Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices 68785 

1See: Reinhardt,TE, Ottmar, RD. 2000. Smoke 

exposure at western wildfires. Res. Pap. PNW–RP– 

525. Portland, OR: U.S. Department of Agriculture, 

Forest Service, Pacific Northwest Research Station. 

Institute for Occupational Safety and 

Health (NIOSH) intends to employ 

existing provisions in 42 CFR Part 84 to 

test and approve air-purifying 

respirators (APRs) and powered airpurifying respirators (PAPRs) that 

provide composite multi-gas and 

particulate protection for inhalation 

hazards associated with wildland firefighting. NIOSH will evaluate candidate 

respirators for inhalation protections 

tailored against exposures identified in 

the National Fire Protection Association 

(NFPA) 1984 standard on respirators for 

wildland fire-fighting (WFF) operations. 

Under 42 CFR Part 84 requirements, 

NIOSH approval is necessary for the 

complete evaluation of WFF respirators 

pursuant to NFPA 1984 (2011). 

SUPPLEMENTARY INFORMATION: 

Background 

Wildland firefighting presents many 

hazards to firefighters, including 

inhalation exposure to smoke and other 

combustion (fire) byproducts. Studies 

indicate that most wildland firefighters 

work in smoke levels that are not 

expected to cause health problems or 

exceed legal and recommended limits.1

However, wildland firefighters 

occasionally experience smoke levels 

that exceed guidelines recommended by 

occupational health experts, and are 

higher than Federal occupational safety 

and health regulations allow. Because 

manufacturers have not yet developed 

respiratory protection for this 

occupational setting, firefighters battling 

wild fires often resort to using devices 

not approved by NIOSH, or NIOSHapproved filtering facepiece respirators 

which are not designed for this use, or 

no respiratory protection at all. Without 

a NIOSH-approved respirator designed 

to protect against the combination of 

particulates, gases and vapors generally 

produced by wildfires, firefighters 

cannot be sure that they are receiving 

adequate or any protection at all. 

Filtering facepiece respirators approved 

under the current NIOSH standards 

provide no protection against fire gases 

or vapors and may structurally fail at 

the elevated temperatures encountered 

in wildland firefighting environments. 

NIOSH is now accepting applications 

for respiratory protective devices 

designed for the inhalation hazards of 

this occupational setting. 

On July 10, 2012 NIOSH issued a 

letter to manufacturers 2 announcing 

that NIOSH was prepared to evaluate 

respirators used for protection against 

the inhalation hazards identified in the 

National Fire Protection Association 

(NFPA) standard 1984 (2011 Edition).3

This new evaluation will be conducted 

in accordance with a Memorandum of 

Understanding between the NIOSH 

National Personal Protective 

Technology Laboratory (NPPTL) and the 

Safety Equipment Institute (SEI), a nongovernmental non-profit organization 

that administers third-party certification 

programs to certify a broad range of 

safety and protective products. Under 

this MOU, NIOSH/NPPTL and SEI will 

coordinate their certification programs. 

SEI will evaluate candidate respirators 

for compliance with NFPA 1984–2011, 

Standard on Respirators for Wildland 

Fire-Fighting Operations, which 

includes Tentative Interim Amendment 

(TIA) No. 11–1. 

Under NFPA 1984, the wildland 

firefighter respirator must be approved 

by NIOSH as an APR or a PAPR. NIOSH 

has developed test procedures for a 

composite particulate and multi-gas 

protection for APR and PAPR approvals 

in accordance with 42 CFR 84.60(b); 

84.63(a), (b), (c), and (d); 84.110(c); and 

84.190(b). The standard test procedures 

are available upon request and will be 

available on the NIOSH NPPTL Web site 

at: http://www.cdc.gov/niosh/npptl/ 

stps/APresp.html. 

FOR FURTHER INFORMATION CONTACT: Tim 

Rehak, NIOSH National Personal 

Protective Technology Laboratory 

(NPPTL), P.O. Box 18070, 626 Cochrans 

Mill Road, Pittsburgh, PA 15236; (412) 

386–5200 (this is not a toll-free 

number). 

Dated: November 8, 2012. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2012–27898 Filed 11–15–12; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10028, CMS– 

10180, CMS–R–199 and CMS–10443] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Children’s 

Health Insurance Program (CHIP) Report 

on Payables and Receivables; Use: 

Collection of CHIP data and the 

calculation of the CHIP Incurred But 

Not Reported (IBNR) estimate are 

pertinent to CMS’ financial audit. The 

CFO auditors have reported the lack of 

an estimate for CHIP IBNR payables and 

receivables as a reportable condition in 

the FY 2005 audit of CMS’s financial 

statements. It is essential that CMS 

collect the necessary data from State 

agencies in FY 2006, so that CMS 

continues to receive an unqualified 

audit opinion on its financial 

statements. Program expenditures for 

the CHIP have increased since its 

inception; as such, CHIP receivables and 

payables may materially impact the 

financial statements. The CHIP Report 

on Payables and Receivables will 

provide the information needed to 

calculate the CHIP IBNR.; Form 

Number: CMS–10180 (OMB#: 0938– 

0988); Frequency: Reporting—Annually; 

Affected Public: State, Local or Tribal 

governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 392. (For policy 

questions regarding this collection 

contact Michele Myers at 410–786– 

7911. For all other issues call 410–786– 

1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid Report 

on Payables and Receivables; Use: The 

Chief Financial Officers (CFO) Act of 

1990, as amended by the Government 

Management Reform Act (GMRA) of 

1994, requires government agencies to 

produce auditable financial statements. 

Because the Centers for Medicare & 

Medicaid Services (CMS) fulfills its 

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68786 Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices 

mission through its contractors and the 

States; these entities are the primary 

source of information for the financial 

statements. There are three basic 

categories of data: expenses, payables, 

and receivables. The CMS–64 is used to 

collect data on Medicaid expenses. The 

CMS–R–199 collects Medicaid payable 

and receivable accounting data from the 

States. Form Number: CMS–R–199 

(OMB#: 0938–0697); Frequency: 

Reporting—Annually; Affected Public: 

State, Local or Tribal governments; 

Number of Respondents: 56; Total 

Annual Responses: 56; Total Annual 

Hours: 336. (For policy questions 

regarding this collection contact 

Michele Myers at 410–786–7911. For all 

other issues call 410–786–1326.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: State Health 

Insurance Assistance Program (SHIP) 

Client Contact Form, Public and Media 

Activity Report Form, and Resource 

Report Form. Use: Section 4360(f) of the 

Omnibus Budget Reconciliation Act 

(OBRA) 1990 requires the Secretary to 

provide a series of reports to the U.S. 

Congress on the performance of the 

program and its impact on beneficiaries 

and to obtain important informational 

feedback from beneficiaries. Further, in 

response to requirements of the 

Balanced Budget Act of 1997, CMS 

launched a comprehensive five-year 

campaign, the National Medicare 

Education Program (NMEP), to raise 

awareness among beneficiaries about 

their Medicare health plan options and 

help them assess the advantages and 

disadvantages each choice holds for 

them. The Medicare Modernization Act 

(MMA) of 2003 required State Health 

Insurance Assistance Programs (SHIPs) 

to be actively engaged in the 

implementation of the Medicare 

Prescription Drug Program (Part D). 

MIPPA legislation and Affordable Care 

Act legislation required SHIPs to 

provide enrollment assistance for the 

Limited Income Subsidy (LIS) and 

Medicare Savings Program (MSP). The 

goal is to ensure that beneficiaries are 

making an informed choice, regardless 

of whether they stay in Original 

Medicare or choose new options. CMS 

is responsible to Congress for 

demonstrating improvement over time 

in the level of awareness and 

understanding beneficiaries have about 

health plan options. The SHIPs are an 

integral component of this initiative. 

The information collected is used to 

fulfill the reporting requirements 

described in Section 4360(f) of OBRA 

1990. CMS will utilize this data. The 

data will be accumulated and analyzed 

to measure SHIP performance in order 

to determine whether and to what 

extent the SHIPs have met the goals of 

improved CMS customer service to 

beneficiaries and better understanding 

by beneficiaries of their health 

insurance options. Further, the 

information will be used in the 

administration of the grants, to measure 

performance and appropriate use of the 

funds by the state grantees, to identify 

gaps in services and technical support 

needed by SHIPs, and to identify and 

share best practices. 

The overall burden of hours and 

expected number of respondents 

increase is based on projected future 

service growth and projected future 

increases in staffing to accommodate the 

increased demand to utilize the SHIP 

network to raise awareness about new 

CMS policies, outreach initiatives, or 

both. However, the instruments 

themselves have not changed. Form 

Number: CMS–10028 (OCN: 0938– 

0850); Frequency: Occasionally; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

17,838; Total Annual Responses: 

2,346,465. Total Annual Hours: 195,642. 

(For policy questions regarding this 

collection contact Gregory Price at 410– 

786–4041. For all other issues call 410– 

786–1326.) 

4. Type of Information Collection 

Request: New collection. Title of 

Information Collection: Transcatheter 

Valve Therapy Registry and KCCQ–10. 

Use: The data collection is required by 

the Centers for Medicare and Medicaid 

Services (CMS) National Coverage 

Determination (NCD) entitled, 

‘‘Transcatheter Aortic Valve 

Replacement (TAVR)’’. The TAVR 

device is only covered when specific 

conditions are met including that the 

heart team and hospital are submitting 

data in a prospective, national, audited 

registry. The data includes patient, 

practitioner and facility level variables 

that predict outcomes such as all cause 

mortality and quality of life. CMS finds 

that the Society of Thoracic Surgery/ 

American College of Cardiology 

Transcatheter Valve Therapy (STS/ACC 

TVT) Registry, one registry overseen by 

the National Cardiovascular Data 

Registry, meets the requirements 

specified in the NCD on TAVR. The 

TVT Registry will support a national 

surveillance system to monitor the 

safety and efficacy of the TAVR 

technologies for the treatment of aortic 

stenosis. 

The data will also include the 

variables on the eight item Kansas City 

Cardiomyopathy Questionnaire (KCCQ– 

10) to assess heath status, functioning 

and quality of life. In the KCCQ, an 

overall summary score can be derived 

from the physical function, symptoms 

(frequency and severity), social function 

and quality of life domains. For each 

domain, the validity, reproducibility, 

responsiveness and interpretability have 

been independently established. Scores 

are transformed to a range of 0–100, in 

which higher scores reflect better health 

status. 

The conduct of the STS/ACC TVT 

Registry and the KCCQ–10 is in 

accordance with Section 1142 of the 

Social Security Act (the Act) that 

describes the authority of the Agency for 

Healthcare Research and Quality 

(AHRQ). Under section 1142, research 

may be conducted and supported on the 

outcomes, effectiveness, and 

appropriateness of health care services 

and procedures to identify the manner 

in which disease, disorders, and other 

health conditions can be prevented, 

diagnosed, treated, and managed 

clinically. Section 1862(a)(1)(E) of the 

Act allows Medicare to cover under 

coverage with evidence development 

(CED) certain items or services for 

which the evidence is not adequate to 

support coverage under section 

1862(a)(1)(A) and where additional data 

gathered in the context of a clinical 

setting would further clarify the impact 

of these items and services on the health 

of beneficiaries. 

The data collected and analyzed in 

the TVT Registry will be used by CMS 

to determine if the TAVR is reasonable 

and necessary (e.g., improves health 

outcomes) for Medicare beneficiaries 

under Section 1862(a)(1)(A) of the Act. 

Furthermore, data from the Registry will 

assist the medical device industry and 

the Food and Drug Administration 

(FDA) in surveillance of the quality, 

safety and efficacy of new medical 

devices to treat aortic stenosis. For 

purposes of the TAVR NCD, The TVT 

Registry has contracted with the Data 

Analytic Centers to conduct the 

analyses. In addition, data will be made 

available for research purposes under 

the terms of a data use agreement that 

only provides de-identified datasets. 

Form Number: CMS–10443 (OCN: 0938- 

New); Frequency: Annual; Affected 

Public: Individuals, Households and 

Private Sector; Number of Respondents: 

12,000; Total Annual Responses: 

24,000; Total Annual Hours: 7,000. (For 

policy questions regarding this 

collection contact JoAnna Baldwin at 

410–786–7205. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

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Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices 68787 

address at http://www.cms.hhs.gov/

PaperworkReductionActof1995, or email 

your request, including your address, 

phone number, OMB number, and CMS 

document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on December 17, 2012. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: November 9, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–27841 Filed 11–15–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0164] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Draft Guidance for 

Industry on Safety Labeling Changes; 

Implementation of the Federal Food, 

Drug, and Cosmetic Act 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by December 

17, 2012. 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Draft Guidance for Industry on 

Safety Labeling Changes; 

Implementation of Section 505(o)(4) of 

the Federal Food, Drug, and Cosmetic 

Act.’’ Also include the FDA docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@fda.hhs.gov. 

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. 

Draft Guidance for Industry on Safety 

Labeling Changes; Implementation of 

Section 505(o)(4) of the Federal Food, 

Drug, and Cosmetic Act—(OMB Control 

Number 0910-New) 

This draft guidance provides 

information on the implementation of 

section 901 of the Food and Drug 

Administration Amendments Act of 

2007, which authorizes FDA to require 

certain drug and biological product 

application holders to make safety 

related labeling changes based upon 

new safety information that becomes 

available after the drug or biological 

product is approved under the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) or the Public Health Service 

Act. FDA plans to request safety 

labeling changes by sending a 

notification letter to the application 

holder. Under section 505(o)(4)(B) of the 

FD&C Act (21 U.S.C. 355(o)(4)(B)), the 

application holder must respond to 

FDA’s notification by submitting a 

labeling supplement or notifying FDA 

that the applicant does not believe the 

labeling change is warranted and 

submitting a statement detailing the 

reasons why the application holder does 

not believe a change is warranted (a 

rebuttal statement). 

The submission of rebuttal statements 

may result in the collection of 

information that is not already approved 

by OMB. Based on FDA’s experience 

thus far with safety labeling changes 

requirements under section 505(o)(4) of 

the FD&C Act, FDA estimates that 

approximately six application holders 

will elect to submit approximately one 

rebuttal statement each year and that 

each rebuttal statement will take 

approximately 6 hours to prepare. 

In addition, in the draft guidance, the 

Agency states that new labeling 

prepared in response to a safety labeling 

change notification should be available 

on the application holder’s Web site 

within 10 calendar days of approval, 

which may result in the collection of 

information that is not already approved 

by OMB. FDA estimates that 

approximately 197 application holders 

will post new labeling one time each 

year in response to a safety labeling 

change notification and that the posting 

of the labeling will take approximately 

4 hours to prepare. 

In the Federal Register of April 13, 

2011 (76 FR 20686), FDA published a 

60-day notice requesting public 

comment on the draft version of this 

guidance. None of the comments we 

received pertained to the information 

collection provisions. 

FDA estimates the burden of the 

collections of information that have not 

already been approved by OMB is as 

follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Rebuttal statement ........................................... 6 1 6 6 36 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

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