14020 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 

removal workers, fabric mill workers, 

and fire fighters. Regulations of the 

Environmental Protection Agency (EPA) 

and the Nuclear Regulatory Commission 

(NRC) also require the use of NIOSHapproved respirators. These regulations 

also establish methods for respirator 

manufacturers to submit respirators for 

testing under the regulation and have 

them certified as NIOSH-approved if 

they meet the criteria given in the above 

regulation. NIOSH, in accordance with 

42 CFR Part 84: (1) Issues certificates of 

approval for respirators which have met 

specified construction, performance, 

and protection requirements; (2) 

establishes procedures and 

requirements to be met in filing 

applications for approval; (3) specifies 

minimum requirements and methods to 

be employed by NIOSH and by 

applicants in conducting inspections, 

examinations, and tests to determine 

effectiveness of respirators; (4) 

establishes a schedule of fees to be 

charged applicants for testing and 

certification; and (5) establishes 

approval labeling requirements. 

Information is collected from those who 

request services under 42 CFR part 84 

in order to properly establish the scope 

and intent of request. Information 

collected from requests for respirator 

approval functions includes contact 

information and information about 

factors likely to affect respirator 

performance and use. Such information 

includes, but is not necessarily limited 

to, respirator design, manufacturing 

methods and materials, quality 

assurance plans and procedures, and 

user instruction and draft labels, as 

specified in the regulation. 

The main instrument for data 

collection for respirator approval 

functions is the SAF, Standard 

Application for the Approval of 

Respirators, currently Version 7. A 

replacement instrument, SAF V.8, 

which collects the same information is 

available for applicants without the 

requisite software environment for V.7. 

Respirator manufacturers are the 

respondents (estimated to average 75 

each year over the years 2011–2013) and 

upon completion of the SAF their 

requests for approval are evaluated. 

Although there is no cost to respondents 

to submit an application other than their 

time to participate, respondents 

requesting respirator approval are 

required to submit fees for necessary 

testing as specified in 42 CFR 84.20–22, 

84.66, 84.258 and 84.1102. In calendar 

year 2010 $395,564.00 was accepted. 

Applicants are required to provide test 

data that shows that the respirator is 

capable of meeting the specified 

requirements in 42 CFR part 84. The 

requirement for submitted test data is 

likely to be satisfied by standard testing 

performed by the manufacturer, and no 

extra burden is expected. 

42 CFR part 84 approvals offer 

corroboration that approved respirators 

are produced to certain quality 

standards. Although 42 CFR part 84, 

subpart E prescribes certain quality 

standards, it is not expected that 

requiring approved quality standards 

will impose an additional cost burden 

over similarly effective quality 

standards that are not approved under 

42 CFR part 84. Manufacturers with 

current approvals are subject to site 

audits by the Institute or its agents. 

There is no fee associated with audits. 

Audits may occur periodically or as a 

result of a reported issue. An average of 

61 site audits were conducted annually 

over the calendar years 2008–2010, and 

this rate is expected to continue. Audits 

take an average of 23.5 burden hours 

from the respondent. 

There are no costs to respondents 

other than their time. 

Form Number of 

respondents 

No. of 

responses per 

respondent 

Avg. burden 

per response 

(in hrs) 

Total burden 

(in hrs) 

Standard Application for the Approval of Respirators ..................................... 75 8 229 137,400 

Audit ................................................................................................................. 60 1 24 1,440 

Total .......................................................................................................... ........................ ........................ ........................ 138,840 

Dated: March 9, 2011. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–5921 Filed 3–14–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–11–0406] 

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) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

State and Local Area Integrated 

Telephone Survey (SLAITS), (OMB No. 

0920–0406, Expiration 04/30/2011)— 

Revision—National Center for Health 

Statistics (NCHS), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

Section 306 of the Public Health 

Service (PHS) Act (42 U.S.C. 242k), as 

amended, authorizes that the Secretary 

of Health and Human Services (DHHS), 

acting through NCHS, shall collect 

statistics on the extent and nature of 

illness and disability of the population 

of the United States. This revision is to 

notify the public of a request to 

continue the SLAITS mechanism for the 

2011 to 2014 survey period. A three year 

clearance is requested. 

SLAITS is an integrated and 

coordinated survey system that has been 

conducted since 1997, in accordance 

with the 1995 initiative to increase the 

integration of surveys within DHHS. It 

is designed to collect needed health and 

well-being data at the national, state, 

and local levels. Using the large 

sampling frame of the ongoing National 

Immunization Survey (NIS) and 

Computer Assisted Telephone 

Interviewing (CATI), and when 

necessary independent samples, mail, 

and Internet modes to support data 

collection activities, SLAITS has 

quickly collected and produced 

household and person-level data to 

monitor health-related areas. 

Questionnaire content is drawn from 

existing surveys within DHHS and other 

Federal agencies, or developed 

specifically to meet project sponsor 

needs. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 14021 

Examples of topical areas include 

infant, child, adolescent, parent, and 

family health, well-being, and 

knowledge, attitude, and behaviors; 

children with special health care needs 

(CSHCN); functioning; life course and 

social determinants of health; 

developmental delays and disabilities; 

acute and chronic conditions; 

immunizations; access to and use of 

health care; program participation; 

adoption; and changes in health 

insurance coverage and experiences. 

Users of SLAITS data include, but are 

not limited to, Congressional offices, 

Federal agencies, state and local 

governments, schools of public health, 

colleges and universities, private 

industry, nonprofit foundations, 

professional associations, clinicians, 

researchers, administrators, advocates, 

and health planners, to evaluate content 

and/or programs. SLAITS data continue 

to be heavily used by Federal and state 

Maternal and Child Health Bureau 

Directors to evaluate programs and 

service needs. Several SLAITS modules 

provided data for multiple 

Congressionally-mandated reports on 

healthcare disparities and quality; at 

least one report to Congress on health 

insurance coverage among children; and 

reports of the National Academy of 

Sciences. Within DHHS, the Office of 

the Assistant Secretary for Planning and 

Evaluation and the Administration for 

Children and Families used SLAITS to 

collect data for the first nationally 

representative survey of adoptive 

families across adoption types for 

children with and without special 

health care needs, and to assess their 

post-adoption service use and unmet 

needs. 

There is no cost to respondents other 

than their time to participate. The total 

estimated annualized burden hours are 

194,675. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response (in 

hours) 

Household screening ................................................................................................................... 1,800,000 1 2/60 

Household interview .................................................................................................................... 306,000 1 25/60 

Pilot work, pre-testing, and planning activities ............................................................................ 12,300 1 35/60 

Dated: March 9, 2011. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–5920 Filed 3–14–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30 Day 11–10GP] 

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) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Clostridium difficile Infection (CDI) 

Surveillance—New—National Center for 

Emerging and Zoonotic Infectious 

Diseases, (NCEZID), Centers for Disease 

Control and Prevention, (CDC). 

Background and Brief Description 

Steady increases in the rate and 

severity of Clostridium difficile 

infection (CDI) indicate a clear need to 

conduct longitudinal assessments of the 

impact of CDI in the United States. C. 

difficile is an anaerobic, spore-forming, 

gram positive bacillus that produces two 

pathogenic toxins: A and B. CDI ranges 

in severity from mild diarrhea to 

fulminant colitis and death. 

Transmission of C. difficile occurs 

primarily in healthcare facilities, where 

environmental contamination by C. 

difficile spores and exposure to 

antimicrobial drugs are common. No 

longer limited to healthcare 

environments, community-associated 

CDI is the focus of increasing attention. 

Recently, several cases of serious CDI 

have been reported in what have been 

considered low-risk populations, 

including healthy persons living in the 

community and peri-partum women. 

The surveillance population will 

consist of persons residing in the 

catchment area of the participating 

Emerging Infections Program (EIP) sites. 

This surveillance poses no more than 

minimal risk to the study participants as 

there will be no interventions or 

modifications to the care study 

participants receive. EIP surveillance 

personnel will perform active case 

finding from laboratory reports of stool 

specimens testing positive for C. 

difficile toxin and abstract data on cases 

using a standardized case report form. 

For a subset of cases (e.g., communityassociated C. difficile cases) sites will 

administer a health interview. Remnant 

stool specimens from cases testing 

positive for C. difficile toxin will be 

submitted to reference laboratories for 

culturing, and isolates will be sent to 

CDC for confirmation and molecular 

typing. Outcomes of this surveillance 

project will include the populationbased incidence of community- and 

healthcare-associated CDI, and a 

description of the molecular 

characteristics of C. difficile strains and 

the epidemiology of this infection 

among the population under 

surveillance. 

There is no cost to respondents to 

participate in this program. The total 

annualized burden for this data 

collection is 5,840 hours. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

per response 

(in hours) 

CDI Surveillance Case Report Form—Complete ...................................................... 10 437 1 


srobinson on DSKHWCL6B1PROD with NOTICES