[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48990-48992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0585]


Draft Guidance for Industry: Necessity of the Use of Food 
Categories in Food Facility Registrations and Updates to Food 
Categories; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Necessity of 
the Use of Food Categories in Food Facility Registrations and Updates 
to Food Categories.'' The draft guidance identifies additional food 
categories to be included in food facility registrations as determined 
appropriate by FDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft guidance before we begin work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 14, 2012.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the draft guidance to the 
Office of Compliance, Division of Field Programs

[[Page 48991]]

and Guidance, Center for Food Safety and Applied Nutrition (HFS-615), 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740. Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Amy Barringer, Center for Food Safety 
and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1988.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Necessity of the Use of Food Categories in Food Facility 
Registrations and Updates to Food Categories.'' This draft guidance 
sets forth FDA's determination of the necessity for additional food 
categories and sets forth the additional food categories to be included 
as mandatory fields in food facility registrations as determined 
appropriate by FDA.
    The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 
2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 350d). Section 415(a)(2) of the FD&C Act, as 
amended by section 102 of FSMA, provides in relevant part that, when 
determined necessary by FDA through guidance, a registrant is required 
to submit a registration to FDA containing information necessary to 
notify FDA of the general food category (as identified in 21 CFR 170.3) 
or any other food categories, as determined appropriate by FDA, 
including by guidance) of any food manufactured, processed, packed, or 
held at such facility. This draft guidance sets forth FDA's 
determination of the necessity for additional food categories and the 
other food categories to be included in food facility registrations as 
determined appropriate by FDA. The inclusion of these additional food 
categories in food facility registrations will help FDA provide a 
quick, accurate, and focused response to an actual or potential 
bioterrorist incident or other food-related emergency.
    FDA is interested in comments regarding including the other food 
categories as mandatory fields in food facility registrations. FDA 
intends to issue a final guidance that identifies the additional food 
categories that will be included as mandatory fields in food facility 
registration forms before the first biennial registration renewal 
period, which begins on October 1, 2012.
    Section 415(a)(2) of the FD&C Act provides in relevant part that a 
food facility is required to submit to FDA a registration containing 
information about the general food category (as identified listed in 
Sec.  170.3 or any other food category as determined appropriate by 
FDA, including ``by guidance'') of a food manufactured/processed, 
packed or held at such facility, if the Agency determines ``through 
guidance'' that such information is necessary. Because of Congress' 
explicit statutory authorization in section 415(a)(2) to establish 
binding requirements based on actions by guidance, this document is not 
subject to the usual restrictions in FDA's good guidance practice (GGP) 
regulations, such as the requirements that guidances not establish 
legally enforceable responsibilities and that they prominently display 
a statement of the document's nonbinding effect. (See 21 CFR 
10.115(d)(i)).
    To comply with the GGP regulations and make sure that regulated 
entities and the public understand that guidance documents are 
nonbinding, FDA guidances ordinarily contain standard language 
explaining that guidances should be viewed only as recommendations 
unless specific regulatory or statutory requirements are cited, and the 
Agency's guidances also ordinarily include language similar to the 
following paragraph:
    This guidance represents the Food and Drug Administration's current 
thinking on this topic. It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. You can 
use an alternative approach if the approach satisfies the requirements 
of the applicable statutes and regulations. If you want to discuss an 
alternative approach, contact the FDA staff responsible for 
implementing this guidance. If you cannot identify the appropriate FDA 
staff, call the appropriate number listed on the title page of this 
guidance.
    FDA is not including this standard language in this draft guidance 
because it is not an accurate description of the effect of this 
guidance. This guidance contains findings that serve as the predicates 
for binding requirements on industry. As stated in ``Guidance for 
Industry on Necessity of the Use of Food Product Categories in 
Registration of Food Facilities'' (2003), which implemented, in part, 
section 415, as added by section 305 of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002, it contains FDA's 
finding that inclusion of the food categories in Sec.  170.3 in food 
facility registrations is necessary for a quick, accurate, and focused 
response to an actual or potential bioterrorist incident or other food-
related emergency. Based in part on this finding, FDA's regulations for 
the registration of food facilities in 21 CFR part 1, subpart H 
currently require that a food facility submit a registration to FDA 
containing information on applicable food product categories as 
identified in Sec.  170.3 for food manufactured/processed, packed, or 
held at such facility. As provided in section 102 of FSMA, this draft 
guidance contains FDA's finding that inclusion of other food categories 
in food facility registrations is also necessary to facilitate such 
rapid communications. In addition, this draft guidance sets forth the 
other food categories to be included in food facility registrations 
determined to be appropriate by FDA for the purposes of food facility 
registration. Insofar as this guidance, if finalized, modifies food 
categories for food facility registration under section 415 of the FD&C 
Act, it will have binding effect. For these reasons, FDA is not 
including the standard guidance paragraph in this draft guidance.

II. The Paperwork Reduction Act of 1995

    This draft guidance contains a collection of information that 
requires clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). FDA intends 
to submit the collection of information to OMB in the near future for 
emergency clearance processing under 5 CFR 1320.13. The draft guidance 
also refers to previously approved collections of information found in 
FDA regulations. The collections of information in 21 CFR 1.230-1.235 
have been approved under OMB control number 0910-0502.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday, and will 
be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either

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http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Always 
access an FDA document using the FDA Web site listed previously to find 
the most current version of the guidance.

    Dated: August 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20038 Filed 8-14-12; 8:45 am]
BILLING CODE 4160-01-P