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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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38629 

1For purposes of this EUA, the term ‘‘general 

public’’ is broad and includes people performing 

work-related duties. This EUA affects only 

requirements applicable under the Federal Food, 

Drug, and Cosmetic Act. It does not affect 

requirements arising from other sources of law, 

such as Occupational Safety and Health 

Administration (OSHA) requirements. 

for emergency use under section 564(a) 

of the FFDCA, 21 U.S.C. 360bbb-3(a). 

An in vitro diagnostic, CDC Human 

Influenza Virus Real-time RT–PCR 

Detection and Characterization Panel 

(rRT–PCR Flu Panel), is cleared by FDA 

for detection of seasonal Influenza A 

and subtype determination. CDC sought 

an EUA to allow this test to be used 

with specimen types and reagents 

additional to those of the cleared test as 

a first tier test for patients suspected of 

having 2009–H1N1 influenza. CDC also 

sought an EUA to allow an in vitro 

diagnostic that has not been previously 

approved or cleared by the FDA, Swine 

Influenza Virus Real-time RT–PCR 

Detection Panel (rRT–PCR Swine Flu 

Panel), to be used in detecting 2009– 

H1N1 influenza. 

CDC also sought EUAs for certain 

antiviral drug products, which are 

approved by FDA for use in treatment 

and prophylaxis of influenza for adult 

and pediatric use. Relenza® (zanamivir) 

is approved to treat acute 

uncomplicated illnesses due to 

influenza in adults and children 7 years 

and older who have been symptomatic 

for less than two days, and for the 

prevention of influenza in adults and 

children 5 years and older. Tamiflu® 

(oseltamivir phosphate) is approved for 

the treatment of acute uncomplicated 

illness due to influenza in patients 1 

year and older who have been 

symptomatic for less than two days, and 

for the prevention of influenza in 

patients 1 year and older. The EUA for 

Tamiflu allows for Tamiflu to also be 

used to treat and prevent influenza in 

children under one year, to treat 

influenza in patients who have been 

symptomatic for more than 2 days, and 

to provide alternate dosing 

recommendations for certain pediatric 

populations. The EUA for Tamiflu also 

authorizes distribution of Tamiflu 

deployed from the Strategic National 

Stockpile (SNS) and that has had its 

expiration date extended under the 

Federal government’s Shelf Life 

Extension Program (SLEP). In addition, 

under the EUAs, both Tamiflu and 

Relenza may be distributed to large 

segments of the population without 

complying with certain prescription 

label requirements otherwise applicable 

to dispensed drug. Under the EUAs, 

Tamiflu and Relenza are authorized to 

be accompanied by certain written 

information pertaining to the 

emergency. The EUAs note that there 

may be distribution of these products by 

a broader range of health care workers, 

including some public health officials 

and volunteers, in accordance with 

applicable State and local laws and/or 

the public health and medical 

emergency response of the authority 

having jurisdiction, subject to the terms 

and conditions of the EUA. 

Finally, certain personal respiratory 

protection devices certified by the 

National Institute for Occupational 

Safety and Health (NIOSH), in 

accordance with 42 CFR part 84, as nonpowered air-purifying particulate 

respirators with a minimum filtration 

efficiency classification of N95 (known 

as N95 respirators) have been cleared by 

FDA for use by the general public in 

public health medical emergencies, 

such as an influenza pandemic. Other 

N95 respirators have been cleared by 

FDA for use in certain workplace 

settings. The disposable N95 respirators 

for which CDC sought an EUA were 

either not previously cleared or 

approved by FDA or were cleared by 

FDA but only for use in certain 

workplace settings. The EUA authorized 

the emergency use, by the general 

public,1 of these products, as deployed 

from the SNS and accompanied by 

emergency use information, to help 

reduce wearer exposure to airborne 

germs during this emergency. The 

specific products covered by the EUA 

are identified in the EUA by 

manufacturer and model number; fifteen 

different models of disposable N95 

respirators are covered. 

With issuance of the EUAs for certain 

in vitro diagnostic products, laboratories 

may receive certain in vitro diagnostics 

covered by the EUAs for use in 

detection of 2009–H1N1 influenza, and 

patients and health care professionals 

may receive emergency use information 

regarding these in vitro diagnostic 

products during this public health 

emergency involving 2009–H1N1 

influenza. With issuance of the EUAs 

for certain antiviral products and 

issuance of the EUA for certain personal 

respiratory products, members of the 

general public may receive certain 

antiviral and personal respiratory 

protection products covered by the 

EUAs, accompanied by emergency use 

information, for immediate use by them 

during this 2009–H1N1 influenza 

emergency. These products and 

accompanying information may help to 

detect the spread of 2009–H1N1 

influenza, protect individuals against 

contracting 2009–H1N1 influenza, and 

treat individuals who are ill following 

exposure to 2009–H1N1 influenza. 

In this public health emergency 

involving 2009–H1N1 influenza, time is 

of the essence in detecting, preventing, 

and treating illness and death by getting 

in vitro diagnostic, antiviral and 

personal respiratory protection 

products, accompanied by emergency 

use information, to the general public, 

laboratories, and public health and 

health care professionals. By 

distributing certain in vitro diagnostic 

products accompanied by emergency 

use information, public health and 

health care professionals can ensure that 

spread of the 2009–H1N1 influenza is 

quickly and accurately detected. By 

dispensing certain personal respiratory 

products accompanied by emergency 

use information, the appropriate State 

and/or public health authority(ies) can 

ensure that the products are provided 

quickly, as appropriate, to help reduce 

wearer exposure to airborne germs. By 

dispensing certain antiviral products 

accompanied by emergency use 

information, public health and medical 

professionals and the authorities having 

jurisdiction to respond to the emergency 

in each locality can ensure that the 

products are provided quickly, as 

appropriate, to those who may have 

been exposed or are ill, accompanied by 

the information most important to their 

emergency use. 

This is one part of the Federal 

Government’s strategy to encourage 

preparedness at all levels of government 

to enable the nation to respond 

effectively in response to this public 

health emergency. 

II. Determination of the Acting 

Secretary of Health and Human 

Services 

On April 26, 2009, pursuant to section 

564(b)(1)(C) of the FFDCA, 21 U.S.C. 

360bbb–3(b)(1)(A), and section 319 of 

the PHS Act, 42 U.S.C. 247d, the Acting 

Secretary of HHS determined, as a 

consequence of confirmed cases of 

Swine Influenza A (swH1N1) (now 

called ‘‘2009–H1N1 influenza’’) in 

California, Texas, Kansas, and New 

York, and after consultation with public 

health officials as necessary, that a 

public health emergency exists 

nationwide involving 2009–H1N1 

influenza that affects or has significant 

potential to affect national security. 

III. Declarations of the Acting Secretary 

of Health and Human Services 

On April 26, 2009, on the basis of the 

Acting Secretary’s determination on 

April 26, 2009, pursuant to section 319 

of the Public Health Service Act, 42 

U.S.C. 247d, that a public health 

emergency exists involving 2009–H1N1 

influenza that affects or has significant 

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38630 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

potential to affect national security, and 

pursuant to section 564(b) of the Federal 

Food, Drug and Cosmetic Act, 21 U.S.C. 

360bbb–3(b), the Acting Secretary 

declared an emergency justifying the 

authorization of the emergency use of 

certain in vitro diagnostics for detection 

of Swine Influenza A (now called 

‘‘2009–H1N1 influenza’’) accompanied 

by emergency use information subject to 

the terms of any authorization issued 

under 21 U.S.C. 360bbb–3(a). The 

Secretary further specified that the 

declaration is a declaration of 

emergency, as defined in the December 

17, 2008, Declaration under the PREP 

Act for Pandemic Influenza Diagnostics, 

Personal Respiratory Protection Devices, 

and Respiratory Support Devices, 

published at 73 FR 78362 (December 22, 

2008). 

Also, on April 26, 2009, on the basis 

of the Acting Secretary’s determination 

on April 26, 2009, pursuant to section 

319 of the Public Health Service Act, 42 

U.S.C. 247d, that a public health 

emergency exists involving Swine 

Influenza A that affects or has 

significant potential to affect national 

security, and pursuant to section 564(b) 

of the Federal Food, Drug and Cosmetic 

Act, 21 U.S.C. 360bbb–3(b), the Acting 

Secretary declared an emergency 

justifying the authorization of the 

emergency use of certain products from 

the neuraminidase class of antivirals 

oseltamivir phosphate and zanamivir 

accompanied by emergency use 

information subject to the terms of any 

authorization issued under 21 U.S.C. 

360bbb–3(a). The Secretary further 

specified that the declaration is a 

declaration of emergency, as defined in 

the October 10, 2008, Declaration under 

the PREP Act for Influenza Antivirals 

Oseltamivir Phosphate and Zanamivir, 

published at 73 FR 61861 (October 17, 

2008), as amended. The Acting 

Secretary’s April 26, 2009, amendment 

to the October 10, 2008 Declaration 

under the PREP Act for Influenza 

Antivirals Oseltamivir Phosphate and 

Zanamivir is separately published 

elsewhere in this issue of the Federal 

Register. 

On April 27, 2009, on the basis of the 

Acting Secretary’s determination on 

April 26, 2009, pursuant to section 319 

of the Public Health Service Act, 42 

U.S.C. 247d, that a public health 

emergency exists involving Swine 

Influenza A that affects, or has 

significant potential to affect, national 

security; and pursuant to section 564(b) 

of the Federal Food, Drug and Cosmetic 

Act, 21 U.S.C. 360bbb–3(b), the Acting 

Secretary declared an emergency 

justifying the authorization of the 

emergency use of certain personal 

respiratory protection devices, 

accompanied by emergency use 

information subject to the terms of any 

authorization issued under 21 U.S.C. 

360bbb–3(a). The Secretary further 

specified that the declaration is a 

declaration of emergency, as defined in 

the December 17, 2008, Declaration 

under the PREP Act for Pandemic 

Influenza Diagnostics, Personal 

Respiratory Protection Devices, and 

Respiratory Support Devices, 73 FR 

78362 (December 22, 2008). 

Notice of the authorizations issued by 

the FDA Commissioner under 21 U.S.C. 

360bbb–3 is provided elsewhere in this 

Federal Register. 

Dated: July 28, 2009. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. E9–18432 Filed 8–3–09; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Office for Civil Rights; Delegation of 

Authority 

Notice is hereby given, that I have 

delegated to the Director of the Office 

for Civil Rights (OCR), with authority to 

redelegate, the following authority 

vested in the Secretary of Health and 

Human Services: 

1. The authority under section 262 of 

the Health Insurance Portability and 

Accountability Act of 1996 (HIPAA), 

Public Law 104–191, as amended, to the 

extent that these actions pertain to the 

‘‘Security Standards for the Protection 

of Electronic Protected Health 

Information,’’ at 45 CFR part 160 and 

part 164, subparts A and C, to 

A. Impose civil money penalties 

under section 1176 of the Social 

Security Act for a covered entity’s 

failure to comply with certain 

requirements and standards; 

B. Issue subpoenas requiring the 

attendance and testimony of witnesses 

and the production of any evidence that 

relates to any matter under investigation 

or compliance review for failure to 

comply with certain requirements and 

standards; and 

C. Make exception determinations, 

under section 1178(a)(2)(A) of the Social 

Security Act, concerning when 

provisions of State laws that are 

contrary to the Federal standards are not 

preempted by the Federal provisions. 

2. The authority under section 262 of 

HIPAA, as amended, to administer the 

regulation ‘‘Security Standards for the 

Protection of Electronic Protected 

Health Information,’’ at 45 CFR part 160 

and part 164, subparts A and C, and 

General Administrative Requirements, 

45 CFR Part 160, as these requirements 

pertain to part 164, subparts A and C, 

and to make decisions regarding the 

interpretation and enforcement of these 

Standards and General Administrative 

Requirements. 

This delegation shall be exercised 

under the Department’s existing 

delegation of authority and policy 

relating to regulations. 

This delegation supersedes the 

memorandum from the Secretary to the 

Administrator, Centers for Medicare & 

Medicaid Services, dated October 7, 

2003, titled ‘‘Delegation of Authority for 

Certain Provisions Under Part C of Title 

XI of the Social Security Act.’’ 

I hereby affirm and ratify any actions 

taken by the Director of OCR or his/her 

subordinates which involved the 

exercise of the authority delegated 

herein prior to the effective date of this 

delegation. 

This delegation is effective 

immediately. 

Dated: July 27, 2009. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. E9–18557 Filed 8–3–09; 8:45 am] 

BILLING CODE 4153–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Implementation of Section 5001 of the 

American Recovery and Reinvestment 

Act of 2009 (ARRA) for Adjustments to 

the Third Quarter of Fiscal Year 2009 

Federal Medical Assistance 

Percentage (FMAP) Rates for Federal 

Matching Shares for Medicaid and 

Foster Care and Adoption Assistance 

AGENCY: Office of the Secretary, DHHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice with comment 

period describes the methodology for 

calculating the higher federal matching 

funding that is made available under 

Section 5001 of the American Recovery 

and Reinvestment Act of 2009 (ARRA). 

Section 5001 of the ARRA provides for 

temporary increases in the Federal 

Medical Assistance Percentage (FMAP) 

rates to provide fiscal relief to States 

and to protect and maintain State 

Medicaid programs in a period of 

economic downturn. The increased 

FMAP rates apply during a recession 

adjustment period that is defined as the 

period beginning on October 1, 2008 

and ending on December 31, 2010. 

mstockstill on DSKH9S0YB1PROD with NOTICES