Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 10369 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

State Health Education ............................... 51 1 30/60 26 

State Physical Education ............................ 51 1 30/60 26 

State Health Services .................................. 51 1 30/60 26 

State Nutrition Services ............................... 51 1 30/60 26 

State Officials ......................... State Healthy and Safe School Environment.51 1 30/60 26 

State Mental Health and Social Services ... 51 1 30/60 26 

Assist with identifying state-level respondents and with recruiting districts and 

schools).

51 1 1 51 

District Officials ...................... District Health Education ............................. 685 1 30/60 343 

District Physical Education .......................... 685 1 40/60 457 

District Health Services ............................... 685 1 40/60 457 

District Nutrition Services ............................ 685 1 30/60 343 

District Healthy and Safe School Environment.685 1 1 685 

District Mental Health and Social Services 685 1 30/60 343 

District Faculty and Staff Health Promotion 685 1 20/60 228 

Assist with identifying district-level respondents and with recruiting schools.685 1 1 685 

Principals, secretaries or designees.Assist with identifying and scheduling 

school-level respondents.

1,043 1 1 1,043 

Health education lead teachers, principals, or designees.School Health Education ............................. 1,043 1 20/60 348 

Physical education lead 

teachers, principals, or designees.

School Physical Education .......................... 1,043 1 40/60 695 

School nurses, principals, or 

designees.

School Health Services ............................... 1,043 1 50/60 869 

Food service managers, principals, or designees.School Nutrition Services ............................ 1,043 1 40/60 695 

Principals or designee ........... School Healthy and Safe School Environment.1,043 1 1.25 1,304 

Counselors, principals, or 

designees.

School Mental Health and Social Services 1,043 1 30/60 522 

Principals or designees ......... School Faculty and Staff Health Promotion 1,043 1 20/60 348 

Health education teachers ..... Classroom Health Education ....................... 2,002 1 50/60 1,668 

Physical education teachers .. Classroom Physical Education .................... 2,002 1 40/60 1,335 

Total ................................ ...................................................................... ........................ ........................ ........................ 12,575 

Dated: February 17, 2011. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–4167 Filed 2–23–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60-Day–11–0020] 

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 404–639–5960 and 

send comments to Carol E. Walker, CDC 

Acting 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 

Coal Workers’ Health Surveillance 

Program (CWHSP)–OMB 0920–0020, 

exp. 4/31/2011—Revision The National 

Institute for Occupational Safety and 

Health (NIOSH), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

This submission will incorporate the 

National Coal Workers’ X-Ray 

Surveillance Program 42 CFR part 37 

(0920–0020) and National Coal Workers’ 

Autopsy Study 42 CFR 37.204 (0920– 


emcdonald on DSK2BSOYB1PROD with NOTICES
10370 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 

0021) into one complete package which 

will be called the Coal Workers’ Health 

Surveillance Program (CWHSP). Upon 

OMB approval, 0920–0021 will be 

discontinued. CWHSP is a 

congressionally-mandated medical 

examination program for monitoring the 

health of underground coal miners, 

established under the Federal Coal Mine 

Health and Safety Act of 1969, as 

amended in 1977 and 2006, Public Law 

95–164 (the Act). The Act provides the 

regulatory authority for the 

administration of the CWHSP. This 

Program, which includes both a health 

surveillance and an autopsy component, 

has been useful in providing tools for 

protecting the health of miners (whose 

participation is entirely voluntary), and 

also in documenting trends and patterns 

in the prevalence of coal workers’ 

pneumoconiosis (‘black lung’ disease) 

among miners employed in U.S. coal 

mines. During the early 1970s, one out 

of every three miners examined through 

the CWHSP who had worked at least 25 

years underground had evidence of 

pneumoconiosis on their chest x-ray. An 

analysis among over 25,000 miners who 

participated in the x-ray Programs from 

1996 to 2002 indicated that the 

proportion of affected individuals had 

decreased to about one in 20. However, 

recent surveillance analyses and 

research studies have confirmed that the 

prevalence of ‘black lung’ disease is 

increasing, there is regional clustering of 

rapidly progressive pneumoconiosis 

cases, and coal miners have a higher 

risk of disease if they perform certain 

jobs, work in smaller mines, or are from 

certain geographic areas. Importantly, 

young coal miners are developing the 

disabling and lethal forms of ‘black 

lung’. 

Coal Workers’ Health Surveillance 

Program (CWHSP) 

Demographic and logistical 

information is gathered from coal mine 

operators and participating x-ray 

facilities. Participating miners also 

provide health and work histories, and 

participating physicians report 

radiographic findings. The Centers for 

Disease Control and Prevention’s 

National Institute for Occupational 

Safety and Health, Division of 

Respiratory Disease Studies, 1095 

Willowdale Road, Morgantown, WV 

26505, also called the Appalachian 

Laboratory for Occupational Safety and 

Health (ALOSH), is charged with 

administration of this Program. 

From October 1, 1999 through 

September 30, 2002, the Mine Safety 

and Health Administration (MSHA), in 

consultation with NIOSH, conducted a 

pilot health surveillance program for 

both underground and surface miners 

(The Miners’ Choice Program). The 

Miners’ Choice Program has been 

continued as an extension of the 

CWHSP (currently called the Enhanced 

Coal Workers’ Health Surveillance 

Program—ECWHSP). This extension of 

the CWHSP currently operates utilizing 

a mobile examination unit which travels 

to mining regions to provide locally 

accessible and more comprehensive 

health surveillance, including chest 

radiography, spirometry, and blood 

pressure screening. 

Under the Act, the provision of 

periodic chest x-ray examinations is 

specifically mandated, and the x-rays 

are to be supplemented by such other 

tests as the Secretary deems necessary. 

In addition to radiographically-apparent 

pneumoconiosis, miners are at risk for 

the development of chronic obstructive 

pulmonary disease (COPD). Chest 

radiographs alone cannot provide a 

measure of airflow obstruction and 

therefore often miss important lung 

disease. For this reason, spirometry, a 

simple breathing test, is an additional 

component that is particularly useful for 

the health assessment of miners. 

Periodic medical history and spirometry 

tests have been recommended by 

NIOSH for both surface and 

underground coal miners since 1995, to 

facilitate preventive actions, increase 

miners’ participation in programs for 

early detection of disease, and improve 

the derivation of representative 

estimates of the burden, distribution, 

and determinants of occupational lung 

disease in relation to coal mining in the 

U.S. Finally, unrecognized hypertension 

has previously been observed among 

many miners, and the ECWHSP offers 

blood pressure screening as a safe, 

simple, and inexpensive test, which can 

help target initiation of proven health 

conserving medications. 

The National Coal Workers’ Autopsy 

Study (NCWAS) provides standardized 

lung specimens for ongoing scientific 

research as well as information to the 

next-of-kin regarding the presence and 

extent of coal workers’ pneumoconiosis 

(black lung) in the lungs of the deceased 

miner. The Consent Release and History 

Form is primarily used to obtain written 

authorization from the next-of-kin to 

perform an autopsy on the deceased 

miner. Because a basic reason for the 

post-mortem examination is research 

(both epidemiological and clinical), a 

minimum of essential information is 

collected regarding the deceased miner, 

including occupational history and 

smoking history. The data collected are 

used by scientists for research purposes 

in defining the diagnostic criteria for 

pneumoconiosis and in correlating 

pathologic changes with exposures and 

x-ray findings. 

There are no costs of the NCWAS to 

respondents other than their time. 

Overall, there are no direct costs to 

CWHSP participants. 

The total estimated annualized 

burden hours is 4120. 

This estimate is based on the 

following: 

• Pathologist Invoice—It is estimated 

that only 5 minutes is required for the 

pathologist to put a statement on the 

invoice affirming that no other 

compensation is received for the 

autopsy. 

• Pathologist Report—Since an 

autopsy report is routinely completed 

by a pathologist, the only additional 

burden is the specific request of abstract 

of terminal illness and final diagnosis 

relating to pneumoconiosis. Therefore, 

only 5 minutes of additional burden is 

estimated for the autopsy report. 

• Consent, Release and History Form 

(2.6)—From past experience, it is 

estimated that 15 minutes is required for 

the next-of-kin to complete this form. 

• Roentgenographic Interpretation 

Form (2.8)—Physicians (B Readers) fill 

out this form regarding their 

interpretations of the x-rays (each x-ray 

has at least two separate 

interpretations). Based on prior practice 

it takes the physician approximately 3 

minutes per form. 

• Interpreting Physician Certification 

Document (2.12)—Physicians taking the 

B Reader Examination are asked to 

complete this registration form that 

takes approximately 10 minutes. 

• Miner Identification Document 

(2.9)—Miners who elect to participate in 

either the CWHSP must fill out this 

document which requires 

approximately 20 minutes. The actual 

shooting of the chest image takes 

approximately 15 minutes. 

• Miners participating in the 

ECWHSP portion of the Program are 

asked to perform a spirometry test 

which requires no additional 

paperwork, but does require 

approximately 15 to 20 minutes for the 

test itself. The 2500 respondents listed 

in the burden table below account for 

about 1⁄2 of the total participants. 

• Coal Mine Operators Plan (2.10)— 

Mine operators are required to file a 

Mine X-ray Plan with NIOSH every 3 

years. To complete this form with all 

requested information (including a 

roster of current employees) takes 

approximately 30 minutes. 

• Facility Certification Document 

(2.11)—X-ray facilities seeking NIOSHapproval to provide miner x-rays under 

the CWHSP must complete an approval 

packet. It is anticipated that since the 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices 10371 

CWHSP will soon be accepting digital 

images as well as the traditional analog 

x-ray films, the number of x-ray 

facilities participating will increase over 

the next several years. This increase is 

reflected in this submission. The forms 

associated with this approval process 

require approximately 30 minutes for 

completion. 

ESTIMATED ANNUALIZED BURDEN

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden/ 

response 

(in hrs) 

Total burden 

(in hrs) 

Invoice-Pathologist ........................................................................................... 50 1 5/60 4 

Report-Pathologist ........................................................................................... 50 1 5/60 4 

Consent, Release and History Form—Next-of-Kin ..........................................

(Form 2.6) ........................................................................................................ 50 1 15/60 13

Roentgenographic Interpretation Form—Physicians (Form 2.8) ..................... 10,000 1 3/60 500 

Interpreting Physician Certification Document—Physicians ............................

(Form 2.12) ...................................................................................................... 300 1 10/60 50

Miner Identification Document—Coal Miners ..................................................

(Form 2.9) ........................................................................................................ 5,000 1 20/60 1,666 

Spirometry Test—Coal Miners ......................................................................... 2,500 1 20/60 833 

X-ray—Coal Miners ......................................................................................... 5000 1 15/60 750 

Coal Mine Operators Plan—Mine Operators ...................................................

(Form 2.10) ...................................................................................................... 200 1 30/60 100 

Facility Certification Document—X-ray Facilities .............................................

(Form 2.11) ...................................................................................................... 100 1 30/60 200 

Total .......................................................................................................... ........................ ........................ ........................ 4,120 

Dated: February 16, 2011. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–4165 Filed 2–23–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control 

Special Emphasis Panel: Occupational 

Safety and Health Training Project 

Grant, Program Announcement PAR 10– 

288, initial review. 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Times and Dates: 8:30 a.m.–5 p.m., March 

17, 2011 (Closed). 

Place: Courtyard Marriott, 2700 

Eisenhower Avenue, Alexandria, Virginia 

22314–4553, Telephone (703) 329–2323. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters to be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of ‘‘Occupational Safety and 

Health Training Project Grant, PAR 10–288.’’ 

Contact Person for More Information: M. 

Chris Langub, PhD, Scientific Review Officer, 

CDC, 1600 Clifton Road NE., Mailstop E74, 

Atlanta, Georgia 30333, Telephone (404) 

498–2543. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 14, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–4197 Filed 2–23–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0622] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Color Additive 

Certification Requests and 

Recordkeeping 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 28, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0216. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. Color Additive 

Certification Requests and 

Recordkeeping—21 CFR part 80 (OMB 

Control Number 0910–0216)— 

Extension. 

FDA has regulatory oversight for color 

additives used in foods, drugs, 

cosmetics, and medical devices. Section 

721(a) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

379e(a)) provides that a color additive 

shall be deemed to be unsafe unless it 


emcdonald on DSK2BSOYB1PROD with NOTICES