Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories; Availability, 48990-48992 [2012-20038]
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48990
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
entitled ‘‘Suicidality: Prospective
Assessment of Occurrence in Clinical
Trials’’ issued in September 2010.
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considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 15,
2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Thomas Laughren, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4114,
Silver Spring, MD 20993–0002, 301–
796–2260.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Suicidal Ideation and Behavior:
Prospective Assessment of Occurrence
in Clinical Trials.’’ The purpose of this
guidance is to assist sponsors in
prospectively assessing the occurrence
of treatment-emergent suicidal ideation
and behavior in clinical trials of drug
and biological products. Specifically,
this guidance addresses FDA’s current
thinking regarding the importance of
suicidal ideation and behavior
assessment in psychiatric and
nonpsychiatric drug trials and the
general principles for how best to
accomplish this assessment during drug
development.
Prospective assessment of suicidal
ideation and behavior involves actively
querying patients about the occurrence
of suicidal thinking and behavior, rather
than relying on patients to report such
occurrences spontaneously, followed by
retrospective classification of events
into appropriate categories. This
guidance recommends a specific
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17:49 Aug 14, 2012
Jkt 226001
suicidal ideation and behavior
assessment instrument that can be used
to conduct such prospective
assessments and offers guidance on the
use of alternative instruments.
This guidance is intended to serve as
a focus for continued discussions among
FDA, pharmaceutical sponsors, the
academic community, and the public.
This guidance does not address the
complex analytic issues involved in the
analysis of the suicidal ideation and
behavior data that will be derived from
prospective assessments of suicidal
ideation and behavior; these issues will
be addressed in separate guidances.
This guidance is a revision of the draft
guidance for industry entitled
‘‘Suicidality: Prospective Assessment of
Occurrence in Clinical Trials’’ issued
September 9, 2010 (75 FR 54889).
Comments we received on the draft
guidance have been considered and the
guidance has been revised. The revision:
(1) Replaces the term ‘‘suicidality’’ with
the terms ‘‘suicidal ideation and
behavior’’; (2) provides an expanded set
of the Columbia Classification
Algorithm for Suicide Assessment (C–
CASA) categories, along with
definitions and explanations; (3) revises
the advice on which trials and patients
would need assessments of suicidal
ideation and behavior and the timing of
such assessments; (4) addresses
concerns about the time burden of
assessments; (5) addresses questions
about the possible value of the
assessments providing protection for
patients in the trials themselves; (6)
makes it clear that use of an assessment
instrument that directly classifies
relevant thoughts and behaviors into C–
CASA categories eliminates the need for
any additional coding; (7) provides
multiple additional references; and (8)
revises advice on evaluation of
alternative instruments.
This 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 Agency’s current thinking
on prospective assessment of occurrence
of suicidal ideation and behavior in
clinical trials. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. 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
PO 00000
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comments. It is no longer necessary to
send two copies of mailed 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19993 Filed 8–14–12; 8:45 am]
BILLING CODE 4160–01–P
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.
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
https://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
SUMMARY:
E:\FR\FM\15AUN1.SGM
15AUN1
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
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:
srobinson on DSK4SPTVN1PROD with NOTICES
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 foodrelated 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
VerDate Mar<15>2010
17:49 Aug 14, 2012
Jkt 226001
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 § 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 § 170.3 in food
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
48991
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 § 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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
E:\FR\FM\15AUN1.SGM
15AUN1
48992
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
https://www.fda.gov/FoodGuidances or
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Endocrinologic
and Metabolic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The meeting will
be held on October 17, 2012, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. A
notice in the Federal Register about last
minute modifications that impact a
VerDate Mar<15>2010
17:49 Aug 14, 2012
Jkt 226001
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site at
https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 203858,
lomitapide capsules, by Aegerion
Pharmaceuticals, Inc. The proposed
indication (use) is as an adjunct to a
low-fat diet and other lipid-lowering
drugs with or without low-density
lipoprotein (LDL) apheresis to reduce
LDL cholesterol, total cholesterol,
apolipoprotein B, and triglycerides in
patients with homozygous familial
hypercholesterolemia. (Apheresis is a
laboratory technology used to remove
LDL from the bloodstream.)
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 2, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
September 24, 2012. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
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notify interested persons regarding their
request to speak by September 25, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Paul Tran at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20013 Filed 8–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0853]
Tobacco Product Manufacturing
Facility Visits
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), Center for
Tobacco Products (CTP) is announcing
an invitation for participation in its
Tobacco Product Manufacturing Facility
Visits. This program is intended to give
FDA staff an opportunity to visit
facilities involved in the manufacturing
of tobacco products, including any
related laboratory testing, and observe
the manufacturing operations of the
tobacco industry. The purpose of this
notice is to invite parties interested in
participating in Tobacco Product
Manufacturing Facility Visits to submit
requests to CTP.
DATES: Submit either an electronic or
written request for participation by
October 15, 2012. See section IV of this
document for information on requests
for participation.
ADDRESSES: If your facility is interested
in participating in Tobacco Product
SUMMARY:
E:\FR\FM\15AUN1.SGM
15AUN1
]]>Agencies
[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48990-48992]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20038]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either
[[Page 48992]]
https://www.fda.gov/FoodGuidances or https://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
