25314 Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices 

86The Commission recognizes, however, that this 

may not apply to independent AG companies, for 

which a large fraction of the company’s drugs may 

be covered. The FTC anticipates that there are few 

such companies, and that their responses are 

especially important to this study. 

annual operating statements. In sum, as 

a result of the combined effects of the 

changes to reduce the burden of both 

financial and document requests, the 

hour burden of the study should be a 

fraction of what it would have been 

pursuant to the requests of the first 

Federal Register notice. 

After taking account of the public 

comments and the burden-reducing 

changes that we have made in response, 

the FTC believes that its previously 

published estimate of the total burden 

hours remains reasonable. The 

Commission has retained a three-tier 

estimate of burden hours depending 

upon the number of drug products for 

which a company is required to provide 

a response: Companies with one to five 

drug products, companies with six to 10 

drug products, and companies with 

more than 10 drug products. As before, 

the Commission anticipates that the 

majority of burden hours will result 

from document production. However, 

given that the Commission seeks only 

high-level documents strongly relevant 

to the AG study, the Commission has 

revised its burden estimates to reflect a 

greater amount of time spent on 

identifying responsive documents, and 

less time spent on retrieving and 

copying. The Commission has also 

increased its estimates of the maximum 

hours for these tasks to reflect the 

possibility that a few companies will 

have a relatively large number of drugs 

responsive to its requests. 

Based on preliminary information, the 

FTC anticipates that it will seek 

information for 1 to 5 drug products 

from approximately 130 companies, 6 to 

10 drug products from 20 companies, 

and for greater than 10 drug products 

from 40 companies. Thus, the 

cumulative hours burden to produce 

documents and prepare the response 

sought will be approximately 40,780 

hours. [(138 hours × 130 companies) + 

(230 × 20 companies) + (456 hours × 40 

companies)] As previously discussed, 

the Commission anticipates that in 

general the number of drugs, and thus 

the number of burden hours, will be 

proportional to company size.86 The 

following table shows the estimated 

burden hours for different tasks for 

companies with different numbers of 

drugs covered by the study: 

Task 

1–5 Drug 

Products 

(hours 

6–10 Drug 

Products 

(hours) 

> 10 Drug 

Products 

(hours) 

Organize document and information retrieval ............................................................................. 12 24 48 

Identify requested documents ..................................................................................................... 40 80 200 

Retrieve and copy requested documents .................................................................................... 10 20 48 

Identify requested financial information ....................................................................................... 40 50 60 

Obtain financial information ......................................................................................................... 12 16 20 

Prepare response ........................................................................................................................ 24 40 80 

Total ...................................................................................................................................... 138 230 456 

It is not possible to calculate with 

precision the labor costs associated with 

answering the planned questions and 

producing the documents requested, 

because responses will entail 

participation by management and/or 

support staff at various compensation 

levels within many different companies. 

Individuals within some or all of those 

labor categories may be involved in the 

information-collection process. 

Nonetheless, the FTC has assumed that 

mid-management personnel and outside 

legal counsel will handle most of the 

tasks involved in gathering and 

producing the responsive information, 

and has applied an average hourly wage 

of $250/hour for their labor. Thus, the 

labor costs per company should range 

between $34,500 (138 hours × $250/ 

hour) and $114,000 (456 hours × $250/ 

hour). 

Estimated Annual Capital or Other 

Non-labor Costs 

The capital or other non-labor costs 

associated with the information requests 

will be minimal. Industry members 

should already have in place the means 

to store information of the volume 

requested. In addition, respondents may 

have to purchase office supplies such as 

file folders, computer CDs or DVDs, 

photocopier toner, or paper in order to 

comply with the Commission’s requests. 

The FTC estimates that such costs will 

be minimal. 

By direction of the Commission, 

Commissioner Harbour recused. 

Donald S. Clark, 

Secretary. 

[FR Doc. E7–8567 Filed 5–3–07; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Delegation of Authority 

Notice is hereby given that I have 

delegated to the Assistant Secretary for 

Preparedness and Response the 

authorities vested in the Secretary of 

Health and Human Services under 

section 319C–2, 319F, and 319I of the 

Public Health Service Act, as amended, 

as it pertains to the functions assigned 

to the Assistant Secretary for 

Preparedness and Response. These 

delegations to the Assistant Secretary 

for Preparedness and Response include 

the authority vested in the Secretary of 

Health and Human Services to continue 

the administration of any grants and 

contracts initially awarded by the 

Health Resources and Services 

Administration under sections 319C–1, 

319C–2, 319F, and 319I of the Public 

Health Service Act. This delegation 

permits the Assistant Secretary for 

Preparedness and Response to 

administer grants and contracts under 

the terms and conditions of the initial 

awards. 

This authority may be redelegated. 

These delegations shall be exercised 

under the Department’s policy on 

regulations and the existing delegation 

of authority to approve and issue 

regulations. This delegation excludes 

the authority to issue reports to 

Congress and to take final action to 

withhold funds from States. 

This delegation supersedes all prior 

delegations of authority to the Health 

Resources and Services 

Administration’s officials to the extent 

that they are inconsistent with the 

provisions of this delegation. 


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Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices 25315 

I have ratified any actions taken by 

the Assistant Secretary for Preparedness 

and Response, or any other Office of the 

Assistant Secretary for Preparedness 

and Response officials, which, in effect, 

involved the exercise of this authority 

prior to the effective date of this 

delegation. 

This delegation is effective 

immediately. 

Dated: April 16, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 07–2193 Filed 5–3–07; 8:45 am] 

BILLING CODE 4150–37–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–07–0639] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at 404–639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Special Exposure Cohort Petitions— 

Extension—National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

On October 30, 2000, the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000 

(EEOICPA), 42 U.S.C. 7384–7385 [1994, 

supp. 2001] was enacted. It established 

a compensation program to provide a 

lump sum payment of $150,000 and 

medical benefits as compensation to 

covered employees suffering from 

designated illnesses incurred as a result 

of their exposure to radiation, 

beryllium, or silica while in the 

performance of duty for the Department 

of Energy and certain of its vendors, 

contractors and subcontractors. This 

legislation also provided for payment of 

compensation for certain survivors of 

these covered employees. The only 

change to the collection is an increase 

in burden hours because more 

petitioners are requesting to have their 

work site named as a special exposure 

cohort. This program has been 

mandated to be in effect until Congress 

ends the funding. 

EEOICPA instructed the President to 

designate one or more Federal Agencies 

to carry out the compensation program. 

Accordingly, the President issued 

Executive Order 13179 (‘‘Providing 

Compensation to America’s Nuclear 

Weapons Workers’’) on December 7, 

2000 (65 FR 77487), assigning primary 

responsibility for administration of the 

compensation program to the 

Department of Labor (DOL). The 

executive order directed the Department 

of Health and Human Services (HHS) to 

perform several technical and 

policymaking roles in support of the 

DOL program. 

Among other duties, the executive 

order directed HHS to establish and 

implement procedures for considering 

petitions by classes of nuclear weapons 

workers to be added to the ‘‘Special 

Exposure Cohort’’ (the ‘‘Cohort’’), various 

groups of workers whose claims for 

cancer under EEOICPA can be 

adjudicated without demonstrating that 

their cancer was ‘‘at least as likely as 

not’’ caused by radiation doses they 

incurred in the performance of duty. In 

brief, EEOICPA authorizes HHS to 

designate such classes of employees for 

addition to the Cohort when NIOSH 

lacks sufficient information to estimate 

with sufficient accuracy the radiation 

doses of the employees, if HHS also 

finds that the health of members of the 

class may have been endangered by the 

radiation dose the class potentially 

incurred. HHS must also obtain the 

advice of the Advisory Board on 

Radiation and Worker Health (the 

‘‘Board’’) in establishing such findings. 

On March 7, 2003, HHS proposed 

procedures for adding such classes to 

the Cohort in a notice of proposed 

rulemaking at 42 CFR part 83. 

The HHS procedures authorize a 

variety of individuals and entities to 

submit petitions, as specified under 

§ 83.7. Petitioners are required to 

provide the information specified in 

§ 83.9 to qualify their petitions for a 

complete evaluation by HHS and the 

Board. HHS has developed two petition 

forms to assist the petitioners in 

providing this required information 

efficiently and completely. Petition 

Form A is a one-page form to be used 

by EEOICPA claimants for whom 

NIOSH will have attempted to conduct 

dose reconstructions and will have 

determined that available information is 

not sufficient to complete the dose 

reconstruction. The form addresses the 

informational requirements specified 

under § 83.9(a) and (b). Petition Form B, 

accompanied by separate instructions, is 

intended for all other petitioners. The 

form addresses the informational 

requirements specified under § 83.9(a) 

and (c). Forms A and B can be 

submitted electronically as well as in 

hard copy. Petitioners should be aware 

that HHS is not requiring petitioners to 

use the forms. Petitioners can choose to 

submit petitions as letters or in other 

formats, but petitions must meet the 

informational requirements referenced 

above. NIOSH expects, however, that all 

petitioners for whom Form A would be 

appropriate will actually use the form, 

since NIOSH will provide it to them 

upon determining that their dose 

reconstruction cannot be completed and 

encourage them to submit the petition. 

NIOSH expects the large majority of 

petitioners for whom Form B would be 

appropriate will also use the form, since 

it provides a simple, organized format 

for addressing the informational 

requirements of a petition. 

NIOSH will use the information 

obtained through the petition for the 

following purposes: (a) Identify the 

petitioner(s), obtain their contact 

information, and establish that the 

petitioner(s) is qualified and intends to 

petition HHS; (b) establish an initial 

definition of the class of employees 

being proposed to be considered for 

addition to the Cohort; (c) determine 

whether there is justification to require 

HHS to evaluate whether or not to 

designate the proposed class as an 

addition to the Cohort (such an 

evaluation involves potentially 

extensive data collection, analysis, and 

related deliberations by NIOSH, the 

Board, and HHS); and, (d) target an 

evaluation by HHS to examine relevant 

potential limitations of radiation 

monitoring and/or dosimetry-relevant 

records and to examine the potential for 

related radiation exposures that might 

have endangered the health of members 

of the class. 

Finally, under § 83.18, petitioners 

may contest the proposed decision of 

the Secretary to add or deny adding 

classes of employees to the cohort by 

submitting evidence that the proposed 

decision relies on a record of either 

factual or procedural errors in the 

implementation of these procedures. 

NIOSH estimates that the time to 

prepare and submit such a challenge is 

45 minutes. Because of the uniqueness 

of this submission, NIOSH is not 

providing a form. The submission 

should be in a letter format. 

There are no costs to petitioners 

unless a petitioner chooses to purchase 


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