Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38627 

1Pursuant to 46 CFR 501.24(a), the Commission 

has delegated to the Secretary the authority to 

approve applications for permission to practice 

before the Commission and to issue admission 

certificates to approved applicants. 

contact labor and management quickly, 

efficiently, and offer dispute resolution 

services. Either party to a contract may 

make a request in writing for a copy of 

the notice filed with FMCS. The F–7 

form was created to allow FMCS to 

gather desired information in a uniform 

manner. The collection of such 

information, including the name of the 

employer or employer association, 

address and phone number, e-mail 

address, official contact, bargaining unit 

and establishment size, location of 

affected establishment and negotiations, 

industry, union address, phone number, 

e-mail address and official contact, 

contract expiration date or renewal date, 

whether the notice is filed on behalf of 

the employer or the union, and whether 

this is a health care industry notice is 

critical for reporting and mediation 

purposes. 

Burden Statement: The current 

annual burden estimate is 

approximately 18,000 respondents. This 

one-page form takes about 10 minutes to 

complete. 

II. Request for Comments 

FMCS solicits comments to: 

(i) Evaluate whether the proposed 

collecton of information is necessary for 

the proper performance of the functions 

of the agency, including whether the 

information to be collected will have 

practical utility. 

(ii) Enhance the accuracy of the 

agency’s estimates of the burden of the 

proposed collection of information. 

(iii) Enhance the quality, utility, and 

clarity of the information to be 

collected. 

(iv) Minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic 

collection technologies or other forms of 

information technology. 

III. The Official Record 

The official record is the paper 

electronic record maintained at the 

address at the beginning of this 

document. FMCS will transfer all 

electronically received comments into 

printed-paper form as they are received. 

Dated: July 30, 2009. 

Michael J. Bartlett, 

Deputy General Counsel. 

[FR Doc. E9–18579 Filed 8–3–09; 8:45 am] 

BILLING CODE 6732–01–P 

FEDERAL RESERVE SYSTEM 

Sunshine Act Meeting 

AGENCY HOLDING THE MEETING: Board of 

Governors of the Federal Reserve 

System. 

TIME AND DATE: 12:00 p.m., Monday, 

August 10, 2009. 

PLACE: Marriner S. Eccles Federal 

Reserve Board Building, 20th and C 

Streets, N.W., Washington, D.C. 20551. 

STATUS: Closed. 

MATTERS TO BE CONSIDERED: 

1. Personnel actions (appointments, 

promotions, assignments, 

reassignments, and salary actions) 

involving individual Federal Reserve 

System employees. 

2. Any items carried forward from a 

previously announced meeting. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Smith, Director, or Dave 

Skidmore, Assistant to the Board, Office 

of Board Members at 202–452–2955. 

SUPPLEMENTARY INFORMATION: You may 

call 202–452–3206 beginning at 

approximately 5 p.m. two business days 

before the meeting for a recorded 

announcement of bank and bank 

holding company applications 

scheduled for the meeting; or you may 

contact the Board’s Web site at http:// 

www.federalreserve.gov for an electronic 

announcement that not only lists 

applications, but also indicates 

procedural and other information about 

the meeting. 

Board of Governors of the Federal Reserve 

System, July 31, 2009. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E9–18757 Filed 7–31–09; 4:15 pm] 

BILLING CODE 6210–01–S 

FEDERAL MARITIME COMMISSION 

[Docket No. 09–05] 

Application of Leonardo Ortiz for 

Admission To Practice Before the 

Federal Maritime Commission; Order 

Initiating Proceeding 

On December 31, 2007, Respondent 

Leonardo Ortiz (‘‘Mr. Ortiz’’) filed his 

Application for Admission to Practice 

before the Federal Maritime 

Commission (‘‘Form FMC–12’’). 

According to his application, Mr. Ortiz 

is self-employed. His business is located 

at 4324 Belton Highway, Anderson, SC 

29621. 

The Federal Maritime Commission 

(‘‘Commission’’) allows for attorney and 

non-attorney practitioners. In order to 

be admitted to practice before the 

Commission as a non-attorney, Rule 27 

of the Commission’s Rules of Practice 

and Procedure, 46 CFR § 502.27, 

requires that the applicant file proof that 

he or she possesses, to the satisfaction 

of the Commission, ‘‘the necessary legal, 

technical, or other qualifications to 

render valuable service before the 

Commission and is otherwise competent 

to advise and assist in the presentation 

of matters before [it].’’ Further, if the 

Commission is not satisfied that the 

applicant has sufficient qualifications, it 

will notify the applicant and, if 

requested, the applicant will be granted 

a hearing ‘‘for the purpose of showing 

his or her qualifications.’’ 46 CFR 

502.29. 

After reviewing his application, the 

Commission determined that Mr. Ortiz 

did not demonstrate that he possesses 

the qualifications required to practice 

before the Commission.1 On April 15, 

2009, the Secretary of the Commission 

notified Mr. Ortiz of the Commission’s 

intent to deny his application for 

admission to practice before it and the 

procedures permitting a request for a 

hearing. On April 29, 2009, Mr. Ortiz 

filed his request for a hearing on the 

issue. 

Now therefore, it is ordered that 

pursuant to Rule 29 of the Commission’s 

Rules of Practice and Procedure, 46 CFR 

502.29, the Commission institute a 

proceeding for the purpose of allowing 

Mr. Ortiz to show his qualifications to 

practice before it as a non-lawyer; 

It is further ordered that this matter be 

heard before the Commission; 

It is further ordered that this 

proceeding is limited to the submission 

of affidavits of fact and memoranda of 

law; 

It is further ordered that any person 

having an interest and desiring to 

intervene in this proceeding shall file a 

petition for leave to intervene in 

accordance with Rule 72 of the 

Commission’s Rules of Practice and 

Procedure, 46 CFR 502.72. Such petition 

shall be accompanied by the petitioner’s 

memorandum of law and affidavit of 

fact, if any, and shall be filed no later 

than the day fixed below; 

It is further ordered that Leonardo 

Ortiz is named as Respondent in this 

proceeding. Affidavits of fact and 

memoranda of law shall be filed by the 

Respondent and any intervenors in 

support of the Respondent no later than 

September 4, 2009; 

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38628 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

It is further ordered that the 

Commission’s Bureau of Enforcement be 

made a party to this proceeding; 

It is further ordered that rebuttal 

affidavits and memoranda of law shall 

be filed by the Bureau of Enforcement 

and any intervenors in opposition to the 

Respondent no later than October 5, 

2009; 

It is further ordered that reply 

affidavits and memoranda of law shall 

be filed by the Respondent and 

intervenors in support no later than 

October 20, 2009; 

It is further ordered that: 

(a) Should any party believe that an 

evidentiary hearing is required, that 

party must submit a request for such a 

hearing together with a statement setting 

forth in detail the facts to be proved, the 

relevance of those facts to the issues in 

this proceeding, a description of the 

evidence which would be adduced, and 

why such evidence cannot be submitted 

by affidavit; 

(b) Should any party believe that an 

oral argument is required, that party 

must submit a request specifying the 

reasons therefor and why argument by 

memorandum is inadequate to present 

the party’s case; and 

(c) Any request for evidentiary 

hearing or oral argument shall be filed 

no later than October 5, 2009; 

It is further ordered that notice of this 

proceeding be published in the Federal 

Register and that a copy thereof be 

served upon Respondent at his last 

known address; 

It is further ordered that all 

documents submitted by any party of 

record in this proceeding shall be filed 

in accordance with Rule 118 of the 

Commission’s Rules of Practice and 

Procedure, 46 CFR 502.118, as well as 

being mailed directly to all parties of 

record; 

Finally, it is ordered that pursuant to 

the terms of Rule 61 of the 

Commission’s Rules of Practice and 

Procedure, 46 CFR 502.61, the final 

decision of the Commission in this 

proceeding shall be issued by February 

17, 2010. 

By the Commission. 

Karen V. Gregory, 

Secretary. 

[FR Doc. E9–18601 Filed 8–3–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Determination and Declarations 

Regarding Emergency Use of Certain 

In vitro Diagnostic, Antiviral, and 

Personal Respiratory Products 

Accompanied by Emergency Use 

Information 

AGENCY: Office of the Secretary (OS), 

HHS. 

ACTION: Notice. 

SUMMARY: The Secretary of Health and 

Human Services (HHS) is issuing this 

notice pursuant to section 564(b) of the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), 21 U.S.C. 360bbb–3(b)(4). On 

April 26, 2009, the Acting Secretary of 

HHS determined that a public health 

emergency exists nationwide involving 

Swine Influenza A (now known as 

2009–H1N1 Influenza A, or 2009–H1N1 

influenza) that affects or has significant 

potential to affect national security. On 

the basis of this determination, on April 

26 and April 27, 2009, the Acting 

Secretary declared emergencies 

justifying the authorization of 

emergency use of certain in vitro 

diagnostic, antiviral, and personal 

respiratory protection products 

accompanied by emergency use 

information subject to the terms of any 

authorization issued by the 

Commissioner of Food and Drugs 

(Commissioner) under 21 U.S.C. 

360bbb–3(a). The Acting Secretary also 

specified that these declarations are 

declarations of emergency as defined by 

former Secretary Michael O. Leavitt in 

the October 10, 2008 Declaration under 

the Public Readiness and Emergency 

Preparedness (PREP) Act for Influenza 

Antivirals Oseltamivir Phosphate and 

Zanamavir, as amended, and the 

December 17, 2008 Declaration under 

the PREP Act for Pandemic Influenza 

Diagnostics, Personal Respiratory 

Protection Devices, and Respiratory 

Support Devices. 

DATES: The declaration of an emergency 

justifying the authorization of 

emergency use of certain in vitro 

diagnostic products is effective April 26, 

2009. The declaration of an emergency 

justifying the authorization of certain 

antiviral products is effective April 26, 

2009. The declaration of an emergency 

justifying the authorization of 

emergency use of certain respiratory 

protection products is effective April 27, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Lurie, M.D., MSPH, Assistant 

Secretary for Preparedness and 

Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Washington, DC 20201, Telephone 

(202) 205–2882 (this is not a toll free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under Section 564 of the FFDCA, the 

Commissioner, acting under delegated 

authority from the Secretary of HHS, 

may issue an Emergency Use 

Authorization (EUA) authorizing the 

emergency use of an unapproved drug, 

an unapproved or uncleared device, or 

an unlicensed biological product, or an 

unapproved use of an approved drug, 

approved or cleared device, or licensed 

biological product. Before an EUA may 

be issued, the Secretary of HHS must 

declare an emergency justifying the 

authorization based on one of three 

determinations: a determination of a 

domestic emergency, or a significant 

potential for a domestic emergency, by 

the Secretary of Homeland Security; a 

determination of a military emergency, 

or a significant potential for a military 

emergency, by the Secretary of Defense; 

or a determination of a public health 

emergency by the Secretary of HHS. See 

21 U.S.C. 360bbb–3(b)(1). In the case of 

a determination by the Secretary of HHS 

(as was made here), the Secretary must 

determine that a public health 

emergency exists under section 319 of 

the Public Health Service (PHS) Act that 

affects, or has a significant potential to 

affect, national security, and that 

involves a specified biological, 

chemical, radiological, or nuclear agent 

or agents, or a specified disease or 

condition that may be attributable to 

such agent or agents. Based on such a 

determination, the Secretary of HHS 

may then declare an emergency that 

justifies the EUA, at which point the 

Commissioner may issue an EUA if the 

criteria for issuance of an authorization 

under section 564 of the FFDCA are 

met. 

The Centers for Disease Control and 

Prevention (CDC), HHS, requested that 

the Food and Drug Administration 

(FDA) issue EUAs for certain in vitro 

diagnostic, antiviral, and personal 

respiratory protection products 

accompanied by emergency use 

information. The determination of a 

public health emergency by the Acting 

Secretary of HHS and the declarations of 

an emergency by the Acting Secretary of 

HHS based on that determination, as 

described below, enabled the Acting 

Commissioner to issue EUAs for certain 

in vitro diagnostic, antiviral, and 

personal respiratory protection products 

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