Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials; Correction, 74730 [2014-29424]
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Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices
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10.115(g)(5)), to ensure that FDA
considers your comment 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 February 17, 2015.
ADDRESSES: Submit written requests for
single copies of the draft CPG to the
Office of Policy and Risk Management,
Office of Regulatory Affairs, Office of
Global Regulatory Operations and
Policy, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857. Send two self-addressed
adhesive labels to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the CPG.
Submit electronic comments on the
draft CPG to https://www.regulations.gov.
Submit written comments on the draft
CPG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mary E. Losikoff, Center for Food Safety
and Applied Nutrition (HFS–325), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–2300.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
the draft CPG entitled ‘‘Compliance
Policy Guide Sec. 540.275 Crabmeat—
Fresh and Frozen—Adulteration with
Filth, Involving the Presence of
Escherichia coli.’’ The draft CPG, when
finalized, will update the previously
issued ‘‘CPG Sec. 540.275 Crabmeat—
Fresh and Frozen—Adulteration with
Filth, Involving the Presence of the
Organism Escherichia coli,’’ which
provides guidance for FDA staff on the
level of E. coli in crabmeat (i.e., 3.6 Most
Probable Number per gram (MPN/g) of
E. coli) at which FDA may consider the
crabmeat to be adulterated with filth
under section 402(a)(4) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 342(a)(4)). We
revised the CPG for clarity and to
update the format. Revisions generally
include the addition of sections on
Background and Policy, updates to the
sections on Regulatory Action Guidance
and Specimen Charges, and FDA office
names. Specifically, in the section on
Regulatory Action Guidance, we clarify
that FDA’s Districts have direct
reference authority for both domestic
seizure and import refusal based on the
criteria described in the draft CPG. We
also clarify the specific types of legal
action to which the criteria for
recommendations apply. In addition, we
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provide specimen charges relating to
domestic seizure and import refusal.
The draft CPG also contains information
that may be useful to the regulated
industry and to the public.
We are issuing the draft CPG
consistent with our good guidance
practices regulation (21 CFR 10.115).
The draft CPG, when finalized, will
represent our current thinking on the
level of E. coli in fresh or frozen
crabmeat at which we may consider the
crabmeat to be adulterated with filth
under section 402(a)(4) of the FD&C Act.
The draft CPG 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. Comments
Interested persons may submit either
electronic comments regarding the draft
CPG 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document from FDA’s
Office of Regulatory Affairs CPG history
page at https://www.fda.gov/ICECI/
ComplianceManuals/CompliancePolicy
GuidanceManual/default.htm or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1697]
Privacy Act of 1974; Report of a New
System of Records; Food and Drug
Administration Commissioning of
State and Local Officials; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of December 8, 2014. The
document misstated the effective date of
the new system of records. This notice
corrects that error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Regulations Editorial
Section, Regulations Policy and
Management Staff, Office of Policy,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–9148.
SUPPLEMENTARY INFORMATION: The
December 8, 2014 (79 FR 72687) notice
published with an incorrect effective
date of December 8, 2014, for the new
system of records. This document
corrects that error. For the convenience
of the reader, the complete DATES
language is set out below.
In 79 FR 72687, published on
December 8, 2014, we are correcting the
DATES section to read as follows:
DATES: Effective Date: The new system
of records and related routine uses will
be effective on January 22, 2015. Submit
either electronic or written comments
by January 22, 2015.
SUMMARY:
Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29424 Filed 12–15–14; 8:45 am]
BILLING CODE 4164–01–P
Dated: December 10, 2014.
Melinda K. Plaisier,
Associate Commissioner for Regulatory
Affairs, Office of Regulatory Affairs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–29314 Filed 12–15–14; 8:45 am]
Submission for OMB Review; 30-Day
comment request; Generic Clearance
for Satisfaction Surveys of Customers
(CSR)
BILLING CODE 4164–01–P
PO 00000
National Institutes of Health
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
SUMMARY:
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Agencies
[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Page 74730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29424]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1697]
Privacy Act of 1974; Report of a New System of Records; Food and
Drug Administration Commissioning of State and Local Officials;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of December 8, 2014. The document
misstated the effective date of the new system of records. This notice
corrects that error.
FOR FURTHER INFORMATION CONTACT: Joyce Strong, Regulations Editorial
Section, Regulations Policy and Management Staff, Office of Policy,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002, 301-796-9148.
SUPPLEMENTARY INFORMATION: The December 8, 2014 (79 FR 72687) notice
published with an incorrect effective date of December 8, 2014, for the
new system of records. This document corrects that error. For the
convenience of the reader, the complete DATES language is set out
below.
In 79 FR 72687, published on December 8, 2014, we are correcting
the DATES section to read as follows:
DATES: Effective Date: The new system of records and related routine
uses will be effective on January 22, 2015. Submit either electronic or
written comments by January 22, 2015.
Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29424 Filed 12-15-14; 8:45 am]
BILLING CODE 4164-01-P