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. 

List of Subjects in 18 CFR Part 375 

Authority delegations (government 

agencies), Seals and insignia, Sunshine 

Act. 

By the Commission. 

Nathaniel J. Davis, Sr., 

Deputy Secretary. 

■ In consideration of the foregoing, the 

Commission amends part 375, chapter I, 

title 18, Code of Federal Regulations, as 

follows. 

PART 375—THE COMMISSION 

■ 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: 

§ 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 

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 

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. 

■ 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: 

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 


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Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Rules and Regulations 32659 

the appropriate Food and Drug 

Administration district office specified 

in part 5, subpart M of this chapter. 

PART 107—INFANT FORMULA 

■ 3. The authority citation for 21 CFR 

part 107 continues to read as follows: 

Authority: 21 U.S.C. 321, 343, 350a, 371. 

■ 4. Section 107.50 is amended by 

revising paragraph (e)(2) to read as 

follows: 

§ 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. 

■ 5. Section 107.240 is amended by 

revising paragraph (b) to read as follows: 

§ 107.240 Notification requirements. 

* * * * * 

(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 

Administration district office listed in 

part 5, subpart M of this chapter. 

* * * * * 

PART 312—INVESTIGATIONAL NEW 

DRUG APPLICATION 

■ 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. 

■ 7. Section 312.310 is amended by 

revising paragraph (d)(1) to read as 

follows: 

§ 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 

■ 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. 

* * * * * 

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 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9485] 

RIN 1545–BF28 

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 


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