in the 
estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    We invite comments on: (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.
    Title: Qualified Facility Attestation Using Form FDA 3942a (for 
Human Food) or Form FDA 3942b (for Animal Food).
    Description: This draft guidance describes FDA procedures regarding 
the submission of attestations as established under both the Preventive 
Controls for Human Food Rule and Preventive Controls for Animal Food 
Rule. Proposed forms FDA 3942a and FDA 3942b have been developed 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 asserting that a 
facility is a ``qualified facility'' under applicable FDA regulations.
    We estimate the burden for this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                         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             0.5          18,567  0.5 (30 minutes)..................           9,284
Section III; Animal Food............           3942b           1,120             0.5             560  0.5 (30 minutes)..................             280
                                     -------------------------------------------------------------------------------------------------------------------
    Total...........................  ..............  ..............  ..............  ..............  ..................................           9,564
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\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 calculate that approximately 37,134 human food 
facilities will spend approximately 30 minutes (0.5 hour) reporting 
their status as such to FDA every 2 years. Thus, dividing this figure 
by 2 to determine the annual burden, we estimate there will be a total 
of 18,567 responses and a total of 9,284 burden hours associated with 
this 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 spend approximately 30 
minutes (0.5 hour) reporting their status as such to FDA every 2 years. 
Thus, dividing this figure by 2 to determine an annual burden, we 
estimate there will be a total of 560 responses and a total of 280 
burden hours associated with this information collection element.
    This draft 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance, 
including its appendices containing instructions for filling out Forms 
FDA 3942a and 3942b and the proposed Forms FDA 3942a and 3942b, at 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. 
Use the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: May 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11439 Filed 5-13-16; 8:45 am]
 BILLING CODE 4164-01-P