51310 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Proposed Rules 

7 In particular, the written request for confidential 

treatment that accompanies the comment must 

include the factual and legal basis for the request, 

and must identify the specific portions of the 

comment to be withheld from the public record. See 

FTC Rule 4.9(c), 16 CFR 4.9(c). 

4.9(c).7 Your comment will be kept 

confidential only if the FTC General 

Counsel, in his or her sole discretion, 

grants your request in accordance with 

the law and the public interest. 

Postal mail addressed to the 

Commission is subject to delay due to 

heightened security screening. As a 

result, we encourage you to submit your 

comments online. To make sure that the 

Commission considers your online 

comment, you must file it at https:// 

ftcpublic.commentworks.com/ftc/ 

unavailabilityruleanpr, by following the 

instructions on the Web-based form. If 

this Notice appears at http:// 

www.regulations.gov/#!home, you also 

may file a comment through that Web 

site. 

If you file your comment on paper, 

write ‘‘16 CFR Part 424—Retail Food 

Store Advertising Rule, Project No. 

P104203’’ on your comment and on the 

envelope, and mail or deliver it to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Room H–113 (Annex N), 600 

Pennsylvania Avenue, NW., 

Washington, DC 20580. If possible, 

submit your paper comment to the 

Commission by courier or overnight 

service. 

Visit the Commission Web site at 

http://www.ftc.gov to read this Notice 

and the news release describing it. The 

FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before October 19, 2011. You can find 

more information, including routine 

uses permitted by the Privacy Act, in 

the Commission’s privacy policy, at 

http://www.ftc.gov/ftc/privacy.htm. 

List of Subjects in 16 CFR Part 424 

Advertising, Foods, Trade practices. 

Authority: 15 U.S.C. 41–58. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2011–21020 Filed 8–17–11; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 51 

[REG–112805–10] 

RIN 1545–BJ39 

Branded Prescription Drug Fee 

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 relating to the branded 

prescription drug fee imposed by the 

Affordable Care Act (ACA). The 

regulations affect persons engaged in the 

business of manufacturing or importing 

certain branded prescription drugs. The 

text of the temporary regulations also 

serves as the text of the proposed 

regulations. 

DATES: Written and electronic comments 

and requests for a public hearing must 

be received by November 16, 2011. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–112805–10), room 

5205, 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–112805– 

10), 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–112805– 

10). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the proposed regulations, 

Celia Gabrysh at (202) 622–3130; 

concerning submissions of comments 

and requests for a hearing 

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

(202) 622–7180 (not toll free numbers). 

SUPPLEMENTARY INFORMATION: 

Paperwork Reduction Act 

The collection of information 

contained in this notice of proposed 

rulemaking has been approved by the 

Office of Management and Budget in 

accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)) and assigned control number 

1545–2209. 

Comments on the collection of 

information should be sent to the Office 

of Management and Budget, Attn: Desk 

Officer for the Department of the 

Treasury, Office of Information and 

Regulatory Affairs, Washington, DC 

20503, with copies to the Internal 

Revenue Service, Attn: IRS Reports 

Clearance Officer, 

SE:W:CAR:MP:T:T:SP, Washington, DC 

20224. Comments on the collection of 

information should be received by 

October 17, 2011. Comments are 

specifically requested concerning: 

Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Internal Revenue Service, including 

whether the information will have 

practical utility; 

The accuracy of the estimated burden 

associated with the proposed collection 

of information; 

How the quality, utility, and clarity of 

the information to be collected may be 

enhanced; 

How the burden of complying with 

the proposed collection of information 

may be minimized, including through 

the application of automated collection 

techniques or other forms of information 

technology; and 

Estimates of capital or start-up costs 

of operation, maintenance, and 

purchase of service to provide 

information. 

The collection of information in this 

proposed regulation is in § 51.7. This 

information is necessary to evaluate 

whether an error report regarding a 

preliminary fee calculation is valid and 

justifies an adjustment to the 

preliminary fee calculation. The likely 

respondents are manufacturers and 

importers of branded prescription drugs. 

Estimated total annual reporting and/ 

or recordkeeping burden: 1800 hours. 

Estimated annual burden per 

respondent/recordkeeper: 40 hours. 

Estimated number of respondents 

and/or recordkeepers: 45. 

Estimated frequency of responses: 

Annually. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless the collection of information 

displays a valid control number. 

Books or records relating to a 

collection of information must be 

retained as long as their contents may 

become material in the administration 

of any internal revenue law. Generally, 

tax returns and tax return information 

are confidential, as required by 26 

U.S.C. 6103. 

Background 

Temporary regulations in the Rules 

and Regulations section of this issue of 

the Federal Register add a new part, 

part 51, to subchapter D, Miscellaneous 

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Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Proposed Rules 51311 

Excise Taxes. Part 51 provides guidance 

on the annual fee imposed on covered 

entities engaged in the business of 

manufacturing or importing branded 

prescription drugs by section 9008 of 

the ACA. The text of those regulations 

also serves as the text of these proposed 

regulations. The preamble to the 

temporary regulations explains the new 

part. 

Special Analyses 

It has been determined that this notice 

of proposed rulemaking is not a 

significant regulatory action as defined 

in Executive Order 12866, as 

supplemented by Executive Order 

13563. Therefore, a regulatory flexibility 

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 to these 

regulations. It is hereby certified that the 

collection of information in these 

regulations will not have a significant 

economic impact on a substantial 

number of small entities. This 

certification is based on the fact that 

these regulations primarily affect large 

corporations. Thus, Treasury 

Department and the IRS do not expect 

a substantial number of small entities to 

be effected. Therefore, a Regulatory 

Flexibility Analysis under the 

Regulatory Flexibility Act (5 U.S.C. 

chapter 6) is not required. Pursuant to 

section 7805(f) of the Internal Revenue 

Code, this notice of proposed 

rulemaking has 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 comments (a signed original and 

eight (8) copies) or electronic comments 

that are submitted timely to the IRS. 

Comments are requested on all aspects 

of the proposed regulations. In addition, 

the IRS and the Treasury Department 

specifically request comments on the 

clarity of the proposed regulations and 

how they may be made easier to 

understand. All comments will be 

available for public inspection and 

copying. A public hearing may be 

scheduled if requested in writing by any 

person that timely submits written 

comments. If a public hearing is 

scheduled, notice of the date, time, and 

place for the hearing will be published 

in the Federal Register. 

Drafting Information 

The principal author of these 

regulations is Celia Gabrysh, Office of 

Associate Chief Counsel (Passthroughs 

and Special Industries). However, other 

personnel from the IRS and the Treasury 

Department participated in their 

development. 

List of Subjects in 26 CFR Part 51 

Drugs, Reporting and recordkeeping 

requirements. 

Proposed Amendments to the 

Regulations 

Accordingly, and under the authority 

of 26 U.S.C. 7805 (sec. 9008, Pub. L. 

111–347 (124 Stat. 119)), 26 CFR part 51 

is proposed to be added to read as 

follows: 

PART 51—BRANDED PRESCRIPTION 

DRUGS 

[The text of proposed §§ 51.1 through 

51.11 is the same as the text of §§ 51.1T 

through 51.11T published elsewhere in 

this issue of the Federal Register.] 

[The text of proposed § 51.6302–1 is 

the same as the text of paragraphs (a) 

and (b) of § 51.6302–1T published 

elsewhere in this issue of the Federal 

Register.] 

Sarah Hall Ingram, 

Deputy Commissioner for Services and 

Enforcement. 

[FR Doc. 2011–21012 Filed 8–15–11; 11:15 am] 

BILLING CODE 4830–01–P 

POSTAL REGULATORY COMMISSION 

39 CFR Part 3020 

[Docket No. RM2011–8; Order No. 666] 

Administrative Practice and Procedure, 

Postal Service 

AGENCY: Postal Regulatory Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: A Federal statute directs the 

Commission to implement a modern 

classification system. This proposal 

responds to that directive by presenting 

a comprehensive Mail Classification 

Schedule. Issuance of this document 

will allow the Commission to consider 

comments and, if appropriate, to make 

revisions prior to adoption of a final 

schedule. 

DATES: Comments are due: September 6, 

2011. 

ADDRESSES: Submit comments 

electronically by accessing the ‘‘Filing 

Online’’ link in the banner at the top of 

the Commission’s Web site (http:// 

www.prc.gov) or by directly accessing 

the Commission’s Filing Online system 

at https://www.prc.gov/prc-pages/filingonline/login.aspx. Commenters who 

cannot submit their views electronically 

should contact the person identified in 

the FOR FURTHER INFORMATION CONTACT

section as the source for case-related 

information for advice on alternatives to 

electronic filing. 

FOR FURTHER INFORMATION CONTACT: 

Stephen L. Sharfman, General Counsel, 

at 202–789–6820 (case-related 

information) or DocketAdmins@prc.gov 

(electronic filing assistance). 

SUPPLEMENTARY HISTORY: Regulatory 

History: 

72 FR 29284, May 25, 2007; 

72 FR 33261, June 15, 2007; 

72 FR 50744, September 4, 2007. 

Table of Contents 

I. Introduction 

II. Background 

III. Accessibility of the Mail Classification 

Schedule 

IV. Mail Classification Schedule Structure 

V. Rule Modifications 

VI. Public Representative 

VII. Public Comments 

VIII. Directions for Federal Register 

Publication and Access to Unpublished 

Material 

I. Introduction 

The Postal Regulatory Commission 

(Commission) establishes a rulemaking 

docket pursuant to its responsibilities 

under the Postal Accountability and 

Enhancement Act (PAEA), Public Law 

109–435, 120 Stat. 3198, December 20, 

2006, to consider modifications to the 

Commission’s rules governing the Mail 

Classification Schedule (MCS). 

Modifications are proposed to add 

material describing some Postal Service 

products and make conforming changes. 

The Commission provides this notice 

and opportunity for comment on 

whether the Commission should 

incorporate the proposed modifications 

by final rule into the Commission’s 

rules at 39 CFR 3020, Subpart A—Mail 

Classification Schedule. 

For products currently being offered 

by the Postal Service, this rulemaking 

does not add products to, remove 

products from, or transfer products 

between the existing market dominant 

or competitive product lists. However, 

this rulemaking does reorganize how 

products appear within each individual 

list. This reorganization is most 

apparent within the competitive 

product list where, at the suggestion of 

the Postal Service, the vestiges of 

‘‘class’’ groupings have been replaced 

with functional product groupings. 

Additionally, the currently published 

product lists require updating to remove 

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