Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Proposed Rules 52805 

comment period to update comments 

and to receive any new information. 

Elsewhere in this issue of the Federal 

Register, FDA is also reopening the 

comment period on a notice of 

availability of a draft guidance 

document that would serve as the 

special control if FDA reclassifies this 

device. 

DATES: Submit written or electronic 

comments on the proposed rule by 

October 14, 2008. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

David Krause, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3638. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 31, 

2006 (71 FR 63728), FDA published a 

proposed rule to reclassify the 

absorbable hemostatic device intended 

to produce hemostasis from class III 

(premarket approval) to class II (special 

controls). FDA invited interested 

persons to comment on the proposed 

rule by January 29, 2007. In the Federal 

Register of May, 8, 2007 (72 FR 26011), 

FDA reopened the comment period for 

30 days in response to two requests for 

additional time for preparation of 

comments. 

On July 2, 2007, FDA received a 

petition under 21 CFR 10.30 and 10.35 

requesting that the agency refrain from 

issuing a final regulation for the 

proposed reclassification and the draft 

special controls guidance for the 

absorbable hemostatic device until an 

updated and complete administrative 

record is made available to the public. 

The petitioner also requested that FDA 

reopen the rulemaking for the proposed 

reclassification to allow submission of 

comments based on the administrative 

record. FDA has updated the 

administrative record in the Division of 

Dockets Management (see ADDRESSES). 

FDA is also reopening the comment 

period for 30 days. Although you can 

comment on any guidance at any time 

(see 21 CFR 10.115(g)(5)), elsewhere in 

this issue of the Federal Register, FDA 

is reopening the comment period on a 

notice of availability of a draft guidance 

document that would serve as the 

special control if the device is 

reclassified. 

II. How to Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments to http://www.regulations.gov 

or two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA through FDMS only. 

Dated: September 4, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21200 Filed 9–10–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 301 

[REG–160868–04] 

RIN 1545–BF61 

Section 6707A and the Failure To 

Include on Any Return or Statement 

Any Information Required To Be 

Disclosed Under Section 6011 With 

Respect to a Reportable Transaction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

by cross-reference to temporary 

regulations. 

SUMMARY: In the Rules and Regulations 

section of this issue of the Federal 

Register, the IRS is issuing temporary 

regulations under section 6707A of the 

Internal Revenue Code (Code), which 

provide the rules relating to the 

assessment of penalties under section 

6707A for the failure to include on any 

return or statement any information 

required to be disclosed under section 

6011 with respect to a reportable 

transaction. The text of those temporary 

regulations also serves as the text of 

these proposed regulations. 

DATES: Written or electronic comments 

and requests for a public hearing must 

be received by December 10, 2008. 

ADDRESSES: Send submission to: 

CC:PA:LPD:PR (REG–160868–04), room 

5203, Internal Revenue Service, P.O. 

Box 7604, Ben Franklin Station, 

Washington, DC 20044. Submissions 

may be hand delivered Monday through 

Friday between the hours of 8 a.m. and 

4 p.m. to: CC:PA:LPD:PR (REG–160868–

04), Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC, or sent 

electronically via the Federal 

eRulemaking Portal at http:// 

www.regulations.gov (IRS REG–160868–

04). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the proposed regulations, 

Matthew Cooper (202) 622–4940; 

concerning submissions of comments 

and requests for a public hearing, 

Richard Hurst (202) 622–2949 (TDD 

telephone) (not toll-free numbers) and 

his e-mail address is 

Richard.A.Hurst@irscounsel.treas.gov. 

SUPPLEMENTARY INFORMATION: 

Background and Explanation of 

Provisions 

Temporary regulations in the Rules 

and Regulations section of this issue of 

the Federal Register amend the 

Procedure and Administration 

Regulations (26 CFR part 301) relating to 

section 6707A. Section 811 of the 

American Jobs Creation Act of 2004, 

Public Law 108–357 (118 Stat. 1418) 

added section 6707A to the Code to 

provide a monetary penalty for the 

failure to include on any return or 

statement any information required to 

be disclosed under section 6011 with 

respect to a reportable transaction. The 

temporary regulations set forth the rules 

relating to the assessment of the penalty 

as well as the factors that the 

Commissioner (or the Commissioner’s 

delegate) will consider in deciding 

whether the penalty should be 

rescinded based on promoting 

compliance with the Code and effective 

tax administration. The text of those 

temporary regulations also serves as the 

text of these proposed regulations. The 

preamble to the temporary regulations 

explains the amendments. 

Special Analyses 

It has been determined that this notice 

of proposed rulemaking is not a 

significant regulatory action as defined 

in Executive Order 12866. Therefore, a 

regulatory assessment is not required. It 

also has been determined that section 

553(b) of the Administrative Procedure 

Act (5 U.S.C. chapter 5) does not apply 


rmajette on PRODPC74 with PROPOSALS
52806 Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Proposed Rules 

to these regulations, and because they 

do not impose a collection of 

information on small entities, the 

Regulatory Flexibility Act (5 U.S.C. 

chapter 6) does not apply. Pursuant to 

section 7805(f) of the Code, these 

regulations have been submitted to the 

Chief Counsel for Advocacy of the Small 

Business Administration for comment 

on its impact on small business. 

Comments and Requests for a Public 

Hearing 

Before these proposed regulations are 

adopted as final regulations, 

consideration will be given to any 

written (a signed original and eight (8) 

copies) or electronic comments that are 

submitted timely to the IRS. The IRS 

and the Treasury Department request 

comments on the clarity of the proposed 

rules and how they can be made easier 

to understand. All comments will be 

made available for public inspection 

and copying. A public hearing may be 

scheduled if requested by any person 

who timely submits comments. If a 

public hearing is scheduled, notice of 

the date, time and place for the public 

hearing will be published in the Federal 

Register. 

Drafting Information 

The principal author of these 

regulations is Matthew Cooper, Office of 

the Associate Chief Counsel (Procedure 

and Administration). 

List of Subjects in 26 CFR Part 301 

Employment taxes, Estate taxes, 

Excise taxes, Gift taxes, Income taxes, 

Penalties, Reporting and recordkeeping 

requirements. 

Proposed Amendments to the 

Regulations 

Accordingly, 26 CFR part 301 is 

proposed to be amended as follows: 

PART 301—PROCEDURE AND 

ADMINISTRATION 

Paragraph 1. The authority citation 

for part 301 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

Par. 2. Section 301.6707A–1 is added 

to read as follows: 

§ 301.6707A–1 Failure to include on any 

return or statement any information 

required to be disclosed under section 6011 

with respect to a reportable transaction. 

[The text of proposed § 301.6707A–1 

is the same as the text of § 301.6707A–

1T published elsewhere in this issue of 

the Federal Register]. 

Linda E. Stiff, 

Deputy Commissioner for Services and 

Enforcement. 

[FR Doc. E8–21158 Filed 9–10–08; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 680 

RIN 0648–AW73 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Allocating Bering Sea 

and Aleutian Islands King and Tanner 

Crab Fishery Resources 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notice of availability of fishery 

management plan amendment; request 

for comments. 

SUMMARY: The Bering Sea/Aleutian 

Islands (BSAI) Crab Rationalization 

Program (Program) allocates BSAI crab 

resources among harvesters, processors, 

and coastal communities. Amendment 

27 would amend the Fishery 

Management Plan for Bering Sea/ 

Aleutian Islands King and Tanner Crabs 

(FMP) and the Program to include the 

statutory requirements of section 122(e) 

of the Magnuson-Stevens Fishery 

Conservation and Management 

Reauthorization Act of 2006 and modify 

the methods used to determine 

individual processor quota share (IPQ) 

use caps when crab are processed under 

custom processing arrangements. 

Amendment 27 also would modify 

limits on the amount of Aleutian Islands 

golden and red king crab IPQ that could 

be processed at a facility. This action is 

intended to promote the goals and 

objectives of the Magnuson-Stevens 

Fishery Conservation and Management 

Act, the FMP, and other applicable 

laws. 

DATES: Comments on the amendment 

must be submitted on or before 

November 10, 2008. 

ADDRESSES: Send comments to Sue 

Salveson, Assistant Regional 

Administrator, Sustainable Fisheries 

Division, Alaska Region, NMFS, Attn: 

Ellen Sebastian. You may submit 

comments, identified by ‘‘RIN 0648–

AW73’’, by any one of the following 

methods: 

• Electronic Submissions: Submit all 

electronic public comments via the 

Federal eRulemaking Portal Web site at 

http://www.regulations.gov. 

• Mail: P.O. Box 21668, Juneau, AK 

99802. 

• Fax: (907) 586–7557. 

• Hand delivery to the Federal 

Building: 709 West 9th Street, Room 

420A, Juneau, AK. 

All comments received are a part of 

the public record and will generally be 

posted to http://www.regulations.gov 

without change. All Personal Identifying 

Information (e.g., name, address) 

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 (enter N/A in the required 

fields if you wish to remain 

anonymous). Attachments to electronic 

comments will be accepted in Microsoft 

Word, Excel, WordPerfect, or Adobe 

portable document file (pdf) formats 

only. 

Copies of Amendment 27, the 

Regulatory Impact Review (RIR)/Initial 

Regulatory Flexibility Analysis (IRFA), 

the categorical exclusion prepared for 

this action, and the Environmental 

Impact Statement (EIS) prepared for the 

Crab Rationalization Program may be 

obtained from the NMFS Alaska Region 

at the address above or from the Alaska 

Region Web site at http:// 

www.fakr.noaa.gov/ 

sustainablefisheries.htm. 

FOR FURTHER INFORMATION CONTACT: 

Glenn Merrill, 907–586–7228. 

SUPPLEMENTARY INFORMATION: The 

Magnuson-Stevens Act requires that 

each regional fishery management 

council submit any fishery management 

plan amendment it prepares to NMFS 

for review and approval, disapproval, or 

partial approval by the Secretary of 

Commerce (Secretary). The MagnusonStevens Act also requires that NMFS, 

upon receiving a fishery management 

plan amendment, immediately publish a 

notice in the Federal Register 

announcing that the amendment is 

available for public review and 

comment. 

The king and Tanner crab fisheries in 

the exclusive economic zone of the 

BSAI are managed under the FMP. The 

FMP was prepared by the North Pacific 

Fishery Management Council (Council) 

under the Magnuson-Stevens Act as 

amended by the Consolidated 

Appropriations Act of 2004 (Pub. L. 

108–199, section 801). Amendments 18 

and 19 to the FMP amended the FMP to 

include the Program. Regulations 


rmajette on PRODPC74 with PROPOSALS