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

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

b Stradtman, 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 optimizetheir 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 

### E STIMATED 

### A NNUALIZED 

### B URDEN

### —H OURS

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 forRPDs 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


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

c According 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. d According 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/splashesfaced 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 clearancecharacteristics 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


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

e Bunyan 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.

f Association 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. 1 The 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 haveselected 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 respiratoryprotective 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 protectworkers 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