Agency Forms Undergoing Paperwork Reduction Act Review, 22902-22903 [2011-9922]

Download as PDF 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 jdjones on DSKHWCL6B1PROD with NOTICES 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). VerDate Mar<15>2010 15:21 Apr 22, 2011 Jkt 223001 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. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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, E:\FR\FM\25APN1.SGM 25APN1 22903 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 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. Number of respondents Type of respondent Form name Physicians B Readers ............ Roentgenographic Interpretation Form—CDC/NIOSH (M) 2.8. Interpreting Physician Certification Document—CDC/NIOSH (M) 2.12. Miner Identification Document—CDC/NIOSH (M) 2.9 ........... No form—X-ray ...................................................................... No form—Spirometry .............................................................. Coal Mine Operator’s Plan—CDC/NIOSH (M) 2.10 .............. Facility Certification Document—CDC/NIOSH (M) 2.11 ........ No form—Invoice .................................................................... No form—Final Diagnosis Report .......................................... Consent, Release, and History Form—CDC/NIOSH (M) 2.6 Miners ..................................... Coal Mine Operators .............. Supervisor at X-ray Facilities .. Pathologist .............................. Next-of-Kin .............................. 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 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. 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 SUMMARY: VerDate Mar<15>2010 15:21 Apr 22, 2011 Jkt 223001 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. 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 https:// 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– ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES jdjones on DSKHWCL6B1PROD with NOTICES There are no costs of the NCWAS to respondents other than their time. The total estimated burden hours are 4,470. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Average burden per response (in hours) Responses per respondent 10,000 1 3/60 300 1 10/60 5,000 5,000 2,500 200 100 50 50 50 1 1 1 1 1 1 1 1 20/60 15/60 20/60 30/60 30/60 5/60 5/60 15/60 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 https://www.regulations.gov E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Notices]
[Pages 22902-22903]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9922]

-----------------------------------------------------------------------

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,

[[Page 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.

----------------------------------------------------------------------------------------------------------------
Average burden
Type of respondent Form name Number of Responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Physicians B Readers............... Roentgenographic 10,000 1 3/60
Interpretation Form--CDC/
NIOSH (M) 2.8.
Interpreting Physician 300 1 10/60
Certification Document--
CDC/NIOSH (M) 2.12.
Miners............................. Miner Identification 5,000 1 20/60
Document--CDC/NIOSH (M)
2.9.
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-- 200 1 30/60
CDC/NIOSH (M) 2.10.
Supervisor at X-ray Facilities..... Facility Certification 100 1 30/60
Document--CDC/NIOSH (M)
2.11.
Pathologist........................ No form--Invoice........... 50 1 5/60
No form--Final Diagnosis 50 1 5/60
Report.
Next-of-Kin........................ Consent, Release, and 50 1 15/60
History Form--CDC/NIOSH
(M) 2.6.
----------------------------------------------------------------------------------------------------------------

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

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