Federal Register / Vol. 79, No. 50 / Friday, March 14, 2014 / Notices 14515 

a 21 CFR 878.4040 (FDA 510(K)Clearance) 

bStradtman, L, Prevalence of Respiratory 

Protective Devices in U.S. Healthcare Systems, 

Internal NIOSH Survey Report, Jan. 7, 2014. 

(available in docket) 

DATES: Comments on the ICR must be 

received on or before April 14, 2014. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Information Collection Clearance staff, 

Information.CollectionClearance@

hhs.gov or (202) 690–6162. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the OMB 

control number 0955–0009 and 

document identifier HHS–OS–21223– 

30D for reference. 

Information Collection Request Title: 

Regional Extension Center Cooperative 

Agreement Program (CRM Tool). 

OMB No.: 0955–0009. 

Abstract: The Customer Relationship 

Management (CRM) application is a 

nimble business intelligence tool being 

used by more than 1,500 users at ONC 

partner organizations and grantees. The 

CRM collects data from a large number 

of users throughout the United States 

who are ‘‘on the ground’’ helping 

healthcare providers adopt and optimize 

their IT systems, it provides near realtime data about the adoption, 

utilization, and meaningful use of EHR 

technology. 

Approximately half of all Primary 

Care Providers in the nation are 

represented in the CRM tool; data points 

include provider location, credential, 

specialty, whether live on an EHR and 

what system, whether they’ve reached 

MU, the time between these, and 

narrative barriers experienced by many 

of these. 

Need and Proposed Use of the 

Information: The CRM tool supplements 

and is regularly merged with other data 

sources both within and outside of HHS 

and tracks program performance and 

progress towards milestones. Combined 

with ONC’s internal analytical capacity, 

this data provides feedback that goes 

beyond anecdotal evidence and can be 

turned into tangible lessons learned that 

are used to focus policy and program 

efforts and ultimately achieve concrete 

outcomes. 

Likely Respondents: Regional 

Extension Centers. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions, to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information, to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information, and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Forms (If necessary) Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

CRM Tool ............................... Regional Extension Center ......................... 60 12 1.5 1,080 

CRM Tool ............................... Community College Consortia .................... 84 20 1.5 2,520 

Total ................................ ..................................................................... ........................ ........................ ........................ 3,600 

Darius Taylor, 

Deputy, Information Collection Clearance 

Officer. 

[FR Doc. 2014–05657 Filed 3–13–14; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[CDC–2014–0005, Docket Number NIOSH– 

272] 

Respiratory Protective Devices Used in 

Healthcare 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of request for 

information and comment. 

SUMMARY: Respiratory protective devices 

(RPDs) that are approved by the 

National Institute for Occupational 

Safety and Health (NIOSH) and also 

cleared by the Food and Drug 

Administration (FDA) a as medical 

devices are widely used in surgical and 

non-surgical healthcare environments. 

There are reports b that other NIOSHapproved RPDs that are not FDA-cleared 

medical devices are also being used to 

protect healthcare workers from 

inhalation hazards. The desirability of 

NIOSH incorporating additional 

requirements and tests in its 42 CFR 

Part 84 respirator approval process to 

parallel the protections in the FDA 

clearance process for Surgical N95 

Respirators in surgical and non-surgical 

healthcare environments has been 

mentioned during broad-based and 

cross-agency discussions for future 

pandemic events as well as day-to-day 

use in healthcare settings. 

NIOSH could augment the existing 

requirements and tests of the 42 CFR 

Part 84 conformity assessment process 

to incorporate requirements included in 

the FDA clearance process, such as fluid 

resistance and flammability. Both FDA 

and NIOSH require demonstration of 

filtration performance. The current 

NIOSH filtration testing requirements 

use non-biological aerosol based on the 

assumption that all particles, biological 

or non-biological, behave according to 

the same principles of aerosol physics 

for filtration: That is, by impaction, 

interception, diffusion, and electrostatic 

attraction. NIOSH is seeking public 

comment with available supporting data 

that either validates or disproves this 

assumption. 

NIOSH is requesting information and 

comments on the following: 

1. Do healthcare stakeholders 

anticipate expanding the use of RPDs to 

include elastomeric air purifying 

respirators and/or Powered Air 

Purifying Respirators (PAPRs)? 

2. For protections appropriate for 

RPDs to be used in surgical and/or nonsurgical healthcare environments, 

should NIOSH consider adding tests 

and requirements to the 42 CFR Part 84 

conformity assessment process for 

splash/spray protection (fluid 

resistance) per ASTM F1862:2000a, or 

other appropriate standards? NIOSH 

seeks evidence related to the 


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14516 Federal Register / Vol. 79, No. 50 / Friday, March 14, 2014 / Notices 

cAccording to the Food, Drug and Cosmetic Act, 

the FDA reviews for clearance medical devices that 

are intended to cure, mitigate, treat, or prevent 

disease in man. 

dAccording to the Food, Drug and Cosmetic Act, 

the FDA reviews for clearance medical devices that 

are intended to cure, mitigate, treat, or prevent 

disease in man. 

performance of existing products 

(NIOSH-approved, but not FDA-cleared 

as a medical device) against this 

standard and the prevalence and 

characteristics of actual sprays/splashes 

faced by healthcare workers during nonsurgical patient care. 

3. For RPDs to be used in surgical 

and/or non-surgical healthcare 

environments, should NIOSH consider 

adding requirements and tests beyond 

those provided in 42 CFR Part 84 for 

protection against flammability hazards 

per 16 CFR 1610, UL 2154, or other 

appropriate standards? NIOSH seeks 

evidence related to the performance of 

existing products (NIOSH-approved, but 

not FDA-cleared as a medical device) 

against this standard and the prevalence 

and characteristics of actual 

flammability hazards faced by 

healthcare workers during patient care 

(i.e., non-surgical activities). 

4. For RPDs to be used in surgical 

and/or non-surgical healthcare 

environments, should NIOSH consider 

adding optional, supplemental filtration 

testing (e.g., ASTM F2101–01 (Bacterial 

Filtration Efficiency) and ASTM 

F1215:1989 (Particulate Filtration 

Efficiency)) in addition to the existing 

NIOSH filter requirements in 42 CFR 

Part 84? NIOSH requests evidence 

related to the performance of existing 

products (NIOSH-approved, but not 

FDA-cleared as a medical device) 

against these alternative filter test 

methods and the prevalence and 

characteristics of airborne exposures 

faced by healthcare workers during 

patient care (i.e., non-surgical 

activities). NIOSH seeks comparative 

results for testing against such candidate 

supplemental standards versus test 

results achieved in the existing filter 

efficiency tests of 42 CFR Part 84. 

DATES: All comments must be received 

by April 14, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Roland Berry Ann, NIOSH NPPTL, P.O. 

Box 18070, Pittsburgh, PA 15236; (412) 

386–6111 (this is not a toll-free 

number). Information requests can also 

be submitted by email to nioshdocket@

cdc.gov. 

ADDRESSES: You may submit comments 

identified by CDC–2014–0005 and 

Docket Number NIOSH–272 by either of 

the two following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

Instructions: All information received 

in response to this notice must include 

the agency name and docket number 

[CDC–2014–0005; NIOSH–272]. All 

relevant comments received will be 

posted without change to 

www.regulations.gov, including any 

personal information provided. All 

electronic comments should be 

formatted as Microsoft Word. For access 

to the docket to read background 

documents or comments received, go to 

www.regulations.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under 42 CFR Part 84, NIOSH 

approves RPDs for protection against 

inhalation hazards in all occupational 

settings. The FDA regulates medical 

devices that are intended to prevent the 

transmission of disease in humans. FDA 

defines a medical device under Section 

201(h) of the Federal Food, Drug and 

Cosmetic Act (21 U.S.C. 321(h)). 

The Occupational Safety and Health 

Administration’s (OSHA’s) Bloodborne 

Pathogens regulation specifies masks in 

combination with eye protection 

devices, such as goggles or glasses with 

solid side shields, or chin-length face 

shields, are to be worn whenever 

splashes, sprays, spatters, or droplets of 

blood or other potentially infectious 

materials may be generated and eye, 

nose, or mouth contamination can be 

reasonably anticipated. (29 CFR 

1910.1030(d)(3)(x)). 

The FDA clears surgical masks (e.g., 

laser masks or procedure masks) as 

medical devices,c in that they are 

intended to prevent disease. They 

protect healthcare workers from 

splashes, sprays, spatters, and droplets 

of respiratory secretions, blood and 

other body fluids. The FDA may issue 

a premarket clearance as a medical 

device only for certain NIOSH-approved 

N95 filtering facepiece respirators 

(FFRs) assessed for clearance 

characteristics equivalent to FDAcleared masks that are used in the 

healthcare setting. Currently, the only 

medical device classification that can be 

applied to a NIOSH-approved respirator 

is that of a Surgical N95 Respirator. 

FDA regulates NIOSH-approved 

Surgical N95 Respirators as medical 

devices intended for use in healthcare 

settings under the regulation 21 CFR 

878.4040. OSHA has the primary 

responsibility for enforcing proper use 

of RPDs in the workplace, including 

healthcare settings, as described in the 

Respiratory Protection standard (29 CFR 

1910.134). According to section 

1910.134, where respirators are 

required, they must be NIOSH-approved 

and used as part of a respiratory 

protection program which includes 

medical evaluation, training, and fit 

testing (when applicable). OSHA does 

not require RPDs used in a healthcare 

setting to be cleared by the FDA. Many 

RPDs used in healthcare settings have 

not been submitted by industry for FDA 

premarket clearance, and therefore have 

not been FDA-cleared as medical 

devices. 

There are two general categories of 

RPDs found in healthcare settings: (1) 

Those approved by NIOSH and (2) those 

approved by NIOSH and receiving FDA 

Premarket Notification [510(k)] 

clearance as a Surgical N95 Respirator 

by the FDA. RPDs approved by NIOSH 

which are not cleared by FDA include 

NIOSH-approved N95, P95, and P100 

FFRs; Powered, Air-Purifying 

Respirators (PAPR); and elastomeric half 

facepiece air-purifying respirators. The 

most common of these is the N95 FFR. 

Surgical N95 Respirators cleared by 

FDA and approved by NIOSH are N95 

FFRs that also meet certain 

requirements for fluid resistance per 

ASTM F1862:2000a and sometimes 

flammability requirements per 16 CFR 

1610 and UL 2154. 

Applicability to Pandemic Preparedness 

During the early stages of a pandemic, 

before vaccines are widely available and 

the mode(s) of disease transmission are 

fully understood, personal protective 

equipment will be an important 

component of a non-pharmaceutical 

intervention strategy to reduce disease 

transmission. Some of the RPDs used as 

part of the intervention could be RPDs 

in frequent or daily use for non-outbreak 

hazards. 

Due to the expected importance of 

RPD use during a pandemic, the HHS 

recommends that healthcare facilities 

stockpile a 6–8 week supply of 

disposable N95 FFRs. However, it has 

been documented d that the stockpiling 

recommendation has been a challenge 

for healthcare facilities. Noted barriers 

to stockpiling N95 FFRs include: lack of 

storage space, limited use within normal 

working parameters, shelf-life 

limitations, and working against the 

typical ‘‘just-in-time’’ supply chains, 

which only allow for a limited number 

of on-hand supplies. This is challenging 

due to the sheer number of RPDs that 

will be needed during a pandemic. 

According to the CDC, an estimated 90 


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Federal Register / Vol. 79, No. 50 / Friday, March 14, 2014 / Notices 14517 

eBunyan D, Ritchie L, Jenkins D, Coia JE. 

Respiratory and facial protection: a critical review 

of recent literature. J Hosp. Infect. 2013 Nov; 

85(3):165–9. 

fAssociation of State and Territorial Health 

Officials. Assessing Policy Barriers to Effective 

Public Health Response in the H1N1 Influenza 

Pandemic. Arlington: Association of State and 

Territorial Health Officials; 2010. 

FFRs are the primary choice of respiratory 

protection over PAPRs or elastomeric respirators for 

numerous reasons. They are disposable and 

therefore do not require cleaning or reprocessing. 

They are lighter in weight and less cumbersome to 

don and doff as straps are generally not adjustable; 

nor are there any filter cartridges to be manipulated. 

Also, they are familiar to HCWs because of their 

resemblance to surgical masks commonly used in 

healthcare environments. 

1The term drug used throughout this guidance 

refers to drugs and biological products. 

million N95 FFRs would be needed to 

protect healthcare workers during a 42- 

day pandemic. The rapid increase in 

RPD usage was apparent during the 

2009 H1N1 pandemic.e f RPD usage may 

also increase beyond pandemic 

recommendations due to concerns about 

disease transmission. 

Because of the potential for splashes 

and sprays (e.g., from a severed artery, 

cough, or sneeze), some facilities have 

selected NIOSH approved and FDAcleared Surgical N95 respirators as the 

primary option for protecting healthcare 

workers during a pandemic. However, 

other NIOSH-approved RPDs might 

need to be considered because there 

may not be enough of the FDA-cleared 

devices to protect healthcare workers 

and other essential personnel during a 

pandemic or outbreak. 

NIOSH-approved respiratory 

protective devices that are also FDAcleared medical devices are widely used 

in surgical and non-surgical healthcare 

environments. There are reports b c that 

other types of NIOSH-approved RPDs 

that are not FDA-cleared medical 

devices are being used as well to protect 

workers in both surgical and nonsurgical healthcare environments from 

inhalation hazards. The desirability of 

NIOSH incorporating additional 

requirements and tests in its 42 CFR 

Part 84 respirator approval process to 

parallel the protections in the FDA 

clearance process for Surgical N95 

Respirators in surgical and non-surgical 

healthcare environments has been 

mentioned during broad-based and 

cross-agency planning discussions for 

dealing with future pandemics. 

NIOSH intends to use this 

information to consider augmenting the 

existing protections of 42 CFR Part 84 to 

incorporate requirements included in 

the FDA clearance process, such as fluid 

resistance and flammability. b c NIOSH is 

seeking public comment on the 

desirability of adding requirements and 

tests in its 42 CFR Part 84 respirator 

approval process to parallel the 

protections in the FDA clearance 

process. 

Both FDA and NIOSH require 

demonstration of filtration performance. 

The current NIOSH filtration testing 

requirements use non-biological aerosol 

based on the assumption that all 

particles, biological or non-biological, 

behave according to the same principles 

of aerosol physics for filtration: that is, 

by impaction, interception, diffusion, 

and electrostatic attraction. NIOSH is 

seeking public comment with available 

supporting data that either validates or 

disproves this assumption. 

Next Steps: NIOSH will determine 

next steps after all comments are 

reviewed and assessed. NIOSH intends 

to provide an entry to the docket 

regarding next steps no later than June 

30, 2014. 

Dated: March 10, 2014. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2014–05611 Filed 3–13–14; 8:45 a.m.] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0248] 

Draft Guidance for Industry on 

Allowable Excess Volume and Labeled 

Vial Fill Size in Injectable Drug and 

Biological Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Allowable Excess 

Volume and Labeled Vial Fill Size in 

Injectable Drug and Biological 

Products.’’ This guidance clarifies the 

FDA requirements and regulations 

pertaining to allowable excess volume 

in injectable vials and reinforces the 

importance of appropriate packaging 

sizes for injectable drug 1 and biological 

products. 

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 on 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 12, 2014. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft 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. 

FOR FURTHER INFORMATION CONTACT: 

Pallavi Nithyanandan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4171, 

Silver Spring, MD 20993–0002, 301– 

796–7546, or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Allowable Excess Volume and Labeled 

Vial Fill Size in Injectable Drug and 

Biological Products.’’ FDA is concerned 

that injectable vial misuse, including 

unsafe handling and injection 

techniques, has led to an increase in vial 

contamination and an increased risk of 

bloodborne illness transmission 

between patients. This guidance 

clarifies the FDA requirements and 

regulations pertaining to allowable 

excess volume in injectable vials and 

describes when justification is needed 

for a proposed excess volume in an 

injectable drug or biological product. 

This guidance also discusses the 

importance of appropriate packaging 

sizes for injectable drug and biological 

products and recommends that labeled 

vial fill sizes be appropriate for the use 

and dosing of the drug and biological 

product. This guidance specifically 

addresses fill and packaging issues for 

injectable drug and biological products 

packaged in vials and ampules. 

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 this topic. It does not create or confer 

any rights for or on any person and does 


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