[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Rules and Regulations]
[Pages 9842-9844]
[FR Doc No: 2012-3940]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-P-0102 (formerly 2000P-1275), FDA-2000-P-0133
(formerly 2000P-1276), and FDA-2006-P-0033 (formerly 2006P-0316)]

Health Claim; Phytosterols and Risk of Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of enforcement discretion.

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SUMMARY: The Food and Drug Administration (FDA) is extending the period
of time that it intends to exercise enforcement discretion concerning
the use of the health claim for phytosterols and risk of coronary heart
disease (CHD), in a manner that is consistent with FDA's February 14,
2003, letter of enforcement discretion to Cargill Health and Food
Technologies, until publication of a final rule.

DATES: Submit either electronic or written comments by April 23, 2012.

ADDRESSES: Submit electronic comments to http://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: Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Pkwy.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: For the reasons described herein, FDA
intends to continue to exercise enforcement discretion with respect to
the use of a health claim regarding reduced risk of coronary heart
disease (CHD) for phytosterol-containing conventional food and dietary
supplements, in a manner that is consistent with FDA's February 14,
2003, letter of enforcement discretion to Cargill Health and Food
Technologies, until publication of a final rule.

I. Regulatory History

    In the Federal Register of September 8, 2000 (65 FR 54686), FDA
issued an interim final rule (IFR) authorizing a health claim for plant
sterol/stanol esters and CHD. Among other requirements, we established
in the IFR that spreads and dressings for salads must contain at least
0.65 grams (g) of plant sterol esters per reference amount customarily
consumed (RACC) to be eligible to bear the health claim and that
spreads, dressings for salad, snack bars, and dietary supplements in
soft gel form must contain at least 1.7 g of plant stanol esters per
RACC to be eligible to bear the health claim.
    FDA received a letter, dated January 6, 2003, from Cargill Health
and Food Technologies requesting that FDA issue a letter stating its
intention not to enforce certain requirements in the IFR. The letter
cited new scientific evidence and comments submitted to FDA in the
plant sterol/stanol esters health claim rulemaking in support of
extending the authorized health claim to all forms and sources of
phytosterols and product forms that might effectively reduce blood
cholesterol levels. In response to the letter submitted by Cargill and
other comments received to the IFR, we issued a letter of enforcement
discretion on February 14, 2003 (the 2003 letter) (Ref. 1). In the
letter, we explained that we would consider exercising enforcement
discretion, pending publication of the final rule, with respect to
certain requirements of the health claim. Specifically, we stated we
would consider such discretion with regard to the use of the claim in
the labeling of a phytosterol-containing food, including foods other
than those specified in Sec.  101.83(c)(2)(iii)(A) (21 CFR
101.83(c)(2)(iii)(A)), if: (1) The food contains at least 400
milligrams (mg) per RACC of phytosterols; (2) mixtures of phytosterol
substances (i.e., mixtures of sterols and stanols) contain at least 80-
percent beta-sitosterol, campesterol, stigmasterol, sitostanol, and
campestanol (combined weight); (3) the food meets the requirements of
Sec.  101.83(c)(2)(iii)(B) through (c)(2)(iii)(D); (4) products
containing phytosterols, including mixtures of sterols and stanols in
free (non-esterified) forms, use a collective term in lieu of the terms
required by Sec.  101.83(c)(2)(i)(D) in the health claim to describe
the substance (e.g., ``plant sterols'' or ``phytosterol''); (5) the
claim specifies that the daily dietary intake of phytosterols that may
reduce the risk of CHD is 800 mg or more per day, expressed as the
weight of free Phytosterol; (6) vegetable oils for home use that exceed
the total fat disqualifying level can bear the health claim along with
a disclosure statement that complies with Sec.  101.13(h); and (7) the
use of the claim otherwise complies with Sec.  101.83. Thus, the 2003
letter described intended enforcement discretion with respect to: (1)
Different forms and mixtures of phytosterols in a wider variety of
products and (2) the use of the claim on foods containing lower levels
of phytosterols than set forth in the IFR.
    In the Federal Register of December 8, 2010 (75 FR 76526), we
published a proposed rule that, if finalized, would amend Sec.  101.83
(the 2010 proposed rule). The 2010 proposed rule, in part, responds to
a health claim petition we received on May 5, 2006, and it also
includes the evaluation of new scientific data that was not available
when we published the IFR.
    We stated in the 2010 proposed rule for phytosterols and the risk
of CHD health claim that, pending publication of a final rule, FDA
intends to consider the exercise of its enforcement discretion on a
case-by-case basis when a health claim regarding phytosterols and CHD
is made in a manner that is consistent with the proposed rule (75 FR
76526 at 76546).
    The 2010 proposed rule also stated that, beginning 75 days after
the date of publication of the proposed rule (February 21, 2011), FDA
did not intend to exercise its enforcement discretion based on the 2003
letter (75 FR 76526 at 76546). We stated that starting on February 21,
2011, all products bearing the health claim would have to be in
compliance with Sec.  101.83, or if health claims were made in a manner
consistent with the proposed rule, we would consider exercising
enforcement discretion pending publication of a final rule.
    In the 2010 proposed rule, we proposed to make several changes to
the requirements for the nature of the food eligible to bear the claim
that differ from the requirements in current Sec.  101.83 and from the
basis for enforcement discretion in the 2003 letter. Among other
changes, FDA proposed to increase the amount of phytosterols that must
be present in the food product from 0.4 to 0.5 g of phytosterols per
RACC and to only allow the use of the claim in dietary supplements
containing the esterified form of phytosterols. In addition, we
proposed that a conventional food would be eligible to bear the claim
if it is the subject of a GRAS notification to which FDA had no further
questions.
    After publication of the proposed rule, we received requests from
industry to extend the 75-day period from the date of publication of
the proposed rule for the exercise of FDA enforcement discretion based
on the 2003 letter. We subsequently issued a notice in the Federal
Register of February 18, 2011, extending the period during which we
intended to exercise enforcement discretion based on the 2003 letter to
February 21, 2012 (76 FR 9525) (the February 18, 2011 notice).\1\
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    \1\ In the February 18, 2011, notice, we identified two letters
(from the Council for Responsible Nutrition and the Consumer
Healthcare Products Association) and two petitions for an
administrative stay of action (from Cargill, Inc., and Pharmachem
Laboratories, Inc.). These two petitions are under FDA consideration
and neither the February 18, 2011 notice, nor this notice,
represents a decision on the petitions, in whole or in part.
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    In the February 18, 2011 notice, FDA stated that it intended to
exercise enforcement discretion until February 21, 2012, with respect
to the use of a claim regarding reduced risk of CHD in the labeling of
a phytosterol-containing food, including foods other than those
specified in Sec.  101.83(c)(2)(iii)(A), based on the factors set forth
in the 2003 letter for the use of such claim in the labeling of food.
FDA also stated that the February 18, 2011 notice did not change how we
intend to consider exercising our enforcement discretion when claims
are made consistent with the proposed requirements in the proposed
rule, and that our decision to extend the period of time during which
we would consider the exercise of our enforcement discretion only
related to FDA's enforcement discretion based on the 2003 letter.

II. Current Extension of Intent To Exercise Enforcement Discretion

    Since publication of the February 18, 2011, notice, we have
received two

additional petitions; one requesting an administrative stay of action
with an embedded citizen petition and the other requesting an
administrative stay of action. Each of the requests for an
administrative stay of action concern FDA's use of enforcement
discretion related to labeling of dietary supplements, pending the
publication of a final rule.\2\ In addition, FDA received numerous
comments on the 2010 proposed rule requesting that FDA extend the
period of enforcement discretion based on the 2003 letter until
publication of a final rule. FDA has received new scientific data and
information, through comments to the 2010 proposed rule, or submitted
with petitions, relating to several of the factors we set forth in the
2003 letter, e.g., the possible health benefit of free phytosterols in
dietary supplements and the minimum daily consumption amount of
phytosterols necessary to achieve the claimed effect. We are reviewing
the comments and information we received and do not intend to make a
determination as to the daily phytosterols consumption amount needed to
achieve the claimed effect or the eligibility of dietary supplements
containing free phytosterols to bear the authorized health claim until
the publication of the final rule.
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    \2\ FDA received a petition for an administrative stay of action
with an embedded citizen petition from Pharmavite LLC (``Pharmavite
petition'') dated February 24, 2011, and a petition for an
administrative stay from Botanical Laboratories, Inc. (``Botanical
petition''), dated March 18, 2011 (Docket Nos. FDA-2000-P-0102, FDA-
2000-P-0133, and FDA-2006-P-0033). Specifically, Pharmavite LLC
requests FDA to stay its February 18, 2011, decision to discontinue
enforcement discretion for dietary supplements containing free
phytosterols that have been shown, through an adequate and well-
controlled clinical trial, to reduce low density lipoprotein (LDL)
and total cholesterol, pending publication of a final rule for the
health claim. In a citizen petition embedded in the petition for an
administrative stay, Pharmavite LLC also asked us to agree that: (1)
A dietary supplement produced by Pharmavite LLC has been shown to
effectively reduce LDL and total cholesterol; (2) FDA will continue
to exercise enforcement discretion to permit this dietary supplement
to bear an appropriately worded claim pursuant to the 2010 proposed
regulation, pending publication of a final rule addressing the
health claim; and (3) the final rule will allow those dietary
supplements containing free phytosterols that have been shown
through an adequate and well-controlled clinical trial to
effectively reduce LDL and total cholesterol to bear the claim.
Botanical Laboratories, Inc., requested that FDA stay its February
18, 2011, decision to discontinue enforcement discretion for dietary
supplements containing phytosterols in liquid form until the
issuance of a final rule for the health claim. We are currently
considering these petitions. This document does not represent a
decision on these petitions, in whole or in part.
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    Based on the new data and information currently under our review
that may be important, to our consideration in deciding what
requirements to include in the final rule, and the need to focus FDA's
resources on other public health priorities, we find it appropriate to
continue to extend our consideration of the exercise of enforcement
discretion for the labeling of foods, including dietary supplements,
bearing a health claim regarding phytosterols and risk of CHD
consistent with the 2003 letter, until publication of the final rule.
    Therefore, FDA is extending the period during which it intends to
exercise enforcement discretion, consistent with the factors set forth
in the 2003 letter, until publication of a final rule for the
phytosterols and risk of CHD health claim. This document does not
change how FDA intends to consider exercising its enforcement
discretion when claims are made consistent with the proposed
requirements in the proposed rule. Food, including dietary supplements,
bearing the health claim would be required to comply with any revised
requirements established in the final rule when the final rule becomes
effective.

III. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m. Monday through Friday.

1. Center for Food Safety and Applied Nutrition, Food and Drug
Administration, Letter of Enforcement Discretion from FDA to Cargill
Health & Food Technologies, Docket No. FDA-2000-P-0102, document ID
DRAFT- 0059 (formerly 2000P-1275/LET3) and Docket No. FDA-2000-P-
0133, document ID DRAFT-0127 (formerly 2000P-1276/LET4), February
14, 2003.

    Dated: February 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3940 Filed 2-17-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Page 37736]
[FR Doc No: 2014-15547]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9913-24-OEI]

 Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of California

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the Environmental Protection Agency
(EPA's) approval of the State of California's request to revise its EPA
Administered Permit Programs: The National Pollutant Discharge
Elimination System EPA-authorized program to allow electronic
reporting.

DATES: EPA's approval is effective on July 2, 2014.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On August 19, 2013, the California State Water Resources Control
Board (CA SWRCB) submitted an application titled ``Electronic Self
Monitoring Report'' for revision of its EPA-authorized authorized Part
123 program under title 40 CFR. EPA reviewed CA SWRCB's request to
revise its EPA-authorized Part 123--EPA Administered Permit Programs:
The National Pollutant Discharge Elimination System program and, based
on this review, EPA determined that the application met the standards
for approval of authorized program revision set out in 40 CFR part 3,
subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's
decision to approve California's request to revise its Part 123--EPA
Administered Permit Programs: The National Pollutant Discharge
Elimination System program to allow electronic reporting under 40 CFR
part 122 is being published in the Federal Register.
    CA SWRCB was notified of EPA's determination to approve its
application with respect to the authorized program listed above.

    Dated: June 23, 2014.
Matthew Leopard,
Acting Director, Office of Information Collection.
[FR Doc. 2014-15547 Filed 7-1-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 13, 2007 (Volume 72, Number 29)]
[Notices]
[Page 6719-6720]
[DOCID:fr13fe07-29]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-71-000]

Dominion Transmission, Inc.; Notice of Application

February 6, 2007.
    Take notice that on January 29, 2007, Dominion Transmission, Inc.
(Dominion), 120 Tredegar Street, Richmond, VA, filed in Docket No.
CP07-71-000, an application pursuant to section 7(b) of the Natural Gas
Act (NGA), to abandon wells CW-427 and CW-449 located in Dominion's
Lost Creek Storage Reservoir located in Lewis County, West Virginia,
all as more fully set forth in the application

which is on file with the Commission and open to public inspection.
This filing may be also viewed on the Web at http://www.ferc.gov using

the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Any questions regarding this application should be directed to
Matthew R. Bley, Manager, Gas Transmission Certificates, Dominion
Transmission, Inc., 120 Tredegar Street, Richmond, VA 23219, at (804)
819-2877, or by facsimile at<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.
    Comment Date: February 27, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E7-2390 Filed 2-12-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Page 46959]
[FR Doc No: 2018-20091]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3431]

Anesthetic and Analgesic Drug Products Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments;
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Anesthetic and Analgesic Drug Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments'' that appeared in the Federal Register of September 11, 2018.
The document announced a forthcoming public advisory committee meeting
of the Anesthetic and Analgesic Drug Products Advisory Committee and
establishment of a public docket for comments. The document was
published with the incorrect docket number. This document corrects that
error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 3330, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday,
September 11, 2018 (83 FR 45941), in FR Doc. 2018-19667, on page 45941,
the following correction is made:
    On page 45941, in the first column, in the header of the document,
and also in the third column under Instructions, ``Docket No. FDA-2018-
N-3276'' is corrected to read ``Docket No. FDA-2018-N-3431''.

    Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20091 Filed 9-14-18; 8:45 am]
 BILLING CODE 4164-01-P


MEMORANDUM

SUBJECT:	Recommendation of Tentative Approval for the State of North
Carolina’s (State) Public Notification Rule

FROM:	James D. Giattina, Director

Water Management Division

TO:		J. I. Palmer, Jr.

Regional Administrator

The purpose of this memorandum is to recommend your approval of the
State’s revision to its Public Water System Supervision Program for
the Public Notification Rule (Rule).  The background for this
recommendation can be found in the attached Fact Sheet.

You will find two items for your approval and signature.  The first is
the Federal Register Notice announcing EPA’s tentative approval of
this Rule.  This notice is necessary in order for EPA to accept the
State’s Rule revision.  The second is a memorandum transmitting the
Federal Register Notice to the Federal Register Liaison in Headquarters.
 Should the public notice period on this Rule end without the filing of
any requests for public hearing, the tentative approval of this Rule
will automatically become a final approval thirty (30) days from the
date of the publication of the notice of tentative approval in the
Federal Register.

If you have any questions or concerns regarding this recommendation,
please contact     E. Stallings Howell, Chief, Ground Water & Drinking
Water Branch at x29329.

_________________

Mary J. Wilkes

Regional Counsel and Director

Office of Environmental Accountability

Attachments:

1.	Memo from Wayne Lee

2.	Fact Sheet for the request to revise North Carolina’s Public
Notification Rule