Change of Contact Information; Technical Amendment, 32658-32659 [2010-13820]
Download as PDF
<![CDATA[
32658
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Rules and Regulations
because this Final Rule concerns agency
procedure and practice and will not
substantially affect the rights of nonagency parties.
10. The Commission is issuing this as
a Final Rule without a period for public
comment. Under 5 U.S.C. 553(b), notice
and comment procedures are
unnecessary where a rulemaking
concerns only agency procedure and
practice, or where the agency finds that
notice and comment is unnecessary.
This rule concerns only matters of
internal agency procedure and will not
significantly affect regulated entities or
the general public.
applications, filings, reports and data
processed by the Office of Energy Policy
and Innovation; and
(3) Accept for filing, data and reports
required by Commission regulations,
rules, or orders, or presiding officers’
initial decisions upon which the
Commission has taken no further action,
if such filings are in compliance with
such regulations, rules, orders or
decisions and, when appropriate, notify
the filing party of such acceptance.
[FR Doc. 2010–13632 Filed 6–8–10; 8:45 am]
BILLING CODE 6717–01–P
List of Subjects in 18 CFR Part 375
Authority delegations (government
agencies), Seals and insignia, Sunshine
Act.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
21 CFR Parts 106, 107, 312, and 803
In consideration of the foregoing, the
Commission amends part 375, chapter I,
title 18, Code of Federal Regulations, as
follows.
Change of Contact Information;
Technical Amendment
[Docket No. FDA–2010–N–0010]
■
1. The authority citation for part 375
continues to read as follows:
■
Authority: 5 U.S.C. 551–557; 15 U.S.C.
717–717w, 3301–3432; 16 U.S.C. 791–825r,
2601–2645; 42 U.S.C. 7101–7352, 16451–
16463.
2. Add new § 375.315 to read as
follows:
■
erowe on DSK5CLS3C1PROD with RULES
§ 375.315 Delegations to the Director of
the Office of Energy Policy and Innovation.
The Commission authorizes the
Director or the Director’s designee to:
(a) Take appropriate action on:
(1) Any notice of intervention or
motion to intervene, filed in an
uncontested proceeding processed by
the Office of Energy Policy and
Innovation; and
(2) Applications for extensions of time
to file required filings, reports, data and
information and to perform other acts
required at or within a specific time by
any rule, regulation, license, permit,
certificate, or order by the Commission.
(b) Undertake the following actions:
(1) Issue reports for public
information purposes. Any report issued
without Commission approval must:
(i) Be of a noncontroversial nature,
and
(ii) Contain the statement, ‘‘This
report does not necessarily reflect the
views of the Commission,’’ in bold face
type on the cover;
(2) Issue and sign requests for
additional information regarding
14:39 Jun 08, 2010
Jkt 220001
Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
PART 375—THE COMMISSION
VerDate Mar<15>2010
AGENCY:
Frm 00010
Fmt 4700
Sfmt 4700
21 CFR Part 106
Food grades and standards, Infants
and children, Nutrition, Reporting and
recordkeeping requirements.
21 CFR Part 107
Food labeling, Infants and children,
Nutrition, Reporting and recordkeeping
requirements, Signs and symbols.
21 CFR Part 312
Drugs, Exports, Imports,
Investigations, Labeling, Medical
research, Reporting and recordkeeping
requirements, Safety.
21 CFR Part 803
Imports, Medical devices, Reporting
and recordkeeping requirements.
■ Therefore under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR Chapter I is
amended as follows:
PART 106—INFANT FORMULA
QUALITY CONTROL PROCEDURES
1. The authority citation for 21 CFR
part 106 continues to read as follows:
■
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to reflect changes in the
contact information for the FDA
Emergency Call Center. This action is
editorial in nature and is intended to
improve the accuracy of the agency’s
regulations.
DATES: This rule is effective June 11,
2010.
FOR FURTHER INFORMATION CONTACT:
Wayne Gorski, Office of Crisis
Management, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 2300, Silver Spring,
MD 20993–0002, 301–796–8248.
SUPPLEMENTARY INFORMATION: FDA is
amending its regulations in 21 CFR
parts 106, 107, 312, and 803 to reflect
a change in the telephone and fax
numbers for the FDA Emergency Call
Center. The phone number will change
from 301–443–1240 to 866–300–4374 on
June 11, 2010. The fax number will
change from 301–827–3333 to 301–847–
8544. We have also amended the
regulations to reflect that the new phone
and fax numbers are for the ‘‘FDA
Emergency Call Center’’.
Publication of this document
constitutes final action on this change
under the Administrative Procedure Act
(5 U.S.C. 553). Notice and public
procedures are unnecessary because
FDA is merely updating nonsubstantive
content.
PO 00000
List of Subjects
Authority: 21 U.S.C. 321, 350a, 371.
2. Section 106.120 is amended by
revising paragraph (b) to read as follows:
■
§ 106.120 New formulations and
reformulations.
*
*
*
*
*
(b) The manufacturer shall promptly
notify the Food and Drug
Administration when the manufacturer
has knowledge (as defined in section
412(c)(2) of the act) that reasonably
supports the conclusion that an infant
formula that has been processed by the
manufacturer and that has left an
establishment subject to the control of
the manufacturer may not provide the
nutrients required by section 412(g) of
the act and by regulations promulgated
under section 412(a)(2) of the act, or
when there is an infant formula that is
otherwise adulterated or misbranded
and that may present risk to human
health. This notification shall be made,
by telephone, to the Director of the
appropriate Food and Drug
Administration district office specified
in part 5, subpart M of this chapter.
After normal business hours (8 a.m. to
4:30 p.m.), contact the FDA Emergency
Call Center at 866–300–4374. The
manufacturer shall send a followup
written confirmation to the Center for
Food Safety and Applied Nutrition
(HFS–605), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, and to
E:\FR\FM\09JNR1.SGM
09JNR1
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Rules and Regulations
the appropriate Food and Drug
Administration district office specified
in part 5, subpart M of this chapter.
Administration district office listed in
part 5, subpart M of this chapter.
*
*
*
*
*
PART 107—INFANT FORMULA
PART 312—INVESTIGATIONAL NEW
DRUG APPLICATION
3. The authority citation for 21 CFR
part 107 continues to read as follows:
■
*
*
*
*
*
(e) * * *
(2) The manufacturer shall promptly
notify FDA when the manufacturer has
knowledge (as defined in section
412(c)(2) of the act) that reasonably
supports the conclusion that an exempt
infant formula that has been processed
by the manufacturer and that has left an
establishment subject to the control of
the manufacturer may not provide the
nutrients required by paragraph (b) or
(c) of this section, or when there is an
exempt infant formula that may be
otherwise adulterated or misbranded
and if so adulterated or misbranded
presents a risk of human health. This
notification shall be made, by
telephone, to the Director of the
appropriate FDA district office specified
in part 5, subpart M of this chapter.
After normal business hours (8 a.m. to
4:30 p.m.), contact the FDA Emergency
Call Center at 866–300–4374. The
manufacturer shall send a followup
written confirmation to the Center for
Food Safety and Applied Nutrition
(HFS–605), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, and to
the appropriate FDA district office
specified in part 5, subpart M of this
chapter.
■ 5. Section 107.240 is amended by
revising paragraph (b) to read as follows:
Notification requirements.
erowe on DSK5CLS3C1PROD with RULES
*
*
*
*
(b) Method of notification. The
notification made pursuant to
§ 107.240(a) shall be made, by
telephone, to the Director of the
appropriate Food and Drug
Administration district office listed in
part 5, subpart M of this chapter. After
normal business hours (8 a.m. to 4:30
p.m.), contact the FDA Emergency Call
Center at 866–300–4374. The
manufacturer shall send written
confirmation of the notification to the
Center for Food Safety and Applied
Nutrition (HFS–605), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, and to
the appropriate Food and Drug
VerDate Mar<15>2010
14:39 Jun 08, 2010
Jkt 220001
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
7. Section 312.310 is amended by
revising paragraph (d)(1) to read as
follows:
26 CFR Part 1
§ 312.310 Individual patients, including for
emergency use.
RIN 1545–BF28
■
Terms and conditions.
*
[FR Doc. 2010–13820 Filed 6–8–10; 8:45 am]
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360bbb, 371; 42 U.S.C. 262.
4. Section 107.50 is amended by
revising paragraph (e)(2) to read as
follows:
■
§ 107.240
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
6. The authority citation for 21 CFR
part 312 continues to read as follows:
■
Authority: 21 U.S.C. 321, 343, 350a, 371.
§ 107.50
32659
*
*
*
*
*
(d) * * *
(1) Emergency expanded access use
may be requested by telephone,
facsimile, or other means of electronic
communications. For investigational
biological drug products regulated by
the Center for Biologics Evaluation and
Research, the request should be directed
to the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research, 301–
827–1800 or 1–800–835–4709, e-mail:
ocod@fda.hhs.gov. For all other
investigational drugs, the request for
authorization should be directed to the
Division of Drug Information, Center for
Drug Evaluation and Research, 301–
796–3400, e-mail:
druginfo@fda.hhs.gov. After normal
working hours (8 a.m. to 4:30 p.m.), the
request should be directed to the FDA
Emergency Call Center, 866–300–4374,
e-mail:
emergency.operations@fda.hhs.gov.
*
*
*
*
*
PART 803—MEDICAL DEVICE
REPORTING
8. The authority citation for 21 CFR
part 803 continues to read as follows:
■
Authority: 21 U.S.C. 352, 360, 360i, 360j,
371, 374.
9. Section 803.12 is amended by
revising paragraph (c) to read as follows:
■
§ 803.12 Where and how do I submit
reports and additional information?
*
*
*
*
*
(c) If an entity is confronted with a
public health emergency, this can be
brought to FDA’s attention by contacting
the FDA Office of Emergency
Operations, Office of Crisis
Management, Office of the
Commissioner, at 866–300–4374,
followed by the submission of an e-mail
to emergency.operations@fda.hhs.gov or
a fax report to 301–847–8544.
*
*
*
*
*
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
[TD 9485]
Contributed Property
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
SUMMARY: This document contains final
regulations under section 704(c) of the
Internal Revenue Code (Code) providing
that the section 704(c) anti-abuse rule
takes into account the tax liabilities of
both the partners in a partnership and
certain direct and indirect owners of
such partners. These final regulations
further provide that a section 704(c)
allocation method cannot be used to
achieve tax results inconsistent with the
intent of subchapter K of the Code. The
final regulations affect partnerships and
their partners.
DATES: Effective Date: These final
regulations are effective June 9, 2010.
Applicability Date: These final
regulations are applicable for taxable
years beginning after June 9, 2010.
FOR FURTHER INFORMATION CONTACT:
Bryan A. Rimmke at (202) 622–3050
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
This document contains amendments
to 26 CFR part 1 under section 704 of
the Internal Revenue Code (Code). On
May 19, 2008, a notice of proposed
rulemaking (REG–100798–06, 2008–23
IRB 1135) was published in the Federal
Register (73 FR 28765) in response to
the Joint Committee on Taxation’s
recommendation that the partnership
rules be strengthened to ensure that the
allocation rules in the regulations under
section 704(c) are not used to generate
unwarranted benefits. See The Report of
Investigation of Enron Corporation and
Related Entities Regarding Federal Tax
and Compensation Issues, and Policy
Recommendations, (JCS–3–03) February
2003 at pg. 220. Because no requests to
speak were submitted by August 18,
2008, no public hearing was held.
Written comments, however, were
E:\FR\FM\09JNR1.SGM
09JNR1
]]>Agencies
[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Rules and Regulations]
[Pages 32658-32659]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13820]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 106, 107, 312, and 803
[Docket No. FDA-2010-N-0010]
Change of Contact Information; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to reflect changes in the contact information for the FDA
Emergency Call Center. This action is editorial in nature and is
intended to improve the accuracy of the agency's regulations.
DATES: This rule is effective June 11, 2010.
FOR FURTHER INFORMATION CONTACT: Wayne Gorski, Office of Crisis
Management, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 2300, Silver Spring, MD 20993-0002, 301-796-8248.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR
parts 106, 107, 312, and 803 to reflect a change in the telephone and
fax numbers for the FDA Emergency Call Center. The phone number will
change from 301-443-1240 to 866-300-4374 on June 11, 2010. The fax
number will change from 301-827-3333 to 301-847-8544. We have also
amended the regulations to reflect that the new phone and fax numbers
are for the ``FDA Emergency Call Center''.
Publication of this document constitutes final action on this
change under the Administrative Procedure Act (5 U.S.C. 553). Notice
and public procedures are unnecessary because FDA is merely updating
nonsubstantive content.
List of Subjects
21 CFR Part 106
Food grades and standards, Infants and children, Nutrition,
Reporting and recordkeeping requirements.
21 CFR Part 107
Food labeling, Infants and children, Nutrition, Reporting and
recordkeeping requirements, Signs and symbols.
21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.
21 CFR Part 803
Imports, Medical devices, Reporting and recordkeeping requirements.
0
Therefore under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
Chapter I is amended as follows:
PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES
0
1. The authority citation for 21 CFR part 106 continues to read as
follows:
Authority: 21 U.S.C. 321, 350a, 371.
0
2. Section 106.120 is amended by revising paragraph (b) to read as
follows:
Sec. 106.120 New formulations and reformulations.
* * * * *
(b) The manufacturer shall promptly notify the Food and Drug
Administration when the manufacturer has knowledge (as defined in
section 412(c)(2) of the act) that reasonably supports the conclusion
that an infant formula that has been processed by the manufacturer and
that has left an establishment subject to the control of the
manufacturer may not provide the nutrients required by section 412(g)
of the act and by regulations promulgated under section 412(a)(2) of
the act, or when there is an infant formula that is otherwise
adulterated or misbranded and that may present risk to human health.
This notification shall be made, by telephone, to the Director of the
appropriate Food and Drug Administration district office specified in
part 5, subpart M of this chapter. After normal business hours (8 a.m.
to 4:30 p.m.), contact the FDA Emergency Call Center at 866-300-4374.
The manufacturer shall send a followup written confirmation to the
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to
[[Page 32659]]
the appropriate Food and Drug Administration district office specified
in part 5, subpart M of this chapter.
PART 107--INFANT FORMULA
0
3. The authority citation for 21 CFR part 107 continues to read as
follows:
Authority: 21 U.S.C. 321, 343, 350a, 371.
0
4. Section 107.50 is amended by revising paragraph (e)(2) to read as
follows:
Sec. 107.50 Terms and conditions.
* * * * *
(e) * * *
(2) The manufacturer shall promptly notify FDA when the
manufacturer has knowledge (as defined in section 412(c)(2) of the act)
that reasonably supports the conclusion that an exempt infant formula
that has been processed by the manufacturer and that has left an
establishment subject to the control of the manufacturer may not
provide the nutrients required by paragraph (b) or (c) of this section,
or when there is an exempt infant formula that may be otherwise
adulterated or misbranded and if so adulterated or misbranded presents
a risk of human health. This notification shall be made, by telephone,
to the Director of the appropriate FDA district office specified in
part 5, subpart M of this chapter. After normal business hours (8 a.m.
to 4:30 p.m.), contact the FDA Emergency Call Center at 866-300-4374.
The manufacturer shall send a followup written confirmation to the
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to
the appropriate FDA district office specified in part 5, subpart M of
this chapter.
0
5. Section 107.240 is amended by revising paragraph (b) to read as
follows:
Sec. 107.240 Notification requirements.
* * * * *
(b) Method of notification. The notification made pursuant to Sec.
107.240(a) shall be made, by telephone, to the Director of the
appropriate Food and Drug Administration district office listed in part
5, subpart M of this chapter. After normal business hours (8 a.m. to
4:30 p.m.), contact the FDA Emergency Call Center at 866-300-4374. The
manufacturer shall send written confirmation of the notification to the
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to
the appropriate Food and Drug Administration district office listed in
part 5, subpart M of this chapter.
* * * * *
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
0
6. The authority citation for 21 CFR part 312 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371;
42 U.S.C. 262.
0
7. Section 312.310 is amended by revising paragraph (d)(1) to read as
follows:
Sec. 312.310 Individual patients, including for emergency use.
* * * * *
(d) * * *
(1) Emergency expanded access use may be requested by telephone,
facsimile, or other means of electronic communications. For
investigational biological drug products regulated by the Center for
Biologics Evaluation and Research, the request should be directed to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, 301-827-1800 or 1-800-835-4709, e-
mail: ocod@fda.hhs.gov. For all other investigational drugs, the
request for authorization should be directed to the Division of Drug
Information, Center for Drug Evaluation and Research, 301-796-3400, e-
mail: druginfo@fda.hhs.gov. After normal working hours (8 a.m. to 4:30
p.m.), the request should be directed to the FDA Emergency Call Center,
866-300-4374, e-mail: emergency.operations@fda.hhs.gov.
* * * * *
PART 803--MEDICAL DEVICE REPORTING
0
8. The authority citation for 21 CFR part 803 continues to read as
follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
0
9. Section 803.12 is amended by revising paragraph (c) to read as
follows:
Sec. 803.12 Where and how do I submit reports and additional
information?
* * * * *
(c) If an entity is confronted with a public health emergency, this
can be brought to FDA's attention by contacting the FDA Office of
Emergency Operations, Office of Crisis Management, Office of the
Commissioner, at 866-300-4374, followed by the submission of an e-mail
to emergency.operations@fda.hhs.gov or a fax report to 301-847-8544.
* * * * *
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13820 Filed 6-8-10; 8:45 am]
BILLING CODE 4160-01-S
