Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Notices 30297 

administered or dispensed. Additional 

persons who are qualified persons 

pursuant to section 319F–3(i)(8)(B) are 

the following: None. 

VII. Additional Time Periods of 

Coverage After Expiration of 

Declaration (as Required by Section 

319F–3(b)(3)(B) of the Act) 

A. I have determined that, upon 

expiration of the applicable time period 

specified in Section III above, an 

additional twelve (12) months is a 

reasonable period to allow for the 

manufacturer to arrange for disposition 

of the Covered Countermeasure, 

including the return of such product to 

the manufacturer, and for covered 

persons to take such other actions as are 

appropriate to limit the administration 

or use of the Covered Countermeasure, 

and the liability protection of section 

319F–3(a) of the Act shall extend for 

that period. 

B. The Federal Government shall 

purchase the entire production of 

Covered Countermeasures under the 

contracts specifically listed by contract 

number in section I for the stockpile 

under section 319F–2 of the Act, and 

shall be subject to the time-period 

extension of section 319F–3(b)(3)(C). 

Production under future contracts for 

the same vaccine will also be subject to 

the time-period extension of section 

319F–3(b)(3)(C). 

VIII. Amendments 

The Declaration for the Use of the 

Public Readiness and Emergency 

Preparedness Act for H5N1 vaccines 

was published on January 26, 2007 and 

amended on November 30, 2007 to add 

H7 and H9 vaccines and on October 17, 

2008 to add H2 and H6 vaccines. This 

Declaration incorporates all 

amendments prior to the date of its 

publication in the Federal Register. Any 

future amendment to this Declaration 

will be published in the Federal 

Register, pursuant to section 319F– 

2(b)(4) of the Act. 

IX. Definitions 

For the purposes of this declaration, 

‘‘pre-pandemic phase’’ means the 

following stages, as defined in the 

National Strategy for Pandemic 

Influenza: Implementation Plan 

(Homeland Security Council, May 

2006): (0) New Domestic Animal 

Outbreak in At-Risk Country; (1) 

Suspected Human Outbreak Overseas; 

(2) Confirmed Human Outbreak 

Overseas; and (3) Widespread Human 

Outbreaks in Multiple Locations 

Overseas. For the purposes of this 

declaration, ‘‘pandemic phase’’ means 

the following stages, as defined in the 

National Strategy for Pandemic 

Influenza: Implementation Plan 

(Homeland Security Council, May 

2006): (4) First Human Case in North 

America; and (5) Spread Throughout 

United States. 

Dated: June 15, 2009. 

Kathleen Sebelius, 

Secretary. 

Appendix 

I. List of U.S. Government Contracts— 

Covered H5N1 Vaccine Contracts 

[January 26, 2007] 

1. HHSN266200400031C 

2. HHSN266200400032C 

3. HHSN266200300039C 

4. HHSN266200400045C 

5. HHSN266200205459C 

6. HHSN266200205460C 

7. HHSN266200205461C 

8. HHSN266200205462C 

9. HHSN266200205463C 

10. HHSN266200205464C 

11. HHSN266200205465C 

12. HHSN266199905357C 

13. HHSN266200300068C 

14. HHSN266200005413C 

15. HHSO100200600021C (formerly 

200200409981) 

16. HHSO100200500004C 

17. HHSO100200500005I 

18. HHSO100200700026I 

19. HHSO100200700027I 

20. HHSO100200700028I 

21. HHSO100200600010C 

22. HHSO100200600011C 

23. HHSO100200600012C 

24. HHSO100200600013C 

25. HHSO100200600014C 

26. HHSO100200600022C (formerly 

200200511758) 

27. HHSO100200600023C (formerly 

200200410431) 

28. CRADA No. AI–0155 NIAID/ 

MedImmune 

29. HHSO100200700029C 

30. HHSO100200700030C 

31. HHSO100200700031C 

[FR Doc. E9–14948 Filed 6–24–09; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–09–09BX] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. 

Alternatively, to obtain a copy of the 

data collection plans and instrument, 

call 404–639–5960 and send comments 

to Maryam I. Daneshvar, CDC Reports 

Clearance Officer, 1600 Clifton Road, 

NE., MS–D74, Atlanta, Georgia 30333; 

comments may also be sent by e-mail to 

omb@cdc.gov. 

Comments are invited on (a) whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have a 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarify of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of information technology. Written 

comments should be received within 60 

days of this notice. 

Proposed Project 

Clostridium difficile Infection (CDI) 

Surveillance—New—National Center for 

Preparedness, Detection, and Control of 

Infectious Diseases (NCPDCID), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

Steady increases in the rate and 

severity of Clostridium difficile infection 

(CDI) indicate a clear need to conduct 

longitudinal assessments of the impact 

of CDI in the United States. C. difficile 

is an anaerobic, spore-forming, gram 

positive bacillus that produces two 

pathogenic toxins: A and B. CDI ranges 

in severity from mild diarrhea to 

fulminant colitis and death. 

Transmission of C. difficile occurs 

primarily in healthcare facilities, where 

environmental contamination by C. 

difficile spores and exposure to 

antimicrobial drugs are common. No 

longer limited to healthcare 

environments, community-associated 

CDI is the focus of increasing attention. 

Recently, several cases of serious CDI 

have been reported in what have been 

considered low-risk populations, 

including healthy persons living in the 

community and peri-partum women. 

For this proposed data collection, the 

surveillance population will consist of 

persons residing in the catchment area 

of the participating Emerging Infections 

Program (EIP) sites. This surveillance 

poses no more than minimal risk to the 

study participants as there will be no 

interventions or modifications to the 

care study participants receive. EIP 

surveillance personnel will perform 

active case finding from laboratory 

reports of stool specimens testing 


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30298 Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Notices 

positive for C. difficile toxin and 

abstract data on cases using a 

standardized case report form. For a 

subset of cases (e.g., communityassociated C. difficile cases) sites will 

administer a health interview. Remnant 

stool specimens from cases testing 

positive for C. difficile toxin will be 

submitted to reference laboratories for 

culturing, and isolates will be sent to 

CDC for confirmation and molecular 

typing. Outcomes of this surveillance 

project will include the populationbased incidence of community- and 

healthcare-associated CDI among 

participating EIP sites, characterization 

of C. difficile strains that are responsible 

for CDI in the population under 

surveillance with a focus on strains 

from community-associated cases, a 

description of the epidemiology of 

community- and healthcare-associated 

CDI, and hypothesis-generation for 

future activities using EIP CDI 

surveillance infrastructure. 

The proposed surveillance for CDI 

through the Emerging Infections 

Program will expand CDC capacity to 

monitor incidence of C. difficile in 

community and healthcare settings as 

well as to monitor and detect 

antimicrobial resistance. This activity 

supports the HHS Action Plan for 

elimination of healthcare-associated 

infections. 

CDC estimates that a total of 7,650 

CDI Surveillance Case Report Forms 

(CRFs) will be completed during a oneyear study period on incident CDI cases 

within the EIP catchment area. 

Approximately 3,825 cases will require 

a completed CRF; the remaining 3,825 

cases will only require a partially 

completed CRF. CDC estimates that 

1,700 CDI Surveillance Health 

Interviews (HI) will be completed 

during a one-year study period. 

Surveillance Officers at the EIP sites 

will complete and submit the case 

report forms and health interviews. 

There are no costs to respondents. 

ESTIMATES OF ANNUALIZED BURDEN

Form name Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

CDI Surveillance Case Report 

Form—Complete.

EIP Surveillance Officer ................... 10 383 1 3,830 

CDI Surveillance Case Report 

Form—Partial.

EIP Surveillance Officer ................... 10 382 15/60 955 

CDI Surveillance Health Interview .... EIP Surveillance Officer ................... 10 170 45/60 1,275 

Total ........................................... ........................................................... ........................ ........................ ........................ 6,060 

Dated: June 17, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–14989 Filed 6–24–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer on (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: HRSA/Bureau of 

Primary Health Care Capital 

Improvement Program Application 

Electronic Health Records (EHR) 

Readiness Checklist (OMB No. 0915– 

0325)—Extension 

The American Recovery and 

Reinvestment Act (ARRA) provides $1.5 

billion in grants to support 

‘‘construction, renovation and 

equipment’’, and ‘‘the acquisition of 

health information technology systems, 

for health centers including health 

center controlled networks receiving 

operating grants under section 330’’ of 

the Public Health Service (PHS) Act, as 

amended (42 U.S.C. 254b). HRSA is 

requesting extension of the approval of 

the Electronic Health Records (EHR) 

Readiness Checklist portion of the 

application where applicants must 

provide information to demonstrate 

readiness for electronic health records if 

they propose to use funds for electronic 

health record (EHR) related purchases. 

Of the $1.5 billion, HRSA will award 

approximately $850 million, through 

limited competition grants, for one-time 

Capital Improvement Program (CIP) 

grant funding in fiscal year (FY) 2009 to 

support existing section 330 funded 

health centers. Funding under this 

opportunity will address pressing 

capital improvement needs in health 

centers, such as construction, repair, 

renovation, and equipment purchases, 

including health information technology 

systems. Applicants must provide 

information using the EHR Readiness 

Checklist that demonstrates 

comprehensive planning and readiness 

for implementing EHRs. 

The estimated annual burden is as 

follows: 


sroberts on PROD1PC70 with NOTICES