
[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Notices]
[Pages 27779-27781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0430]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Voluntary Submission of Food/Feed Facility Profile 
Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed 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 
FDA's program of voluntary submission of food facility profile 
information and new Form FDA 3797, which may be submitted 
electronically via the FDA Industry Systems Web site.

DATES: Submit either electronic or written comments on the collection 
of information by July 10, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

SUPPLEMENTARY 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 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.

Voluntary Submission of Food/Feed Facility Profile Information (OMB 
Control Number 0910--New)

    FDA has broad legal authority under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) and the Public Health Service Act to 
protect the public health and the safety of the nation's food supply. 
In addition, under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (Pub. L. 107-188) (the 
``Bioterrorism Act'') FDA was further authorized to improve the ability 
of the United States to prevent, prepare for, and respond to 
bioterrorism and other public health emergencies. The Bioterrorism Act 
added section 415 of the FD&C Act (21 U.S.C. 350d), which 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. FDA regulations at 21 CFR 1.230 through 1.235 set 
forth the procedures for registration of food (including animal food/
feed) facilities. Information provided to FDA under these regulations 
helps us notify quickly the facilities that might be affected by a 
deliberate or accidental contamination of the food supply. Furthermore, 
the FDA Food Safety Modernization Act (Pub. L. 11-353) (FSMA) added 
section 421 of the FD&C Act (21 U.S.C. 350j), which directed FDA to 
allocate resources to inspect facilities according to the known safety 
risks of the facilities. We propose to collect additional food/feed 
facility profile information on a voluntary basis from firms that 
complete the FDA food facility registration process. Food facility 
profile information voluntarily provided to FDA will help us to 
determine whether a firm is high-risk or non-high-risk. We will use the 
profile information to assist us in determining the frequency at which 
we will inspect the firm. Facilities that voluntarily submit the food 
facility profile information would benefit from our advance preparation 
through interaction with better-informed investigators and potentially 
reduced inspection time. The need for this collection of information 
derives from our objective to obtain current, timely, and policy-
relevant information to carry out our statutory functions. The FDA 
Commissioner is authorized to undertake this collection as specified in 
section 1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)).

[[Page 27780]]

    Firms will be offered the opportunity to voluntarily complete a 
food/feed facility profile after they register with FDA using the 
electronic system known as the Food Facility Registration Module, which 
is available at http://www.access.fda.gov, the FDA Industry Systems Web 
site. The use of an electronic form would enhance our ability to store 
the information in a searchable form. Ideally, a searchable electronic 
system could allow FDA to assess information when a problem occurs with 
certain types of foods or controls, so that we could target inspections 
to facilities that manufacture, process, or pack foods that are at 
increased risk for a food safety problem. After completing their 
registration process, firms will see a popup screen by which they will 
be able to navigate to the food facility profile screens to provide the 
profile information. Food and feed facility profile information will 
only be collected electronically in English.
    Information we propose to request in the voluntary food and feed 
facility profile includes, among other things:
     The facility type (e.g., manufacturer/processor, repacker/
packer, or warehouse/holding facility);
     The products, and hazards (e.g., biological, physical, 
chemical) and preventive control measures associated with those 
products where either there is a regulation in place requiring 
identification of hazards and preventive control measures, e.g., 
seafood and juice, or the firm as a matter of its own business 
practices voluntarily identifies hazards and implements preventive 
control measures; and
     Other facility information (e.g., food safety training, 
facility size, operational schedule, and number of employees).
    Firms will be given the option of providing or updating their 
profile information whenever the firm accesses the Food Facility 
Registration Module (e.g., when completing their initial registration 
process or when updating their registration information). FDA will also 
provide a direct URL that a firm may use to submit the facility profile 
information at a time when they are not registering or updating their 
registration information.
    Description of Respondents: The respondents to this information 
collection include 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                               Number of
                 Activity                    FDA Form No.      Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses
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Submission of New Domestic Food Facility          FDA 3797           6,780               1           6,780  0.25 (15 minutes)...........           1,695
 Profile.
Submission of New Foreign Food Facility           FDA 3797          11,685               1          11,685  0.75 (45 minutes)...........           8,764
 Profile.
Submission of Update to Existing Food             FDA 3797          59,265               1          59,265  0.0833 (5 minutes)..........           4,937
 Facility Profile.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ..............  ............................          15,396
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimate is based on our experience and the average number of 
new facility registrations and updates estimated in the notice 
published in the Federal Register of May 28, 2010 (75 FR 30033) (the 
May 2010 notice) during the most recent request for extension of OMB 
approval under the PRA for the FDA food facility registration process 
(approved under OMB control number 0910-0502). In the May 2010 notice, 
we estimated that the annual number of new domestic facility 
registrations will be 13,560. Assuming that approximately half of these 
firms will also choose to provide the food facility profile 
information, we estimate that 6,780 domestic firms will voluntarily 
submit Form FDA 3797 annually. We estimate that submitting the food 
facility profile information will require a burden of approximately 
0.25 hour (15 minutes) per average domestic facility. Thus, the total 
annual burden for the submission of new domestic food facility profiles 
is estimated to be 1,695 hours (6,780 x 0.25 hour = 1,695 hours).
    In the May 2010 notice, we estimated that the annual number of new 
foreign facility registrations will be 23,370. Assuming that 
approximately half of these firms will also choose to provide the food 
facility profile information, we estimate that 11,685 foreign firms 
will voluntarily submit Form FDA 3797 annually. We estimate that 
submitting the food facility profile information will require a burden 
of approximately 0.75 hour (45 minutes) per average foreign facility, 
taking into account that for some foreign facilities the respondent 
completing the registration may not be fluent in English. The 
information must be submitted electronically in the English language. 
Thus, the total annual burden for the submission of new foreign food 
facility profiles is estimated to be 8,764 hours (11,685 x 0.75 hour = 
8,763.75 rounded to 8,764 hours).
    In the May 2010 notice, we estimated that we will receive 118,530 
registration updates annually. Assuming that approximately half of 
these firms will also choose to update their food facility profile 
information, we estimate that 59,265 firms will voluntarily submit Form 
FDA 3797 for that purpose annually. FDA estimates that updating food 
facility profile information will require a burden of approximately 
0.0833 hour (5 minutes) per average facility, taking into account 
fluency in English. Thus, we estimate the total annual burden for 
updating food facility profiles to be 4,937 hours (59,265 x 0.0833 hour 
= 4,936.77 rounded to 4,937 hours).
    We recognize that the May 2010 notice was issued prior to the 
passage of FSMA, which was signed into law on January 4, 2011. Section 
102(a) of FSMA amended section 415 of the FD&C Act to create section 
415(a)(3) (21 U.S.C. 350d(a)(3)), which requires that during the period 
beginning on October 1 and ending on December 31 of each even-numbered 
year, a registrant that has previously registered shall submit a 
renewal registration. We anticipate that this provision will impact the 
number of firms that access the Food Facility Registration Module and 
that are therefore given the option of providing or updating their 
profile information. Estimates regarding the impact of section 
415(a)(3) will be provided in our next request for extension of OMB

[[Page 27781]]

approval under the PRA for the FDA food facility registration process 
(approved under OMB control number 0910-0502).

    Dated: May 8, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-11457 Filed 5-10-12; 8:45 am]
BILLING CODE 4160-01-P


