Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13329 

Labor, and any relevant supporting data, 

including payroll records, that the 

contracting officer may reasonably 

require. The information is used by 

Government contracting officers to 

establish the contract price adjustment 

for the construction requirements of a 

contract, generally if the contract 

requirements are predominantly 

services subject to the Service Contract 

Act. 

B. Annual Reporting Burden 

Respondents: 842. 

Responses per Respondent: 1. 

Annual Responses: 842. 

Hours per Response: 40. 

Total Burden Hours: 33,680. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (MVCB), 1275 

First Street NE., Washington, DC 20417, 

telephone (202) 501–4755. Please cite 

OMB Control No. 9000–0154, DavisBacon Act—Price Adjustment (Actual 

Method), in all correspondence. 

Dated: February 28, 2012 

Laura Auletta, 

Director, Office of Governmentwide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Governmentwide Policy. 

[FR Doc. 2012–5322 Filed 3–5–12; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

[OMB Control No. 9000–0163; Docket 2011– 

0076; Sequence 6] 

Information Collection; Small Business 

Size Representation 

AGENCIES: Department of Defense (DOD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Notice of request for an 

extension to an existing OMB clearance. 

SUMMARY: Under the provisions of the 

Paperwork Reduction Act, the 

Regulatory Secretariat will be 

submitting to the Office of Management 

and Budget (OMB) a request for 

approval of a previously approved 

information collection requirement 

regarding small business size 

representation. 

DATES: Submit comments on or before: 

May 7, 2012. 

ADDRESSES: Submit comments 

identified by Information Collection 

9000–0163, Small Business Size 

Representation, by any of the following 

methods: 

• Regulations.gov: http:// 

www.regulations.gov. 

Submit comments via the Federal 

eRulemaking portal by inputting 

‘‘Information Collection 9000–0163, 

Small Business Size Representation’’ 

under the heading ‘‘Enter Keyword or 

ID’’ and selecting ‘‘Search’’. Select the 

link ‘‘Submit a Comment’’ that 

corresponds with ‘‘Information 

Collection 9000–0163, Small Business 

Size Representation’’. Follow the 

instructions provided at the ‘‘Submit a 

Comment’’ screen. Please include your 

name, company name (if any), and 

‘‘Information Collection 9000–0163, 

Small Business Size Representation’’ on 

your attached document. 

• Fax: 202–501–4067. 

• Mail: General Services 

Administration, Regulatory Secretariat 

(MVCB), 1275 First Street NE., 

Washington, DC 20417. Attn: Hada 

Flowers/IC 9000–0163, Small Business 

Size Representation. 

Instructions: Please submit comments 

only and cite Information Collection 

9000–0163, Small Business Size 

Representation, in all correspondence 

related to this collection. All comments 

received will be posted without change 

to http://www.regulations.gov, including 

any personal and/or business 

confidential information provided. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Karlos Morgan, Procurement Analyst, 

Office of Governmentwide Acquisition 

Policy, GSA (202) 501–0044 or 

karlos.morgan@gsa.gov. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

Federal Acquisition Regulation (FAR) 

19.301 and the FAR clause at 52.219–28, 

Post-Award Small Business Program 

Representation implement the Small 

Business Administration (SBA) Final 

Rule (71 FR 66434), Small Business Size 

Regulations; Size for Purposes of 

Governmentwide Acquisition Contracts, 

Multiple Award Schedule Contracts and 

Other Long-Term Contracts; 8(a) 

Business Development/Small 

Disadvantaged Business; Business 

Status Determinations. FAR 19.301 and 

the FAR clause at 52.219–28, requires 

that contractors represent size status by 

updating their representations and 

certifications at the prime contract level 

in the Online Representations and 

Certifications Application (ORCA), and 

notify the contracting office that it has 

made the required representation. 

The purpose of implementing small 

business rerepresentation in the FAR is 

to ensure that small business size status 

is accurately represented and reported 

over the life of long-term contracts. The 

FAR also provides for provisions 

designed to ensure more accurate 

reporting of size status for contracts that 

are novated, merged or acquired by 

another business. This information is 

used by the SBA, Congress, Federal 

agencies and the general public for 

various reasons such as determining if 

agencies are meeting statutory goals, setaside determinations, and market 

research. 

B. Annual Reporting Burden 

Respondents: 10,000. 

Responses per Respondent: 1. 

Hours per Response: 0.5. 

Total Burden Hours: 5,000. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (MVCB), 1275 

First Street NE., Washington, DC 20417, 

telephone (202) 501–4755. Please cite 

OMB Control No. 9000–0163, Small 

Business Size Rerepresentation, in all 

correspondence. 

Dated: February 28, 2012. 

Laura Auletta, 

Director, Office of Governmentwide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Governmentwide Policy. 

[FR Doc. 2012–5323 Filed 3–5–12; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Pandemic Influenza Vaccines— 

Amendment 

ACTION: Notice of Amendment to the 

March 1, 2010 Republished Declaration 

under the Public Readiness and 

Emergency Preparedness Act. 

SUMMARY: Amendment to declaration 

issued on March 1, 2010 (75 FR 10268) 

pursuant to section 319F–3 of the Public 

Health Service Act (42 U.S.C. 247d–6d) 

to extend the effective time period, 

reformat the declaration, modify or 

clarify terms of the declaration and 

republish the declaration in its entirety, 

as amended. 

DATES: The amendment of the 

republished declaration issued on 

March 1, 2010 is effective as of February 

29, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Lurie, MD, MSPH, Assistant 


pmangrum on DSK3VPTVN1PROD with NOTICES
13330 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

1 72 FR 4710 (2007). 

2 72 FR 67731 (2007). 

3 73 FR 61871 (2008). 

4 74 FR 30294 (2009). 

5 74 FR 51153 (2009). 

6 75 FR 10268 (2010). 7 42 U.S.C. 247d–6d(b)(1). 

8See 42 U.S.C. 247d–6d(b)(1). 

9 42 U.S.C. 247d–6d(b)(6). 

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: 

Background 

The Public Readiness and Emergency 

Preparedness Act (‘‘PREP Act’’) 

authorizes the Secretary of Health and 

Human Services (‘‘the Secretary’’) to 

issue a declaration to provide liability 

immunity to certain individuals and 

entities (‘‘Covered Persons’’) against any 

claim of loss caused by, arising out of, 

relating to, or resulting from the 

administration or use of medical 

countermeasures (‘‘Covered 

Countermeasures’’), except for claims 

that meet the PREP Act’s definition of 

willful misconduct. Using this 

authority, the Secretary issued a 

declaration for pandemic influenza 

vaccines, which has been amended a 

number of times. The original pandemic 

influenza vaccine declaration was 

published on January 26, 2007,1 and 

was amended on November 21, 2007,2

October 17, 2008,3 June 15, 2009,4

September 28, 2009 5 and March 1, 

2010.6 The March 1, 2010 amendment is 

effective through February 28, 2012. The 

original declaration and its 

amendments, as well as additional 

information about the PREP Act and the 

Secretary’s declarations for other 

medical countermeasures, can be found 

here: http://www.phe.gov/Preparedness/ 

legal/prepact/Pages/default.aspx. 

The major actions taken by this 

pandemic influenza vaccine declaration 

are the following: (1) Changing the 

format to make the declaration easier for 

readers to follow; (2) clarifying that 

liability immunity is provided not only 

to vaccines and adjuvants, but also to 

vaccine components and constituent 

materials used as part of a covered 

vaccine; (3) explicitly extending liability 

immunity to devices and their 

constituent components used in the 

administration of vaccines, e.g., needles 

(which provides for uniform coverage 

for devices, regardless of whether they 

are manufactured or packaged with the 

vaccine or combined later for 

administration by a healthcare 

provider); (4) clarifying that liability 

immunity extends to recommended 

activities related to any Federal 

agreements including e.g., clinical trials 

agreements by adding the term ‘‘other 

Federal agreements’’ to the clause 

describing the types of federal 

agreements for which immunity is in 

effect; (5) narrowing the definition of 

‘‘administration’’ to cover ‘‘slip and 

fall’’ claims only to the extent they are 

directly tied to the operation of a 

countermeasure program; and (6) 

extending the time period for which 

liability immunity is in effect for the 

Covered Countermeasures to December 

31, 2015. Other modifications and 

clarifications are also made, as more 

fully explained below. 

The declaration is republished in full. 

We explain both the substantive and 

format changes in this supplementary 

section. 

The PREP Act was enacted on 

December 30, 2005 as Public Law 109– 

148, Division C, section 2, 119 Stat 

2818. It amended the Public Health 

Service (‘‘PHS’’) Act, adding section 

319F–3, which addresses liability 

immunity, and section 319F–4, which 

creates a compensation program. These 

sections are codified in the U.S. Code as 

42 U.S.C. 247d-6d and 42 U.S.C. 247d– 

6e, respectively. Unless otherwise 

noted, all statutory citations below are 

to the U.S. Code. 

Section I, Determination of Public 

Health Emergency or Credible Risk of 

Future Public Health Emergency 

Before issuing a declaration under the 

PREP Act, the Secretary is required to 

determine that a disease or other health 

condition or threat to health constitutes 

a public health emergency or that there 

is a credible risk that the disease, 

condition, or threat may in the future 

constitute such an emergency.7 This 

determination is separate and apart from 

a declaration issued by the Secretary 

under section 319 of the PHS Act, 42 

U.S.C. 247d, that a disease or disorder 

presents a public health emergency or 

that a public health emergency, 

including significant outbreaks of 

infectious diseases or bioterrorist 

attacks, otherwise exists, or other 

declarations or determinations made 

under other authorities of the Secretary. 

In previous PREP Act declarations 

(‘‘declaration’’ or ‘‘declarations’’), this 

determination appeared in the 

declarations’ introduction as the 

conclusion to the ‘‘whereas’’ clauses. 

The determination is now stated in the 

first section of the declaration. This 

change was made to improve readability 

and is not intended to have any 

substantive legal effect. 

In addition, we made a substantive 

change to the determination. The 

determination made in the ‘‘whereas’’ 

clauses in the March 1, 2010 declaration 

stated that the Secretary ‘‘determined 

there is a credible risk that the spread 

of pandemic influenza A viruses and 

those with pandemic potential and 

resulting disease does or could 

constitute a public health emergency.’’ 

The Secretary is amending this 

determination: (1) To substitute ‘‘may in 

the future’’ for ‘‘could’’ in order to be 

consistent with the language used in the 

PREP Act 8; and (2) to remove the words 

‘‘the spread of’’ and ‘‘does or’’ to clarify 

that the 2009 H1N1 Influenza virus and 

resulting disease are not currently 

causing a public health emergency. As 

discussed further in section VI of this 

supplementary information section, we 

also changed ‘‘and those’’ to ‘‘and 

influenza A viruses with’’ for clarity. 

We also specified that the viruses could 

potentially cause an influenza pandemic 

. Thus, in this amended declaration, the 

Secretary determines ‘‘that there is a 

credible risk that pandemic influenza A 

viruses and influenza A viruses with 

pandemic potential could cause an 

influenza pandemic with resulting 

disease that may in the future constitute 

a public health emergency.’’ 

Section II, Factors Considered 

In deciding whether and under what 

circumstances to issue a declaration 

with respect to a Covered 

Countermeasure, the Secretary must 

consider the desirability of encouraging 

the design, development, clinical testing 

or investigation, manufacture, labeling, 

distribution, formulation, packaging, 

marketing, promotion, sale, purchase, 

donation, dispensing, prescribing, 

administration, licensing, and use of the 

countermeasure.9 We previously stated 

these considerations in the introductory 

‘‘whereas’’ clauses to the declaration. 

The declaration now states these 

considerations in section II. We made 

this change to improve readability and 

do not intend that it have any 

substantive legal effect. 

Section III, Recommended Activities 

The Secretary must recommend the 

activities for which the PREP Act’s 

liability immunity is in effect. These 

activities may include, under conditions 

as the Secretary may specify, the 

manufacture, testing, development, 

distribution, administration, or use of 

one or more Covered Countermeasures 


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Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13331 

10 42 U.S.C. 247d–6d(b)(1). 

11 42 U.S.C. 247d–6d(b)(1). 

12 42 U.S.C. 247d–6d(a)(1). 

13 42 U.S.C. 247d–6d (i)(2). 

14 42 U.S.C. 247d–6d(i). 

15 42 U.S.C. 247d–6d(i)(4). 

16 42 U.S.C. 247d–6d(i)(3). 

17 42 U.S.C. 247d–6d(i)(6). 

18 42 U.S.C. 247d–6d(i)(8). 

19 42 U.S.C. 247d–6d(i)(5). 

20 42 U.S.C. 247d–6d(i)(1). Section 564 of the 

FD&C Act may be found at 21 U.S.C. 360bbb–3. 

21 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i) 

22 42 U.S.C. 247d–6d(i)(1)(A), (i)(7). 

23 21 U.S.C. 321(g)(1), (h);42 U.S.C. 262(i). 

24 42 U.S.C. 247d–6d(i)(1)(B),(c)(1)(B). 

25 21 U.S.C. 301 et seq. 

26 42 U.S.C. 262. 

27 21 U.S.C. 360bbb–3. 

28 21 U.S.C. 355(i), 360j(g). 

(‘‘Recommended Activities’’).10 In 

previous declarations, we included the 

Recommended Activities in the 

introductory ‘‘whereas’’ clauses to the 

declaration. The declaration now states 

them in section III. We made this 

change to improve readability and do 

not intend that it have any substantive 

legal effect. 

Section IV, Liability Immunity 

The Secretary must also state that 

liability protections available under the 

PREP Act are in effect with respect to 

the Recommended Activities.11 These 

liability protections provide that, 

‘‘[s]ubject to other provisions of [the 

PREP Act], a covered person shall be 

immune from suit and liability under 

Federal and State law with respect to all 

claims for loss caused by, arising out of, 

relating to, or resulting from the 

administration to or use by an 

individual of a covered countermeasure 

if a declaration * * * has been issued 

with respect to such 

countermeasure.’’ 12 In previous 

declarations, we included this statement 

in section I of the declaration, entitled 

‘‘Covered Countermeasures.’’ The 

declaration now makes the statement 

that liability immunity is in effect for 

Recommended Activities in a separate 

section IV. We made this change to 

improve readability and do not intend 

that it have any substantive legal effect. 

Section V, Covered Persons 

The PREP Act’s liability immunity 

applies to ‘‘Covered Persons’’ with 

respect to administration or use of a 

Covered Countermeasure. The term 

‘‘Covered Persons’’ has a specific 

meaning, and is defined in the PREP Act 

to include manufacturers, distributors, 

program planners, and qualified 

persons, and their officials, agents, and 

employees, and the United States.13 The 

PREP Act further defines the terms 

‘‘manufacturer,’’ ‘‘distributor,’’ 

‘‘program planner,’’ and ‘‘qualified 

person’’ as described below.14

A manufacturer includes a contractor or 

subcontractor of a manufacturer; a supplier 

or licenser of any product, intellectual 

property, service, research tool or component 

or other article used in the design, 

development, clinical testing, investigation 

or manufacturing of a Covered 

Countermeasure; and any or all of the 

parents, subsidiaries, affiliates, successors, 

and assigns of a manufacturer; 15

A distributor means a person or entity 

engaged in the distribution of drug, biologics, 

or devices, including but not limited to: 

manufacturers; repackers; common carriers; 

contract carriers; air carriers; own-label 

distributors; private-label distributors; 

jobbers; brokers; warehouses and wholesale 

drug warehouses; independent wholesale 

drug traders; and retail pharmacies; 16

A program planner means a State or local 

government, including an Indian Tribe; a 

person employed by the State or local 

government; or other person who supervises 

or administers a program with respect to the 

administration, dispensing, distribution, 

provision, or use of a Covered 

Countermeasure, including a person who 

establishes requirements, provides policy 

guidance, or supplies technical or scientific 

advice or assistance or provides a facility to 

administer or use a Covered Countermeasure 

in accordance with the Secretary’s 

declaration; 17 Under this definition, a 

private sector employer or community group 

or other ‘‘person’’ can be a program planner 

when it carries out the described activities. 

A qualified person means a licensed health 

professional or other individual who is 

authorized to prescribe, administer, or 

dispense Covered Countermeasures under 

the law of the State in which the 

countermeasure was prescribed, 

administered, or dispensed; or a person 

within a category of persons identified as 

qualified in the Secretary’s declaration.18

Under this definition, the Secretary can 

describe in the declaration other qualified 

persons, such as volunteers, who are Covered 

Persons. Section V describes other qualified 

persons covered by this declaration. 

The PREP Act also defines the word 

‘‘person’’ as used in the Act: a person 

includes an individual, partnership, 

corporation, association, entity, or 

public or private corporation, including 

a Federal, State, or local government 

agency or department; 19

The provisions regarding Covered 

Persons previously appeared as a 

definition in section X, ‘‘Definitions’’ 

and as section VI, ‘‘Other Qualified 

Persons.’’ We combined these two 

provisions into a new section V, 

‘‘Covered Persons’’ and added ‘‘to 

perform an activity’’ to the description 

of ‘‘Other Qualified Persons’’ for clarity. 

We made these changes to improve 

readability and clarity and do not intend 

them to have any substantive legal 

effect. 

Section VI, Covered Countermeasures 

As noted above, section III describes 

the Secretary’s Recommended Activities 

for which liability immunity is in effect. 

This section identifies the 

countermeasures for which the 

Secretary has recommended such 

activities. The PREP Act states that a 

‘‘Covered Countermeasure’’ must be: a 

‘‘qualified pandemic or epidemic 

product,’’ or a ‘‘security 

countermeasure,’’ as described 

immediately below; or a drug, biological 

product or device authorized for 

emergency use in accordance with 

section 564 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act).20

A qualified pandemic or epidemic 

product means a drug or device, as 

defined in the FD&C Act or a biological 

product, as defined in the PHS Act 21, 

that is: Manufactured, used, designed, 

developed, modified, licensed or 

procured to diagnose, mitigate, prevent, 

treat, or cure a pandemic or epidemic or 

limit the harm such a pandemic or 

epidemic might otherwise cause; or 

manufactured, used, designed, 

developed, modified, licensed, or 

procured to diagnose, mitigate, prevent, 

treat, or cure a serious or lifethreatening disease or condition caused 

by such a drug, biological product or 

device.22

A security countermeasure is a drug 

or device, as defined in the FD&C Act 

or a biological product, as defined in the 

PHS Act 23 that: The Secretary 

determines to be a priority to diagnose, 

mitigate, prevent or treat harm from any 

biological, chemical, radiological, or 

nuclear agent identified as a material 

threat by the Secretary of Homeland 

Security, or to diagnose, mitigate, 

prevent, or treat harm from a condition 

that may result in adverse health 

consequences or death and may be 

caused by administering a drug, 

biological product, or device against 

such an agent; and is determined by the 

Secretary of Health and Human Services 

to be a necessary countermeasure to 

protect public health.24

To be a Covered Countermeasure, 

qualified pandemic or epidemic 

products and security countermeasures 

also must be approved or cleared under 

the FD&C Act; 25 licensed under the PHS 

Act; 26 or authorized for emergency use 

under the FD&C Act.27 In addition, a 

qualified pandemic or epidemic product 

may be a Covered Countermeasure 

when it is exempted under the FD&C 

Act for use as an investigational drug or 

device 28 that is the object of research for 


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13332 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

29 42 U.S.C. 247d–6d(a)(5), (b)(2)(E). 

30See, e.g., 42 U.S.C. 247d–7d(c)(5). 

possible use for diagnosis, mitigation, 

prevention, treatment, cure or limit 

harm of a pandemic or epidemic or 

serious or life-threatening condition 

caused by such a drug or device. A 

security countermeasure also may be a 

Covered Countermeasure if it may 

reasonably be determined to qualify for 

approval or licensing within eight years 

after the Department’s determination 

that procurement of the countermeasure 

is appropriate. 

Provisions regarding Covered 

Countermeasures previously appeared 

in section I of the declaration, ‘‘Covered 

Countermeasures,’’ and included not 

only a description of the Covered 

Countermeasure but also additional 

conditions characterizing 

countermeasures. We have simplified 

this section so that it now only 

identifies the Covered Countermeasures. 

We have relocated the other conditions 

previously included in the ‘‘Covered 

Countermeasure’’ section to a new 

section, ‘‘Limitations on Distribution,’’ 

to improve readability. We do not 

intend for this change to have any 

substantive legal effect. 

We have also revised the definition of 

the Covered Countermeasure. 

Previously, the declaration included in 

section X, ‘‘Definitions,’’ a definition of 

the term ‘‘Pandemic influenza A viruses 

and those with pandemic potential.’’ In 

this declaration, the Secretary defines 

the Covered Countermeasures as 

‘‘vaccines against pandemic influenza A 

viruses and influenza A viruses with 

pandemic potential.’’ We replaced the 

phrase ‘‘and those’’ with ‘‘and influenza 

A’’ before ‘‘viruses with pandemic 

potential’’ to clarify that the declaration 

covers vaccines only for influenza A 

viruses that have pandemic potential, 

not all influenza viruses that have 

pandemic potential. This change is 

made throughout the declaration 

wherever the phrase is used. We also 

changed ‘‘and any associated adjuvants’’ 

to ‘‘and all components and constituent 

materials of these vaccines’’ to clarify 

the Secretary’s intent that all 

components and constituent materials, 

such as preservatives, diluents, 

antibiotics as well as adjuvants are 

covered as part of the vaccine. This 

change does not negatively affect the 

Secretary’s view that the manufacturer 

of an adjuvant used in a vaccine 

qualifying as a covered countermeasure 

would qualify as a manufacturer under 

this declaration and would be afforded 

the liability immunity provided by the 

PREP Act. We also added ‘‘and all 

devices and their constituent 

components used in the administration 

of these vaccines’’ to clarify that 

coverage extends to these devices when 

used in the administration of these 

vaccines. Devices such as needles, 

syringes, and aerosols, and their 

components and constituent materials 

are an integral part of the administration 

of the vaccine. They are covered 

regardless of whether they are 

manufactured or packaged with the 

vaccine, or combined later for 

administration by a healthcare provider. 

Finally, we added a statement 

referencing the statutory definitions of 

Covered Countermeasures to indicate 

that certain statutory requirements must 

also be met. These statutory 

requirements are discussed in the first 

two paragraphs of this section of the 

preamble. 

Finally, we moved language 

previously included in section VIII, 

‘‘Category of Disease, Health Condition, 

or Threat’’ and modified previous 

section VI, ‘‘Covered Countermeasures,’’ 

to provide that vaccines (including any 

components and constituent materials 

and devices used to administer 

vaccines) covered under the National 

Vaccine Injury Compensation Program 

are not covered countermeasures under 

this declaration. This language was 

moved from previous section X to 

section VI to clarify the Secretary’s 

determination concerning coverage of 

vaccines under this declaration in the 

event that a strain of influenza meeting 

the requirements set forth in section VIII 

is included in vaccines covered by the 

National Vaccine Injury Compensation 

Program. In such circumstances, such 

vaccines (those covered by the National 

Vaccine Injury Compensation Program) 

would be automatically excluded from 

this declaration. However, to the extent 

that the same strain of influenza is 

included in other vaccines that are not 

covered by the National Vaccine Injury 

Compensation Program, such vaccines 

could still qualify as covered 

countermeasures under this declaration 

(assuming they meet other requirements 

set forth in this declaration, including 

the description of the disease, health 

condition, or threat set forth in section 

VIII). Currently, the only types of 

influenza vaccines covered by the 

National Vaccine Injury Compensation 

Program are trivalent influenza 

vaccines. Thus, such vaccines are not 

covered by this declaration. This 

modification is meant to clarify that 

potentially one formulation of influenza 

vaccines (e.g., monovalent or 

quadrivalent vaccines) could qualify as 

covered countermeasures under this 

declaration (if such vaccines were not 

covered under the National Vaccine 

Injury Compensation Program) and, at 

the same time, another influenza 

vaccine containing the exact same strain 

of influenza virus (e.g., a trivalent 

influenza vaccine) could be covered by 

the National Vaccine Injury 

Compensation Program (and excluded 

from coverage under this declaration). 

Section VII, Limitations on Distribution 

The Secretary may specify that 

liability immunity is in effect only to 

Covered Countermeasures obtained 

through a particular means of 

distribution.29 These limitations on 

distribution previously appeared in 

section I, ‘‘Covered Countermeasures,’’ 

and section X, ‘‘Definitions.’’ We now 

state the limitations in a separate 

section and combine them with relevant 

definitions for improved readability. 

The declaration states that liability 

immunity is afforded to Covered 

Persons for Recommended Activities 

related to: 

(a) Present or future Federal contracts, 

cooperative agreements, grants, other 

transactions, interagency agreements, or 

memoranda of understanding or other 

Federal agreements; or 

(b) Activities authorized in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction to prescribe, 

administer, deliver, distribute or 

dispense the pandemic countermeasures 

following a declaration of an emergency. 

For governmental program planners 

only, liability immunity is afforded only 

to the extent they obtain Covered 

Countermeasures through voluntary 

means, such as (1) donation; (2) 

commercial sale; (3) deployment of 

Covered Countermeasures from Federal 

stockpiles; or (4) deployment of 

donated, purchased, or otherwise 

voluntarily obtained Covered 

Countermeasures from State, local, or 

private stockpiles. 

In regard to (a), we added the phrase 

‘‘other transactions’’, which may be 

used for some Covered Countermeasure 

activities,30 and the phrase ‘‘or other 

Federal agreements’’ to clarify that the 

provision is intended to cover all types 

of Federal agreements. We changed the 

conjunction ‘‘and’’ to ‘‘or’’ between (a) 

and (b) to clarify that immunity is 

available under either of these 

circumstances; the activities do not have 

to both relate to a Federal award or 

agreement and be used in a public 

health and medical response in order for 

immunity to apply. The conjunction 

‘‘and’’ used in previous declarations 

was a drafting error; the Secretary’s 

intent in those previous declarations has 

been the meaning conferred by the term 


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Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13333 

31 42 U.S.C. 247d–6d(b)(2)(A). 32 42 U.S.C. 247d–6d(a). 33 42 U.S.C. 247d–6d(b)(2)(C). 

‘‘or’’. Provisions (a) and (b) are intended 

to afford immunity to Federal 

government supported activities that 

precede a public health emergency and 

to activities in accordance with all 

Authorities Having Jurisdiction during a 

declared public health emergency. 

In regard to (b), the meaning of the 

terms ‘‘Authority Having Jurisdiction’’ 

and ‘‘Declaration of an Emergency’’ are 

unchanged. 

Finally, we slightly modified the last 

limitation by deleting extraneous 

statutory references and other language 

and by replacing the final sentence with 

the word ‘‘only’’ after ‘‘planners’’ to 

improve readability. We do not intend 

for the changes to this provision to alter 

its substantive legal effect. As stated in 

the ‘‘whereas’’ clauses of the March 1, 

2010 declaration, this limitation on 

distribution is intended to deter 

program planners that are government 

entities from seizing privately held 

stockpiles of Covered Countermeasures. 

It does not apply to any other Covered 

Persons, including other program 

planners who are not government 

entities. 

Section VIII, Category of Disease, 

Health Condition, or Threat 

The Secretary must identify, for each 

Covered Countermeasure, the categories 

of diseases, health conditions, or threats 

to health for which the Secretary 

recommends the administration or use 

of the countermeasure.31 This 

information previously appeared in 

section II, ‘‘Category of Disease,’’ and in 

section X, ‘‘Definitions.’’ These 

provisions now are combined into a 

single section to improve readability. In 

addition, we replaced the description of 

the influenza A virus as it previously 

appeared in section II with the term 

‘‘pandemic influenza A viruses and 

influenza A viruses with pandemic 

potential’’ and then followed that term 

with the definition that previously 

appeared in section X. We made these 

changes to remove redundancy and 

improve consistency and do not intend 

for it to alter the substantive legal effect. 

Finally, we removed the phrase ‘‘except 

those included in seasonal influenza 

vaccines and/or covered under the 

National Vaccine Injury Compensation 

Program’’ from this section and instead 

included similar language in section VI, 

for clarity as described above. 

Section IX, Administration of Covered 

Countermeasures 

The PREP Act does not explicitly 

define the term ‘‘administration’’ but 

does assign the Secretary the 

responsibility to provide relevant 

conditions in the declaration. This 

definition previously appeared in 

section X, ‘‘Definitions.’’ We have 

moved it to a separate section to 

improve readability. The Secretary has 

also narrowed the definition of 

‘‘administration’’ that was previously 

provided in the declaration. The 

declaration previously defined the term 

‘‘administration’’ to include physical 

provision of a Covered Countermeasure, 

as well as management and operation of 

systems and locations at which Covered 

Countermeasures may be provided to 

recipients: 

Administration of a Covered 

Countermeasure: As used in section 319F– 

3(a)(2)(B) of the Act includes, but is not 

limited to, public and private delivery, 

distribution, and dispensing activities 

relating to physical administration of the 

countermeasures to recipients, management 

and operation of delivery systems, and 

management and operation of distribution 

and dispensing locations. 

The definition has been revised as 

follows: 

Administration of a Covered 

Countermeasure: As used in section 319F– 

3(a)(2)(B) of the Act, means physical 

provision of the countermeasures to 

recipients, or activities and decisions directly 

relating to public and private delivery, 

distribution and dispensing of the 

countermeasures to recipients; management 

and operation of countermeasure programs; 

or management and operation of locations for 

purpose of distributing and dispensing 

countermeasures. 

As clarified, the definition of 

‘‘administration’’ extends only to 

physical provision of a countermeasure 

to a recipient, such as vaccination or 

handing drugs to patients, and to 

activities related to management and 

operation of programs and locations for 

providing countermeasures to 

recipients, such as decisions and actions 

involving security and queuing, but 

only insofar as those activities directly 

relate to the countermeasure activities. 

Claims for which Covered Persons are 

provided immunity under the Act are 

losses caused by, arising out of, relating 

to, or resulting from the administration 

to or use by an individual of a Covered 

Countermeasure consistent with the 

terms of a declaration issued under the 

Act.32 Under the Secretary’s definition, 

these liability claims are precluded if 

the claims allege an injury caused by 

physical provision of a countermeasure 

to a recipient, or if the claims are 

directly due to conditions of delivery, 

distribution, dispensing, or management 

and operation of countermeasure 

programs at distribution and dispensing 

sites. 

Thus, it is the Secretary’s 

interpretation that, when a declaration 

is in effect, the Act precludes, for 

example, liability claims alleging 

negligence by a manufacturer in creating 

a vaccine, or negligence by a health care 

provider in prescribing the wrong dose, 

absent willful misconduct. Likewise, the 

Act precludes a liability claim relating 

to the management and operation of a 

countermeasure distribution program or 

site, such as a slip-and-fall injury or 

vehicle collision by a recipient receiving 

a countermeasure at a retail store 

serving as an administration or 

dispensing location that alleges, for 

example, lax security or chaotic crowd 

control. However, a liability claim 

alleging an injury occurring at the site 

that was not directly related to the 

countermeasure activities is not 

covered, such as a slip and fall with no 

direct connection to the 

countermeasure’s administration or use. 

In each case, whether immunity is 

applicable will depend on the particular 

facts and circumstances. 

Section X, Population 

The Secretary must identify, for each 

Covered Countermeasure specified in a 

declaration, the population or 

populations of individuals for which 

liability immunity is in effect with 

respect to administration or use of the 

countermeasure.33 This section explains 

which individuals should use the 

countermeasure or to whom the 

countermeasure should be 

administered—in short, those who 

should be vaccinated or take a drug or 

other countermeasure. These provisions 

previously appeared in section IV, 

‘‘Population,’’ and section X, 

‘‘Definitions,’’ stating that the 

population included any person who 

used or was administered a Covered 

Countermeasure: In a clinical trial 

conducted or supported by the Federal 

Government; in a pre-pandemic phase, 

or in a pandemic phase. We have 

amended the declaration to provide that 

the population includes any individual 

who uses or who is administered a 

Covered Countermeasure in accordance 

with the declaration. We believe this 

broad statement accurately encompasses 

all of the previously listed populations 

and ensures that no populations that use 

or are administered the Covered 

Countermeasures in accordance with 

the terms of the declaration are omitted, 

including those who use or are 

administered the Covered 

Countermeasures in a post pandemic 


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34 42 U.S.C. 247d–6d(a)(4). 

35 42 U.S.C. 247d–6d(b)(2)(D). 

36 42 U.S.C. 247d–6d(a)(4). 

37 42 U.S.C. 246d–6d(b)(2)(B), (b)(6). 

38 42 U.S.C. 247d–6d(b)(3). 

39 42 U.S.C. 247d–6e. 

40 42 CFR Part 110. 

41 42 U.S.C.247d–6e. 

42 42 U.S.C.247d–6e(b)(4). 

43 42 U.S.C. 247d–6d(b)(4). 

phase during the disposition period, 

discussed below in section XII. We 

deleted definitions of ‘‘pre-pandemic 

phase’’ and ‘‘pandemic phase’’ as those 

descriptions and distinctions did not 

prove to be useful or necessary in 

practice. These definitions presumed 

the first outbreak would be outside of 

the United States, which will not 

necessarily be the case. 

In addition, the PREP Act specifies 

that liability immunity is afforded: (1) 

To manufacturers and distributors 

without regard to whether the 

countermeasure is used by or 

administered to this population; and (2) 

to program planners and qualified 

persons when the countermeasure is 

either used by or administered to this 

population or the program planner or 

qualified person reasonably could have 

believed the recipient was in this 

population.34 We included these 

statutory conditions in the declaration 

for clarity. 

Section XI, Geographic Area 

The Secretary must identify, for each 

Covered Countermeasure specified in 

the declaration, the geographic area or 

areas for which liability immunity is in 

effect with respect to administration or 

use of the countermeasure, including, as 

appropriate, whether the declaration 

applies only to individuals physically 

present in the area or, in addition, 

applies to individuals who have a 

described connection to the area.35 This 

section previously appeared in section 

V, ‘‘Geographic Area.’’ 

In addition, the PREP Act specifies 

that liability immunity is afforded: (1) 

To manufacturers and distributors 

without regard to whether the 

countermeasure is used by or 

administered to individuals in the 

geographic areas; and (2) to program 

planners and qualified persons when 

the countermeasure is either used or 

administered in the geographic areas or 

the program planner or qualified person 

reasonably could have believed the 

countermeasure was used or 

administered in the areas.36 We 

included these statutory conditions in 

the declaration for clarity. 

Section XII, Effective Time Period 

The Secretary must identify, for each 

Covered Countermeasure, the period or 

periods during which liability immunity 

is in effect, designated by dates, 

milestones, or other description of 

events, including factors specified in the 

PREP Act.37 This section previously 

appeared as section III, ‘‘Effective Time 

Period.’’ 

The declaration is amended to clarify 

when liability takes effect for different 

distribution methods, and to extend the 

period for which liability immunity is 

in effect. Rather than referring to the 

September 28, 2009 declaration as 

defining when the effective period 

commenced, we have incorporated 

language from that declaration. We also 

clarified that for any Covered 

Countermeasure that becomes covered 

under the National Vaccine Injury 

Compensation Program after the 

declaration is issued, liability immunity 

expires under the PREP Act 

immediately upon such coverage. We 

made these changes for clarity and do 

not intend them to have legal effect. 

Section XIII, Additional Time Period of 

Coverage 

The Secretary must specify a date 

after the ending date of the effective 

period of the declaration that is 

reasonable for manufacturers to arrange 

for disposition of the Covered 

Countermeasure, including return of the 

product to the manufacturer, and for 

other Covered Persons to take 

appropriate actions to limit 

administration or use of the Covered 

Countermeasure.38 In addition, the 

PREP Act specifies that for Covered 

Countermeasures that are subject to a 

declaration at the time they are obtained 

for the Strategic National Stockpile 

under 42 U.S.C. 247d–6b(a), the 

effective period of the declaration 

extends through the time the 

countermeasure is used or administered 

pursuant to a distribution or release 

from the Stockpile. Liability immunity 

under the provisions of the PREP Act 

and the conditions of the declaration 

continues during these additional time 

periods. Thus, liability immunity is 

afforded during the ‘‘Effective Time 

Period,’’ described under XII of the 

declaration, plus the ‘‘Additional Time 

Period’’ described under section XIII of 

the declaration. The provision for 

additional time periods previously 

appeared as section VII, ‘‘Additional 

Time Periods of Coverage After 

Expiration of the Declaration’’. The 

provision is amended to clarify the 

statutory provision that extended 

coverage applies to any products 

obtained for the Strategic National 

Stockpile during the effective period of 

the declaration. We included the 

statutory provision for clarity. 

Section XIV, Countermeasures Injury 

Compensation Program 

Section 319F–4 of the PREP Act 

authorizes a Countermeasures Injury 

Compensation Program (CICP) to 

provide benefits to eligible individuals 

who sustain a serious physical injury or 

die as a direct result of the 

administration or use of a Covered 

Countermeasure.39 Compensation under 

the CICP for an injury directly caused by 

a Covered Countermeasure is based on 

the requirements set forth in this 

declaration, the administrative rules for 

the Program,40 and the statute.41 To 

show direct causation between a 

Covered Countermeasure and a serious 

physical injury, the statute requires 

‘‘compelling, reliable, valid, medical 

and scientific evidence.’’ 42 The 

administrative rules for the Program 

further explain the necessary 

requirements for eligibility under the 

CICP. Please note that, by statute, 

requirements for compensation under 

the CICP may not always align with the 

requirements for liability immunity 

provided under the PREP Act. This 

section previously appeared as section 

VIII, ‘‘Compensation Fund.’’ We have 

added language to explain the type of 

injury and standard of evidence needed 

to be considered for compensation 

under the CICP. We included this 

information for clarity. 

Section XV, Amendments 

The Secretary may amend any portion 

of a declaration through publication in 

the Federal Register.43 This section 

previously appeared in section IX, 

‘‘Amendments.’’ The section has been 

updated to reflect that this declaration 

amends the prior March 1, 2010 

declaration and that the declaration 

incorporates all prior amendments. 

Deleted Sections 

The prior declaration contained a 

definitions section. These definitions 

have been incorporated into the relevant 

sections of the declaration as noted 

above, and modified or deleted where 

indicated above. 

An appendix previously appeared in 

the declaration that listed Federal 

government contracts for research, 

development, and procurement of 

Covered Countermeasures. We deleted 

this appendix to clarify that liability 

immunity under the provisions of the 

PREP Act and terms of the declaration 

is not limited to the contracts listed in 


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Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13335 

the appendix. Coverage is available for 

any award or agreement that meets the 

description provided in section I of the 

declaration. In addition, deleting the 

appendix relieves the Department of the 

need to periodically update the 

appendix. 

We made these deletions for clarity 

and do not intend them to have legal 

effect. 

Republished Declaration 

Declaration, as Amended, for Public 

Readiness and Emergency 

Preparedness Act Coverage for 

Vaccines Against Pandemic Influenza A 

Viruses and Influenza A Viruses With 

Pandemic Potential 

This declaration amends and 

republishes the March 1, 2010 

Republished Declaration, as Amended, 

for coverage under the Public Readiness 

and Emergency Preparedness (‘‘PREP’’) 

Act for Pandemic Influenza Vaccines, 

42 U.S.C. 247d–6d, 247d–6e. To the 

extent any term of the March 1, 2010 

Republished Declaration is inconsistent 

with any provision of this Republished 

Declaration, the terms of this 

Republished Declaration are controlling. 

I. Determination of Public Health 

Emergency or Credible Risk of Future 

Public Health Emergency 

42 U.S.C. 247d–6d(b)(1) 

I have determined that there is a 

credible risk that pandemic influenza A 

viruses and influenza A viruses with 

pandemic potential could cause an 

influenza pandemic with resulting 

disease that may in the future constitute 

a public health emergency. 

II. Factors Considered 

42 U.S.C. 247d–6d(b)(6) 

I have considered the desirability of 

encouraging the design, development, 

clinical testing or investigation, 

manufacture, labeling, distribution, 

formulation, packaging, marketing, 

promotion, sale, purchase, donation, 

dispensing, prescribing, administration, 

licensing, and use of the Covered 

Countermeasures. 

III. Recommended Activities 

42 U.S.C. 247d–6d(b)(1) 

I recommend, under the conditions 

stated in this declaration, the 

manufacture, testing, development, 

distribution, administration, or use of 

the Covered Countermeasures. 

IV. Liability Immunity 

42 U.S.C. 247d–6d(a), 247d–6d(b)(1) 

Liability immunity as prescribed in 

the PREP Act and conditions stated in 

this declaration is in effect for the 

Recommended Activities described in 

section III. 

V. Covered Persons 

42 U.S.C. 247d–6d(i)(2),(3),(4),(6),(8)(A) 

and (B) 

Covered Persons who are afforded 

liability immunity under this 

declaration are ‘‘manufacturers,’’ 

‘‘distributors,’’ ‘‘program planners,’’ 

‘‘qualified persons,’’ and their officials, 

agents, and employees, as those terms 

are defined in the PREP Act, and the 

United States. 

In addition, I have determined that 

the following additional persons are 

qualified persons: 

(a) Any person authorized in accordance 

with the public health and medical 

emergency response of the Authority Having 

Jurisdiction, as described in section VII 

below, to prescribe, administer, deliver, 

distribute or dispense the Covered 

Countermeasures, and their officials, agents, 

employees, contractors and volunteers, 

following a declaration of an emergency; 

(b) Any person authorized to prescribe, 

administer, or dispense the Covered 

Countermeasures or who is otherwise 

authorized to perform an activity under an 

Emergency Use Authorization in accordance 

with section 564 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). 

VI. Covered Countermeasures 

42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 

247d–6d(i)(1) and (7) 

Covered Countermeasures are 

vaccines against pandemic influenza A 

viruses and influenza A viruses with 

pandemic potential, all components and 

constituent materials of these vaccines, 

and all devices and their constituent 

components used in the administration 

of these vaccines, except that influenza 

A vaccines and their associated 

components, constituent materials and 

devices covered under the National 

Vaccine Injury Compensation Program 

are not Covered Countermeasures. 

Covered Countermeasures must be 

‘‘qualified pandemic or epidemic 

products,’’ or ‘‘security 

countermeasures,’’ or drugs, biological 

products, or devices authorized for 

emergency use, as those terms are 

defined in the PREP Act, the FD&C Act, 

and the Public Health Service Act. 

VII. Limitations on Distribution 

42 U.S.C. 247d–6d(a)(5) and (b)(2)(E) 

I have determined that liability 

immunity is afforded to Covered 

Persons only for Recommended 

Activities involving Covered 

Countermeasures that are related to: 

(a) Present or future Federal contracts, 

cooperative agreements, grants, other 

transactions, interagency agreements, 

memoranda of understanding, or other 

Federal agreements; 

or 

(b) Activities authorized in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction to prescribe, 

administer, deliver, distribute or 

dispense the Covered Countermeasures 

following a declaration of an emergency. 

i. The Authority Having Jurisdiction 

means the public agency or its delegate 

that has legal responsibility and 

authority for responding to an incident, 

based on political or geographical (e.g., 

city, county, Tribal, State, or Federal 

boundary lines) or functional (e.g., law 

enforcement, public health) range or 

sphere of authority. 

ii. A declaration of emergency means 

any declaration by any authorized local, 

regional, State, or Federal official of an 

emergency specific to events that 

indicate an immediate need to 

administer and use the Covered 

Countermeasures, with the exception of 

a Federal declaration in support of an 

emergency use authorization under 

section 564 of the FD&C Act unless such 

declaration specifies otherwise; 

I have also determined that for 

governmental program planners only, 

liability immunity is afforded only to 

the extent such program planners obtain 

Covered Countermeasures through 

voluntary means, such as (1) donation; 

(2) commercial sale; (3) deployment of 

Covered Countermeasures from Federal 

stockpiles; or (4) deployment of 

donated, purchased, or otherwise 

voluntarily obtained Covered 

Countermeasures from State, local, or 

private stockpiles. 

VIII. Category of Disease, Health 

Condition, or Threat 

42 U.S.C. 247d–6d(b)(2)(A) 

The category of disease, health 

condition, or threat for which I 

recommend the administration or use of 

the Covered Countermeasures is the 

threat of or actual human influenza that 

results from the infection of humans 

following exposure to pandemic 

influenza A viruses or influenza A 

viruses with pandemic potential. 

(a) Pandemic influenza A viruses and 

influenza A viruses with pandemic 

potential mean: animal and/or human 

influenza A viruses that are circulating 

in wild birds and/or domestic animals 

that cause or have significant potential 

to cause sporadic or ongoing human 

infections, or historically have caused 

pandemics in humans, or have mutated 

to cause pandemics in humans, and for 

which the majority of the population is 

immunologically naı ̈ve. 


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(b) 

IX. Administration of Covered 

Countermeasures 

42 U.S.C. 247d–6d(a)(2)(B) 

Administration of the Covered 

Countermeasure means physical 

provision of the countermeasures to 

recipients, or activities and decisions 

directly relating to public and private 

delivery, distribution and dispensing of 

the countermeasures to recipients, 

management and operation of 

countermeasure programs, or 

management and operation of locations 

for purpose of distributing and 

dispensing countermeasures. 

X. Population 

42 U.S.C. 247d–6d(a)(4), 247d– 

6d(b)(2)(C) 

The populations of individuals 

include any individual who uses or is 

administered the Covered 

Countermeasures in accordance with 

this declaration. 

Liability immunity is afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered to this 

population; liability immunity is 

afforded to program planners and 

qualified persons when the 

countermeasure is used by or 

administered to this population or the 

program planner or qualified person 

reasonably could have believed the 

recipient was in this population. 

XI. Geographic Area 

42 U.S.C. 247d–6d(a)(4), 247d– 

6d(b)(2)(D) 

Liability immunity is afforded for the 

administration or use of a Covered 

Countermeasure without geographic 

limitation. 

Liability immunity is afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered in these 

geographic areas; liability immunity is 

afforded to program planners and 

qualified persons when the 

countermeasure is used by or 

administered in these geographic areas, 

or the program planner or qualified 

person reasonably could have believed 

the recipient was in these geographic 

areas. 

XII. Effective Time Period 

42 U.S.C. 247d–6d(b)(2)(B) 

For any Covered Countermeasure 

subsequently covered under the 

National Vaccine Injury Compensation 

Program, liability immunity expires 

immediately upon such coverage. 

Liability immunity began June 15, 

2009 for Covered Countermeasures 

against the 2009 H1N1 pandemic 

influenza and is provided through 

December 31, 2015 or until the Covered 

Countermeasure is covered under the 

National Vaccine Injury Compensation 

Program, whichever occurs first. 

Liability immunity for 

countermeasures against other 

pandemic influenza A viruses and 

influenza A viruses with pandemic 

potential for means of distribution other 

than those in accordance with the 

public health and medical response of 

the Authority Having Jurisdiction begins 

on December 1, 2006 and lasts through 

December 31, 2015 or until the Covered 

Countermeasure is covered under the 

National Vaccine Injury Compensation 

Program, whichever occurs first. 

Liability immunity for Covered 

Countermeasures against other 

pandemic influenza A viruses or 

influenza A viruses with pandemic 

potential administered or used in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction begins with a 

declaration and lasts through: (1) The 

final day that the emergency declaration 

is in effect, (2) December 31, 2015, or (3) 

until the Covered Countermeasure is 

covered under the National Vaccine 

Injury Compensation Program, 

whichever occurs first. 

XIII. Additional Time Period of 

Coverage 

42 U.S.C. 247d–6d(b)(3)(B) and (C) 

I have determined that an additional 

twelve (12) months of liability 

protection is reasonable to allow for the 

manufacturer(s) to arrange for 

disposition of the Covered 

Countermeasure, including return of the 

Covered Countermeasures to the 

manufacturer, and for Covered Persons 

to take such other actions as are 

appropriate to limit the administration 

or use of the Covered Countermeasures. 

Covered Countermeasures obtained 

for the Strategic National Stockpile 

(SNS) during the effective period of this 

declaration are covered through the date 

of administration or use pursuant to a 

distribution or release from the SNS. 

XIV. Countermeasures Injury 

Compensation Program 

42 U.S.C 247d–6e 

The PREP Act authorizes a 

Countermeasures Injury Compensation 

Program (CICP) to provide benefits to 

certain individuals who sustain a 

serious physical covered injury as the 

direct result of the administration or use 

of the Covered Countermeasures and 

benefits to survivors or estates of 

individuals who die as a direct result of 

the administration or use of the Covered 

Countermeasures. The causal 

connection between the countermeasure 

and the serious physical injury must be 

supported by compelling, reliable, valid, 

medical and scientific evidence in order 

for the individual to be considered for 

compensation. The CICP is 

administered by the Health Resources 

and Services Administration (HRSA), 

within the Department of Health and 

Human Services. Information about the 

CICP is available at the toll free number 

1–888–275–4772 or at http:// 

www.hrsa.gov/countermeasurescomp/ 

default.htm. 

XV. Amendments 

42 U.S.C. 247d–6d(b)(4) 

The Declaration for the Use of the 

Public Readiness and Emergency 

Preparedness Act for H5N1 was first 

published on January 26, 2007. That 

declaration provided liability immunity 

for vaccines against H5N1 pandemic 

influenza under the terms and 

conditions stated in the declaration. The 

declaration was amended on November 

30, 2007 to add H7 and H9 vaccines; 

amended on October 17, 2008 to add H2 

and H6 vaccines; amended on June 15, 

2009 to add 2009 H1N1 vaccines and 

republished in its entirety; amended on 

September 28, 2009 to provide targeted 

liability protections for pandemic 

countermeasures to enhance 

distribution and to add provisions 

consistent with other declarations and 

republished in its entirety; and 

amended on March 1, 2010 to revise the 

Covered Countermeasures and extend 

the effective date and republished in its 

entirety. This declaration incorporates 

all amendments prior to the date of its 

publication in the Federal Register. 

Any further amendments to this 

declaration will be published in the 

Federal Register. 

Authority: 42 U.S.C. 247d–6d. 

Dated: February 28, 2012. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2012–5312 Filed 3–5–12; 8:45 am] 

BILLING CODE P 


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