Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment, 27727-27728 [E8-10727]
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rfrederick on PROD1PC67 with RULES
Federal Register / Vol. 73, No. 94 / Wednesday, May 14, 2008 / Rules and Regulations
Houston, TX, Ellington Field, Takeoff and
Minimums and Obstacle DP, Amdt 2
Houston, TX, George Bush Intercontinental/
Houston, ILS OR LOC RWY 8L, ILS RWY
8L (CAT II), ILS RWY 8L (CAT III), Amdt
1A
Houston, TX, George Bush Intercontinental/
Houston, ILS OR LOC RWY 8R, Amdt 22B
Houston, TX, George Bush Intercontinental/
Houston, ILS OR LOC RWY 9, Amdt 7A
Houston, TX, George Bush Intercontinental/
Houston, ILS OR LOC RWY 15R, Amdt 1A
Houston, TX, George Bush Intercontinental/
Houston, ILS OR LOC RWY 26L, ILS RWY
26L (CAT II), ILS RWY 26L (CAT III), Amdt
18A
Houston, TX, George Bush Intercontinental/
Houston, ILS OR LOC RWY 26R, ILS RWY
26R (CAT II), ILS RWY 26R (CAT III),
Amdt 1A
Houston, TX, George Bush Intercontinental/
Houston, ILS OR LOC RWY 27, ILS RWY
27 (CAT II), ILS RWY 27 (CAT III), Amdt
6A
Houston, TX, George Bush Intercontinental/
Houston, RNAV (GPS) RWY 15R, Amdt 1A
Houston, TX, George Bush Intercontinental/
Houston, RNAV (GPS) Z RWY 8L, Amdt 2
Houston, TX, George Bush Intercontinental/
Houston, RNAV (GPS) Z RWY 8R, Amdt
1A
Houston, TX, George Bush Intercontinental/
Houston, RNAV (GPS) Z RWY 9, Amdt 2A
Houston, TX, George Bush Intercontinental/
Houston, RNAV (GPS) Z RWY 26L, Amdt
1A
Houston, TX, George Bush Intercontinental/
Houston, RNAV (GPS) Z RWY 26R, Amdt
1A
Houston, TX, George Bush Intercontinental/
Houston, RNAV (GPS) Z RWY 27, Amdt
1A
Houston, TX, George Bush Intercontinental/
Houston, Takeoff and Minimums and
Obstacle DP, Amdt 2
Houston, TX, Houston-Southwest, Takeoff
and Minimums and Obstacle DP, Amdt 5
Houston, TX, Lone Star Executive, Takeoff
and Minimums and Obstacle DP, Amdt 2
Houston, TX, Sugar Land Rgnl, Takeoff and
Minimums and Obstacle DP, Amdt 7
Houston, TX, Weiser Air Park, Takeoff and
Minimums and Obstacle DP, Amdt 2
Houston, TX, West Houston, Takeoff and
Minimums and Obstacle DP, Amdt 2
Houston, TX, William P. Hobby, Takeoff and
Minimums and Obstacle DP, Amdt 5
La Porte, TX, La Porte Muni, Takeoff and
Minimums and Obstacle DP, Amdt 4
Louisa, VA, Louisa County/Freeman Field,
LOC/DME RWY 27, Amdt 2
Charlotte Amalie, VI, Cyril E King, Takeoff
Minimums and Obstacle DP, Amdt 1
Appleton, WI, Outagamie County Rgnl, LOC
BC RWY 11, Amdt 1B, CANCELLED
Ashland, WI, John F. Kennedy Memorial,
RNAV (GPS) RWY 2, Orig
Ashland, WI, John F. Kennedy Memorial,
RNAV (GPS) RWY 13, Orig
Ashland, WI, John F. Kennedy Memorial,
RNAV (GPS) RWY 20, Orig
Ashland, WI, John F. Kennedy Memorial,
RNAV (GPS) RWY 31, Orig
Ashland, WI, John F. Kennedy Memorial,
VOR RWY 2, Amdt 6
Ashland, WI, John F. Kennedy Memorial,
VOR RWY 31, Amdt 7
VerDate Aug<31>2005
14:57 May 13, 2008
Jkt 214001
Ashland, WI, John F. Kennedy Memorial,
Takeoff and Minimums and Obstacle DP,
Amdt 1
La Pointe, WI, Madeline Island, RNAV (GPS)
RWY 4, ORIG
La Pointe, WI, Madeline Island, RNAV (GPS)
RWY 22, ORIG
La Pointe, WI, Madeline Island, Takeoff and
Minimums and Obstacle DP, Orig
Lone Rock, WI, Tri-County Rgnl, RNAV
(GPS) RWY 9, Orig
Lone Rock, WI, Tri-County Rgnl, RNAV
(GPS) RWY 27, Orig
Lone Rock, WI, Tri-County Rgnl, VOR–A,
Amdt 7
Oshkosh, WI, Wittman Rgnl, RNAV (GPS)
RWY 9, Orig
Oshkosh, WI, Wittman Rgnl, RNAV (GPS)
RWY 18, Orig
Oshkosh, WI, Wittman Rgnl, RNAV (GPS)
RWY 27, Orig
Oshkosh, WI, Wittman Rgnl, VOR RWY 9,
Amdt 9
Oshkosh, WI, Wittman Rgnl, VOR RWY 18,
Amdt 7
Oshkosh, WI, Wittman Rgnl, GPS RWY 27
Orig-A, CANCELLED
Oshkosh, WI, Wittman Rgnl, Takeoff and
Minimums and Obstacle DP, Orig
* * * Effective 3 JUL 2008
Warroad, MN, Warroad Intl Memorial, ILS
OR LOC RWY 31, Amdt 1A
Rome, NY, Griffiss Airfield, Rome, NY,
Takeoff Minimums and Obstacle DP, Orig
[FR Doc. E8–10546 Filed 5–13–08; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 111
[Docket No. FDA–2008–N–0152] (Formerly
Docket No. 1996N–0417)
RIN 0910–AB88
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements; Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
final rule that appeared in the Federal
Register of June 25, 2007 (72 FR 34752).
The final rule established current good
manufacturing practice (CGMP)
requirements in manufacturing,
packaging, labeling, or holding
operations for dietary supplements. The
final rule was published with an
inadvertent error in the codified section.
This document corrects that error. This
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
27727
action is being taken to improve the
accuracy of the agency’s regulations.
DATES: This rule is effective May 14,
2008.
FOR FURTHER INFORMATION CONTACT:
Vasilios H. Frankos, Center for Food
Safety and Applied Nutrition (HFS–
810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1696.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 25, 2007 (72 FR
34752), FDA established CGMP
requirements in manufacturing,
packaging, labeling, or holding
operations for dietary supplements (part
111 (21 CFR part 111)). In the codified
section of the rule, § 111.75(c)(3)
provides that ‘‘You must provide
adequate documentation of your basis
for determining compliance with the
specification(s) selected under
paragraph (c)(1) of this section, through
the use of appropriate tests or
examinations conducted under
paragraph (c)(2) of this section, will
ensure that your finished batch of the
dietary supplement meets all product
specifications for identity, purity,
strength, and composition, and the
limits on those types of contamination
that may adulterate, or that may lead to
the adulteration of, the dietary
supplement’’ (72 FR 34752 at 34949).
Due to an inadvertent error, the word
‘‘that’’ was omitted between
‘‘determining’’ and ‘‘compliance.’’ This
document corrects that error.
List of Subjects in 21 CFR Part 111
Dietary foods, Drugs, Foods,
Packaging and containers.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 111 is
amended as follows:
PART 111—CURRENT GOOD
MANUFACTURING PRACTICE IN
MANUFACTURING, PACKAGING,
LABELING, OR HOLDING
OPERATIONS FOR DIETARY
SUPPLEMENTS
1. The authority citation for 21 CFR
part 111 continues to read as follows:
I
Authority: 21 U.S.C. 321, 342, 343, 371,
374, 381, 393; 42 U.S.C. 264.
2. Section 111.75 is amended by
revising paragraph (c)(3) to read as
follows:
I
§ 111.75 What must you do to determine
whether specifications are met?
*
*
*
(c) * * *
E:\FR\FM\14MYR1.SGM
14MYR1
*
*
27728
Federal Register / Vol. 73, No. 94 / Wednesday, May 14, 2008 / Rules and Regulations
(3) You must provide adequate
documentation of your basis for
determining that compliance with the
specification(s) selected under
paragraph (c)(1) of this section, through
the use of appropriate tests or
examinations conducted under
paragraph (c)(2) of this section, will
ensure that your finished batch of the
dietary supplement meets all product
specifications for identity, purity,
strength, and composition, and the
limits on those types of contamination
that may adulterate, or that may lead to
the adulteration of, the dietary
supplement; and
*
*
*
*
*
List of Subjects
26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
§ 1.937–2
[Amended]
Par. 5. Section 1.937–2 is amended as
follows:
In paragraph (k) Example 2. (i), the
fourth sentence, the language ‘‘On June
1, 2010, R’s interest in Partnership P is
not a marketable security within the
meaning of section 731(c)(2).’’ is
removed and the language ‘‘On June 1,
2010, R’s interest in Partnership P is not
a marketable security within the
meaning of paragraph (f)(1)(vii)(A) of
this section.’’ is added in its place.
§ 1.937–3
Paragraph 1. The authority citation
for part 1 continues to read, in part, as
follows:
Par. 6. Section 1.937–3 is amended as
follows:
In paragraph (e) Example 5. (ii), the
last sentence, the language
‘‘Accordingly, the U.S. income rule of
section 937(b)(2), § 1.937–2(c)(1), and
paragraph (c)(1) of this section does not
operate to prevent Corporation B’s
services income from being Territory X
source or Possession X effectively
connected income within the meaning
of section 937(b)(1).’’ is removed and
the language ‘‘Accordingly, the U.S.
income rule of section 937(b)(2),
§ 1.937–2(c)(1), and paragraph (c)(1) of
this section does not operate to prevent
Corporation B’s services income from
being Possession X source or Possession
X effectively connected income within
the meaning of section 937(b)(1).’’ is
added in its place.
I
26 CFR Part 301
Employment taxes, Estate taxes,
Excise taxes, Gift taxes, Income taxes,
Penalties, Reporting and recordkeeping
requirements.
Correction of Publication
I
DEPARTMENT OF THE TREASURY
Internal Revenue Service
I
26 CFR Parts 1 and 301
[TD 9391]
Authority: 26 U.S.C. 7805 * * *
RIN 1545–BF85
Source Rules Involving U.S.
Possessions and Other Conforming
Changes; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendments.
AGENCY:
rfrederick on PROD1PC67 with RULES
As published, final regulations (TD
9391) contain errors that may prove to
be misleading and are in need of
clarification.
PART 1—INCOME TAXES
BILLING CODE 4160–01–S
SUMMARY: This document contains
corrections to final regulations (TD
9391) that were published in the
Federal Register on Wednesday, April
9, 2008 (73 FR 19350) providing rules
under section 937(b) of the Internal
Revenue Code for determining whether
income is derived from sources within
a U.S. possession or territory specified
in section 937(a)(1) (generally referred
to in this preamble as a ‘‘territory’’) and
whether income is effectively connected
with the conduct of a trade or business
within a territory.
DATES: This correction is effective May
14, 2008, and is applicable on April 9,
2008.
FOR FURTHER INFORMATION CONTACT: J.
David Varley, (202) 622–7790 (not a tollfree number).
SUPPLEMENTARY INFORMATION:
Background
The final regulations and removal of
temporary regulations that are the
subjects of this document are under
14:57 May 13, 2008
Need for Correction
Virgin Islands.’’ is removed and the
language ‘‘In the case of an individual
who is required to file an income tax
return with the United States as a
consequence of failing to satisfy the
requirements of paragraphs (c)(2)(i)(A)
or (B) of this section, there will be
allowed as a credit against the tax
imposed by this chapter for the taxable
year an amount equal to the amount of
the tax liability referred to in section
934(a) to the extent paid to the Virgin
Islands.’’ is added in its place.
Accordingly, 26 CFR parts 1 and 301
are corrected by making the following
correcting amendments:
Dated: May 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–10727 Filed 5–13–08; 8:45 am]
VerDate Aug<31>2005
sections 1, 170A, 861, 871, 876, 881,
884, 901, 931, 932, 933, 934, 935, 937,
957, 1402, 6012, 6038, 6046, 6688, and
7701 of the Internal Revenue Code.
Jkt 214001
I Par. 2. Section 1.881–5 is amended as
follows:
In paragraph (f)(2), the language
‘‘Section 935’’ possession is defined in
§ 1.935–1(a)(3)(i).’’ is removed and the
language ‘‘Section 935 possession’’ is
defined in § 1.935–1(a)(3)(i).’’ is added
in its place.
§ 1.884–0
[Amended]
Par. 3. Section 1.884–0 is amended as
follows:
In paragraph (b)(1), the last sentence,
the language ‘‘The preceding sentence
applies for taxable years ending after
April 11, 2005.’’ is removed and the
language ‘‘The preceding sentence
applies for taxable years ending after
April 9, 2008.’’ is added in its place.
I
§ 1.932–1
[Amended]
I Par. 4. Section 1.932–1 is amended as
follows:
In paragraph (c)(3), the first sentence,
the language ‘‘In the case of an
individual who is required to file an
income tax return with the United
States as a consequence of failing to
satisfy the requirements of paragraphs
(c)(2)(i)(A) and (B) of this section, there
will be allowed as a credit against the
tax imposed by this chapter for the
taxable year an amount equal to the
amount of the tax liability referred to in
section 934(a) to the extent paid to the
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Sfmt 4700
[Amended]
I
PART 301—PROCEDURE AND
ADMINISTRATION
I Par. 7. The authority citation for part
301 continues to read, in part, as
follows:
Authority: 26 U.S.C. 7805 * * *
Par. 8. Section 301.6688–1 is
amended as follows:
In paragraph (c), in the first sentence
of the paragraph, the language ‘‘(1) In
general. The penalty set forth in
paragraph (a) of this section will not
apply if it is established to the
satisfaction of the appropriate tax
authority (as defined in paragraph (c)(2)
of this section) that the failure to file the
information return or furnish the
I
E:\FR\FM\14MYR1.SGM
14MYR1
]]>Agencies
[Federal Register Volume 73, Number 94 (Wednesday, May 14, 2008)]
[Rules and Regulations]
[Pages 27727-27728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10727]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 111
[Docket No. FDA-2008-N-0152] (Formerly Docket No. 1996N-0417)
RIN 0910-AB88
Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements; Technical
Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that appeared in the Federal Register of June 25, 2007 (72 FR
34752). The final rule established current good manufacturing practice
(CGMP) requirements in manufacturing, packaging, labeling, or holding
operations for dietary supplements. The final rule was published with
an inadvertent error in the codified section. This document corrects
that error. This action is being taken to improve the accuracy of the
agency's regulations.
DATES: This rule is effective May 14, 2008.
FOR FURTHER INFORMATION CONTACT: Vasilios H. Frankos, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1696.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 2007 (72
FR 34752), FDA established CGMP requirements in manufacturing,
packaging, labeling, or holding operations for dietary supplements
(part 111 (21 CFR part 111)). In the codified section of the rule,
Sec. 111.75(c)(3) provides that ``You must provide adequate
documentation of your basis for determining compliance with the
specification(s) selected under paragraph (c)(1) of this section,
through the use of appropriate tests or examinations conducted under
paragraph (c)(2) of this section, will ensure that your finished batch
of the dietary supplement meets all product specifications for
identity, purity, strength, and composition, and the limits on those
types of contamination that may adulterate, or that may lead to the
adulteration of, the dietary supplement'' (72 FR 34752 at 34949). Due
to an inadvertent error, the word ``that'' was omitted between
``determining'' and ``compliance.'' This document corrects that error.
List of Subjects in 21 CFR Part 111
Dietary foods, Drugs, Foods, Packaging and containers.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
111 is amended as follows:
PART 111--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
0
1. The authority citation for 21 CFR part 111 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42
U.S.C. 264.
0
2. Section 111.75 is amended by revising paragraph (c)(3) to read as
follows:
Sec. 111.75 What must you do to determine whether specifications are
met?
* * * * *
(c) * * *
[[Page 27728]]
(3) You must provide adequate documentation of your basis for
determining that compliance with the specification(s) selected under
paragraph (c)(1) of this section, through the use of appropriate tests
or examinations conducted under paragraph (c)(2) of this section, will
ensure that your finished batch of the dietary supplement meets all
product specifications for identity, purity, strength, and composition,
and the limits on those types of contamination that may adulterate, or
that may lead to the adulteration of, the dietary supplement; and
* * * * *
Dated: May 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10727 Filed 5-13-08; 8:45 am]
BILLING CODE 4160-01-S
