This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

63141 

Vol. 72, No. 216 

Thursday, November 8, 2007 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 54 

[Docket No. PRM–54–4] 

Friends United for Sustainable Energy; 

Denial of Petition for Rulemaking 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Denial of petition for 

rulemaking. 

SUMMARY: The Nuclear Regulatory 

Commission (NRC) is denying a petition 

for rulemaking (PRM–54–4) submitted 

by Susan Shapiro, Esquire, Friends 

United for Sustainable Energy. The 

petitioner requested that the NRC issue 

an order to enjoin the NRC from 

considering any new license 

applications until the NRC can amend 

its regulations so that the regulations do 

not suppress and/or eliminate a 

stakeholder’s right to redress, due 

process and equal protection in the 

licensing renewal process. A notice of 

receipt of this petition was not 

published in the Federal Register. 

ADDRESSES: For a copy of the petition, 

write to Michael T. Lesar, Chief, 

Rulemaking, Directives, and Editing 

Branch, Division of Administrative 

Services, Office of Administration, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001. 

Publicly available documents related 

to this petition may be viewed 

electronically on public computers in 

the NRC’s public document Room 

(PDR), O–1 F21, One White Flint North, 

11555 Rockville Pike, Rockville, 

Maryland. The PDR reproduction 

contractor will copy documents for a 

fee. 

Publicly available documents created 

or received at the NRC after November 

1, 1999, are also available electronically 

at the NRC’s Electronic Reading Room at 

http://www.nrc.gov/NRC/ADAMS/ 

index.html. From this site, the public 

can gain entry into the NRC’s 

Agencywide document Access and 

Management System (ADAMS), which 

provides text and image files of NRC’s 

public documents. If you do not have 

access to ADAMS or if there are 

problems in accessing the documents 

located in ADAMS contact the NRC’s 

PDR Reference staff at 1–800–397–4209, 

301–415–4737, or by e-mail to 

pdr@nrc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Michael T. Lesar, Chief, Rulemaking, 

Directives, and Editing Branch, Division 

of Administrative Services, Office of 

Administration, U.S. Nuclear Regulatory 

Commission, Washington, DC 20555– 

0001, Telephone: 301–415–7163, or toll 

free: 800–368–5642, e-mail 

MTL@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

The Petition 

The petitioner requested that the NRC 

issue an order to enjoin the NRC from 

considering any new license 

applications until the NRC can amend 

its regulations so that the regulations do 

not suppress and/or eliminate a 

stakeholder’s right to redress, due 

process and equal protection in the 

licensing renewal process. 

Reasons for Denial 

The NRC is denying this petition 

because the petitioner does not provide 

any new information that was not 

previously considered by the NRC in 

denying the petitions submitted by 

County Executive Andrew Spano of 

Westchester County, New York in PRM– 

54–2 and Mayor Joseph Scarpelli of 

Brick Township, New Jersey in PRM– 

54–3 (December 13, 2006; 72 FR 74848). 

These petitions were denied because 

they raised issues: (1) That the 

Commission already considered at 

length in developing the license renewal 

rule (December 13, 1991; 56 FR 64943); 

(2) that are managed by the ongoing 

regulatory process or under other 

regulations; or (3) that are beyond the 

Commission’s regulatory authority. 

The petitioner did not present any 

new information that contradicts 

positions taken by the Commission 

when the December 13, 1991, regulation 

was established or demonstrates that 

sufficient reason exists to modify the 

current regulations. 

For the reasons cited in this 

document, the NRC denies this petition. 

Dated at Rockville, Maryland, this 29th day 

of October 2007. 

For the Nuclear Regulatory Commission. 

Luis A. Reyes, 

Executive Director for Operations. 

[FR Doc. E7–21928 Filed 11–7–07; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 2 

[Docket No. 2007N–0262] 

RIN 0910–AF92 

Use of Ozone-Depleting Substances; 

Removal of Essential-Use Designation 

(Epinephrine); Public Meeting; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; notice of public 

meeting and extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to solicit comments on 

a proposed rule that would amend 

FDA’s regulation on the use of ozonedepleting substances (ODSs) in selfpressurized containers to remove the 

essential-use designation for oral 

pressurized metered-dose inhalers 

(MDIs) containing epinephrine. The 

proposed rule was published in the 

Federal Register of September 20, 2007 

(72 FR 53711). Information from the 

public meeting, which is required by 

agency regulations, will be considered 

in finalizing the rulemaking. In 

addition, the comment period on the 

proposed rule is being extended to 

December 19, 2007, to accommodate the 

meeting and to provide a short period 

after the meeting to receive additional 

comments. 

DATES: The comment period for the 

September 20, 2007 (72 FR 53711) 

proposed rule is being extended to 

December 19, 2007. The public meeting 

will be held on December 5, 2007, from 

9 a.m. to 3:30 p.m. Submit written or 

electronic comments for consideration 

at the meeting and requests to speak at 

the meeting by November 23, 2007. 

Register to attend the meeting by 

November 23, 2007. Submit written or 

electronic comments on the proposed 


rwilkins on PROD1PC63 with PROPOSALS
63142 Federal Register / Vol. 72, No. 216 / Thursday, November 8, 2007 / Proposed Rules 

1‘‘HFA’’ is used in the pharmaceutical industry, 

and is used here, to refer to the hydrofluoralkane 

HFA–134a, a non-ozone-depleting propellant. 

rule and this document by December 19, 

2007. 

ADDRESSES: The public meeting will be 

held at FDA, Center for Drug Evaluation 

and Research, Advisory Committee 

Conference Room, 5630 Fishers Lane, 

rm. 1066, Rockville, MD 20852. 

You may submit comments, identified 

by Docket No. 2007N–0262 and RIN 

number RIN 0910–AF92, by any of the 

following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted directly to the 

agency by e-mail. FDA encourages you 

to continue to submit electronic 

comments by using the Federal 

eRulemaking Portal or the agency Web 

site, as described previously in the 

ADDRESSES portion of this document 

under Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For additional 

information on submitting comments, 

see the ‘‘Request for Comments’’

heading of the SUPPLEMENTARY

INFORMATION section of this document. 

Docket: For access to the docket to 

read the proposed rule, background 

documents, or comments received, go to 

http://www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number 2007N–0262, into the ‘‘Search’’

box and follow the prompts and/or go 

to the Division of Dockets Management, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Rose 

Cunningham, Center for Drug 

Evaluation and Research (HFD–6), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–443–

5383, E-mail: CDEREXSEC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Clean Air Act, FDA, in 

consultation with the Environmental 

Protection Agency, is required to 

determine whether an FDA-regulated 

product that releases an ODS is an 

essential use of the ODS. In the Federal 

Register of September 20, 2007 (72 FR 

53711) (the proposed rule), we proposed 

to amend our regulation on the use of 

ODSs in self-pressurized containers to 

remove the essential-use designation of 

MDIs containing epinephrine. You may 

find copies of the proposed rule on the 

Division of Dockets Management Web 

site (see ADDRESSES) and the GPO 

Access Web site at http:// 

www.gpoaccess.gov/fr/index.html. If the 

essential-use designation is removed, 

epinephrine MDIs containing an ODS 

could not be marketed after the effective 

date of the final rule removing the 

essential-use designation. 

In proposing to remove the essentialuse designation for epinephrine, we 

applied the criterion for removing an 

essential-use designation in § 2.125(g)(2) 

(21 CFR 2.125(g)(2)). Under 

§ 2.125(g)(2), an essential-use 

designation can be removed if it no 

longer meets the criteria specified in 

§ 2.125(f) for adding a new essential use. 

The criteria in § 2.125(f)(1) are: ‘‘(i) 

Substantial technical barriers exist to 

formulating the product without ODSs; 

(ii) The product will provide an 

unavailable important public health 

benefit; and (iii) Use of the product does 

not release cumulatively significant 

amounts of ODSs into the atmosphere or 

the release is warranted in view of the 

unavailable important public health 

benefit.’’

We proposed that the removal of the 

essential-use designation for 

epinephrine be made effective on 

December 31, 2010. Depending on the 

data presented to us in the course of the 

rulemaking, we may determine that it is 

appropriate to have a different effective 

date than the one we proposed. 

The provisions in § 2.125(g)(2) that 

provide the procedures and criteria 

being used in this rulemaking require 

that a public meeting be held before an 

essential use may be removed. This 

document announces the meeting that 

will be held to fulfill that requirement, 

which will also better inform the 

decisions we will be making during the 

rulemaking. 

II. Issues and Questions for Discussion 

and Comment 

If you are going to speak at the 

meeting or submit a written comment, 

you may address any issue raised in the 

proposed rule or on any other issue that 

is relevant to our decision on the 

proposed rule. You may wish to discuss 

how the criteria described in section I 

of this document apply to MDIs 

containing epinephrine. You may wish 

to discuss how the fact that epinephrine 

MDIs are the most widely used over-thecounter (OTC) treatment for the 

symptoms of asthma should affect our 

decision. You may also wish to discuss 

whether a different effective date is 

appropriate. We invite discussion of 

issues on which we specifically asked 

for comments in the proposed rule, 

including the following. 

• Will production of albuterol HFA1

MDIs (a primary therapeutic alternative 

to OTC epinephrine MDIs) be able to 

meet any increased demand caused by 

this rulemaking? (72 FR 53711 at 53716) 

• Will inhaled epinephrine become 

available in a non-ODS formulation and 

when can a non-ODS inhaledepinephrine product be reasonably 

expected to enter the market? (72 FR 

53711 at 53716) 

• Should the availability of an 

inhaled-epinephrine OTC drug product 

that does not contain ODSs affect 

whether we publish a final rule or the 

effective date of any such rule? (72 FR 

53711 at 53716) 

• What efforts are currently being 

made to develop non-ODS inhaledepinephrine drug products that would 

be suitable for OTC sale? (72 FR 53711 

at 53718) 

• What are the impediments to 

developing non-ODS inhaledepinephrine drug products that would 

be suitable for OTC sale? (72 FR 53711 

at 53718) 

• How many people who face barriers 

to health care purchase epinephrine 

MDIs because of those barriers to health 

care? (72 FR 53711 at 53720) 

• Will programs providing free or lowcost drugs reduce any adverse impact on 

the public health caused by the removal 

of OTC epinephrine MDIs from the 

market? (72 FR 53711 at 53722) 

• Do risks of self-treatment of asthma 

outweigh the public health benefits that 

OTC epinephrine MDIs may provide? 

(72 FR 53711 at 53722) 

• What are the expected costs and 

public health effects to individuals with 

asthma if OTC epinephrine MDIs were 

removed from the market without a 


rwilkins on PROD1PC63 with PROPOSALS
Federal Register / Vol. 72, No. 216 / Thursday, November 8, 2007 / Proposed Rules 63143 

similar product being available OTC? 

(72 FR 53711 at 53722) 

We consulted with FDA’s 

Nonprescription Drugs Advisory 

Committee and Pulmonary and Allergy 

Drugs Advisory Committee at a joint 

meeting held on January 24, 2006, to 

discuss the essential-use status of MDIs 

containing epinephrine. During the 

meeting, several committee members 

expressed opinions that MDIs 

containing epinephrine provide 

important public health benefits to 

individuals with asthma who face 

barriers to health care and cannot obtain 

prescription drugs. You may wish to 

read the transcript of the joint meeting 

(available on the Division of Dockets 

Management Web site (see ADDRESSES)) 

or the summaries of the discussions at 

the meeting in the proposed rule (72 FR 

53711 at 53716 to 53724). 

III. Registration, Agenda, and 

Transcript 

There is no fee to register for the 

meeting, but registration is required and 

space is limited. Interested parties are 

therefore encouraged to register early. 

Limited visitor parking is available for 

a fee, and the Twinbrook Metro Stop is 

within walking distance of the meeting 

site. Early arrival is encouraged, as there 

will be security screening. You will be 

asked for government-issued picture 

identification by the security officers. If 

you need special accommodations due 

to a disability, please include this 

information when registering. 

Registration for General Attendees. 

Registration is required to attend the 

public meeting. If you wish to attend the 

meeting, you must register by November 

23, 2007, via e-mail to: 

CDEREXSEC@fda.hhs.gov. Please 

indicate ‘‘Essential-Use Designation of 

Epinephrine’’ in the SUBJECT line and 

provide complete contact information 

for each attendee (including name, title, 

affiliation, e-mail address, and phone 

number(s)). Upon receipt and review for 

adequacy of information, an e-mail will 

be sent to confirm registration. 

Registration for Speaking Attendees. 

If you wish to speak at the meeting, you 

must register by November 23, 2007, via 

e-mail to: CDEREXSEC@fda.hhs.gov. 

Please indicate ‘‘Speaker--Essential UseDesignation of Epinephrine’’ in the 

SUBJECT line. When registering, 

speakers must provide the following 

information: (1) The topic or issue to be 

addressed; (2) the speaker’s name, title, 

company or organization, address, 

phone number, and e-mail address; and 

(3) the approximate length of time 

requested to speak. We encourage 

consolidation of like-minded 

presentations to enable a broad range of 

views to be presented. 

Agenda and Transcript. The agenda 

for the public meeting will be available 

on FDA’s Center for Drug Evaluation 

and Research (CDER) Web site at: http:// 

www.fda.gov/cder/meeting/ 

ozone2007.htm. After the meeting, the 

agenda, presentations, and transcript 

will be placed on file in the Division of 

Dockets Management under Docket No. 

2007N–0262 and on CDER’s Web site 

identified previously. 

Copies of the transcript may be 

requested in writing from the Freedom 

of Information Office (HFI–35), Food 

and Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857, 

approximately 20 working days after the 

meeting at a cost of 10 cents per page, 

or on compact disc at a cost of $14.25 

each. You may also examine the 

transcript at the Division of Dockets 

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

Monday through Friday, and on the 

Internet at http://www.fda.gov/ohrms/ 

dockets/default.htm. 

IV. Extension of the Comment Period 

for the Proposed Rule 

FDA is extending the comment period 

for the proposed rule to December 19, 

2007. We believe that extending the 

comment period is reasonable to 

accommodate the public meeting and to 

provide a short period after the meeting 

to receive additional comments. 

V. Request for Comments 

Regardless of your attendance at the 

meeting, you may submit to the Division 

of Dockets Management (see ADDRESSES) 

written or electronic comments related 

to the proposed rule (see DATES). All 

relevant data and information should be 

submitted with the written comments. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one copy. 

Comments are to be identified with 

Docket No. 2007N–0262. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: November 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–5593 Filed 11–5–07; 4:01 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–140206–06] 

RIN–1545–BF93 

Withholding Procedure Under Section 

1441 for Certain Distributions to Which 

Section 302 Applies; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to notice of proposed 

rulemaking. 

SUMMARY: This document contains 

corrections to proposed regulations 

(REG–140206–06) that were published 

in the Federal Register on Wednesday, 

October 17, 2007 (72 FR 58781) 

regarding a withholding agent’s 

obligation to withhold and report tax 

under Chapter 3 of the Internal Revenue 

Code when there is a distribution in 

redemption of stock of a corporation 

that is actively traded on an established 

financial market. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn Holman at (202) 622–3840 (not 

a’’. 

SUPPLEMENTARY INFORMATION: 

Background 

The notice of proposed rulemaking 

(REG–140206–06) that is the subject of 

this correction is under section 1441 of 

the Internal Revenue Code. 

Need for Correction 

As published, this notice of proposed 

rulemaking (REG–140206–06) contains 

an error that may prove to be misleading 

and is in need of clarification. 

Correction of Publication 

Accordingly, the notice of proposed 

rulemaking (REG–140206–06) that was 

the subject of FR Doc. E7–20504 is 

corrected as follows: 

On page 58781, column 3, in the 

preamble, under the caption ‘‘FOR

FURTHER INFORMATION CONTACT:’’, line 2, 

the language ‘‘Kathryn Holman, (202) 

622–3440 (not a’’ is corrected to read 

‘‘Kathryn Holman, (202) 622–3840 (not 

a)’’. 

Cynthia Grigsby, 

Senior Federal Register Liaison, Publications 

and Regulations Branch, Legal Processing 

Division, Associate Chief Counsel (Procedure 

and Administration). 

[FR Doc. E7–21904 Filed 11–7–07; 8:45 am] 

BILLING CODE 4830–01–P 


rwilkins on PROD1PC63 with PROPOSALS