Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food; Availability, 20326-20327 [2013-07809]
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Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 / Notices
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Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07854 Filed 4–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0126]
Draft Compliance Policy Guide Sec.
100.250 Food Facility Registration—
Human and Animal Food; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of draft Compliance Policy
Guide Sec. 100.250 Food Facility
Registration—Human and Animal Food
(the draft CPG). The draft CPG, when
finalized, will provide guidance for FDA
staff on issues related to food facility
registration under a section of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), including the requirement
that certain food facilities register with
FDA, the requirement that registered
facilities biennially renew their
registrations with FDA, and FDA’s
authority to suspend a food facility’s
registration.
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
CPG before it begins work on the final
version of the CPG, submit either
electronic or written comments on the
draft CPG by May 6, 2013.
ADDRESSES: Submit written requests for
single copies of the draft CPG to the
Division of Compliance Policy (HFC–
230), Office of Enforcement, Food and
Drug Administration, 12420 Parklawn
Dr., Rockville, MD 20857. Send two selfDATES:
E:\FR\FM\04APN1.SGM
04APN1
Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 / Notices
addressed adhesive labels to assist that
office in processing your request, or fax
your request to 240–632–6861. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft CPG.
Submit electronic comments on the
draft CPG 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:
Mischelle B. Ledet, Center for Food
Safety and Applied Nutrition (HFS–
615), Food and Drug Administration,
5100 Paint Branch Pkwy., College
Park, MD 20740, 240–205–1165; or
Kim R. Young, Center for Veterinary
Medicine (HFV–230), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9200.
SUPPLEMENTARY INFORMATION:
wreier-aviles on DSK5TPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft CPG entitled ‘‘Compliance Policy
Guide Sec. 100.250 Food Facility
Registration—Human and Animal
Food.’’ The draft CPG is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft CPG, when finalized, will
replace ‘‘Compliance Policy Guide Sec.
110.300 Registration of Food Facilities
Under the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002.’’
Section 415 of the FD&C Act (21
U.S.C. 350d) requires owners, operators,
or agents in charge of domestic and
foreign facilities that manufacture,
process, pack, or hold food for human
or animal consumption in the United
States to register their facilities with
FDA, unless an exception applies (see
21 CFR 1.226 and 1.227). The FDA Food
Safety Modernization Act (FSMA) (Pub.
L. 111–353), enacted on January 4, 2011,
amended section 415 of the FD&C Act
in relevant part to require registrants for
food facilities to submit additional
registration information to FDA, and to
require facilities required to register
with FDA to renew such registrations
biennially. FSMA also amended section
415 of the FD&C Act to provide FDA
with authority to suspend the
registration of a food facility in certain
circumstances. Specifically, if FDA
determines that food manufactured,
processed, packed, received, or held by
a registered facility has a reasonable
probability of causing serious adverse
health consequences or death to humans
or animals, FDA may by order suspend
the registration of a facility that: (1)
Created, caused, or was otherwise
VerDate Mar<15>2010
14:48 Apr 03, 2013
Jkt 229001
responsible for such reasonable
probability; or (2) knew of, or had
reason to know of, such reasonable
probability; and packed, received, or
held such food.
The draft CPG is intended to provide
guidance for FDA staff regarding
enforcement of the food facility
registration provisions of section 415 of
the FD&C Act, including the
requirement that certain food facilities
register with FDA, the requirement that
registered facilities biennially renew
their registrations with FDA, and FDA’s
authority to suspend a food facility’s
registration. The draft CPG also contains
information that may be useful for the
regulated industry and to the public.
The draft CPG, when finalized, will
represent the Agency’s current thinking
on food facility registration
requirements of section 415 of the FD&C
Act. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternate approach may be used if such
approach satisfies the requirements of
the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and section 415 of the FD&C Act. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 1.230 through 1.235 and section
415 of the FD&C Act have been
approved under OMB Control No. 0910–
0502.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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 CPG from FDA’s
Office of Regulatory Affairs history
page. It may be accessed at https://
www.fda.gov/ICECI/
ComplianceManuals/
CompliancePolicyGuidanceManual/
default.htm. Guidance documents are
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
20327
also available at https://
www.regulations.gov.
Dated: March 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–07809 Filed 4–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Joint Meeting of the Advisory
Committee for Reproductive Health
Drugs and the Drug Safety and Risk
Management Advisory Committee;
Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of the joint meeting of the
Advisory Committee for Reproductive
Health Drugs and the Drug Safety and
Risk Management Advisory Committee.
This meeting was announced in the
Federal Register of March 14, 2013 (78
FR 16271–16272). The amendment is
being made to reflect a change in the
Agenda portion of the document. There
are no other changes.
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, 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,
ACRHD@fda.hhs.gov, or use the FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 14, 2013,
FDA announced that a joint meeting of
the Advisory Committee for
Reproductive Health Drugs and the Drug
Safety and Risk Management Advisory
Committee would be held on April 18,
2013. On page 16272, in the first
column, the Agenda portion of the
document is changed to read as follows:
Agenda: The committee will discuss
the efficacy and safety of new drug
application (NDA) 22219, AVEED
(testosterone undecanoate)
intramuscular injection, submitted by
Endo Pharmaceutical Solutions, Inc., for
the proposed indication of replacement
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Notices]
[Pages 20326-20327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0126]
Draft Compliance Policy Guide Sec. 100.250 Food Facility
Registration--Human and Animal Food; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of draft Compliance Policy Guide Sec. 100.250 Food
Facility Registration--Human and Animal Food (the draft CPG). The draft
CPG, when finalized, will provide guidance for FDA staff on issues
related to food facility registration under a section of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), including the requirement that
certain food facilities register with FDA, the requirement that
registered facilities biennially renew their registrations with FDA,
and FDA's authority to suspend a food facility's registration.
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 comments on
this draft CPG before it begins work on the final version of the CPG,
submit either electronic or written comments on the draft CPG by May 6,
2013.
ADDRESSES: Submit written requests for single copies of the draft CPG
to the Division of Compliance Policy (HFC-230), Office of Enforcement,
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857.
Send two self-
[[Page 20327]]
addressed adhesive labels to assist that office in processing your
request, or fax your request to 240-632-6861. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft CPG.
Submit electronic comments on the draft CPG 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:
Mischelle B. Ledet, Center for Food Safety and Applied Nutrition (HFS-
615), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, 240-205-1165; or
Kim R. Young, Center for Veterinary Medicine (HFV-230), Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9200.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft CPG entitled
``Compliance Policy Guide Sec. 100.250 Food Facility Registration--
Human and Animal Food.'' The draft CPG is being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The draft
CPG, when finalized, will replace ``Compliance Policy Guide Sec.
110.300 Registration of Food Facilities Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002.''
Section 415 of the FD&C Act (21 U.S.C. 350d) requires owners,
operators, or agents in charge of domestic and foreign facilities that
manufacture, process, pack, or hold food for human or animal
consumption in the United States to register their facilities with FDA,
unless an exception applies (see 21 CFR 1.226 and 1.227). The FDA Food
Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January
4, 2011, amended section 415 of the FD&C Act in relevant part to
require registrants for food facilities to submit additional
registration information to FDA, and to require facilities required to
register with FDA to renew such registrations biennially. FSMA also
amended section 415 of the FD&C Act to provide FDA with authority to
suspend the registration of a food facility in certain circumstances.
Specifically, if FDA determines that food manufactured, processed,
packed, received, or held by a registered facility has a reasonable
probability of causing serious adverse health consequences or death to
humans or animals, FDA may by order suspend the registration of a
facility that: (1) Created, caused, or was otherwise responsible for
such reasonable probability; or (2) knew of, or had reason to know of,
such reasonable probability; and packed, received, or held such food.
The draft CPG is intended to provide guidance for FDA staff
regarding enforcement of the food facility registration provisions of
section 415 of the FD&C Act, including the requirement that certain
food facilities register with FDA, the requirement that registered
facilities biennially renew their registrations with FDA, and FDA's
authority to suspend a food facility's registration. The draft CPG also
contains information that may be useful for the regulated industry and
to the public.
The draft CPG, when finalized, will represent the Agency's current
thinking on food facility registration requirements of section 415 of
the FD&C Act. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternate
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations and section 415 of the FD&C Act.
These collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR 1.230
through 1.235 and section 415 of the FD&C Act have been approved under
OMB Control No. 0910-0502.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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 CPG from
FDA's Office of Regulatory Affairs history page. It may be accessed at
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm. Guidance documents are also
available at https://www.regulations.gov.
Dated: March 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07809 Filed 4-3-13; 8:45 am]
BILLING CODE 4160-01-P