Federal Register / Vol. 70, No. 173 / Thursday, September 8, 2005 / Notices 53369 

Texas Department of Health has 

received reports of ciguatoxic fish 

caught on Texas offshore oil rigs, and 

anecdotal reports to researchers at the 

University of Texas suggest that the 

incidence of ciguatera fish poisoning is 

greater than what has been reported to 

the Texas Department of Health. We 

propose to continue to conduct 

surveillance activities to identify the 

prevalence of ciguatera fish poisoning in 

Texas Gulf Coast oil rigs. This study 

will provide critical data in guiding 

efforts to characterize the scope of 

ciguatera poisonings, to identify risk 

factors, and to prevent an emerging 

illness associated with reef ecosystems. 

A questionnaire will be administered 

over a three-year period to Texas 

saltwater fishermen (recreational 

spearfishers and to hook-and-line 

anglers) who have consumed fish caught 

on the reef ecosystems off the Texas 

Gulf coast. There is no cost to 

respondents other than their time. 

ESTIMATE OF ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

Texas Saltwater Fishermen ............................................................................. 500 1 20/60 167 

Dated: August 30, 2005. 

Joan F. Karr, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 05–17764 Filed 9–7–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–05–0576] 

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. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call (404) 371–5983 and 

send comments to Seleda Perryman, 

CDC Assistant Reports Clearance 

Officer, 1600 Clifton Road, MS–D74, 

Atlanta, GA 30333 or send an 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 

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 

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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Possession, Use, and Transfer of 

Select Agents and Toxins (OMB Control 

No. 0920–0576)—Extension—Office of 

the Director (OD), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (Pub. L. 107–188) 

specifies that the Secretary of Health 

and Human Services (HHS) shall 

provide for the establishment and 

enforcement of standards and 

procedures governing the possession, 

use, and transfer of select agents and 

toxins. The Act specifies that facilities 

that possess, use, and transfer select 

agents register with the Secretary. The 

Secretary has designated CDC as the 

agency responsible for collecting this 

information. 

CDC is requesting continued OMB 

approval to collect this information 

through the use of five separate forms. 

These forms are: (1) Application for 

Registration; (2) Request to Transfer 

Select Agent or Toxin; (3) Report of 

Theft, Loss, or Release of Select Agent 

and Toxin; (4) Report of Identification of 

Select Agent or Toxin; and (5) Request 

for Exemption. 

The Application for Registration (42 

CFR 73.7(d)) will be used by entities to 

register with CDC. The Application for 

Registration requests facility 

information; a list of select agents or 

toxins in use, possession, or for transfer 

by the entity; characterization of the 

select agent or toxin; and laboratory 

information. Estimated average time to 

complete this form is 3 hours, 45 

minutes for an entity with one principal 

investigator working with one select 

agent or toxin. CDC estimates that 

entities will need an additional 45 

minutes for each additional investigator 

or agent. In our regulatory analysis, we 

have estimated that 70% of the 350 

entities have 1–3 principal investigators, 

15% have 5 principal investigators, and 

15% have 10 principal investigators. We 

have used these figures to calculate the 

burden for this section. Estimated 

burden for the Application for 

Registration is 2,191 hours. 

Entities may amend their registration 

(42 CFR 73.7(h)(1)) if any changes occur 

in the information submitted to CDC. To 

apply for an amendment to a certificate 

of registration, an entity must obtain the 

relevant portion of the application 

package and submit the information 

requested in the package to CDC. 

Estimated time to amend a registration 

package is 1 hour. 

The Request to Transfer Select Agent 

or Toxin form (42 CFR 73.16) will be 

used by entities requesting transfer of a 

select agent or toxin to their facility, and 

by the entity receiving the agent. CDC 

revised the Request to Transfer Select 

Agent or Toxin form by removing the 

requirement that entities provide 

written notice within five business days 

when select agents or toxins are 

consumed or destroyed after a transfer. 

Estimated average time to complete this 

form is 1 hour, 30 minutes. 

The Report of Theft, Loss, or Release 

of Select Agent and Toxin form (42 CFR 

73.19(a)(b)) must be completed by 

entities whenever there is theft, loss, or 

release of a select agent or toxin. 

Estimated average time to complete this 

form is 1 hour. 

The Report of Identification of Select 

Agent or Toxin form 42 CFR 73.5(a)(b) 

and 73.6(a)(b)) will be used by clinical 

and diagnostic laboratories to notify 

CDC that select agents or toxins 

identified as the result of diagnostic or 

proficiency testing have been disposed 

53370 Federal Register / Vol. 70, No. 173 / Thursday, September 8, 2005 / Notices 

of in a proper manner. In addition, the 

form will be used by Federal law 

enforcement agencies to report the 

seizure and final disposition of select 

agents and toxins. Estimated average 

time to complete this form is 1 hour. 

The Request for Exemption form (42 

CFR 73.5(d)(e) and 73.6(d)(e)) will be 

used by entities that are using an 

investigational product that are, bear, or 

contain select agents or toxins or in 

cases of public health emergency. 

Estimated average time to complete this 

form is 1 hour. 

In addition to the standardized forms, 

this regulation also outlines situations 

in which an entity must notify or may 

make a request of the HHS Secretary in 

writing. An entity may apply to the HHS 

Secretary for an expedited review of an 

individual by the Attorney General (42 

CFR 73.10(e)). To apply for this 

expedited review, an entity must submit 

a request in writing to the HHS 

Secretary establishing the need for such 

action. The estimated time to gather the 

information and submit this request is 

30 minutes. CDC has not developed 

standardized forms to use in the above 

situations. Rather, the entity should 

provide the information as requested in 

the appropriate section of the 

regulation. 

An entity may also apply to the HHS 

Secretary for an exclusion of an 

attenuated strain of a select agent or 

toxin that does not pose a severe threat 

to public health and safety (42 CFR 

73.3(e)(1) and 73.4(e)(1)). The estimated 

time to gather the information and 

submit this request is 1 hour. 

As part of the duties of the 

Responsible Official, the Responsible 

Official is required to conduct regular 

inspections (at least annually) of the 

laboratory where select agents or toxins 

are stored. Results of these selfinspections must be documented (42 

CFR 73.9(a)(5)). CDC estimates, that, on 

average, such documentation will take 1 

hour. 

As part of the training requirements of 

this regulation, the entity is required to 

record the identity of the individual 

trained, the date of training, and the 

means used to verify that the employee 

understood the training (42 CFR 

73.15(c)). Estimated time for this 

documentation is 2 hours per principal 

investigator. 

An individual or entity may request 

administrative review of a decision 

denying or revoking certification of 

registration or an individual may appeal 

a denial of access approval (42 CFR 

73.20). This request must be made in 

writing and within 30 calendar days 

after the adverse decision. This request 

should include a statement of the 

factual basis for the review. CDC 

estimates the time to prepare and 

submit such a request is 4 hours. 

Finally, an entity must implement a 

system to ensure that certain records 

and databases are accurate and that the 

authenticity of records may be verified 

(42 CFR 73.17(b)). The time to 

implement such a system is estimated to 

average 4 hours. 

The cost to respondents is their time 

to complete the forms and comply with 

the reporting and recordkeeping 

components of the Act plus a one-time 

purchase of a file cabinet (estimated cost 

$400) to maintain records. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

CFR reference Data collection Number of 

respondents 

Responses 

per 

respondent 

Average 

hourly 

burden 

Total annual 

burden 

(in hours) 

73.7(d) ........................................................... Registration Application ....... 350 1 3.75 1,313 

73.7(d) ........................................................... Additional Investigators ........ 245 2 45/60 368 

73.7(d) ........................................................... Additional Investigators ........ 53 4 45/60 159 

73.7(d) ........................................................... Additional Investigators ........ 52 9 45/60 351 

73.7(h)(1) ....................................................... Amendment to Registration 

Application.

350 2 1 700 

73.19(a)(b) ..................................................... Notification of Theft, Loss, or 

Release form.

12 1 1 12 

73.5 & 73.6 (d–e)/73.3 & 73.4(e)(1) ............. Request for Exemption/Exclusion.17 1 1 17 

73.16 ............................................................. Request to Transfer Select 

Agent or Toxin.

350 2 1.50 1,050 

73.5 & 73.6(a)(b) ........................................... Report of Identification of 

Select Agent or Toxin form.

325 4 1 1,300 

73.10(e) ......................................................... Request expedited review ... 10 1 0.5 5 

73.9(a)(5) ....................................................... Documentation of self-inspection.350 1 1 350 

73.15(c) ......................................................... Documentation of training .... 350 1 2 700 

73.20 ............................................................. Administrative Review .......... 15 1 4 60 

73.17(b) ......................................................... Ensure secure recordkeeping system.350 1 4 1,400 

Total .............................. ........................ ........................ ........................ 7,785 

Federal Register / Vol. 70, No. 173 / Thursday, September 8, 2005 / Notices 53371 

Dated: August 30, 2005. 

Joan F. Karr, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 05–17765 Filed 9–7–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–05–05CV] 

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. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–371–5983 and 

send comments to Seleda Perryman, 

CDC Assistant Reports Clearance 

Officer, 1600 Clifton Road, MS–D74, 

Atlanta, GA 30333 or send an 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 

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 

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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

National Survey of 911 Emergency 

Treatment for Heart Disease and Stroke 

—New—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The purpose of this project is to 

enhance CDC’s understanding of 

emergency medical services (EMS) 

administration and oversight, identify 

important stakeholders for partnering 

and cooperation, and gather data on 

heart disease and stroke emergency 

treatment protocols in use. This project 

will fill an important gap in CDC’s 

understanding of heart disease and 

stroke emergency medical care by 

providing detailed information from a 

sample of EMS organizations on 

operational resources, configurations of 

certification levels, treatment protocols 

and performance measures, and other 

significant issues at a local and state 

level in 9 states (FL, MA, KS, MT, NM, 

PA, OR, SC, AR), in order to ultimately 

contribute to the development and 

implementation of best practices for 

emergency treatment of heart disease 

and stroke. 

The objectives of the data collection 

are to prepare a comprehensive 

description of the ‘‘state of the practice’’

of pre-hospital emergency medical 

services related to cardiac and stroke 

care. This will include organizational 

and administrative aspects of EMS at 

state, sub-state district, and local levels, 

major public and private stakeholders in 

the conduct of EMS, technical support 

issues, and practices related to positive 

outcomes in pre-hospital cardiac and 

stroke emergency care. Data analysis 

will include a compilation of the 

practices in use and comparison of 

organizational and administrative 

configurations. 

Data collection includes: (1) A 

telephone survey with a random sample 

of 250 local EMS agency supervisors 

(total N=2,250) in each of 9 States on the 

status of capabilities represented and 

treatment protocols used in EMS 

organizations related to cardiac and 

stroke care; (2) in-person interviews 

with state level EMS officials (e.g., State 

EMS Director, State EMS Medical 

Director, or public health agency 

representative) (N=18) who are involved 

in policy and practice of the EMS 

system in the state and, (3) telephone 

interviews with a purposive sample five 

sub-state level EMS officials (e.g., 

county or district directors) (N=45) in 

each of the 9 states to examine 

responsibilities and objectives at a substate level for the state’s EMS system. 

There are no costs to the respondents 

other than their time. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

per response 

(in hrs) 

Total burden 

hours 

Survey of Local Level EMS agencies in nine states ....................................... 2,250 1 15/60 563 

Survey of State Level EMS Directors/State Medical Directors in 9 states ..... 18 1 1 18 

Survey of Sub-state (district/county) EMS officials in 9 states ....................... 45 1 45/60 34 

Total .......................................................................................................... ........................ ........................ ........................ 615