information that would alter this view or support the technical
feasibility of conducting such tests for all types of dietary supplement
products.  However, nothing in this final rule would preclude a
manufacturer from establishing such requirements.  A manufacturer should
have data to support any specifications it establishes for parameters
such as dissolution, disintegration, and bioavailability.

     (Comment 184)  One comment questions the requirements in the 2003
CGMP Proposal that all manufacturers quantify certain marker compounds
in their products.  The comment offers two reasons why such testing
should not be required for botanical products: their food-like
composition and legal status; and the assertion that scientifically
valid analytical methods may prove to be irrelevant or even hinder the
development of superior products.

     (Response)  The final rule does not require any specific testing
requirements, such as testing for marker compounds.  You would determine
the specific testing requirements, and whether to use a marker compound
in those tests, depending on your product and process. In the 2003 CGMP
Proposal (68 FR 12157 at 12172), we merely discussed how a marker
compound could help you identify whether you have a particular species
of an herb to differentiate, for example, between a poisonous and
nonpoisonous species.

4.  Final § 111.75(e)

     Final § 111.75(e) requires you, before you package or label a
product you receive for packaging or labeling as a dietary supplement
(and for distribution rather than for return to the supplier), to
visually examine the product and have documentation to determine whether
the specifications that you established under final § 111.70 (f) are
met.  Final § 111.75(e) derives from proposed § 111.35(e)(1) and (g)
and from proposed § 111.40(a)(2).

     (Comment 185)  Some comments request we clarify the roles and
testing obligations of the various parties in the “pre-consumer supply
chain” for dietary supplements.  Some comments argue that redundant
tests should not be required at every transaction point in the
pre-consumer supply chain.  The comments contend that any testing
already performed by a supplier, manufacturer, or packager should
suffice, so long as other CGMP certification, and chain of custody
standards, are met.  Other comments urge us to give companies the
flexibility to devise testing procedures and point out that different
testing is needed for different roles in the supply chain.

     One comment requests clarification of the testing requirements
applicable to packagers/labelers.  The comment states it is unclear how
a packager or labeler/distributor could conduct testing of component
ingredients if all the firm receives is a finished product for which
there is no scientifically valid testing method.

     (Response)  As discussed in section VI, you are responsible for the
CGMP requirements that are applicable to your operations. We agree that
redundant tests should not be required.  Further, we agree that it is
the responsibility of the manufacturer to do component testing.  The
packager or labeler does not need to do any required component testing
because the packager or labeler does not receive components, rather it
receives a finished dietary supplement.  Under final § 111.70(f) if you
receive a product from a supplier for packaging or labeling as a dietary
supplement (and for distribution rather than for return to the
supplier), you must establish specifications to provide sufficient
assurance that the product you receive is adequately identified and is
consistent with your purchase order.

	Under final § 111.75(e), before you package or label such a product,
you must visually examine the product and have documentation to
determine whether the specifications that you established under final
§ 111.70(f) are met.  Your documentation may consist of an invoice,
certificate, guarantee, or other documentation from the supplier to
ensure that the product is adequately identified and is the product that
you ordered.  Final § 111.75(e) does not require that the
documentation consist of the result of testing or examination by the
packager or labeler of such a product.

     As with final § 111.70(f), final § 111.75(e) applies to
“product that you receive for *** for distribution rather than for
return to the supplier” and, thus, applies to product that has left
the control of the person who manufactured the batch.  If you are a
packager or labeler who packages and labels a dietary supplement for the
manufacturer, and you will return the packaged and labeled dietary
supplement to the manufacturer, we would not consider that you are
“receiving” product within the meaning of final § 111.75(e).
Thus, you would not be subject to final § 111.70(f).

5. Final § 111.75(f)

	Before you use packaging, final § 111.75(f)(1) requires you, at a
minimum, to conduct a visual identification of the containers and
closures and review the supplier’s invoice, guarantee, or
certification to determine whether packaging specifications are met.
Before you use labels, final § 111.75(f)(2) requires you, at a minimum,
to conduct a visual examination of the label and review the supplier’s
invoice, guarantee, or certification to determine whether labeling
specifications are met.  Final § 111.75(f)(1) and (2) derive from
proposed § 111.40(b)(2) which, in part, would require you, for
packaging and labels you receive, to conduct at least a visual
identification on the containers and closures.  Proposed § 111.40(b)(2)
also would require you, in part, for packaging and labels you receive,
to quarantine the packaging and labels until your quality control unit
tests or examines a representative sample to determine whether
specifications are met.  Consistent with changes that we are making to
the requirements for packaging and labels that you receive (see
discussion of final § 111.160 in section XII), final § 111.75(f)(1)
and (f)(2) include a requirement analogous to proposed § 111.40(a)(2)
which would require you to visually examine the supplier’s invoice,
guarantee, or certification to determine whether the components, dietary
ingredients, or dietary supplements you receive are consistent with your
purchase order and to perform testing, as needed, to determine whether
specifications are met.

6. Final § 111.75(g)

	Final § 111.75(g) requires you, at a minimum, to conduct a visual
examination of the packaging and labeling of the finished packaged and
labeled dietary supplements to determine whether you used the specified
packaging and applied the specified label.  Final § 111.75(g) derives
from proposed § 111.37(b)(11)(iv) which would require the quality
control unit to collect representative samples of each batch of packaged
and labeled dietary ingredients or dietary supplements to determine
whether you used the packaging specified in the master manufacturing
record and applied the label specified in the master manufacturing
record.  Final § 111.75(g) is associated with final § 111.70(g) which
requires you to establish specifications for the packaging and labeling
for the finished packaged and labeled dietary supplements, including
specifications that ensure you used the specified packaging and applied
the specified label.

7.  Final § 111.75(h)

     Final § 111.75(h)(1) requires you to ensure that the tests and
examinations you use to determine whether the specifications are met are
appropriate and scientifically valid methods.  Final § 111.75(h)(1)
derives from proposed § 111.35(h).  Final § 111.75(h)(1) includes
editorial changes associated with the reorganization and changes that we
are making after considering comments.

     Final § 111.75(h)(2) requires that the tests and examinations you
use include at least one of the following: (i) gross organoleptic
analysis; (ii) macroscopic analysis; (iii) microscopic analysis; (iv)
chemical analysis; or (v) other scientifically valid methods.  Final
§ 111.75(h)(2) derives from proposed § 111.35(l).

     (Comment 186)  Some comments suggest that the tests listed in
proposed § 111.35(l) be incorporated into proposed § 111.35 (h),
relating to appropriate test methods.

     (Response)  We agree with the comment, and final § 111.75(h)(2)
combines these requirements as requested.

     (Comment 187)  One comment states that the list of tests should be
deleted because it is not sufficient to cover the types of testing that
will be required for compliance with proposed § 111.35(g).

	(Response)  The comment does not identify the types of tests that would
not be covered.  We believe that final § 111.75(h)(2)(v)’s
“catch-all” provision, which requires that one of the tests that you
use be an “other scientifically valid method” is sufficient to cover
all other types of testing required under this final rule.

     (Comment 188)  One comment states that the final rule should make
clear that organolepsis is an acceptable method for identity testing.
The comment contends it is imperative for the survival of small
businesses that organolepsis be allowed, coupled as necessary with
macroscopic and morphological examination and comparison with voucher
specimens or photographs. Another comment requests clarification of
whether gross organoleptic analysis alone can be a test for releasing
finished products.  Some comments assert that several organizations have
published relevant methods that include macroscopic methods that can be
used in identifying herbal ingredients.

     (Response)  Organolpetic analysis would be an acceptable method
under the 2003 CGMP Proposal and remains an acceptable method under the
final rule, which clarifies that the method you use, including
organoleptic analysis, must be appropriate.  Organoleptic analysis may
not be an appropriate method of testing for certain substances.  This is
particularly true when the nature of the substance decreases the
reliability of organoleptic analysis.  For example, while organoleptic
analysis may be an appropriate identity test for whole or coarsely-cut
botanical parts, it may not be an appropriate identity test for powdered
or extracted botanicals because of decreased reliability, or in those
instances where misidentification of botanicals is known to occur.
Additionally, we recognize “macroscopic analysis” is one of the
tests or examinations you may select to determine whether specifications
are met.

     (Comment 189)  One comment remarks that the appropriateness of the
test depends on the material being tested, and the method selected by
the manufacturer may be inappropriate.  One comment believes the methods
stated in proposed § 111.35(l) (organoleptic, microscopy, chemical)
for establishment of identity and purity would not be applicable to
animal products.  This comment suggests that a separate list of test
methods should be identified for those materials.

(Response)  We agree that the appropriateness of the test depends on the
material being tested.  However, we are not revising the rule to
identify methods that are, or are not, appropriate for specific
circumstances (such as the case of animal-derived ingredients).  There
are so many distinct circumstances that such a list would be neither
practical nor useful.  Beyond that, the manufacturer is responsible for
choosing the appropriate test.

(Comment 190)  One comment asks us to clarify in the final rule the
requirement that methods be scientifically valid applies only to
quantitative methods.

(Response)  In proposed § 111.35(h), we did not intend that the
proposed requirement that you use scientifically valid methods apply
only to quantitative methods, because we also proposed that tests in
accordance with proposed § 111.35 must include at least one of the
following: (1) Gross organoleptic analysis; (2) microscopic analysis;
(3) chemical analysis; or (4) other appropriate test.  To clarify that
the requirement that methods be scientifically valid applies to all the
tests and examinations you use, rather than to quantitative tests alone,
final § 111.75(h)(1) does not use the term “analytical.”

(Comment 191)  One comment states that the proposed definition of
“appropriate test” (i.e., “a scientifically valid analytical
method”) is extremely onerous and violates Congressional intent. The
comment believes that mandating specific methods is inappropriate, and
dietary supplement CGMPs should comply with E.O. 12866 and not impose
additional requirements on small businesses that are better left to
normal business practices.

	Several comments take issue with our statement that we were not aware
of a situation where an appropriate scientifically valid method is not
available when, in fact, valid test methods are not always available for
testing dietary ingredients or dietary supplements.  One comment
contends the 2003 CGMP Proposal contains conflicting information about
available test methods.  For example, the preamble to the 2003 CGMP
Proposal states that we are “not aware of a situation where an
appropriate scientifically valid analytical method is not available,”
and our cost analysis does not address costs of method development.  At
the same time, however, we set out alternatives to finished product
testing in cases where adequate methods are unavailable, and we decline
to require expiration dating because there may not be adequate methods
available for assessing the strength of a dietary ingredient.  The
comment cites numerous ongoing efforts in methods development by both
industry and government that illustrate the lack of existing methods
necessary to confirm compliance with all quality specifications.

(Response)  These comments appear to take our statements out of context.
 In the 2003 CGMP Proposal, we stated: “If an AOAC or FDA method is
not available, a scientifically valid analytical method is one that is
based on scientific data or results published in, for example,
scientific journals, references, text books, or proprietary research.
Although there may not be an Association of Official Analytical Chemist
(AOAC) or FDA method available, we are not aware of a situation where an
appropriate scientifically valid analytical method is not available”
(68 FR 12157 at 12198). We also stated: “We recognize that certain
tests for identity, purity, quality, strength, or composition for
certain finished product may not be available due to complex finished
matrices that would make such testing impracticable” (68 FR 12157 at
12197).  We disagree that our statement acknowledging that the available
tests may not be practicable in certain matrices is inherently
inconsistent with our statement that we are not aware of a situation
where an appropriate scientifically valid analytical method is not
available.  One statement relates to the availability of methods, the
other relates to the practicality of using an available method in
particular circumstances.

In any case, under final § 111.75(d)(1) you may exempt a product
specification from the verification requirements of final §
111.75(c)(1) if you show that: (1) the specifications selected to verify
that the product meets all product specifications are not able to verify
that the control system is producing a dietary supplement that meets the
exempted product specification and (2) there is no scientifically valid
method for testing or examining the exempted product specification at
the finished batch stage.  Section 111.75(c)(1) also requires you to
document why other information, such as component and in-process
testing, will determine whether the exempted product specification is
met without finished batch testing.  Although we agree that there may be
some circumstances where there is not a scientifically valid method
available for finished product testing, we believe that there would be
some scientifically valid method available for component or in-process
testing.

(Comment 192) One comment encourages flexibility toward the development
of a quality system that is based on a balance of prevention, appraisal,
and process verification activities.  Another comment asks whether the
industry should use industry standards and tests now used.

A few comments request that we clarify proposed § 111.35(h) to make it
clear whether the section recommends or requires the use of available
USP, AOAC or FDA methods.  One comment recommends that the final rule
give companies flexibility to use the method(s) most suitable to the
ingredient they are testing and the specification they have set.  The
comment adds that companies should then be required to ensure, through
appropriate rationale and data, that the method is indeed suitable and
produces accurate and reproducible results.

(Response)  We agree that companies should have the flexibility to adopt
the method most suitable to the ingredient they are testing.  As
discussed in the preamble to the proposal (68 FR 12157 at 12163, 12208),
official methods, such as AOAC International methods, are validated in
collaborative studies using several laboratories under identical
conditions and the AOAC International methods are often cited as
“official validated methods.”  Other method validations are
conducted in a single laboratory by repeating the same test multiple
times.  In the case of methods used to support specific regulatory
applications to FDA, data and information about methods that are
developed and conducted in a single laboratory by repeating the test
multiple times are sent to us, together with appropriate samples and
reference materials so the test can be repeated in an agency laboratory.
 Typical validation characteristics include accuracy, precision,
specificity, detection limit, quantitation limit, linearity, range, and
robustness.

The process of method validation discussed above is a formal process for
demonstrating that procedures are suitable for their intended use.
Although many methods that are scientifically valid have been formally
validated, other methods may not have been subject to the formal
validation process, (e.g., by collaborative studies using multiple
laboratories) but nonetheless remain scientifically valid because they
are, in fact, suitable for their intended use.  For this reason, we
stated that the 2003 CGMP Proposal would permit tests using methods
other than those that are officially validated (68 FR 12157 at 12163).
Consistent with the view that we expressed in the 2003 CGMP Proposal, we
believe a scientifically valid method is one that is accurate, precise,
and specific for its intended purpose.  In other words, a scientifically
valid test is one that consistently does what it is intended to do.

Under final § 111.75(h)(1), you must ensure the tests and examinations
you use to determine whether the specifications are met are appropriate,
scientifically valid methods.  Under final § 111.75(h)(2) the tests and
examinations you use must include at least one of the following: (1)
Gross organoleptic analysis, (2) Macroscopic analysis, (3) Microscopic
analysis, (4) Chemical analysis, or (5) Other scientifically valid
methods.

(Comment 193)  One comment questions how a company would know of all the
available scientifically valid methods when it deals with hundreds of
items.  The comment states it cannot be expected to have expertise in
the assay methodology for so many different ingredients.

Several comments suggest we make fuller use of available monographs and
other resources on test methods and method development.  These sources
include USP and American Herbal Pharmacopoeia monographs, AOAC
International, the European Pharmacopoeia, and the WHO.  The comments
urge us to disseminate information on these additional resources.

Many comments assert that several organizations have published relevant
analytical methods, such as macroscopic, microscopic, and chemical
methods, that can be used in identifying herbal ingredients.  These
comments suggest that we should acknowledge those methods and
organizations as authoritative sources of quality standards.

(Response) In the preamble to the 2003 CGMP Proposal (68 FR 12157 at
12209), we acknowledged that validated methods exist in official
compendia for vitamins, minerals, and several botanicals, and we
recommended you use validated methods whenever such methods are
available.  We explicitly stated that you may use validated methods that
can be found in official references, such as AOAC International, USP,
and others.

As discussed in this section (see response to comment 196), we believe
that it is sufficient to provide in this preamble general guidance on
what we consider to be scientifically valid tests, such as those based
on scientific data or results published in, for example, scientific
journals, references, text books, or proprietary research, and leave it
to the manufacturer to decide what scientifically valid tests or
examinations to use in a given operation.  In the future, we may
consider issuing guidance as to sources of appropriate tests or
examinations, along with other guidances that we may find useful that
relate to certain dietary supplement CGMP.

     (Comment 194)  One comment states the act prohibits us from
imposing testing requirements for which scientifically valid methods are
not generally available, and other comments believe that not all
components have scientifically valid identification tests.  Given the
substantial ongoing efforts towards method development, the comments
believe that the proposed requirements for testing would impose
standards on many products and ingredients that cannot be met through
current and generally available methods.

     (Response) We disagree that the statute prohibits us from imposing
testing requirements.  Section 402(g)(2) of the act states that dietary
supplement CGMP regulations “may not impose standards for which there
is no current and generally available analytical methodology.”  We are
not imposing such standards.  The manufacturer must establish
specifications for its product and components, and we have provided
flexibility for how the manufacturer can determine whether those
specifications are met. The manufacturer can  test, examine, rely on a
certificate of analysis (other than to verify the identity of dietary
ingredients), or, in the case of a specification that is exempted from
periodic testing of a finished batch, rely on other information that
ensures that such an exempted product  specification is met.

	(Comment 195)  One comment requests clarification on the definition of
“examination” and asks whether it includes monitoring of process
parameters as established in the master manufacturing record.  If so,
the comment questions whether this practice would satisfy the
requirement now in final § 111.75(h)(1).

     (Response)  Under final § 111.75(h) scientifically valid tests and
examinations include techniques such as gross organoleptic analysis,
macroscopic analysis, chemical analysis, and other scientifically valid
methods.  As discussed in the response to comment 169, monitoring
in-process parameters could encompass tests such as measuring pH or
viscosity.  Such tests would fall under “other scientifically valid
methods.”

    (Comment 196)  One comment contends that botanical identification is
largely ignored in the 2003 CGMP Proposal.  The comment states that
botanical identification forms the basic foundation for botanical
authenticity and that manufacturers have a legal responsibility to
ensure the authenticity of claimed ingredients.  The comment recommends
that specific requirements for authentication of botanical ingredients
be included in the final rule.

      One comment points out the difficulty in identifying and analyzing
all naturally occurring ingredients in herbs and plants and suggests
several alternatives to testing for all such ingredients.  Another
comment requests that an herbal product containing 20 percent or more
ethanol have relaxed testing requirements due to the bacteriostata
properties of ethanol.  One comment lists some alternatives for testing
naturally occurring ingredients.

     One comment requests clarification on the testing requirements for
bovine cartilage products.  The comment states there is no published
method for extracting chondroitin sulfate from bovine cartilage.  As a
result, the comment assumes that testing for chondroitin sulfate would
not be required for these products.

	(Response)  We believe that it is sufficient to provide in this
preamble general guidance about testing, such as our discussion that
scientifically valid tests include official, validated methods as well
as tests based on scientific data or results published in, for example,
scientific journals, references, text books, or proprietary research.
It is the manufacturer’s responsibility to choose which scientifically
valid tests or examinations to use in a given operation.  Therefore, the
final rule does not address the specific testing circumstances described
in these comments, such as testing requirements for an herbal product
that contains 20 percent or more ethanol, or for bovine cartilage
products.  The manufacturer is responsible for establishing
specifications and meeting such specifications, consistent with the
requirements in this final rule.  In the future, we may consider issuing
detailed guidance as to specific tests or examinations, along with other
guidances that may be useful that relate to certain dietary supplement
CGMP.

	With respect to the comments that discuss botanical identification, we
note that the 2003 CGMP Proposal referred to the draft report of the
Dietary Supplement Working Group of FDA’s Food Advisory Committee
(FAC)(68 FR 12157 at 12161) (Ref. 329).  The draft report discusses the
selection of the most appropriate and reliable identity test and the
general principles for consideration in setting performance standards
for such tests (Ref. 329).  This report may provide useful guidance.

8.  Final § 111.75(i)

     Final § 111.75(i) requires you to establish corrective action
plans for use when an established specification is not met.  Final
§ 111.75(i) derives from proposed § 111.35(i)(1).

	(Comment 197) One comment asks whether the proposed requirement to
establish corrective action plans for use when an established
specification is not met (proposed § 111.35(i)(1)) would apply to
specifications for raw materials and finished goods as well as to
in-process specifications.

     (Response) The requirement to establish corrective action plans
(final § 111.75(i)) applies to components, in-process specifications,
and to the finished batch.

	(Comment 198) One comment states that corrective action plans would be
difficult to prepare for a variety of situations, such as for complex
multivitamin and mineral formulas.  One comment recommends this
requirement be deleted.  Another comment asserts that establishment of
corrective action plans should be at the manufacturer’s discretion.

     (Response)  We disagree that the final rule should not require you
to establish corrective plans or that having such plans should be at the
manufacturer’s discretion.  The purpose of having corrective action
plans in place before a problem occurs is to help you to deal quickly
and efficiently with problems as they arise.

	You may have a corrective action plan to determine the steps to take if
something goes wrong such as not meeting a specification. Moreover, a
corrective action plan may include steps not only for dealing with an
acute problem, but also for dealing with steps you would take to
followup after the acute problem is resolved.  For example, after you
resolve an acute problem, such as a failure to meet an in-process
specification, your corrective action plan may include testing of every
finished batch, rather than a subset of finished batches, for some
period of time to verify that the problem is resolved.

     We acknowledge that it may not be practical to establish a
corrective action plan for all circumstances, because not all
circumstances are foreseeable.  However, the comment asserting that it
would be difficult to establish corrective action plans for the variety
of situations that could come up for complex multivitamin and mineral
formulas provided no basis for why manufacturers of such formulas could
not anticipate specific situations that present potential problems.

     (Comment 199)  Some comments recommend that proposed §
111.35(i)(1) state “Establish procedures,” rather than “Establish
corrective action plans.”

     (Response)  The comments did not explain what, if any, practical
difference would exist between “procedures” and “corrective action
plans.”  A corrective action plan is a procedure for which you must
have a record in the master manufacturing record (final §
111.210(h)(5)).  Because “corrective action plans” is a term that is
commonly used in the industry, we have retained it in the final rule.

J. What Must You do if Established

Specifications are Not Met?

(Final § 111.77)

	1. Final § 111.77

	As we explain in section II, we reorganized the final rule to make it
more “user-friendly” and to clarify the rule’s applicability to
certain persons, items, or activities.  Final § 111.77 is a new
provision that clarifies your responsibilities and identifies those
responsibilities in a more “user-friendly” fashion.  We have
identified in one final § 111.77 the consequences of not meeting the
specifications you establish under this subpart and when you can
consider a treatment, in-process adjustment, or reprocessing to correct
a failure to meet and established specification for a component, dietary
supplement, packaging, or label.  Subpart F does identify these
consequences in several provisions which deal with the responsibility of
the quality control personnel unit to review and approve or reject
components, dietary supplements, packaging, and labels.  We determined
it would add clarity to state the consequences for not meeting a
specification in the same subpart in which the requirements to establish
specifications are located.

	2. Final § 111.77(a)

	Final § 111.77(a) requires that for specifications established under
§ 111.70(a), (b)(2), (b)(3), (c), (d), (e), and (g) that you do not
meet, the quality control personnel unit, in accordance with the
requirements in subpart F of this part, must reject the component,
dietary supplement, package or label unless it approves a treatment, an
in-process adjustment, or reprocessing that will ensure the quality of
the finished dietary supplement and that the dietary supplement is
packaged and labeled as specified in the master manufacturing record.
No finished batch of dietary supplements may be released for
distribution unless it complies with final § 111.123(bB).

	This provision identifies those specifications, if not fully met, that
may be able to be corrected by treatment, in-process adjustment, or
reprocessing and approved by the quality control personnelunit.  We
emphasize, however, that even if, for example, corrections are approved,
the finished batch of dietary supplement can not be released for
distribution unless it is compliance with the requirements of final §
111.123(b) (discussed in section XI).

	Final § 111.77(a) derives from the following proposed provisions:

•   § 111.50(d)(2) which would require the quality control unit not
to approve and release for distribution any batch of dietary supplement
that does not meet all specifications;

•   § 111.50(f) which would require you to not reprocess a batch that
deviates from the master manufacturing record unless approved by the
quality control unit.

•    § 111.50(g) which would require that a reprocessed batch of
dietary supplement meet all specifications and that the quality control
unit approve its release for distribution.

•    § 111.35(i)(4)(i) which would require, for any deviation or
unanticipated occurrence which resulted in or could lead to adulteration
of the component, dietary supplement, packaging, or label, you to reject
the component, dietary supplement, packaging, or label, unless the
quality control unit determines that in-process adjustments are possible
to correct the deviation or occurrence.

•    § 111.35(i)(4)(ii) which would require, for any deviation or
unanticipated occurrence which resulted in or could lead to adulteration
of the component, dietary supplement, packaging, or label, you to not
reprocess a rejected component or dietary supplement unless approved by
the quality control unit.

	3. Final § 111.77(b)

	Final § 111.77(b) requires that for specifications established under
final § 111.70(b)(1) that you do not meet, the quality control
personnel unit must reject the component and the component must not be
used in manufacturing the dietary supplement.  Final § 111.77(b)
complements final § 111.70(b)(1) which requires you to establish an
identity specification for components; final § 111.75(a)(1) which
requires you to conduct at least one appropriate test or examination to
verify the identity of any component that is a dietary ingredient; and
final § 111.75(a)(2) which requires you to confirm the identity of all
other components.  As discussed earlier in this section, many comments
recommended the final rule include a requirement for an identity test of
incoming components to ensure quality and safety.  We agree with these
comments and earlier comments that point out it may not be possible to
confirm the identity of some components after they have been processed
into the finished batch of the dietary supplement.  For these reasons,
we have concluded that, if the component specification for identity is
not met, you may not use the component in the manufacture of the dietary
supplement.  This component specification must be met and the quality
control personnel unit is are restricted in what action it must be taken
if this specification is not met.

	4. Final § 111.77(c)

	Final § 111.77(c) requires that if you do not meet the specifications
established under § 111.70(f), the quality control personnelunit must
reject the product and the product must not be packaged or labeled for
distribution as a dietary supplement.  As with final § 111.77(b), final
§ 111.77(c) limits the actions you can take to package and label
product you receive for packaging and labeling from a supplier for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier).  Final § 111.77(c) complements
final § 111.70(f), which requires you to establish a specification for
such received product and final § 111.75(e), which requires you to
visually examine the product, before you package or label it, and have
documentation to determine whether the specifications that you
established under § 111.70(f) are met.  If you do not meet the
specifications under final § 111.70(f), you must reject the product
and not package or label the product for distribution as a dietary
supplement.

	K.  Comments on Shelf-Life

	In the preamble to the 2003 CGMP Proposal (68 FR 12157 at 12203), we
stated that we had considered whether to propose requirements for
expiration dating, shelf-life dating, or “best if used by” dating
(referred to in this preamble as shelf-life or expiration dating).  We
recognized that there are current and generally available methods to
determine the expiration date of some dietary ingredients, such as
vitamin C.  However, we were uncertain whether there are current and
generally available methods to determine the expiration dating of other
dietary ingredients, especially botanical dietary ingredients.  We did
not propose to require expiration dating because we had insufficient
scientific information to determine the biological activity of certain
dietary ingredients used in dietary supplements, and such information
would be necessary to determine an expiration date.  Further, because
official validated testing methods (i.e., AOAC or FDA) for dietary
supplements are evolving, especially for botanical dietary ingredients,
such methods are not always available to assess the strength of a
dietary ingredient in a dietary supplement.

     The preamble to the 2003 CGMP Proposal emphasized that, if you use
an expiration date on a product, you should have data to support that
date (68 FR 12157 at 12204).  We recommended that you have a written
testing program designed to assess the stability characteristics of the
dietary supplement, and that you use the results of the stability
testing to determine appropriate storage conditions and expiration
dates.

    In the 2003 CGMP Proposal (68 FR 12157 at 12204), we invited comment
on whether any final rule should contain provisions regarding expiration
dating and the feasibility of conducting tests needed to support such
dates.  We also invited comment on whether to require expiration dating
on certain dietary ingredients and not others, for example, require
expiration dating of vitamin, mineral, and amino acid, but not of
botanical dietary ingredients.

     (Comment 200)  Several comments agree with our decision not to
require expiration dating on labels for dietary supplements at this
time, because of the wide range of products and the need for additional
data.  Most of these comments state, however, that manufacturers should
be allowed to include a “best if used by” date.  One comment
suggests addressing the issue in a separate rulemaking.  Other comments
support an expiration date because consumers and retailers expect one,
and some markets require one. Some comments state that the expiration
date or statement of product shelf life will help ensure that the
product meets its label claims and potency.

     Many comments state an expiration date on a label must be supported
by a rationale or data on stability testing.  Some of those comments
suggest that manufacturers should have flexibility in the type of
supporting data used.  Although label claims should be confirmed by
shelf-life testing when analytical methods exist, data could come from a
manufacturer’s experience with the product or accelerated stability
testing on similar products with the same storage container.  One
comment points out that some manufacturers already use stability
testing.  Another comment recommends that we provide a guidance document
on supporting data.

     One comment suggests stringent supporting data are not needed for a
“best if used by” date, because that date provides a recommended
time frame to ensure the best quality.  Another comment asserts that the
discussion about expiration dates in the 2003 CGMP Proposal gives the
impression that the required level of supporting data is similar to the
requirements for drug labeling, rather than the requirements for food
shelf life labeling.  Another comment recommends that a general maximum
shelf life of four or five years should be included in the rule, with
shortened or lengthened shelf lives for individual products as data
become available.

     (Response)  These comments do not provide data or information that
would reduce the uncertainty about the feasibility of conducting tests
to support an expiration date and, thus, do not persuade us to alter our
position not to require that you establish an expiration date for your
product.  Indeed, the comments generally concur with that position.
Because the final rule does not require that you establish an expiration
date, we decline to offer guidance on the type of data that are
acceptable to support an expiration date, other than to repeat that any
expiration date that you place on a product label (including a “best
if used by” date) should be supported by data.

	L.  What Representative Samples Must You Collect?

	(Final § 111.80)

	Final § 111.80 sets forth requirements to collect representative
samples of components, packaging, and labels (final § 111.80(a));
in-process materials (final § 111.80(b)); the finished batch of
dietary supplement (final § 111.80(c)); product you receive for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier) (final § 111.80(d)); and
packaged and labeled dietary supplements (final § 111.80(e)).  Final
§ 111.80(a) through (e) derive from proposed § 111.37(b)(11)(i)
through (b)(ll)(iv).

1.  Final § 111.80(a)

     Final § 111.80(a) requires you to collect representative samples
of each unique lot of components, packaging, and labels that you use to
determine whether the components, packaging, and labels meet
specifications established in accordance with § 111.70(b) and (d), and
as applicable, final § 111.70(a) (and, when you receive components,
packaging, or labels from a supplier, representative samples of each
unique shipment, and of each unique lot within each unique shipment).
Final § 111.80(a) derives from proposed § 111.37(b)(11)(i).  Final
§ 111.80(a) includes changes related to our review of the proposed
requirements for clarity.  We had used the term “shipment lot” in
several proposed requirements, including § 111.35(g)(1)(i) (requirement
to test components that you receive), § 111.37(b)(11)(i) (requirement
to collect representative samples of components that you receive), §
111.40(a)(4) (requirements for components that you receive), §
111.40(b)(5) (requirements for packaging and labels that you receive)
and § 111.50(c)(5) (requirement to identify materials that you use in
the batch production record).  Some of these proposed requirements
(e.g., those in §§ 111.40(a)(4), 111.40(b)(3), and 111.50(b)(5)) make
clear that you must be able to trace each lot of materials you receive
to each separate shipment that contains that lot.  To clarify and
emphasize this meaning of shipment lot, we are revising proposed §
111.37(b)(11)(i) so that the representative samples you collect must
come from “each unique shipment, and of each unique lot within each
unique shipment.”  We make analogous revisions throughout the final
rule as necessary.

	As discussed in this section, final § 111.70(b) sets forth the
requirements to establish specifications for components, final § 111.73
requires you to determine if the specifications established are met, and
final § 111.75(a) sets forth the criteria you use to determine whether
these specifications are met.  Likewise, final § 111.70(f) sets forth
the requirements to establish specifications for product that you
receive from a supplier for packaging or labeling as a dietary
supplement (and for distribution rather than for return to the
supplier), final § 111.73 requires you to determine if specifications
established are met, and final § 111.75(e) sets forth the criteria to
use to determine whether these specifications are met.

	 For consistency with the regulations in final §§ 111.70 and 111.75,
we are separating the requirement to collect representative samples of
components (final § 111.80(a)) from the requirement to collect
representative samples of product that you receive from a supplier for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier)(final § 111.(80)(d)).

	We did not receive comments specific to proposed § 111.37(b).

2.  Final 111.80(b)

     Final § 111.80(b) requires you to collect representative samples
of in-process materials for each manufactured batch at points, steps, or
stages, in the manufacturing process as specified in the master
manufacturing record, where control is necessary to ensure the identity,
purity, strength, and composition of dietary supplements, to determine
whether the  materials meet specifications established under final
§ 111.70(c), and as applicable, final § 111.70(a).  Final §
111.80(b) derives from proposed § 111.37(b)(11)(ii).

     We did not receive comments specific to proposed §
111.37(b)(11)(ii).

3.  Final 111.80(c)

     Final § 111.80(c) requires you to collect representative samples
of a subset of finished batches of each dietary supplement you
manufacture, which you identify through a sound statistical sampling
plan (or otherwise every finished batch), before releasing for
distribution, to verify that the finished batch of dietary supplement
meets product specifications established in accordance with final §
111.70(e), and as applicable, final § 111.70(a).  Final § 111.80(c)
derives from proposed § 111.37(b)(11)(iii).  Final § 111.80(c)
includes changes associated with final § 111.75(c) which provides
flexibility for you to test or examine a subset of finished batches you
select through a sound statistical sampling plan rather than to test or
examine all finished batches.  Under final § 111.75(c) the tests or
examinations you conduct at the finished batch stage verify that your
process is in control.

     We did not receive comments specific to proposed §
111.37(b)(11)(iii).

4.  Final § 111.80(d)

	Final § 111.80(d) requires you to collect representative samples of
each unique shipment, and of each unique lot within each unique
shipment, of product you receive for packaging or labeling as a dietary
supplement (and for distribution rather than for return to the supplier)
to determine whether the received product meets the specifications
established under final § 111.70(f), and as applicable, final
§ 111.70(a).  Final § 111.80(d) derives from proposed
§ 111.37(b)(11)(i).  We did not receive comments specific to this
proposed requirement.  However, we are making changes to final
§ 111.80(d) consistent with those described for final § 111.80(a).

5.  Final § 111.80(e)

     Final § 111.80(e) requires you to collect representative samples
of each lot of packaged and labeled dietary supplements to determine
whether the packaging and labeling of the packaged and labeled dietary
supplements meet specifications established in accordance with final
§111.70 (g), and as applicable, final § 111.70(a).  Final
§ 111.80(e) derives from proposed § 111.37(b)(11)(iv).  Final §
111.80(e) includes revisions associated with final § 111.70(g), which
requires you to establish specifications for the packaging and labeling
of the finished packaged and labeled dietary supplements.  Final
§ 111.70(g) includes specifications that determine whether you used
the packaging specified in the master manufacturing record and you
applied the label specified in the master manufacturing record.  Under
final § 111.70(a) and (g) the parameters that we proposed to specify
under proposed § 111.37(b)(11)(iv) are the required specifications for
packaged and labeled dietary supplements.

	Final § 111.80(e) includes a change to clarify the exact
specifications by citing the relevant sections.  Final § 111.80(e)
also includes an editorial change in that you are required to
“determine whether” specifications are met rather than to
“determine that” specifications are met.  We are making this change
because “determine that specifications are met” may be interpreted
as a predetermined outcome -- i.e., that specifications will, in fact,
be met.

     We did not receive comments specific to proposed §
111.37(b)(11)(iv).

	M.  What Are the Requirements for Reserve Samples?

	(Final § 111.83)

     Final § 111.83 sets forth requirements to collect and hold
reserve samples of dietary supplements.  Final § 111.83 derives from
proposed §§ 111.37(b)(12), 111.50 and 111.83(b)(2).

     Under proposed § 111.37(b)(12) we would require holding reserve
samples as an operation performed by the quality control unit.  Under
proposed § 111.50(h), we proposed that you collect representative
reserve samples of each batch of dietary supplement.  Consistent with
the changes that we are making to final § 111.80, final § 111.83
does not specify who must collect and hold the required reserve samples.
 However, under final § 111.105(g), the quality control personnelunit
retains oversight of the collection and holding of the required reserve
samples.  Because the requirement to collect and hold reserve samples is
not an operation that must be performed by the quality control
personnelunit, we are including the requirement to collect reserve
samples in subpart E as part of the elements of a production and process
control system rather than in subpart F as part of the requirements for
the quality control personnelunit.

     For consistency with terms used elsewhere in the final rule, final
§ 111.83 requires that you “hold” reserve samples rather than
“keep” them.

1.  Final § 111.83(a)

     Final § 111.83(a) requires you to collect and hold reserve
samples of each lot of packaged and labeled dietary supplements that you
distribute.  Final § 111.83(a) derives, in part, from proposed §
111.37(b)(12) which would require the quality control unit to keep the
reserve samples and, in part, from proposed § 111.50(h), which would
require you to collect representative reserve samples from each batch of
dietary supplement.

     (Comment 201)  Several comments ask for clarification of the
requirements for representative and reserve samples as proposed in §
111.37(b)(11) and (12).  One comment notes that proposed
§ 111.37(b)(11) does not indicate whether representative samples are
also collected to serve as the reserve samples described in proposed §
111.37(b)(12) and asks whether the items in proposed
§ 111.37(b)(11)(i) through (b)(11)(iv) are to be kept as reserve
samples.

     (Response)  As discussed in section VI, we are adding a definition
of “reserve sample” to reduce the potential for confusion between
requirements for reserve samples and requirements for representative
samples.  A reserve sample is a representative sample that is held for a
designated period of time.

2.  Final § 111.83(b)(1)

     Final § 111.83(b)(1) requires the reserve samples to be held
using the same container-closure system in which the packaged and
labeled dietary supplement is distributed, or if distributing dietary
supplements to be packaged and labeled, using a container-closure system
that provides essentially the same characteristics to protect against
contamination or deterioration as the one in which it is distributed for
packaging and labeling elsewhere.  Final § 111.83(b)(1) derives from
proposed § 111.83(b)(2) which we proposed to include with the
requirements for holding and distributing.  The final sections that
derive from proposed § 111.83(b)(2) are in subpart M (final
§ 111.465). However, we are duplicating these requirements in final
§ 111.83(b)(1) for clarity and ease of use, so that you have
information about the requirements for the container-closure system for
holding reserve samples of packaged and labeled dietary supplements in
the same section as the requirements to collect the samples.

3.  Final § 111.83(b)(2)

     Final § 111.83(b)(2) requires that reserve samples be identified
with the batch, lot, or control number.  Final § 111.83(b)(2) derives
from proposed § 111.37(b)(12)(i) with editorial changes associated with
the reorganization.  We have added “control” number to the provision
for consistency with other provisions of the final rule which refer to a
“control number” in addition to a “batch or lot number.”

     We did not receive comments specific to proposed
§ 111.37(b)(12)(i).

4.  Final § 111.83(b)(3)

	Final § 111.83(b)(3) requires that reserve samples be retained for
one year past the shelf life date (if shelf life dating is used), or for
23 years from the date of distribution of the last batch of dietary
supplements associated with those reserve samples, for use in
appropriate investigations.  Final § 111.83(b)(3) derives from
proposed § 111.37(b)(12) which would require the quality control unit
to keep the reserve samples for 3 years from the date of manufacture for
use in appropriate investigations including, but not limited to,
consumer complaint investigations to determine, for example, whether the
dietary supplement associated with a consumer complaint failed to meet
any of its specifications for identity, purity, quality, strength, and
composition, as well as from proposed § 111.50(h) which would require
reserve samples to be kept for 3 years from the date of manufacture.  We
discuss the change from 3 years to 2 years and the change from “date
of manufacture” to “the date of distribution” in connection with
the recordkeeping requirements in subpart P, section XXI.

    Final § 111.83(b)(3) thus provides flexibility in determining how
long you must hold reserve samples of packaged and labeled dietary
supplements.

    Final § 111.83(b)(3) does not include the proposed examples of
investigations that may require the use of reserve samples because these
examples are not requirements.

     (Comment 202) Many comments address the requirement to keep the
reserve samples after manufacture and recommend that expiration dates be
a factor when determining the amount of time reserve samples should be
kept and maintained.  Most of the comments recommend holding reserve
samples of packaged and labeled dietary supplements for three years from
the date of manufacture or, when an expiration date has been established
by the manufacturer, for 1 year after the expiration date.  Other
comments recommend holding reserve samples for time periods ranging from
6 months to 2 years after the expiration date.

     (Response)  The final rule contains requirements similar to the
suggestions made by the comments.  The final rule provides flexibility
to hold reserve samples for one year past the shelf life date, when such
dating is used.  Any shelf life date that you include on the label of
the product should be supported by scientific data.

 5.  Final § 111.83(b)(4)

     Final § 111.83(b)(4) requires that reserve samples consist of at
least twice the quantity necessary for all tests or examinations to
determine whether or not the dietary supplement meets product
specifications.  Final § 111.83(b)(4) derives from proposed
§ 111.37(b)(12)(ii) which would require that the reserve samples
consist of at least twice the quantity necessary for tests.

     Final § 111.83(b)(4) provides that the reserve samples may be
used for examinations or tests and to determine whether or not the
dietary supplement meets product specifications, as a revision
associated with final § 111.75.

     (Comment 203)  One comment agrees that twice the quantity necessary
for testing should be collected and held.

     (Response) The final rule is consistent with this comment.

N. Who Conducts a Material Review and

 Makes a Disposition Decision?

(Final § 111.87)

     Final § 111.87 requires the quality control personnel unit to
conduct all required material reviews and make all required disposition
decisions.  Final § 111.87 derives from a number of proposed
requirements for conducting a material review and making a disposition
(§§ 111.35(i), 111.35(n), 111.37(b)(5), 111.37(b)(14), 111.40(a)(3),
111.50(d)(1), 111.85(a), and 111.85(c)).  Under each of these
provisions, the quality control unit would have an oversight role and
would review and approve all material reviews and all disposition
decisions.  Under some of these provisions (i.e., §§ 111.50(d)(1),
111.85(a), and 111.85(c)) the quality control unit would conduct the
material review itself and make the disposition decision.

     (Comment 204)  One comment disagrees that the quality control unit
must conduct the material review and make the disposition decision.  The
comment argues that manufacturing personnel are better qualified to
conduct the review and make disposition decisions because they are often
engineers and have the relevant expertise regarding the use of machinery
and people to produce a product.  In contrast, the comment asserts that
quality control unit personnel generally are chemists with expertise
only in testing and little expertise in manufacturing.  The comment
asserts that the quality control unit should not be expected to make
decisions concerning manufacturing operations; however, it should be
informed of changes so it can evaluate the results of reprocessing on
the finished product.

     (Response)  We agree, in part, with the comments and the final rule
simplifies the provisions regarding a material review and disposition
decision.  The qQuality control personnel unit can conduct the material
review and disposition decision by reviewing the underlying information
gathered or obtained by other qualified personnel and then making the
final decision.  Under the final rule, we retain the principle that
qualified individuals other than those in the quality control personnel
unit can contribute to the quality control personnelunit’s material
review and disposition decision.  The final rule sets forth the
following requirements:

●    Under final § 111.87 the quality control personnel unit must
conduct all required material reviews and make all required disposition
decisions;

●    Under final § 111.103 you must establish and follow written
procedures for conducting a material review and making a disposition
decision; and

●    Under final § 111.140(b)(3)(vii) documentation of a material
review and disposition decision and followup must include the signature
of the individual(s) designated to perform the  from the quality control
operations, unit who conducted the material review and made the
disposition decision, and of any qualified individual who provided
information relevant to that material review and disposition decision.

     Taken in total, the final rule establishes a system in which you
have flexibility to develop procedures that suit your organization,
including having qualified individuals, other than outside of the
designated quality control personnel, unit provide information relevant
to the material review and disposition decision.  For example, under
final § 111.140(b)(3), you could have a qualified individual in the
production department prepare a report that includes all the required
documentation and information and provide a signed copy of that report
to designated the quality control personnel unit.  An individual from
the designated to perform quality control operations unit would then
read that report, add to it if necessary, conduct any additional
investigations if necessary, and if he or she agrees with the report,
co-sign the report or an amended report that includes additional
documentation or information, thus completing a material review and
disposition decision.

	The final rule provides for the participation of qualified individuals,
other than those designated to perform in the quality control operations
unit, in conducting the material review.  In addition, as already
discussed, under final § 111.12(b) you may assign a qualified
individual who has responsibilities for operations other than quality
control to perform quality control operations, provided that the
individual has distinct and separate responsibilities related to
performing quality control operations.

O.  What Requirements Apply to Treatments, In-process Adjustments, and
Reprocessing When There

is a Deviation or Unanticipated Occurrence or When a Specification
Established in Accordance with § 111.70 is not Met?

	(Final § 111.90)

1.  Final § 111.90

    Final § 111.90 is a unified provision that clarifies your
responsibilities regarding treatment or in-process adjustments to a
component, and in-process adjustments or reprocessing of a dietary
supplement, in a more “user-friendly” fashion.  We have identified
in one provision the restrictions that apply to these operations.  Final
§ 111.90 derives from proposed §§ 111.35(i)(4)(i), (ii) and (iii),
111.50(d)(1), (f), and (g), and 111.65(d).

       Final § 111.90 includes the following changes we are making to
the proposed provisions for consistency and clarity.

•	We are making revisions to make the section consistent with the
definition of “reprocessing” in final § 111.3, which refers only to
“components or dietary supplements that have been previously removed
from manufacturing.”

•	We are adding “treatments” as a step that the quality control
personnel unit could approve, because that term better describes actions
that could be taken to correct a deviation or unanticipated occurrence
with a component, packaging or label.

•	We are clarifying that it is the quality control personnel unit that
who rejects components, packaging, or labels.

•	We are clarifying that the quality control personnel unit approves
the treatment, in-process adjustment, or reprocessing rather than
determines whether the treatment, in-process adjustment, or reprocessing
is possible.

•	We are clarifying that, with respect to labels, the provision
applies to the potential that a label not specified in the master
manufacturing record could be used.

• 	We are making changes to be consistent with the new provision,
final § 111.77.

     (Comment 205) One comment recommends deletion of proposed §
111.35(i)(4) and (i)(4)(i), arguing that the principles of those
sections are covered under proposed § 111.35(i)(2) and (i)(3).

     (Response) We disagree with the comment’s assertion.  The
requirements of proposed § 111.35(i)(4) and (i)(4)(i) are not covered
by proposed § 111.35(i)(2) and (i)(3).  All the sections are related,
but deal with different aspects of corrective action.  Proposed
§ 111.35(i)(2) and (i)(3) would require the firm to conduct a material
review and make a disposition decision, while proposed § 111.35(i)(4)
would prohibit the use of rejected ingredients unless the quality
control unit determines that in-process adjustments are possible to
correct the deviations or occurrence.  We are making no changes as
suggested by this comment and the primary elements of proposed §
111.35(i)(4) are retained in final § 111.90.

    (Comment 206)  A few comments state their support for the
requirement that the quality control unit have the authority to
determine whether adjustments are possible to correct a deviation.

     (Response)  We are retaining the proposed requirement for quality
control personnel in final § 111.90.

2.  Final § 111.90(a)

     Final § 111.90(a) requires that you must not reprocess a rejected
dietary supplement, treat or provide an in-process adjustment to a
component, packaging, or label to make it suitable for use in the
manufacture of a dietary supplement, unless: (1) the quality control
personnel unit conducts a material review and makes a disposition
decision to approve the reprocessing, treatment, or in-process
adjustment; and (2) the reprocessing, treatment, or in-process
adjustment is permitted by § 111.77.

	Final § 111.90(a) derives from proposed §§ 111.35(i)(4)(ii) and
111.50(d)(1).  We revised this provision to be consistent with the
changes in final § 111.77.

     (Comment 207) Several comments state their support for proposed
§ 111.35(i)(4)(ii) which would require the quality control unit to
approve the reprocessing of any rejected component, dietary ingredient,
or dietary supplement.  However, not all comments agree that the quality
control should have to conduct (under proposed § 111.50(d)(1)), rather
than review and approve, a material review and disposition decision.

(Response) As discussed in this section, by “conduct a material review
and make a disposition decision,” we do not intend to limit those who
may participate in a material review and disposition decision to only
those persons acting in their capacity as the designated quality control
personnelunit.  Others may assist the quality control personnel unit in
gathering and considering information relevant to the review and
decision, however the quality control personnelunit havehas the
responsibility to conduct a material review and make disposition
decisions.  Thus, we are retaining the requirements in proposed
§§ 111.25(i)(4)(ii) and 111.50(d)(1) in final § 111.90(a).

3.  Final § 111.90(b)

     Final § 111.90(b) requires that you must not reprocess anyor
dietary supplement, treat or provide and in-process adjustment to a
component to make it suitable for use in the manufacture of a dietary
supplement, unless: (1) your quality control personnelunit conducts a
material review and makes a disposition decision based on a
scientifically valid reason and approves the reprocessing, treatment, or
in-process adjustment; and (2) the reprocessing, treatment or in-process
adjustment is permitted by § 111.77.  Final § 111.90(b) derives from
proposed §§ 111.35(i)(4)(iii), 111.50(f), and 111.65(d).  We revised
this provision to be consistent with the changes in final § 111.77.

     (Comment 208) As discussed in section VI (discussion of the
definition of “reprocessing”), some comments object to the
restrictions in the definition of reprocessing in proposed § 111.3,
because the definition would not permit the reprocessing of ingredients
that may have been removed because of insanitary conditions even if
there are processes available that are safe and effective in removing
foreign matter, microorganisms, or chemicals that may have rendered the
ingredient “insanitary.”  These comments also object to proposed §
111.35(i)(4)(iii) for the same reasons.  A few comments argue that a
manufacturer should be able to reprocess a component or dietary
supplement if it has been rejected because of contamination with
microorganisms or types of contamination, such as heavy metals, if the
quality control unit approves the reprocessing.  These comments indicate
this is the industry practice, one based on a scientific rationale for
doing the reprocessing and that ensures other quality attributes of the
product are not affected.

     Some comments state that the requirement is more strict than the
food or drug CGMP requirements, noting that reprocessing is widely
accepted and allowed in the food CGMPs.  Other comments believe that the
prohibition in proposed § 111.35(i)(4)(iii) against reprocessing
materials contaminated with microorganisms should be limited to
materials contaminated with health-hazardous microorganisms.

     (Response) As we discussed in the response to comment 53 for the
definition of “reprocessing”, we agree with the comments that state
that in-process materials can be reprocessed when there are suitable
processes available.  However, as noted by the comments, it is critical
that there be appropriate oversight of the reprocessing so the quality
of the dietary supplement is not compromised.  Final § 111.90(b)
provides for the flexibility requested by the comments, provided that
there is oversight by the quality control personnelunit.

     (Comment 209) Proposed § 111.35(i)(4)(iii) mentions
“microorganism or other contaminants, such as heavy metals.”  One
comment proposes that other contaminants, such as pesticides and
aflatoxin, should be mentioned.  Another comment suggests that the final
rule should specify limits for heavy metals in dietary supplements.

     (Response)  We decline to revise the final rule as suggested by the
comments.  It is impractical to provide an exhaustive list of relevant
types of contamination, and a list that is longer, but not exhaustive,
is more likely to be misunderstood as suggesting that the only types of
contamination that are significant are the types of contamination in the
list.  For that reason, we have eliminated the reference to
contamination to clarify that in any instance where it is appropriate
the quality control unit personnel must ensure that the disposition
decision is based on a scientifically valid reason and it also approves
the reprocessing.

     (Comment  210)  One comment notes that in the May 9, 2003,
satellite broadcast concerning the 2003 CGMP Proposal, we indicated that
treating a component or dietary supplement with irradiation as a means
to reduce or eliminate the microbial load was acceptable as long as the
treatment was part of the process for producing that material.  The
comment asks for confirmation that irradiation of components or dietary
supplements is allowed under part 179, even though such treatments are
not listed in the table provided in § 179.26 (b).

    (Response)  We are unable to provide the requested confirmation.
Under section 201(s) of the act, irradiation intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food is a food additive that
requires premarket review and approval before it can be used in food.
Our Office of Food Additive Safety is currently reviewing a food
additive petition for the use of irradiation on dietary ingredients and
dietary supplements.  Until that review process is completed and we have
authorized this use of irradiation through a final rule codified in part
179, irradiation of dietary ingredients and dietary supplements as a
means to reduce or eliminate microbial loads is not permitted.  However,
you may use an irradiated component (such as a spice that is used to
flavor a dietary supplement) when the irradiation of that component is
allowed under § 179.26.

4.  Final § 111.90(c)

     Final § 111.90(c) requires that any batch of dietary supplement
that is reprocessed, that contains components that you have treated, or
to which you have made in-process adjustments to make them suitable for
use in the manufacture of the dietary supplement must be approved by the
quality control personnel unit and comply with final § 111.23(b) before
releasing for distribution. Final § 111.90(c) derives from proposed
§ 111.50(g).

     Final § 111.90(c) also includes conforming revisions to clarify
that a dietary supplement that contains a component treated before use
or adjusted in-process, or that has had in-process adjustments to make
it suitable for use in the manufacture of a dietary supplement, must be
approved by the quality control personnelunit and comply with final §
111.23(b) before releasing for distribution.  We revised this provision
to be consistent with the changes in final § 111.77 and final §
111.23(b).

     Final § 111.90(c) also includes revisions to reflect the final
provisions that relate to reprocessing and in-process adjustments (see
final §§ 111.113, 111.120, and 111.155).

     (Comment 211)  One comment asserts that a reprocessed product
should be retested to confirm that it meets product specifications.

     (Response) Under final § 111.75(c) and (d) the quality control
personnel unit haves flexibility to determine whether tests or
examinations are necessary to ensure that a reprocessed product meets
product specifications.

	P.  Under this Subpart, What Records Must You Make and Keep?

	(Final § 111.95)

1.  § 111.95(a)

     Final § 111.95(a) requires you to make and keep records required
under this subpart in accordance with subpart P.  Final § 111.95(a)
derives from proposed § 111.35(o).  Some of the records required under
subpart E are set forth as recordkeeping requirements in other subparts
of this final rule, such as those related to receiving records for
components, packaging, and labels in subpart G, and the results of
testing or examination in subpart J.  The record requirements not
specifically required in other related subparts are listed in subpart E.

     (Comment 212)  One comment supports the recordkeeping requirements,
states that the records provide a valuable paper trail that will allow
manufacturers to identify and fix problems in the process, and suggests
the requirements protect consumers from adulterated and misbranded
products.

     (Response)  We agree.  Under final § 111.95(a) firm must make and
keep records required by subpart E in accordance with subpart P.  As
discussed in this section, firms are required to keep the records
necessary for determining whether their products are made in accordance
with specifications.  This will help them identify and correct any
problems.  In addition, under subpart P, the records must be kept for 1
year past the shelf life date (if shelf life dating is used) or twothree
years beyond the date of distribution of the last batch of dietary
supplements associated with those records.  Moreover, firms must make
their records available to us for inspection and copying, which will
permit us to determine whether firms are manufacturing, packaging,
labeling, and holding dietary supplements in accordance with the
requirements of this rule.

2.  § 111.95(b)

     Final § 111.95(b) specifies the records you must make and keep
under subpart E.  Under the reorganization several recordkeeping
requirements of proposed § 111.35 are set forth in other subparts.

     Final § 111.95(b)(1) requires you to make and keep records of the
specifications established.  Final § 111.95(b)(1) derives from proposed
§ 111.35(o)(1).

     Final § 111.95(b)(2) requires you to make and keep records of
your qualification of a supplier for the purpose of relying on the
supplier’s certificate of analysis.  Final § 111.95(b)(2) is a
record that is required under final § 111.75(a)(2)(B).

     Final § 111.95(b)(3) requires you to make and keep documentation
for why meeting in-process specifications, in combination with meeting
component specifications, helps ensure that the dietary supplement meets
the specifications for identity, purity, strength, and composition and
for limits on those types of contamination that may adulterate or may
lead to adulteration of the finished batch of the dietary supplement.
Final § 111.95(b)(3) refers to records required under final
§ 111.70(c)(2).

     Final § 111.95(b)(4) requires you to make and keep documentation
for why the results of appropriate tests or examinations for the product
specifications selected under final § 111.75(c)(1) ensures that the
dietary supplement meets all product specifications.  Final
§ 111.95(b)(4) is a record that is required under final
§ 111.75(c)(3).

	Final § 111.95(b)(5) requires you to make and keep documentation for
why any component and in-process testing, examination, or monitoring,
and any other information, will ensure that a product specification that
is exempted under final § 111.75(d) is met without verification through
periodic testing of the finished batch, including documentation that the
selected specifications tested or examined under final § 111.75(c)(1)
are not able to verify that the production and process control system is
producing a dietary supplement that meets the exempted product
specification and there is no scientifically valid method for testing or
examining such exempted product specification at the finished batch
stage.  Final § 111.95(b)(5) refers to a record  required under final
§ 111.75(d)(1).  As previously discussed in this section, we are
issuing an Interim Final Rule, published elsewhere in this FEDERAL
REGISTER, that sets forth a procedure for requesting an exemption from
exception to the requirement that the manufacturer conduct at least one
appropriate test or examination to verify the identity of any component
that is a dietary ingredient.  Included in the Interim Final Rule is an
amendment to final § 111.95(b) adding a new subparagraph (6) requiring
the retention of FDA’s response to a petition submitted under
§ 111.75(a)(1)(ii) that provides for an exemption from the provision
of § 111.75(a)(1)(i).

	(Comment 213)  One comment recommends the recordkeeping requirements of
proposed § 111.35(m) be moved to follow the requirements for
appropriate test methods, because these requirements are related and
probably best understood without intervening information.

     (Response)  Consistent with this comment, the recordkeeping
requirements of proposed § 111.35(m) are set forth in final subpart J
instead of this subpart.

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al function. Succeeding editions upgraded the specifications for these
substances and added specifications for substances that come into
contact with foods and some that are regarded as foods, rather than as
additives. The FCC is available for purchase at 1-800-624-6242 or at
www.nap.edu.

FDA-Internal-Deliberative-Confidential

Final Subpart E 9-28-05, 6-26-06, 3-30-07, 5-4-07

Page   PAGE  473


[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Rules and Regulations]
[Pages 40598-40600]
[FR Doc No: 2011-16777]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30791; Amdt. No. 3433]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective July 11, 2011. The compliance date for
each SIAP, associated Takeoff Minimums,

and ODP is specified in the amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of July 11, 2011.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169; or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1.FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2.The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

     Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on June 24, 2011.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97, 14 CFR part 97, is amended by
amending Standard Instrument Approach Procedures, effective at 0901 UTC
on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC date            State               City               Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
28-Jul-11............  OK               Ada................  Ada Muni...........       1/1077      5/27/11  RNAV (GPS) RWY 35, Orig.
28-Jul-11............  WI               Sheboygan..........  Sheboygan County          1/5993      6/15/11  VOR RWY 21, Amdt 8.
                                                              Memorial.

28-Jul-11............  WI               Sheboygan..........  Sheboygan County          1/5994      6/15/11  RNAV (GPS) RWY 21, Amdt 2.
                                                              Memorial.
28-Jul-11............  FL               Fort Lauderdale....  Fort Lauderdale/          1/7769      6/16/11  RNAV (RNP) Z RWY 9R, Orig-C.
                                                              Hollywood Intl.
28-Jul-11............  DC               Washington.........  Washington Dulles         1/9881      5/26/11  RNAV (RNP) Z RWY 1R, Orig-A.
                                                              Intl.
28-Jul-11............  DC               Washington.........  Washington Dulles         1/9891      5/26/11  RNAV (RNP) Z RWY 19L, Orig-A.
                                                              Intl.
28-Jul-11............  FL               Orlando............  Orlando Intl.......       1/9893      5/26/11  RNAV (RNP) Z RWY 17L, Orig.
28-Jul-11............  FL               Orlando............  Orlando Intl.......       1/9894      5/26/11  RNAV (RNP) Z RWY 36R, Orig.
28-Jul-11............  FL               Orlando............  Orlando Intl.......       1/9895      5/26/11  RNAV (RNP) Z RWY 18R, Orig.
28-Jul-11............  DC               Washington.........  Ronald Reagan             1/9896      5/26/11  RNAV (RNP) RWY 19, Orig-B.
                                                              Washington
                                                              National.
28-Jul-11............  FL               Orlando............  Orlando Intl.......       1/9897      5/26/11  RNAV (RNP) Z RWY 36L, Orig.
28-Jul-11............  FL               Orlando............  Orlando Intl.......       1/9899      5/26/11  RNAV (RNP) Z RWY 17R, Orig.
28-Jul-11............  FL               Orlando............  Orlando Intl.......       1/9900      5/26/11  RNAV (RNP) Z RWY 35R, Orig.
28-Jul-11............  DC               Washington.........  Ronald Reagan             1/9909      5/26/11  RNAV (RNP) RWY 1, Orig.
                                                              Washington
                                                              National.
28-Jul-11............  FL               Orlando............  Orlando Intl.......       1/9910      5/26/11  RNAV (RNP) Z RWY 35L, Orig.
28-Jul-11............  FL               Orlando............  Orlando Intl.......       1/9911      5/26/11  RNAV (RNP) Z RWY 18L, Orig.
28-Jul-11............  FL               West Palm Beach....  Palm Beach Intl....       1/9913       6/3/11  RNAV (RNP) Z RWY 32, Orig-A.
28-Jul-11............  FL               West Palm Beach....  Palm Beach Intl....       1/9915       6/3/11  RNAV (RNP) Z RWY 14, Orig-A.
28-Jul-11............  FL               West Palm Beach....  Palm Beach Intl....       1/9916       6/3/11  RNAV (RNP) Z RWY 28R, Orig-A.
28-Jul-11............  DC               Washington.........  Washington Dulles         1/9919      5/26/11  RNAV (RNP) Z RWY 19C, Orig-B.
                                                              Intl.
28-Jul-11............  DC               Washington.........  Washington Dulles         1/9925      5/26/11  RNAV (RNP) Z RWY 1C, Orig-C.
                                                              Intl.
28-Jul-11............  NC               Raleigh/Durham.....  Raleigh-Durham Intl       1/9930      5/26/11  RNAV (RNP) Z RWY 23L, Amdt 1.
28-Jul-11............  NC               Raleigh/Durham.....  Raleigh-Durham Intl       1/9931      5/26/11  RNAV (RNP) Z RWY 23R, Amdt 1.
28-Jul-11............  NC               Raleigh/Durham.....  Raleigh-Durham Intl       1/9932      5/26/11  RNAV (RNP) Z RWY 5L, Amdt 1.
28-Jul-11............  NC               Raleigh/Durham.....  Raleigh-Durham Intl       1/9933      5/26/11  RNAV (RNP) Z RWY 5R, Amdt 1.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-16777 Filed 7-8-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 15, 2009 (Volume 74, Number 113)]
[Notices]
[Page 28231-28232]
[DOCID:fr15jn09-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-420-000]

Gulf South Pipeline Company, LP; Notice of Application

June 8, 2009.
    Take notice that on May 22, 2009, Gulf South Pipeline Company, LP
(Gulf South), filed with the Federal Energy Regulatory Commission
(Commission) an application under section 7(c) of the Natural Gas Act
(NGA) seeking: (i) authorization to construct, install, own, operate
and maintain three new compressor units and yard and station piping,
including appurtenant and auxiliary facilities, at two existing Gulf
South compressor stations in the State of Louisiana--the Hall Summit
Compressor Station, Bienville Parish, Louisiana, where two new turbine
compressor units totaling 32,913 horsepower (HP) are proposed, and at
the Tallulah Compressor Station, Madison Parish, Louisiana, where one
new 17,558 hp turbine compressor unit is proposed, and (ii) a
predetermination that Gulf South may charge incremental rates for the
capacity created by the compression upgrades, all as more fully
described in the application.
    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: J.
Kyle Stephens, Vice President of Regulatory Affairs, Boardwalk Pipeline
Partners, LP, 9 Greenway Plaza, Suite 2800, Houston, Texas 77046, at
713-479-8033 or fax 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, before the
comment date of this notice, 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.
    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: June 29, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-13960 Filed 6-12-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 23, 2006 (Volume 71, Number 56)]
[Notices]
[Page 14746-14747]
[DOCID:fr23mr06-76]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 1-00368]

Issuer Delisting; Notice of Application of Chevron Corporation,
To Withdraw Its Common Stock, $.75 Par Value, From Listing and
Registration on the Pacific Exchange, Inc.

March 16, 2006.
    On March 13, 2006, Chevron Corporation, a Delaware corporation
(``Issuer''), filed an application with the Securities and Exchange
Commission (``Commission''), pursuant to Section 12(d) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 12d2-2(d)
thereunder,\2\ to withdraw its common stock, $.75 par value
(``Security''), from listing and registration on the Pacific Exchange,
Inc. (``PCX'').
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78l(d).
    \2\ 17 CFR 240.12d2-2(d).
---------------------------------------------------------------------------

    The Board of Directors (``Board'') of the Issuer approved a
resolution on February 28, 2006 to withdraw the Security from listing
on PCX. The Issuer stated that the Board decided to withdraw the
Security from listing on PCX because the benefits of continued listing
on PCX do not outweigh the incremental cost of the listing fees and the
administrative burden associated with listing on PCX. The Issuer stated
that the Security is listed on the New York Stock Exchange, LLC
(``NYSE'') and will remain listed on NYSE.
    The Issuer stated in its application that it has complied with
applicable rules of PCX by providing PCX with the required documents
governing the withdrawal of securities from listing and registration on
PCX. The Issuer's application relates solely to the withdrawal of the
Security from listing on PCX and shall not affect its continued listing
on NYSE or its obligation to be registered under Section 12(b) of the
Act.\3\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78l(b).
---------------------------------------------------------------------------

    Any interested person may, on or before April 11, 2006, comment on
the facts bearing upon whether the application has been made in
accordance with the rules of PCX, and what terms, if any, should be
imposed by the Commission for the protection of investors. All comment
letters may be submitted by either of the following methods:

Electronic Comments

     Send an e-mail to<EMAIL_ADDRESS>Please include
the File Number 1-00368 or;

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number 1-00368. This file
number should be included on the subject line if e-mail is used. To
help us process and review your comments more efficiently, please use
only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/delist.shtml).

Comments are also available for public inspection and copying in the
Commission's Public Reference Room. All comments received will be
posted without change; we do not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly.
    The Commission, based on the information submitted to it, will
issue an order granting the application after the date mentioned above,
unless the Commission determines to order a hearing on the matter.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\4\
---------------------------------------------------------------------------

    \4\ 17 CFR 200.30-3(a)(1).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-4177 Filed 3-22-06; 8:45 am]

BILLING CODE 8010-01-P


Comment Info: =================

General Comment:Gulf South Pipeline  Docket No. PHMSA-2006-26533    Notice of Operation under Special Permit Parameters