22902 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 

projects; 

Æ Fund-raising experience; 

Æ Fiscal management experience, 

including management of the flow 

of funds among the partners. 

This RFI is for information and 

planning purposes only and should not 

be construed as a solicitation or as an 

obligation on the part of HHS. HHS does 

not intend to award a grant or contract 

to pay for the preparation of any 

information submitted or for the use of 

such information by HHS. 

Acknowledgment of receipt of responses 

may not be made, nor will respondents 

be notified of the evaluation by HHS of 

the information received. No basis for 

claims against HHS shall arise as a 

result of a response to this request for 

information or to the use of such 

information by HHS as either part of our 

evaluation process or in developing 

specifications for any subsequent 

announcement. Any proprietary 

information submitted should be clearly 

marked for confidentiality. 

Dated: April 20, 2011. 

James J. Berger, 

Associate Public Health Advisor for Blood, 

Organ, and Tissue Safety. 

[FR Doc. 2011–9966 Filed 4–22–11; 8:45 am] 

BILLING CODE 4150–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30 Day–11–0020] 

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 

e-mail to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC 20503 or by fax to (202) 395–5806. 

Written comments should be received 

within 30 days of this notice. 

Proposed Project 

Coal Workers’ Health Surveillance 

Program (CWHSP)—OMB 0920–0020– 

Reinstatement With Change—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 37 (0920– 

0020) and National Coal Workers’ 

Autopsy Study 42 CFR part 37.204 

(0920–0021) 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, PL–91–173 

(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’. 

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, 


jdjones on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 22903 

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. The 

total estimated burden hours are 4,470. 

Type of respondent Form name Number of 

respondents 

Responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Physicians B Readers ............ Roentgenographic Interpretation Form—CDC/NIOSH (M) 

2.8.

10,000 1 3/60 

Interpreting Physician Certification Document—CDC/NIOSH 

(M) 2.12.

300 1 10/60 

Miners ..................................... Miner Identification Document—CDC/NIOSH (M) 2.9 ........... 5,000 1 20/60 

No form—X-ray ...................................................................... 5,000 1 15/60 

No form—Spirometry .............................................................. 2,500 1 20/60 

Coal Mine Operators .............. Coal Mine Operator’s Plan—CDC/NIOSH (M) 2.10 .............. 200 1 30/60 

Supervisor at X-ray Facilities .. Facility Certification Document—CDC/NIOSH (M) 2.11 ........ 100 1 30/60 

Pathologist .............................. No form—Invoice .................................................................... 50 1 5/60 

No form—Final Diagnosis Report .......................................... 50 1 5/60 

Next-of-Kin .............................. Consent, Release, and History Form—CDC/NIOSH (M) 2.6 50 1 15/60 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–9922 Filed 4–22–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0125] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007; 

Availability; Agency Information 

Collection Activities; Proposed 

Collection; Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007.’’ 

This draft guidance provides 

information on how a manufacturer may 

demonstrate that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. In this 

draft guidance, FDA provides 

recommendations on the evidence that 

a manufacturer may use to demonstrate 

that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. This 

draft guidance is not final nor is it in 

effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 24, 2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Establishing That a 

Tobacco Product Was Commercially 

Marketed in the United States as of 

February 15, 2007’’ to the Center for 

Tobacco Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

guidance document may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Annette Marthaler, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373, 

e-mail: annette.marthaler@fda.hhs.gov. 

With regard to the proposed 

collection of information: Jonna 

Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, e-mail: Jonnalynn.Capezzuto@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance provides 

information on how a manufacturer may 

establish that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. In this 

draft guidance, FDA provides 

recommendations on the information 

that a manufacturer may use to establish 

that a tobacco product was 

commercially marketed in the United 

States on February 15, 2007, and is, 

therefore, a grandfathered product not 

subject to premarket review 

requirements. In the draft guidance 

document, FDA recommends that this 

information may include, among other 

things, dated copies of advertisements, 

dated catalog pages, and dated 

promotional material. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on ‘‘Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007.’’ 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

An electronic version of the draft 

guidance document is available on the 

Internet at http://www.regulations.gov 


jdjones on DSKHWCL6B1PROD with NOTICES