Electronic Tariff Filings, 63886 [E8-25611]
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Federal Register / Vol. 73, No. 209 / Tuesday, October 28, 2008 / Rules and Regulations
33°37′ N., longitude 86°45′ W.; thence to
latitude 32°30′ N., longitude 86°25′ W.;
thence to latitude 33°22′ N., longitude
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longitude 79°20′ W.; thence to latitude
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thence to latitude 41°43′ N., longitude
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longitude 72°44′ W.; thence to latitude
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longitude 67°55′ W., point of beginning.
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Issued in Washington, DC, on October 23,
2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. E8–25692 Filed 10–27–08; 8:45 am]
BILLING CODE 4910–13–P
and the word ‘‘mailed’’ is removed, and
the word ‘‘posted’’ is added in its place.
§ 35.14
[Corrected]
2. On page 57532, in the third column,
in § 35.14, instruction 15a is revised to
read as follows: In paragraph (a),
introductory text, the phrase ‘‘(fuel
clause)’’ is added after the phrase ‘‘Fuel
adjustment clauses’’, and the phrase ‘‘,
tariffs or service agreements’’ is added
after the phrase ‘‘rate schedules’’
anywhere it appears in the paragraph’s
introductory text.
■
Kimberly D. Bose,
Secretary.
[FR Doc. E8–25611 Filed 10–27–08; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DEPARTMENT OF ENERGY
21 CFR Parts 201, 208, and 209
Federal Energy Regulatory
Commission
[Docket No. FDA–2003–N–0313] (formerly
Docket No. 2003N–0342)
18 CFR Part 35
RIN 0910–AC35
[Docket No. RM01–5–000, Order No. 714]
Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products
Electronic Tariff Filings
October 22, 2008.
AGENCY:
Federal Energy Regulatory
Commission.
ACTION: Final rule; correction.
AGENCY:
ACTION:
The Federal Energy
Regulatory Commission published a
document in the Federal Register on
October 3, 2008 (73 FR 57515), revising
Commission rules. That document
inadvertently included two nonsubstantive errors in the instructions for
the amendatory language. This
document corrects those instructions.
DATES: Effective Date: Effective on
November 3, 2008.
FOR FURTHER INFORMATION CONTACT:
Andre Goodson, Office of the General
Counsel, Federal Energy Regulatory
Commission, 888 First Street, NE.,
Washington, DC 20426, (202) 502–8560,
Andre.Goodson@ferc.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
E8–22500 appearing on page 57515 in
the Federal Register of Friday, October
3, 2008, the following corrections are
made:
ebenthall on PROD1PC60 with RULES
SUMMARY:
§ 35.13
[Corrected]
1. On page 57532, in the second
column, in § 35.13, instruction 14g is
revised to read as follows: In paragraph
(b)(3), the word ‘‘schedule’’ is removed;
■
VerDate Aug<31>2005
14:54 Oct 27, 2008
Jkt 217001
Food and Drug Administration,
HHS.
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is issuing a final
rule that confirms the interim final rule
entitled ‘‘Toll-Free Number for
Reporting Adverse Events on Labeling
for Human Drug Products’’ (73 FR 402,
January 3, 2008) (interim final rule) and
responds to comments submitted in
response to the request for comments in
the proposed rule of the same title (69
FR 21778, April 22, 2004) (proposed
rule). This final rule affirms the interim
final rule’s requirement for the addition
of a statement to the labeling for certain
human drug products for which an
application is approved under section
505 of the Federal Food, Drug, and
Cosmetic Act (the act). The statement
includes a toll-free number and advises
that the number is to be used only for
reporting side effects and is not
intended for medical advice (the side
effects statement). This final rule also
affirms the interim final rule’s addition
of new part 209 to the regulations
requiring distribution of the side effects
statement. This final rule implements
provisions of the Best Pharmaceuticals
for Children Act (the BPCA) and the
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
Food and Drug Administration
Amendments Act of 2007 (FDAAA).
DATES: Effective Date: This final rule is
effective November 28, 2008.
Compliance Date: The compliance
date for this final rule is July 1, 2009.
For more information on the compliance
date see section II of the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
Carol Drew, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6306, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION:
I. Background
A. BPCA and Proposed Rule
The BPCA (Public Law 107–109)
directed FDA to issue a final rule
requiring the labeling of each human
drug product for which an application
is approved under section 505 of the act
(21 U.S.C. 355) to include: (1) A toll-free
number maintained by FDA for the
purpose of receiving reports of adverse
events regarding drugs and (2) a
statement that the number is to be used
for reporting purposes only, not to
receive medical advice. Collectively, we
refer to the toll-free number and
reporting statement as the ‘‘side effects
statement.’’ The BPCA stated that the
final rule must implement the labeling
requirement to reach the broadest
consumer audience and minimize the
cost to the pharmacy profession.
On April 22, 2004 (69 FR 21778), FDA
published a proposed rule entitled
‘‘Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products.’’ FDA received 22
comments on the proposed rule.
B. FDAAA Requirements and Interim
Final Rule
On September 27, 2007, the President
signed into law FDAAA (Public Law
110–85). Among other things, FDAAA
reauthorized the BPCA. Section 502(f) of
FDAAA stated that ‘‘the proposed rule
* * * ‘Toll-Free Number for Reporting
Adverse Events on Labeling for Human
Drug Products’ * * * shall take effect
on January 1, 2008,’’ unless FDA issues
a final rule before that date. FDA was in
the process of analyzing the comments
on the proposed rule and conducting
research on consumer comprehension of
the proposed side effects statements
when FDAAA was enacted. FDA did not
issue a final rule prior to January 1,
2008. Therefore, by operation of law, the
proposed rule took effect on January 1,
2008.
FDAAA mandated one change to the
proposed rule. Section 502(f)(2) of
E:\FR\FM\28OCR1.SGM
28OCR1
]]>Agencies
[Federal Register Volume 73, Number 209 (Tuesday, October 28, 2008)]
[Rules and Regulations]
[Page 63886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25611]
=======================================================================
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DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
18 CFR Part 35
[Docket No. RM01-5-000, Order No. 714]
Electronic Tariff Filings
October 22, 2008.
AGENCY: Federal Energy Regulatory Commission.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Federal Energy Regulatory Commission published a document
in the Federal Register on October 3, 2008 (73 FR 57515), revising
Commission rules. That document inadvertently included two non-
substantive errors in the instructions for the amendatory language.
This document corrects those instructions.
DATES: Effective Date: Effective on November 3, 2008.
FOR FURTHER INFORMATION CONTACT: Andre Goodson, Office of the General
Counsel, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, (202) 502-8560, Andre.Goodson@ferc.gov.
SUPPLEMENTARY INFORMATION: In FR Doc. E8-22500 appearing on page 57515
in the Federal Register of Friday, October 3, 2008, the following
corrections are made:
Sec. 35.13 [Corrected]
0
1. On page 57532, in the second column, in Sec. 35.13, instruction 14g
is revised to read as follows: In paragraph (b)(3), the word
``schedule'' is removed; and the word ``mailed'' is removed, and the
word ``posted'' is added in its place.
Sec. 35.14 [Corrected]
0
2. On page 57532, in the third column, in Sec. 35.14, instruction 15a
is revised to read as follows: In paragraph (a), introductory text, the
phrase ``(fuel clause)'' is added after the phrase ``Fuel adjustment
clauses'', and the phrase ``, tariffs or service agreements'' is added
after the phrase ``rate schedules'' anywhere it appears in the
paragraph's introductory text.
Kimberly D. Bose,
Secretary.
[FR Doc. E8-25611 Filed 10-27-08; 8:45 am]
BILLING CODE 6717-01-P
