Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010; Withdrawal of Draft Guidance, 4360 [2011-1530]
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Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component
Total cost
Annualized
cost
Publication of Results ......................................................................................................................................................
Project Management ........................................................................................................................................................
Overhead .........................................................................................................................................................................
149,476
70,313
175,095
66,434
31,250
77,820
Total ..........................................................................................................................................................................
600,055
266,691
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: January 3, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–1169 Filed 1–24–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
[Docket No. FDA–2010–N–0370]
Draft Guidance for Industry: Questions
and Answers Regarding
Implementation of the Menu Labeling
Provisions of Section 4205 of the
Patient Protection and Affordable Care
Act of 2010; Withdrawal of Draft
Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
VerDate Mar<15>2010
18:40 Jan 24, 2011
Jkt 223001
withdrawal of a draft guidance entitled
‘‘Draft Guidance for Industry: Questions
and Answers Regarding Implementation
of the Menu Labeling Provisions of
Section 4205 of the Patient Protection
and Affordable Care Act of 2010’’ dated
August 2010, that was announced in the
Federal Register of August 25, 2010.
FDA now intends to complete the notice
and comment rulemaking process for
the Patient Protection and Affordable
Care Act of 2010 (hereinafter ‘‘section
4205’’) before initiating enforcement
activities based, in part, on extensive
comments on the draft guidance
submitted to the Agency. FDA believes
that this approach to implementing
section 4205 will minimize uncertainty
and confusion among all interested
persons.
The withdrawal is effective
January 25, 2011.
DATES:
FOR FURTHER INFORMATION CONTACT:
Geraldine A. June, Center for Foods
Safety and Applied Nutrition (HFS–
820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–2371.
In a notice
published in the Federal Register of
August 25, 2010 (75 FR 52426), FDA
announced the availability of a draft
guidance entitled ‘‘Draft Guidance for
Industry: Questions and Answers
Regarding Implementation of the Menu
Labeling Provisions of Section 4205 of
the Patient Protection and Affordable
Care Act of 2010.’’ As stated in the draft
guidance, certain provisions of section
4205 became requirements immediately
upon enactment of the law. FDA
recognized that industry may need
additional guidance from the Agency
and time to comply with these
provisions. As a result, FDA stated that
it expected to refrain from initiating
enforcement action against
establishments that are subject to, but
not in compliance with, the provisions
of section 4205 that became
requirements immediately upon
enactment of the law until a time period
established in the draft guidance. FDA
also stated that it anticipated issuing the
guidance in December 2010.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
Based, in part, on extensive comments
on the draft guidance submitted to the
Agency, FDA now intends to complete
the notice-and-comment rulemaking
process for section 4205 before initiating
enforcement activities. As noted in the
draft guidance, FDA is required to issue
proposed regulations to carry out
provisions of section 4205 no later than
March 23, 2011. FDA intends to meet
this statutory deadline. In the course of
developing the proposed rule, the
Agency has considered the comments
received on the draft guidance. FDA
will then review the comments it
receives on the proposed rule and issue
a final rule expeditiously.
FDA believes that this approach to
implementing section 4205 will
minimize uncertainty and confusion
among all interested persons. The
Agency also believes that expeditious
completion of the rulemaking process
will most rapidly lead to full and
consistent availability of the newly
required nutrition information for
consumers.
For these reasons, FDA is at this time
withdrawing the draft guidance entitled
‘‘Draft Guidance for Industry: Questions
and Answers Regarding Implementation
of the Menu Labeling Provisions of
Section 4205 of the Patient Protection
and Affordable Care Act of 2010.’’
Dated: January 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–1530 Filed 1–21–11; 12:00 pm]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0559]
Guidance for Industry on Process
Validation: General Principles and
Practices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Page 4360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1530]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0370]
Draft Guidance for Industry: Questions and Answers Regarding
Implementation of the Menu Labeling Provisions of Section 4205 of the
Patient Protection and Affordable Care Act of 2010; Withdrawal of Draft
Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a draft guidance entitled ``Draft Guidance for Industry:
Questions and Answers Regarding Implementation of the Menu Labeling
Provisions of Section 4205 of the Patient Protection and Affordable
Care Act of 2010'' dated August 2010, that was announced in the Federal
Register of August 25, 2010. FDA now intends to complete the notice and
comment rulemaking process for the Patient Protection and Affordable
Care Act of 2010 (hereinafter ``section 4205'') before initiating
enforcement activities based, in part, on extensive comments on the
draft guidance submitted to the Agency. FDA believes that this approach
to implementing section 4205 will minimize uncertainty and confusion
among all interested persons.
DATES: The withdrawal is effective January 25, 2011.
FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Foods
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 25, 2010 (75 FR 52426), FDA announced the
availability of a draft guidance entitled ``Draft Guidance for
Industry: Questions and Answers Regarding Implementation of the Menu
Labeling Provisions of Section 4205 of the Patient Protection and
Affordable Care Act of 2010.'' As stated in the draft guidance, certain
provisions of section 4205 became requirements immediately upon
enactment of the law. FDA recognized that industry may need additional
guidance from the Agency and time to comply with these provisions. As a
result, FDA stated that it expected to refrain from initiating
enforcement action against establishments that are subject to, but not
in compliance with, the provisions of section 4205 that became
requirements immediately upon enactment of the law until a time period
established in the draft guidance. FDA also stated that it anticipated
issuing the guidance in December 2010.
Based, in part, on extensive comments on the draft guidance
submitted to the Agency, FDA now intends to complete the notice-and-
comment rulemaking process for section 4205 before initiating
enforcement activities. As noted in the draft guidance, FDA is required
to issue proposed regulations to carry out provisions of section 4205
no later than March 23, 2011. FDA intends to meet this statutory
deadline. In the course of developing the proposed rule, the Agency has
considered the comments received on the draft guidance. FDA will then
review the comments it receives on the proposed rule and issue a final
rule expeditiously.
FDA believes that this approach to implementing section 4205 will
minimize uncertainty and confusion among all interested persons. The
Agency also believes that expeditious completion of the rulemaking
process will most rapidly lead to full and consistent availability of
the newly required nutrition information for consumers.
For these reasons, FDA is at this time withdrawing the draft
guidance entitled ``Draft Guidance for Industry: Questions and Answers
Regarding Implementation of the Menu Labeling Provisions of Section
4205 of the Patient Protection and Affordable Care Act of 2010.''
Dated: January 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1530 Filed 1-21-11; 12:00 pm]
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