50758 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Proposed Rules 

should be subject to part 803 of this 

chapter to protect the public health. For 

Class I and certain Class II devices you 

must submit reportable malfunctions on 

a quarterly basis using a summary 

format. You must also submit any 

required followup reports to a 

‘‘malfunction report’’ required by 

§ 803.56 of this chapter. 

(3) If your combination product 

contains a drug or a biological product 

constituent part, you must submit a 

postmarketing 15-day ‘‘alert report’’, for 

each adverse experience associated with 

the use of a drug or biological product 

constituent part of the combination 

product, whether or not considered drug 

or biological product related, that is 

both serious and unexpected, whether 

foreign or domestic, as soon as possible 

but in no case later than 15 calendar 

days of initial receipt of the information 

by the reporter, as required by 

§ 314.80(c)(1)(i) or § 600(c)(1)(i) of this 

chapter. You must also promptly 

investigate and submit any required 

followup reports to a postmarketing 15- 

day ‘‘alert report’’ as required by 

§ 314.80(c)(1)(ii) or § 600(c)(1)(ii) of this 

chapter. 

(4) If your combination product 

contains a drug constituent part, you 

must submit a field alert report within 

3 working days of your receipt to the 

FDA district office that is responsible 

for the facility involved, by telephone or 

other rapid communication means and 

prompt written followup, information 

concerning: 

(i) Any incident that causes the drug 

constituent part of a distributed 

combination product or its labeling to 

be mistaken for, or applied to, another 

article; or 

(ii) Any bacteriological contamination 

or any significant chemical, physical, or 

other change or deterioration in the drug 

constituent part of a distributed 

combination product, or any failure of 

one or more distributed batches of a 

drug constituent part of a combination 

product to meet the specification 

established for it in the application. 

(5) If your combination product 

contains a biological product 

constituent part containing blood or a 

blood component, and a complication of 

blood collection or transfusion is 

confirmed to be fatal as described in 

§ 606.170(b) of this chapter, you must 

submit a blood fatality report by 

telephone, facsimile, express mail, or email as soon as possible, and a written 

report within 7 days after the fatality. 

(c) Periodic reports. (1) If your 

combination product is approved under 

an NDA, ANDA, or BLA, you must also 

include information in reports 

submitted in accordance with 

paragraphs (b)(1), (b)(2), and (b)(5) of 

this section in the periodic reports you 

submit under §§ 314.80(c)(2)(ii)(a) and 

600.80(c)(2)(ii)(a) of this chapter. 

Information on these additional reports 

should be treated as 15-day alert reports, 

i.e., included in narrative summary and 

analysis of the information in the report 

and an analysis of the 15-day alert 

reports submitted during the reporting 

interval (all 15-day alert reports being 

appropriately referenced by the 

applicant’s patient identification 

number, adverse reaction term(s), and 

date of submission to FDA). The history 

of actions taken since the last report 

because of adverse drug experiences (for 

example, labeling changes or studies 

initiated) should include information on 

the combination products as a whole 

(i.e., all of its constituent parts). 

(2) If your combination product is 

approved under a PMA, you must also 

include information in reports 

submitted in accordance with 

paragraphs (b)(3), (b)(4), and (b)(5) of 

this section in the periodic reports you 

submit under §814.82(a)(7) of this 

chapter. 

§ 4.104 How do I report if another reporter 

is responsible for a constituent part of my 

combination product? 

(a) If another person holds an 

application used to approve or clear a 

constituent part of your combination 

product, or legally markets a constituent 

part of your combination product 

without an approved or cleared 

marketing application, in addition to the 

requirements of § 4.103(a), you must 

submit the information you received 

about the event to FDA or the other 

person within 5 calendar days of your 

receipt of the information. 

(b) If you receive information from the 

other person that holds an application 

used to approve or clear a constituent 

part of your combination product, or 

legally markets a constituent part of 

your combination product without an 

approved or cleared marketing 

application, you must investigate and, if 

required, report the event in accordance 

with § 4.103(a) and (b). 

§ 4.105 How, where, and when do I submit 

postmarketing safety reports for 

combination products? 

(a) You must submit the field alert 

reports described in § 4.103(b)(4) to the 

FDA district office that is responsible 

for the facility involved within 3 

working days of receipt of the 

information. 

(b) You must submit all other 

postmarketing safety reports required 

under this subpart (i.e., required under 

§ 4.103(a), (b)(1), (b)(2), (b)(3), (b)(5), and 

(c)) using the submission methods and 

timeframes identified in the regulations 

applicable under § 4.103(a), (b), and (c) 

for your combination product or your 

constituent part. 

§ 4.106 What are the postmarketing safety 

reporting recordkeeping requirements? 

(a) You must maintain records of 

postmarketing safety reports required by 

§ 4.103(a) in accordance with the 

recordkeeping requirements of the 

underlying regulation(s) identified in 

§ 4.103(a) that are applicable to your 

combination product or your 

constituent part. 

(b) You must maintain records of 

reportable events required by § 4.103(b) 

and (c) for the time period specified as 

follows: 

(1) 5-day and malfunction reports 

described in § 4.103(b)(1) and (b)(2): for 

2 years or the expected life of the 

combination product, whichever is 

longer; 

(2) Postmarketing 15-day ‘alert 

reports’ field alert reports, and blood 

fatality reports described in 

§ 4.103(b)(3), (b)(4), and (b)(5), and 

periodic reports as described in 

§ 4.103(c): for 10 years. 

Dated: September 24, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23519 Filed 9–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–139068–08] 

RIN 1545–BI31 

Modification to Consolidated Return 

Regulation Permitting an Election To 

Treat a Liquidation of a Target, 

Followed by a Recontribution to a New 

Target, as a Cross-Chain 

Reorganization; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to a notice of 

proposed rulemaking by cross-reference 

to temporary regulations. 

SUMMARY: This document contains 

corrections to a notice of proposed 

rulemaking by cross-reference to 

temporary regulations (REG–139068–08) 

that were published in the Federal 

Register on Friday, September 4, 2009 

(74 FR 45789) modifying the election 

under which a consolidated group can 

avoid immediately taking into account 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Proposed Rules 50759 

an intercompany item after the 

liquidation of a target corporation. This 

modification was made necessary in 

light of the regulations under section 

368 that were issued in October 2007 

addressing transfers of assets or stock 

following a reorganization. 

FOR FURTHER INFORMATION CONTACT: 

Mary W. Lyons, (202) 622–7930 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

A notice of proposed rulemaking by 

cross-reference to temporary regulations 

that is the subject of this document is 

under section 1502 of the Internal 

Revenue Code. 

Need for Correction 

As published, a notice of proposed 

rulemaking by cross-reference to 

temporary regulations (REG–139068–08) 

contains errors that may prove to be 

misleading and are in need of 

clarification. 

Correction of Publication 

Accordingly, the publication of a 

notice of proposed rulemaking by crossreference to temporary regulations 

(REG–139068–08), which was the 

subject of FR Doc. E9–21323, is 

corrected as follows: 

§ 1.1502–13 [Corrected] 

1. On page 45791, column 1, 

paragraph (f)(5)(ii)(B)(1), lines 2 and 3, 

the language ‘‘amendments to § 1.1502– 

13(B)(1) is the same as the text of 

§ 1.1502–13T(B)(1)’’ is corrected to read 

‘‘amendments to § 1.1502– 

13(f)(5)(ii)(B)(1) is the same as the text 

of § 1.1502–13T(f)(5)(ii)(B)(1)’’. 

2. On page 45791, column 1, 

paragraph (f)(5)(ii)(B)(2), lines 2 and 3, 

the language ‘‘amendments to § 1.1502– 

13(B)(2) is the same as the text of 

§ 1.1502–13T(B)(2)’’ is corrected to read 

‘‘amendments to § 1.1502– 

13(f)(5)(ii)(B)(2) is the same as the text 

of § 1.1502–13T(f)(5)(ii)(B)(2)’’. 

3. On page 45791, column 1, 

paragraph (f)(5)(ii)(F), lines 2 and 3, the 

language ‘‘amendments to § 1.1502– 

13(F) is the same as the text of § 1.1502– 

13T(F)’’ is corrected to read 

‘‘amendments to § 1.1502–13(f)(5)(ii)(F) 

is the same as the text of § 1.1502– 

13T(f)(5)(ii)(F)’’. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration). 

[FR Doc. E9–23645 Filed 9–30–09; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 0909011267–91269–01] 

RIN 0648–AY19 

Magnuson-Stevens Fishery 

Conservation and Management Act 

Provisions; Fisheries of the 

Northeastern United States 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule; request for 

comments. 

SUMMARY: NMFS is proposing to 

implement a regulatory amendment to 

modify the fishing vessel permit 

regulations to include specific terms 

and conditions for Federal fishing vessel 

permits obtained through the purchase 

of fishing vessels using Federal grant 

awards. The terms and conditions 

would authorize the NMFS 

Administrator, Northeast Region 

(Regional Administrator), to suspend, 

cancel, fail to renew, modify, or 

otherwise rescind any Federal fishing 

vessel permit, or the rights thereto, if the 

terms and conditions of any Federal 

grant award used to obtain said permit, 

or an associated memorandum of 

understanding, are violated by the grant 

recipient. 

DATES: Written comments must be 

received no later than 5 p.m., eastern 

standard time, on November 2, 2009. 

ADDRESSES: You may submit comments, 

identified by RIN 0648–AY19, by any of 

the following methods: 

• Electronic submissions: Submit all 

electronic public comments via the 

Federal e-Rulemaking portal http:// 

www.regulations.gov. 

• Fax: (978) 281–9135, Attn: Michael 

Pentony. 

• Mail: Patricia A. Kurkul, Regional 

Administrator, NMFS, Northeast 

Regional Office, 55 Great Republic 

Drive, Gloucester, MA 01930. Mark the 

outside of the envelope: ‘‘Comments on 

Vessel Permit Regulatory Amendment.’’ 

Instructions: All comments received 

are part of the public record and will 

generally be posted to http:// 

www.regulations.gov without change. 

All Personal Identifying Information (for 

example, name, address, etc.) 

voluntarily submitted by the commenter 

may be publicly accessible. Do not 

submit confidential business 

information or otherwise sensitive or 

protected information. 

NMFS will accept anonymous 

comments. Attachments to electronic 

comments will be accepted via 

Microsoft Word, Microsoft Excel, 

WordPerfect, or Adobe PDF file formats 

only. 

Copies of the Regulatory Impact 

Review (RIR) are available upon request 

from Patricia A. Kurkul, Regional 

Administrator, NMFS, Northeast 

Regional Office, 55 Great Republic 

Drive, Gloucester, MA 01930. 

FOR FURTHER INFORMATION CONTACT: 

Michael Pentony, Senior Fishery Policy 

Analyst, phone (978) 281–9283. 

SUPPLEMENTARY INFORMATION: 

Background 

This proposed rule would implement 

changes to the Northeast (NE) fisheries 

regulations at 50 CFR part 648 to 

authorize the Regional Administrator to 

suspend, cancel, fail to renew, modify, 

or otherwise rescind any Federal fishing 

vessel permit, including the rights 

thereto, held by a person, corporation, 

non-profit organization, or government 

entity if the terms and conditions of any 

Federal grant award used to obtain said 

permit, or an associated memorandum 

of understanding, are violated by the 

grant recipient. The intent of this 

proposed action is to establish a new 

regulatory mechanism through which 

NOAA would be able to enforce the 

terms and conditions of any Federal 

grant award used to obtain Federal 

fishing vessel permits in the NE Region. 

As several fisheries in the NE Region 

begin to transition to catch-share 

management strategies, various fishing 

organizations, conservations groups, 

and states are exploring alternatives to 

the traditional vessel-permit ownership 

model. Traditionally, an individual or 

corporation invests in a fishing vessel 

and obtains the appropriate vessel 

permits necessary to participate in the 

target fishery. An individual or 

corporation may own multiple vessels, 

but each of these vessels is generally 

associated with a unique vessel permit 

(or, a unique set of permits to operate 

in different fisheries may be associated 

with each vessel). An alternative model 

known as ‘‘permit banking’’ is 

developing in the Northeast, whereby an 

organization obtains a suite of permits 

in a particular fishery, with the option 

to lease out the fishing rights associated 

with those permits. 

Permit banks hold promise for 

addressing two important issues related 

to the development and implementation 

of effective catch-share management 

programs: First, permit banks can be 


jlentini on DSKJ8SOYB1PROD with PROPOSALS