Federal Register Vol. 81, No.42,

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-4229; Directorate Identifier 2015-CE-038-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Transport Canada, which is the aviation authority for Canada, has issued AD No. CF-2015-21, dated July 30, 2015 (referred to after this as “the MCAI”), to correct an unsafe condition for all Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes. The MCAI states:

The MCAI requires visually inspecting the elevator control rod assemblies, the elevator actuating lever on the control column, and the control column torque tube for corrosion, cracking, and/or other damages, and repairing or replacing damaged parts. The MCAI also requires incorporating revisions into the maintenance program and adds a life limit to certain elevator control rod assemblies. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4229.

Viking Air Limited has issued DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `C', dated July 17, 2015. The service information describes procedures for doing detailed visual inspections of the elevator control rod assemblies, the elevator actuating lever on the control column, and the control column torque tube for corrosion, cracking, and/or other damages. The service bulletin also describes procedures for repairing or replacing damaged parts. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this NPRM.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We estimate that this proposed AD will affect 135 products of U.S. registry. We also estimate that it would take about 11.5 work-hours per product to comply with the basic inspection requirements of this proposed AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of the basic inspection requirements of this proposed AD on U.S. operators to be $131,962.50, or $977.50 per product.

In addition, we estimate that any necessary follow-on actions would take about 8 work-hours and require parts costing $1,859, for a cost of $2,539 per product. Contact Viking Air Limited at the address identified in the ADDRESSES section of this NPRM for current pricing and lead time. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-4231; Directorate Identifier 2015-CE-042-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

On September 28, 2000, we issued AD 2000-20-11, Amendment 39-11922 (65 FR 60845; October 13, 2000) (“AD 2000-20-11”). That AD required actions intended to address an unsafe condition on BLANIK LIMITED Model L-13 Blanik gliders and was based on mandatory continuing airworthiness information (MCAI) originated by the Civil Aviation Authority, which is the aviation authority for the Czech Republic. That MCAI (AD CAA-AD-T-112/1999R1, dated November 23, 1999), was issued to correct an unsafe condition for EVECTOR, spol. s.r.o. Models L 13 SEH VIVAT and L 13 SDM VIVAT gliders and BLANIK LIMITED Models L-13 Blanik and L-13 AC Blanik gliders. The MCAI states:

You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4231.

A review of records since issuance of AD 2000-20-11 revealed that the FAA inadvertently did not address this MCAI for the EVECTOR, spol. s.r.o. Model L 13 SDM VIVAT gliders and the BLANIK LIMITED Model L-13 AC Blanik gliders. This proposed AD would supersede AD 2000-20-11 to add the BLANIK LIMITED Model L-13 AC Blanik gliders to the applicability of the AD.

The FAA will address the EVECTOR, spol. s.r.o. Model L 13 SDM VIVAT gliders in another AD action.

LET Aeronautical Works has issued LET Mandatory Bulletin No.: L13/085a, dated November 17, 1999. The service information describes procedures for testing the material strength of attachment fitting part number A 102 021 N and instructions for contacting the manufacturer for replacement information if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this NPRM.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We estimate that this proposed AD will affect 124 products of U.S. registry. We also estimate that it would take about 4 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $42,160, or $340 per product.

In addition, we estimate that any necessary follow-on actions would take about 16 work-hours and require parts costing $500, for a cost of $1,860 per product. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class D airspace at Destin Executive Airport, Destin, FL, and Duke Field Eglin AFB, FL; and remove Class D airspace at Eglin AF Aux No 3 Duke Field; and amend Class D and Class E airspace at Eglin Air Force Base, FL.

Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (FAA Docket No. FAA-2015-7203; Airspace Docket No. 15-ASO-14) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-7203; Airspace Docket No. 15-ASO-14.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded from and comments submitted through http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal Holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, Georgia 30337.

Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking distribution System, which describes the application procedure.

This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to establish Class D airspace up to and including 1,600 feet within a 4.4 mile radius of at Destin Executive Airport, Destin, FL, providing the controlled airspace required to support the Air Traffic Control Tower. Additionally, this action would remove the Class D designator for Eglin AF Aux No 3 Duke Field, FL, and replace it with Duke Field, Eglin AFB, FL. This action would also adjust the geographic coordinates in Class D airspace, Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface for Eglin Air Force Base, FL, Destin Executive Airport, Duke Field, and Hurlburt Field, to stay in concert with the FAA's database. Also, Destin-Fort Walton Beach Airport would be changed to Destin Executive Airport.

Class D and Class E airspace designations are published in Paragraphs 5000, 6002, and 6005, respectively of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Tucker-Guthrie Memorial Airport, Harlan, KY.

Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (FAA Docket No. FAA-2016-3108; Airspace Docket No. 15-ASO-16) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-3108; Airspace Docket No. 15-ASO-16.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded from and comments submitted through http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal Holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, Georgia 30337.

Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking distribution System, which describes the application procedure.

This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to establish Class E airspace extending upward from 700 feet above the surface within a 13-mile radius of Tucker-Guthrie Memorial Airport, Harlan, KY, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for Tucker-Guthrie Memorial Airport. Controlled airspace is necessary for IFR operations.

Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore; (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act). Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act). Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act). Under section 513(d)(1) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as “preamendments devices”), are classified after FDA: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution before May 28, 1976 (generally referred to as “postamendments devices”) are classified automatically by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until: FDA reclassifies the device into class I or II; or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807). A person may market a preamendments device that has been classified into class III through premarket notification procedures without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.

On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the reclassification process from rulemaking to administrative order. Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: Publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b) of the FD&C Act, and consideration of comments to a public docket. The proposed reclassification order must set forth the proposed reclassification and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including the public health benefits of the use of the device, and the nature and incidence (if known) of the risk of the device. (See section 513(e)(1)(A)(i) of the FD&C Act.)

Section 513(e)(1) provides that FDA may, by administrative order, reclassify a device based on “new information.” FDA can initiate a reclassification under section 513(e) or an interested person may petition FDA. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland-Rantos v. United States Dep't of Health, Educ. & Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously before the Agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see Bell v. Goddard, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in “medical science.” (See Upjohn v. Finch, 422 F.2d at 951.) Whether data before the Agency are past or new data, the “new information” to support reclassification under section 513(e) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1985).)

Blood lancets were classified in part 878 (21 CFR part 878) in a final rule published in the Federal Register on June 24, 1988 (53 FR 23856) that classified 51 general and plastic surgery devices. This 1988 rule classified blood lancets into class I (general controls). These devices were grouped with other devices under “Manual surgical instrument for general use” in § 878.4800 (21 CFR 878.4800). At the time, blood lancets had been in common use in medical practice for many years, and FDA believed that general controls were sufficient to provide reasonable assurance of the safety and effectiveness of those devices. The rule was amended on April 5, 1989 (54 FR 13826) to clarify that manual surgical instruments for general use made of the same materials as used in preamendment devices were exempt from premarket notification 510(k) review.

On December 7, 1994, FDA further amended the classification when it published a final rule in the Federal Register (59 FR 63005) that exempted 148 class I devices from premarket notification, with limitations. Blood lancets were one of those devices. FDA determined that manufacturers' submissions of premarket notifications were unnecessary for the protection of the public health and that FDA's review of such submissions would not advance its public health mission.

On August 26, 2010, FDA and the Centers for Disease Control and Prevention (CDC) issued a joint initial communication warning that the use of fingerstick devices (blood lancets) to obtain blood from more than one patient posed a risk of transmitting bloodborne pathogens. The communication was updated on November 29, 2010 (Ref. 1). FDA's communication update, “Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/29/2010” stated that “[o]ver the past 10-15 years, the CDC and FDA have noted a progressive increase in reports of bloodborne infection transmission (primarily hepatitis B virus [HBV]) resulting from the shared use of fingerstick and POC [or ‘Point of Care’] blood testing devices.” FDA and CDC recommended, among other things, that health care professionals and patients never use a blood lancet for more than one person.

On November 29, 2010, FDA published a guidance entitled “Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling” (75 FR 73107) (Ref. 2). This guidance includes labeling recommendations to address concerns that both health care providers and patients may be unaware of the serious adverse health risks associated with using the same blood lancet for assisted withdrawal of blood from more than one patient, even when the blood lancet blade is changed for each blood draw. FDA recommends in the guidance that all blood lancets be labeled for use only on a single patient. FDA recommends in the guidance that a statement limiting use to a single patient should also appear on the label attached to the device, if possible. The guidance was for immediate implementation. When final, this order will supersede this labeling guidance.

On June 26, 2013, FDA held a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Panel) to discuss the potential reclassification of blood lancets (Ref. 3). The Panel discussed new scientific information (see section VII of this document), the risks to health from blood lancets, whether blood lancets should be reclassified or remain in class I, and possible special controls for these devices if reclassified into class II. The Panel agreed that general controls were not sufficient to provide a reasonable assurance of safety and effectiveness of any of the four types of blood lancets (the four types are explained in section III). The Panel believed that because multiple use blood lancets for multiple patient use presented a potential unreasonable risk of illness or injury, and insufficient information existed to establish special controls for these devices, they should be reclassified into class III. The Panel recommended that all other blood lancet devices be reclassified into class II (special controls). FDA is not aware of new information since this Panel meeting that would provide a basis for a different recommendation or findings.

A blood lancet is used to puncture the skin to obtain small blood specimens for testing blood glucose, hemoglobin, and other blood components. Some blood lancets are used with POC blood testing devices, such as blood glucose meters and Prothrombin Time and International Normalized Ratio (PT/INR) anticoagulation meters. Today, probably the most common use for a blood lancet is in diabetes monitoring. These devices are used in both home and professional health care settings. Only a small blood sample is needed for testing of blood glucose level. The blood sample is dropped onto a test strip and inserted into a blood glucose meter for results.

FDA has identified four subsets of blood lancets:

1. A single use only blood lancet with an integral sharps injury prevention feature is a disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use;

2. A single use only blood lancet without an integral sharps injury prevention feature is a disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes;

3. A multiple use blood lancet for single patient use only is a multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes; and

4. A multiple use blood lancet for multiple patient use is a multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

FDA is proposing to reclassify the following three subsets of blood lancets from class I (general controls) exempt from premarket review to class II (special controls) and subject to premarket review: (1) Single use only blood lancets with an integral sharps injury prevention feature, (2) single use only blood lancets without an integral sharps injury prevention feature, and (3) multiple use blood lancets for single patient use only. FDA believes that general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness for these devices, and that there is sufficient information to establish special controls to provide such assurance.

The Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 105-115) added section 510(m) to the FD&C Act. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&C Act, if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device. The Agency does not intend to exempt these devices from premarket notification (510(k)) submission as allowed under section 510(m) of the FD&C Act. FDA believes premarket notification is necessary for these devices to provide a reasonable assurance of safety and effectiveness.

FDA is proposing that a fourth subset of blood lancets, multiple use blood lancets for multiple patient use, be reclassified from class I (general controls) without premarket review to class III (premarket approval). FDA believes that insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness for these devices, which present a potential unreasonable risk of illness or injury (see section 513(a)(1)(C) of the FD&C Act).

Elsewhere in this issue of the Federal Register, FDA is proposing to require the filing of a PMA or notice of completion of a product development protocol (PDP) for these devices, which will be finalized only if FDA reclassifies multiple use blood lancets for multiple patient use to class III.

FDA continues to believe that multiple use blood lancets for use in multiple patients present significant risks to public health. Specifically, multiple patient use blood lancets pose a risk of transmission of bloodborne pathogen infections, including HBV and hepatitis C. Bloodborne pathogens may be transmitted between patients by blood or blood products taken from a patient with a transmissible infection. FDA believes that certain design characteristics would be required to help mitigate these risks. For example, multiple use blood lancets for use in multiple patients would need to be designed to allow for rigorous, thorough cleaning plus a disinfection or sterilization process capable of reduction of bloodborne pathogens to a clinically acceptable level between each use in a different patient in order to be safe for this intended use. The cleaning and disinfection/sterilization process to be used to render a multiple use blood lancet safe for use in multiple patients would need to be effective in spite of potential health care provider noncompliance with manufacturer's Instructions for Use. More importantly, the multiple use blood lancet for use in multiple patients would need to be designed such that repeat operation of the device is not possible until the device has been thoroughly cleaned and disinfected, using validated processes, by the health care user. Such a mechanism is necessary to prevent health care providers, especially those working in facilities that provide relatively little staff education or supervision, such as assisted living facilities (ALF), from failing to comply with manufacturer recommendations regarding rendering multiple patient use blood lancets safe for use in more than one patient. Therefore, the safety of the multiple use blood lancets for multiple patients, especially the effectiveness of their design and reprocessing instructions to render the device safe for use on more than one patient and the ability of health care providers to follow these instructions completely, must be rigorously demonstrated, independently of any other blood lancet. Because blood lancets for use on multiple patients present a potential unreasonable risk of illness or injury and insufficient information exists for FDA to determine that special controls would provide reasonable assurance of safety and effectiveness of the device, the Agency believes that these devices should be reclassified into class III.

As required by section 513(e)(1)(A)(I) of the FD&C Act, FDA is providing a substantive summary of the valid scientific evidence regarding the public health benefit of blood lancets, and the nature and, if known, the incidence of the risk of the devices. Since the 1990s, because of outbreaks of HBV infections associated with blood lancets and meters used in blood glucose monitoring, CDC and FDA have recommended that blood lancets should be limited to one individual's use (Refs. 1 and 4 to 6). Nevertheless, there have been continuing reports of bloodborne pathogen transmission from the shared use of blood lancets. Improper use of blood lancets can endanger public health, and FDA is concerned about the persistent risk of transmission of hepatitis and other bloodborne pathogens when blood lancets are used to obtain blood from more than one patient in health care settings. Certain bloodborne pathogens, such as HBV, are very stable at ambient temperatures and HBV infected patients, who often lack clinical symptoms of hepatitis, can have high concentrations of HBV in their blood or body fluids, thus serving as unsuspected sources of the infectious agent available for transmission to other patients when blood lancets are misused (Refs. 7 to 32).

These findings were discussed by the June 26, 2013, General and Plastic Surgery Devices Panel. The Panel agreed that the risks to health identified in this section are applicable to blood lancet devices, particularly the risk of cross-contamination between patients when the same lancet is used on multiple patients (Ref. 3).

After considering the information discussed by the Panel and in published literature, as well as medical device reports relating to blood lancets, and reported outbreaks of various bloodborne pathogen infections, FDA believes that the risks to health associated with the use of blood lancets are (1) bloodborne pathogen transmission, (2) sharp object injuries, (3) local tissue infections, and (4) adverse tissue reaction (not infection). The June 26, 2013, Panel also believed that these were the risks for the device (Ref. 3).

Bloodborne pathogens such as HBV, hepatitis C virus, and potentially any other pathogen present in the bloodstream of a patient can be transmitted from one patient to another by the following mechanisms:

• Reuse of the same lancet blade to draw blood from more than one patient or

• Failure/inability to adequately clean the base of a multiple use blood lancet resulting in the blood contamination of the next “new” lancet blade when blood is drawn from more than one patient.

The blade of a blood lancet device is designed to pierce the skin and draw blood. Except when the used lancet blade is immediately and automatically covered by a sharps safety feature, which renders the blade inaccessible, the exposed sharp blade of a blood lancet presents a puncture hazard to anyone coming in contact with it. Blade exposure can result due to either the lack of a sharps safety feature or device breakage.

Human skin always carries a population of bacteria and often fungi (normal skin flora), which causes no problem for the host when skin is intact. However, puncture injuries to the skin by sharp objects such as blood lancet blades can carry these microbes into the normally sterile tissue below the skin. Such injuries have the potential to cause local skin/soft tissue infections.

Tissue contact with some materials, metals, and material colorants can cause skin inflammation, irritation, or exanthems (rashes). These reactions may be due to either hypersensitivity to a specific compound/metal or to a non-specific reaction.

FDA believes that blood lancets for use on a single patient only should be reclassified into class II because special controls, in addition to general controls, can be established to provide reasonable assurance of safety and effectiveness of the device. FDA further believes that blood lancets for use on multiple patients should be reclassified into class III because multiple patient use blood lancets present a potential unreasonable risk of illness or injury and insufficient information exists for FDA to determine that special controls would provide reasonable assurance of safety and effectiveness of the device.

The June 26, 2013 reclassification Panel recommended that single patient blood lancets be reclassified into class II and multiple patient blood lancets into class III. The Panel did not believe that general controls alone were sufficient to ensure the safety and effectiveness of blood lancets. The Panel believed that special controls could be established to provide reasonable assurance of the safety and effectiveness of single use blood lancets, with and without integral sharps injury prevention features, and multiple use lancets for single patients, but that special controls could not be established to provide reasonable assurance of safety and effectiveness for multiple use lancets for multiple patients. Hence, the Panel agreed that blood lancets for use on a single patient only should be reclassified into class II (special controls), and multiple use lancets for multiple patients should be reclassified into class III (premarket approval).

FDA uses the bloodborne pathogens definition in 29 CFR 1910.1030(b). Bloodborne pathogens, such as HBV, may be transmitted between patients by blood and certain body fluids (Ref. 32). Since HBV-infected patients, who often lack clinical symptoms of hepatitis, have high concentrations of HBV in their blood and HBV is stable at ambient temperatures, transmission of HBV may result from exposure to equipment that has not been adequately disinfected or by the misuse of “single use only” medical devices (e.g., needles and syringes) (Ref. 33).

The history of recognized bloodborne pathogen transmission by blood lancets may have started in 1923 when an outbreak of jaundice occurred in the Goteborg Hospital diabetic clinic in Sweden, which was described by Schmid, et al. (Ref. 10). All patients had blood drawn for glucose testing from their ear lobes by a spring-activated “Schnepper” device, which was cleaned “perfunctorily” between uses. As a result, 26 clinic patients developed jaundice. Outbreaks of hepatitis in English diabetic patients were described by Graham in 1938 (Ref. 11) and by Droller in 1945 (Ref. 12). In both of these outbreaks, venous blood for glucose measurement was drawn using syringes that were only chemically disinfected between uses while the needles were boiled; cleaning procedures were not mentioned in the reports. Syringes and needles are now single-use-only devices because the procedures used to reprocess these devices many years ago have long been recognized to be inadequate, resulting in outbreaks of hepatitis transmission (Ref. 10). There were also two case reports, in 1985 and 1997, of the transmission of HBV infection due to sharing personal use blood lancets for home glucose monitoring with one other person who already had HBV. One report was from the United States and one was from Hungary (Refs. 13 and 14). In addition, Mendez et al. reported a 75-year-old patient with diabetes who died of acute hepatitis, whose only risk factor for HBV infection appeared to be her diabetic care at a local outpatient facility where she had repeated fingersticks for blood glucose monitoring (Ref. 15).

During the 1990s, several bloodborne pathogen transmission issues led to CDC and FDA involvement. In 1990, CDC learned of a nosocomial outbreak of HBV transmission due to the use of a spring-loaded lancet device whose disposable platform was not removed and discarded after each use of the device while it was used for the care of multiple patients (Ref. 4).1 CDC reported this outbreak to FDA; FDA then issued a safety alert warning users of the precautions needed for the safe use of this device (Ref. 5). This was the first reported outbreak of HBV transmission associated with the use of a blood lancet device in the United States (Refs. 5 and 7).

CDC's outbreak investigation revealed that a patient who had diabetes and also a chronic HBV infection caused by a relatively rare viral subtype was admitted to the outbreak ward in 1989. Twelve of the 23 patients who acquired HBV after admission to the same ward as the chronic HBV source patient were serotyped, and all were found to have the same viral subtype causing their HBV infections. The first nosocomially infected patient had a very long-term stay on the ward and so served as a source of transmission to other patients over a period of 12 months. Twenty of the 23 outbreak patients had diabetes; they and the three other case-patients all experienced numerous POC fingerstick blood draws with the same type of blood lancet while hospitalized on the outbreak ward. The implicated blood lancet device included a disposable platform to stabilize the patient's finger; the single use lancet blade penetrated a hole in that platform to reach the patient's skin. Half the ward nursing staff who performed fingersticks with this lancet acknowledged not changing the device platform with each use of the lancet. A similar outbreak of hepatitis transmission was reported in 1990 in France in which a similar blood lancet device was implicated. Douvin et al. (Ref. 8) reported that examination of the device implicated in the French outbreak showed visible blood contamination of the lancet platform in 24 percent of studied uses of that device. Shier et al. (Ref. 9) reported in 1993 that the use of another spring-loaded lancet device in a volunteer study of blood glucose levels resulted in visible blood contamination on 29 percent of the device end caps. This device was intended for “personal” use only.

As a result of the 1990 outbreak of HBV transmission due to blood lancet use in the United States, FDA and CDC recommended that spring-loaded blood lancet devices should have only single use only “platforms” as well as single use only blades; the devices were to be cleaned and disinfected per the manufacturer's instructions (Refs. 4 and 5). The 1990 FDA Safety Alert also advised “Devices [blood lancets] without a removable platform should only be used with one patient in the hospital or outpatient setting. After the patient is discharged, the device may be reused only if it is disinfected according to the manufacturer's instructions. If there are no instructions for disinfection, the device should be discarded.”

Since 1990, the incidence of diabetes mellitus has increased significantly in the United States, especially in adults aged 65-79 (Refs. 34 and 35). At the same time, clinical practice in the care of these patients increasingly emphasized the need for improved blood glucose level control, resulting in the increased use of POC blood glucose monitoring both in health care facilities and at home (Refs. 36 to 38). Unfortunately, along with the increased incidence of diabetes has come a progressive increase in the reports of bloodborne infection transmission (primarily HBV), resulting from the shared use of fingerstick and POC blood testing devices (Ref. 1). In 2011, the CDC reported that 25 of 29 outbreaks of HBV infection occurring in long-term care facilities since 1996 involved adults with diabetes receiving assisted blood glucose monitoring (Ref. 39).

In 1997, CDC reported two outbreaks of HBV transmission, one in a nursing home in Ohio and one in a hospital in New York City (NYC) (Ref. 16). Two different blood lancet devices were used at the two sites. However, both lancet devices included the use of an “end cap” that came in contact with patient skin. This was a separate, individual use component of the lancet device used in Ohio; the nursing home was reusing both the lancet and the cap for multiple patients. The end cap was a part of the disposable, single use only lancet blade assembly in the device used in NYC. The exact mechanism of blood transmission was not entirely clear in the NYC setting; staff claimed they had discarded the end cap after each use. CDC postulated that either blood-contaminated nurses gloves worn for the care of multiple patients or the pen-like lancet-holding device itself might have been the source of the blood cross-contamination of the lancet. A similar outbreak was reported by Quale et al. in 1998 from a hospital in New York (Ref. 17). The recognition of 3 cases of nosocomially acquired HBV infection resulted in an investigation that uncovered another 11 cases. Reuse by hospital staff of a disposable lancet end cap with the lancet in multiple patients was identified as the probable cause of hepatitis cross-transmission to patients; contamination of the lancet wound from blood on unchanged gloves worn by nurses during collection of blood samples from multiple patients may also have contributed to the nosocomial transmission of HBV in this outbreak.

CDC reviewed the incidence of reported outbreaks of HBV and hepatitis C infection in nonhospital health care settings between 1998 and 2008 and noted a significant increase in such nosocomial transmission of bloodborne pathogens (Refs. 18 to 21). N.D. Thompson et al. identified 33 outbreaks of nosocomial hepatitis transmission in nonhospital health care settings (Ref. 18). Of these 33 outbreaks, 15 were found to be due to blood glucose monitoring in long-term care facilities. Only half of these outbreak investigations were published in the scientific literature; the others were recognized by health department investigations and reports to CDC. In 9 of the 15 outbreaks of nosocomial hepatitis in patients with diabetes, blood lancet devices were shared among multiple patients. In two additional outbreaks, lancets were not noted to be shared, but blood-soiled glucose meters were stored together with lancets without cleaning/disinfection of the devices and gloves were not regularly changed between each patient. These failures of proper infection control practice could have led to blood contamination of individual blood lancets in these two facilities.

N.D. Thompson et al. also investigated blood glucose monitoring practices in long-term care facilities in Pinellas County, FL, in 2007 and found that 22 percent of the participating facilities that used reusable fingerstick devices used them in multiple patients (Ref. 22). Patel et al. reported in 2009 on the efforts of the Virginia Department of Health to improve blood glucose monitoring practices in ALFs in Virginia (Ref. 23). This effort followed two separate outbreaks of HBV infections in two ALFs. In those outbreaks, one of the three acutely symptomatic initial patients died of HBV infection. Of 68 patients undergoing blood glucose monitoring in these 2 facilities, a total of 11 patients acquired HBV infection. Both facilities used reusable blood lancets to obtain blood from multiple patients and did not clean or disinfect them between uses. The Virginia Department of Health then mailed an educational packet on safe blood glucose monitoring practices to all ALFs (640) in the State. A random sample of ALFs was contacted after the educational intervention and invited to participate in a survey to evaluate the response to the educational packet. The results found that 16 percent of the facilities that used lancets to monitor blood glucose levels were still using these devices to obtain blood from multiple patients.

Y.G. McIntosh et al. investigated outbreaks of nosocomial HBV transmission in four ALFs between 2009 and 2011 and found that in all four facilities, pen-style lancets were used to obtain blood for glucose monitoring from multiple patients even though two facilities provided each patient with dedicated “single patient use only pen-style lancets” according to their policies (Ref. 24). Z. Moore et al. reported another outbreak of nosocomial HBV transmission in an ALF in North Carolina in 2010 in which blood lancet devices were shared among multiple patients. Six of the eight elderly patients who acquired acute HBV in this outbreak died from complications of hepatitis (Ref. 25). M.K. Schaefer et al. surveyed a stratified, random sample of ambulatory surgery centers (ASCs) in three volunteer states in 2009 (Ref. 26). Of the 53 ASCs that performed blood glucose monitoring, 11 (21 percent) reused pen-style blood lancets on multiple patients and 17 (32 percent) also failed to clean and disinfect blood glucose meters after each use.

Thompson and Schaefer reported the analysis of four outbreaks of nosocomial HBV in ALFs in 2009-2010 (Ref. 27). One was also reported separately by Z. Moore et al. (Ref. 24). Two of the three other outbreaks occurred in Virginia and one in Florida; these 3 outbreaks resulted in 21 new patients acquiring acute HBV. In two of the three facilities, use of reusable blood lancets to draw blood from multiple patients was observed or reported. The third facility denied that it permitted the sharing of reusable lancets. However, used lancets and glucose meters were stored together, along with clean supplies; visible blood contamination was observed on several glucose meters and one reusable lancet by the investigator. Thompson and Schaefer also reported in their paper on two patient notification campaigns resulting from the misuse of reusable blood lancets with preloaded lancet cartridges, intended and cleared only for single patient use, which were used to obtain blood from multiple patients. One episode involved a community health center and was reported when personnel noted that the lancet blades were not retracting properly, which might have resulted in blade use for more than one patient. The second episode occurred at a community health fair in which physician assistant students were offering diabetes screening. During the fair, the students realized that the lancet blades had not been advanced properly so that each patient received a new blade. The first episode exposed 283 patients to a contaminated lancet blade; the second incident exposed approximately 60 patients. The results of the patient notification studies were not reported.

As a result of this significant increase in such nosocomial transmission of bloodborne pathogens, on August 26, 2010, FDA and the CDC issued a Safety Communication (Ref. 1) and a Clinical Reminder (Ref. 6), respectively, warning that the use of blood lancets to obtain blood from more than one patient risks the transmission of bloodborne pathogen infections from one patient to other patients. Both FDA and CDC recommended that blood lancets should never be used to obtain blood from more than one patient. In addition, the Centers for Medicare and Medicaid Services issued a Survey and Certification Memorandum for Point of Care Devices and Infection Control in Nursing Homes identifying the use of blood lancet devices for more than one patient as an infection control standards deficiency (Ref. 40). On November 29, 2010, FDA issued “Guidance for Industry and Food and Drug Administration Staff: Blood Lancet Labeling,” which provided guidance for lancet manufacturers on the labeling of all blood lancets, including those capable of reuse, as “single patient use only” devices (Ref. 2).

In 2012, another outbreak of acute HBV was reported in an ALF in Virginia (Ref. 28). The source patient had been recently transferred from another ALF where she had acquired nosocomial HBV infection from the shared use of blood lancets for multiple patients (Ref. 24). This ALF also reused blood lancets to obtain blood from multiple patients for glucose monitoring. This dangerous practice resulted in two new nosocomial HBV infections in this ALF.

Outbreaks of hepatitis transmission due to use of blood lancets to draw blood from more than one patient for blood glucose monitoring have not been limited to the United States. In 2001, Desenclos et al. described an outbreak of nosocomial hepatitis C transmission in an inpatient ward for children with cystic fibrosis and diabetes in a French hospital in 1994-1995 (Ref. 29). Blood glucose monitoring was done by the nursing staff for the patients with cystic fibrosis as well as for the patients with diabetes using a spring-loaded lancet with a disposable platform to stabilize the finger. These devices were shared among patients between 1986 and 1992 during repeated admissions to the inpatient unit. After 1992, patients were supposed to use only their own lancet devices for blood glucose monitoring. The retrospective prevalence of prior hepatitis C infection was found to be 58 percent in patients with cystic fibrosis and 17 percent in patients with diabetes in 1994. At the time (1994), the prevalence of antibody to hepatitis C in the general public in France was 1.1 percent. The patients with cystic fibrosis had more frequent and longer admissions to the inpatient ward and more of the exposed cystic fibrosis patients (66.7 percent) were screened for hepatitis C infection than were the patients with diabetes admitted to the inpatient ward during the exposure period (39.5 percent). These factors may have influenced the apparent difference in hepatitis C transmission in these two groups of exposed patients.

In 2005, De Schrijver et al. described an outbreak of acute HBV infection in a nursing home in Antwerp (Ref. 30). The initial report of a fulminant case of acute HBV infection in an 83-year-old resident of the home resulted in an investigation that identified acute HBV infection in another four patients there. Four of the five acutely infected patients had diabetes and received assisted blood glucose sampling by the nursing home staff. The two blood lancet models used in the facility (one each in two sections) were used to obtain blood from multiple patients. The device platforms were not disposable. The lancets were washed only when blood was visible on the device and they were not disinfected. Nurses did not routinely wash their hands or wear gloves when obtaining blood. Two of the five patients with acute nosocomial HBV died of their infections.

In 2008, Gotz et al. reported the investigation of two cases of acute HBV infection among patients at a nursing home in the Netherlands (Ref. 31). The nursing home stay of these two patients overlapped with that of a patient with known chronic HBV infection. Early in this time period, the nursing home changed the lancet device used for glucose monitoring from a spring-loaded device with a disposable platform (used for multiple patients) to a device with a rotating drum dispensing new lancet blades, which was also used to draw blood from multiple patients, although it was labeled for single patient use only. This device was used for about a month until the staff realized that active rotation of the drum was occasionally forgotten, resulting in the reuse of a lancet blade on more than one patient. The new device was then removed from the facility and the spring-loaded lancet was returned to use. The two patients with acute HBV received blood glucose monitoring as did the source patient with chronic HBV, sometimes on the same day. Two other patients who also received blood glucose monitoring escaped infection. The investigators stated that they believed the rotating lancet drum device was likely the means of transmission of HBV infection between patients.

In 2011, Duffell et al. reported on the investigations of five reports of HBV transmission in community health care settings in the United Kingdom (Ref. 32). All of the nine initially reported patients with HBV had diabetes and were receiving blood glucose monitoring. Further investigation identified another 12 patients with acute HBV infection. The care settings in which hepatitis transmission occurred were described as a “private residential home” (one patient), “nursing and residential home” (one patient), “private nursing and residential home” (one patient) and “local care home” (two patients). Eleven of the 21 acutely infected patients had symptomatic HBV; 7 of these patients died, 5 due to the HBV infection. All of the care sites in which acute HBV transmission occurred were using blood lancets intended for single patient use only; these devices were either routinely or occasionally used for multiple patients. One facility also used a single glucometer for multiple patients and did not clean or disinfect it between patients. The authors also noted that information reported on patients found to have acute HBV infection between 1990 and 2003 identified only four patients with blood glucose monitoring as a possible risk factor; one of these patients was infected as a result of in-hospital transmission from another patient on the same ward, although details were not provided. Between 2004 and 2006, the 9 patients described previously in this document were reported and investigation led to the discovery of an additional 12 cases of health care-related HBV transmission due to the improper use of blood lancets during patient blood glucose monitoring.

FDA believes that the special controls identified in the paragraphs that follow—in addition to general controls—are necessary to provide reasonable assurance of safety and effectiveness for this device when it is for single patient use only. Special controls were discussed at the June 26, 2013, reclassification Panel (Ref. 3). The Panel agreed that the special controls as presented would provide a reasonable assurance of safety and effectiveness for these devices, emphasizing in discussions the need for adequate labeling for these devices. FDA believes that the special controls proposed for single use only blood lancets with an integral sharps injury prevention feature in § 878.4850(a)(2), in addition to the general controls, mitigate the risks to health discussed in section V and are necessary to provide reasonable assurance of safety and effectiveness.

Table 1 depicts how each risk to health would be mitigated by the proposed special controls.

FDA believes that the special controls proposed for single use only blood lancets without an integral sharps injury prevention feature in proposed in § 878.4850(b)(2), in addition to the general controls, mitigate these risks to health discussed in section V and are necessary to provide reasonable assurance of safety and effectiveness.

Table 2 depicts how each risk to health would be mitigated by the proposed special controls.

The FD&C Act, as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513(d)(1) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as “preamendments devices”), are classified after FDA: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as “postamendments devices”), are classified automatically by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, FDA reclassifies the device into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).

A person may market a preamendments device that has been classified into class III through premarket notification procedures, and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1) of the FD&C Act directs FDA to issue an order requiring premarket approval for a preamendments class III device.

Section 515(f) of the FD&C Act provides an alternative pathway for meeting the premarket approval requirement. Under section 515(f), manufacturers may meet the premarket approval requirement if they file a notice of completion of a product development protocol (PDP) approved under section 515(f)(4) of the FD&C Act and FDA declares the PDP completed under section 515(f)(6)(B) of the FD&C Act. Accordingly, the manufacturer of a class III preamendments device may comply with a call for PMAs by filing a PMA or a notice of completion of a PDP. In practice, however, the option of filing a notice of completion of a PDP has rarely been used. For simplicity, although the PDP option remains available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for the filing and obtaining approval of a PMA.

On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(b) of FDASIA (126 Stat. 1056) amended section 515(b) of the FD&C Act, changing the process for requiring premarket approval for a preamendments class III device from rulemaking to an administrative order.

Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: Publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b) of the FD&C Act, and consideration of comments to a public docket.

In June 2013, FDA held a meeting of a device classification panel described in section 513(b) of the FD&C Act to discuss the classification of multiple use blood lancets for multiple patient use. Although, to FDA's knowledge, no device is currently being marketed for this use, one device has been cleared for this use. As explained further in section V.A of this document, this device classification panel meeting discussed whether multiple use blood lancets for multiple patient use should be reclassified into class III or remain in class I, and the discussion included whether PMAs should be required for these devices. The panel recommended that, because multiple use blood lancets for multiple patient use present a potential unreasonable risk of illness or injury and insufficient information exists to establish special controls for multiple use blood lancets for multiple patient use, the device should be reclassified into class III. FDA is not aware of new information that would provide a basis for a different recommendation or findings.

Section 515(b)(2) of the FD&C Act provides that a proposed order to require premarket approval shall contain: (1) The proposed order, (2) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved PMA and the benefit to the public from the use of the device, (3) an opportunity for the submission of comments on the proposed order and the proposed findings, and (4) an opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.

Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).

A preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act becomes effective, whichever is later (section 501(f) of the FD&C Act (21 U.S.C. 351(f)). Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order to reclassify multiple use blood lancets for multiple patient use from class I to class III. Therefore, assuming both the reclassification order and the order to require PMAs are finalized at the same time, the date by which a PMA for multiple use blood lancets for multiple patient use must be filed will be 30 months after the date FDA issues the final order reclassifying multiple use blood lancets for multiple patients. If a PMA is not filed for such device by the later of the two dates, as specified in section 501(f)(2)(B) of the FD&C Act, then the device would be deemed adulterated under section 501(f) of the FD&C Act unless the device is distributed for investigational use under an approved application for an investigational device exemption (IDE).

In accordance with section 515(b) of the FD&C Act, interested persons are being offered the opportunity to request reclassification of multiple use blood lancets for multiple patient use.

Elsewhere in this issue of the Federal Register, FDA is proposing to reclassify multiple use blood lancets for multiple patient use into class III under section 513(e) of the FD&C Act.

Blood lancets were classified in part 878 (21 CFR part 878) by a final rule published in the Federal Register on June 24, 1988 (53 FR 23856) that classified 51 general and plastic surgery devices. This 1988 rule classified blood lancets into class I (general controls). These devices were grouped with other devices under “Manual surgical instrument for general use,” 21 CFR 878.4800. At the time, blood lancets had been in common use in medical practice for many years, and FDA believed that general controls were sufficient to provide reasonable assurance of the safety and effectiveness of those devices. This rule was amended on April 5, 1989 (54 FR 13826) to clarify that manual surgical instruments for general use made of the same materials as used in preamendment devices were exempt from premarket notification 510(k) review.

On December 7, 1994, FDA further amended the classification when it published a final rule in the Federal Register (59 FR 63005) that exempted 148 class I devices from premarket notification, with limitations. Blood lancets were one of those devices. FDA determined that manufacturers' submissions of premarket notifications were unnecessary for the protection of the public health and that FDA's review of such submissions would not advance its public health mission.

On August 26, 2010, FDA and the Centers for Disease Control and Prevention (CDC) issued joint initial communications warning that the use of fingerstick devices (blood lancets) to obtain blood from more than one patient posed a risk of transmitting bloodborne pathogens. The communication was updated on November 29, 2010 (Ref. 1). FDA's communication update, “Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/29/2010”, stated that “[o]ver the past 10-15 years, the CDC and the FDA have noted a progressive increase in reports of bloodborne infection transmission (primarily hepatitis B virus) resulting from the shared use of fingerstick and POC [or ‘Point of Care’] blood testing devices.” FDA and CDC recommended, among other things, that health care professionals and patients never use a blood lancet for more than one person.

On November 29, 2010, FDA published a guidance entitled “Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling” (75 FR 73107) (Ref. 2). This guidance includes labeling recommendations to address concerns that both health care providers and patients may be unaware of the serious adverse health risks associated with using the same blood lancet for assisted withdrawal of blood from more than one patient, even when the blood lancet blade is changed for each blood draw. FDA recommends in the guidance that all blood lancets be labeled for use only on a single patient. FDA recommends in the guidance that a statement limiting use to a single patient should also appear on the label attached to the device, if possible. The guidance was for immediate implementation. When final, this order will supersede this labeling guidance.

On June 26, 2013, FDA held a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Panel) to discuss the potential reclassification of blood lancets (Ref. 3). The Panel discussed new scientific information, the risks to health from blood lancets, whether blood lancets should be reclassified or remain in class I, and possible special controls for these devices if reclassified into class II. The Panel agreed that general controls were not sufficient to provide a reasonable assurance of safety and effectiveness of blood lancets. The Panel believed that because multiple use blood lancets for multiple patient use presented a potential unreasonable risk of illness or injury, and insufficient information existed to establish special controls for these devices, they should be reclassified into class III. The Panel recommended that all other blood lancet devices be reclassified into class II (special controls). FDA is not aware of new information since this Panel meeting that would provide a basis for a different recommendation or finding.

Assuming FDA finalizes the order proposing reclassification of multiple use blood lancets for multiple patient use found elsewhere in this issue of the Federal Register, this device will be classified into class III. In accordance with sections 501(f)(2)(B) and 515(b) of the FD&C Act, FDA is proposing to require that a PMA be filed with the Agency for multiple use blood lancets for multiple patient use devices and accessories by the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective, or on the 90th day after the date of the issuance of a final order under 515(b), whichever is later. Assuming this order is finalized at or near the same time the final order to reclassify these devices into class III, this requirement will take effect 30 months after the reclassification order issues. An applicant whose device was legally in commercial distribution before May 28, 1976, or whose device has been found to be substantially equivalent to such a device, will be permitted to continue marketing such class III devices during FDA's review of the PMA provided that a PMA is timely filed. FDA intends to review any PMA for the device within 180 days. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “. . . the continued availability of the device is necessary for the public health.”

Under the FD&C Act, if any multiple use blood lancets for multiple patient use are currently in distribution and no PMA is submitted for these devices by the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective or within 90 days of a final order calling for PMAs, or a denial is rendered on a filed PMA, these devices would be considered adulterated under section 501(f)(1) of the FD&C Act. In addition, no new devices will be permitted in interstate commerce without approval of a PMA. The device may be distributed for investigational use only if the requirements of the IDE regulations are met. The requirements for significant risk devices include submitting an IDE application to FDA for review and approval. An approved IDE is required to be in effect before an investigation of the device may be initiated or continued under § 812.30 (21 CFR 812.30). FDA, therefore, recommends that IDE applications be submitted to FDA at least 30 days before the end of the 30-month period after the issuance of the final order to avoid interrupting any ongoing investigations.

FDA intends that under § 812.2(d), the publication in the Federal Register of any final order based on this proposal will include a statement that, as of the date on which the filing of a PMA is required, the exemptions in § 812.2(c)(1) and (2) from the requirements of the IDE regulations for preamendments class III devices will cease to apply to any device that is: (1) Not legally on the market on or before that date, or (2) legally on the market on or before that date but for which a PMA is not filed by that date, or for which PMA approval has been denied or withdrawn.

Elsewhere in this issue of the Federal Register, FDA is proposing to identify multiple use blood lancet for multiple patient use in a new 21 CFR 878.4850(d) in the following way: A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

As required by section 515(b) of the FD&C Act, FDA is publishing its proposed findings regarding: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that this device have an approved PMA, and (2) the benefits to the public from the use of the device.

These findings are based on the reports and recommendations of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Panel) from the meeting on June 26, 2013 (Ref. 3) and any additional information that FDA has obtained. Additional information regarding the risks as well as classification associated with this device type can be found in section V.C as well as in the proposed order published elsewhere in this issue of the Federal Register proposing to reclassify these devices into class III. The device has the potential to benefit the public by puncturing the skin to obtain small blood specimens for testing blood glucose, hemoglobin, and other blood components. In addition, acute care hospitals may consider reusing a single device or using one device with multiple blades to have benefits in that doing so may expedite procedures. The risks associated with the device include bloodborne pathogen transmission, sharp object injuries, local tissue infections, and adverse tissue reaction (not infection).

FDA uses the bloodborne pathogens definition in 29 CFR 1910.1030(b). Bloodborne pathogens, such as HBV, may be transmitted between patients by blood and certain body fluids (Ref. 4). Since HBV-infected patients, who often lack clinical symptoms of hepatitis, have high concentrations of HBV in their blood and HBV is stable at ambient temperatures, transmission of HBV may result from exposure to equipment that has not been adequately disinfected or by the misuse of “single use only” medical devices (e.g., needles and syringes) (Ref. 5).

The history of recognized bloodborne pathogen transmission by blood lancets may have started in 1923 when an outbreak of jaundice occurred in the Goteborg Hospital diabetic clinic in Sweden, which was described by Schmid et al. (Ref. 6). All patients had blood drawn for glucose testing from their ear lobes by a spring-activated “Schnepper” device, which was cleaned “perfunctorily” between uses. As a result, 26 clinic patients developed jaundice. Outbreaks of hepatitis in English diabetic patients were described by Graham in 1938 (Ref. 7) and by Droller in 1945 (Ref. 8). In both of these outbreaks, venous blood for glucose measurement was drawn using syringes that were only chemically disinfected between uses while the needles were boiled; cleaning procedures were not mentioned in the reports. Syringes and needles are now single-use-only devices because the procedures used to reprocess these devices many years ago have long been recognized to be inadequate, resulting in outbreaks of hepatitis transmission (Ref. 6). There were also two case reports, in 1985 and 1997, of the transmission of HBV infection due to sharing personal use blood lancets for home glucose monitoring with one other person who already had HBV. One report was from the United States and one was from Hungary (Refs. 9 and 10). In addition, Mendez et al. reported a 75-year-old patient with diabetes who died of acute hepatitis, whose only risk factor for HBV infection appeared to be her diabetic care at a local outpatient facility where she had repeated fingersticks for blood glucose monitoring (Ref. 11).

During the 1990s, several bloodborne transmission issues led to CDC and FDA involvement. In 1990, CDC learned of a nosocomial outbreak of HBV transmission due to the use of a spring-loaded lancet device whose disposable platform was not removed and discarded after each use of the device while it was used for the care of multiple patients (Ref. 12).1 CDC reported this outbreak to FDA; FDA then issued a safety alert warning users of the precautions needed for the safe use of this device (Ref. 13). This was the first reported outbreak of HBV transmission associated with the use of a blood lancet device in the United States (Refs. 13 and 14).

CDC's outbreak investigation revealed that a patient who had diabetes and also a chronic HBV infection caused by a relatively rare viral subtype was admitted to the outbreak ward in 1989. Twelve of the 23 patients who acquired hepatitis B after admission to the same ward as the chronic HBV source patient were serotyped, and all were found to have the same viral subtype causing their hepatitis B infections. The first nosocomially infected patient had a very long-term stay on the ward and so served as a source of transmission to other patients over a period of 12 months. Twenty of the 23 outbreak patients had diabetes; they and the three other case-patients all experienced numerous POC fingerstick blood draws with the same type of blood lancet while hospitalized on the outbreak ward. The implicated blood lancet device included a disposable platform to stabilize the patient's finger; the single use lancet blade penetrated a hole in that platform to reach the patient's skin. Half the ward nursing staff who performed fingersticks with this lancet acknowledged not changing the device platform with each use of the lancet. A similar outbreak of hepatitis transmission was reported in 1990 in France in which a similar blood lancet device was implicated. Douvin et al. (Ref. 15) reported that examination of the device implicated in the French outbreak showed visible blood contamination of the lancet platform in 24 percent of studied uses of that device. Shier et al. (Ref. 16) reported in 1993 that the use of another spring-loaded lancet device in a volunteer study of blood glucose levels resulted in visible blood contamination on 29 percent of the device end caps. This device was intended for “personal” use only.

As a result of the 1990 outbreak of HBV transmission due to blood lancet use in the United States, FDA and CDC recommended that spring-loaded blood lancet devices should have only single use only “platforms” as well as single use only blades; the devices were to be cleaned and disinfected per the manufacturer's instructions (Refs. 12 and 13). The 1990 FDA Safety Alert also advised “Devices (blood lancets) without a removable platform should only be used with one patient in the hospital or outpatient setting. After the patient is discharged, the device may be reused only if it is disinfected according to the manufacturer's instructions. If there are no instructions for disinfection, the device should be discarded.”

Since 1990, the incidence of diabetes mellitus has increased significantly in the United States, especially in adults aged 65-79 (Refs. 17 and 18). At the same time, clinical practice in the care of these patients increasingly emphasized the need for improved blood glucose level control, resulting in the increased use of POC blood glucose monitoring both in health care facilities and at home (Refs. 19-21). Unfortunately, along with the increased incidence of diabetes has come a progressive increase in the reports of bloodborne infection transmission (primarily HBV), resulting from the shared use of fingerstick and POC blood testing devices (Ref. 1). In 2011, the CDC reported that 25 of 29 outbreaks of HBV infection occurring in long-term care facilities since 1996 involved adults with diabetes receiving blood glucose monitoring (Ref. 22).

In 1997, CDC reported two outbreaks of HBV transmission, one in a nursing home in Ohio and one in a hospital in New York City (NYC) (Ref. 23). Two different blood lancet devices were used at the two sites. However, both lancet devices included the use of an “end cap” that came in contact with patient skin. This was a separate, individual use component of the lancet device used in Ohio; the nursing home was reusing both the lancet and the cap for multiple patients. The end cap was a part of the disposable, single use only lancet blade assembly in the device used in NYC. The exact mechanism of blood transmission was not entirely clear in the NYC setting; staff claimed they had discarded the end cap after each use. CDC postulated that either blood-contaminated nurses gloves worn for the care of multiple patients or the pen-like lancet-holding device itself might have been the source of the blood cross-contamination of the lancet. A similar outbreak was reported by Quale et al. in 1998 from a hospital in New York (Ref. 24). The recognition of 3 cases of nosocomially acquired HBV infection resulted in an investigation that uncovered another 11 cases. Reuse by hospital staff of a disposable lancet end cap with the lancet in multiple patients was identified as the probable cause of hepatitis cross-transmission to patients; contamination of the lancet wound from blood on unchanged gloves worn by nurses during collection of blood samples from multiple patients may also have contributed to the nosocomial transmission of HBV in this outbreak.

CDC reviewed the incidence of reported outbreaks of HBV and hepatitis C infection in nonhospital health care settings between 1998 and 2008 and noted a significant increase in such nosocomial transmission of bloodborne pathogens (Refs. 25-28). N.D. Thompson et al. identified 33 outbreaks of nosocomial hepatitis transmission in nonhospital health care settings (Ref. 25). Of these 33 outbreaks, 15 were found to be due to blood glucose monitoring in long-term care and assisted living facilities. Only half of these outbreak investigations were published in the scientific literature; the others were recognized by health department investigations and reports to CDC. In 9 of the 15 outbreaks of nosocomial hepatitis in patients with diabetes, blood lancet devices were shared among multiple patients. In two additional outbreaks, lancets were not noted to be shared, but blood-soiled glucose meters were stored together with lancets without cleaning/disinfection of the devices and gloves were not regularly changed between each patient. These failures of proper infection control practice could have led to blood contamination of individual blood lancets in these two facilities.

N.D. Thompson et al. also investigated blood glucose monitoring practices in long-term care facilities in Pinellas County, Florida, in 2007 and found that 22 percent of the participating facilities that used reusable fingerstick devices used them in multiple patients (Ref. 29). Patel et al. reported in 2009 on the efforts of the Virginia Department of Health to improve blood glucose monitoring practices in assisted living facilities (ALFs) in Virginia (Ref. 30). This effort followed two separate outbreaks of HBV infections in two assisted living facilities. In those outbreaks, one of the three acutely symptomatic initial patients died of HBV infection. Of 68 patients undergoing blood glucose monitoring in these two facilities, a total of 11 patients acquired HBV infection. Both facilities used reusable blood lancets to obtain blood from multiple patients and did not clean or disinfect the lancets between uses. The Virginia Department of Health then mailed an educational packet on safe blood glucose monitoring practices to all ALFs (640) in the State. A random sample of ALFs was contacted after the educational intervention and invited to participate in a survey to evaluate the response to the educational packet. The results found that 16 percent of the facilities that used lancets to monitor blood glucose levels were still using these devices to obtain blood from multiple patients.

Y.G. McIntosh et al. investigated outbreaks of nosocomial HBV transmission in four ALFs between 2009 and 2011 and found that in all four facilities, pen-style lancets were used to obtain blood for glucose monitoring from multiple patients even though two facilities provided each patient with dedicated “single patient use only pen-style lancets” according to their policies (Ref. 31). Z. Moore et al. reported another outbreak of nosocomial HBV transmission in an ALF in NC in 2010 in which blood lancet devices were shared among multiple patients. Six of the eight elderly patients who acquired acute HBV in this outbreak died from complications of hepatitis (Ref. 32). M.K. Schaefer et al. surveyed a stratified, random sample of ambulatory surgery centers (ACS) in three volunteer states in 2009 (Ref. 33). Of the 53 ACS that performed blood glucose monitoring, 11 (21 percent) reused pen-style blood lancets on multiple patients and 17 (32 percent) also failed to clean and disinfect blood glucose meters after each use.

Thompson and Schaefer reported the analysis of four outbreaks of nosocomial HBV in ALFs in 2009-2010 (Ref. 34). One was also reported separately by Z. Moore et al. (Ref. 32). Two of the three other outbreaks occurred in Virginia and one in Florida; these 3 outbreaks resulted in 21 new patients acquiring acute hepatitis B. In two of the three facilities, use of reusable blood lancets to draw blood from multiple patients was observed or reported. The third facility denied that it permitted the sharing of reusable lancets. However, used lancets and glucose meters were stored together, along with clean supplies; visible blood contamination was observed on several glucose meters and one reusable lancet by the investigator. Thompson and Schaefer also reported in their paper on two patient notification campaigns resulting from the misuse of reusable blood lancets with preloaded lancet cartridges, intended and cleared only for single patient use, which were used to obtain blood from multiple patients. One episode involved a community health center and was reported when personnel noted that the lancet blades were not retracting properly, which might have resulted in blade use for more than one patient. The second episode occurred at a community health fair in which physician assistant students were offering diabetes screening. During the fair, the students realized that the lancet blades had not been advanced properly so that each patient received a new blade. The first episode exposed 283 patients to a contaminated lancet blade; the second incident exposed approximately 60 patients. The results of the patient notification studies were not reported.

As a result of this significant increase in such nosocomial transmission of bloodborne pathogens, on August 26, 2010, FDA and the CDC issued a Safety Communication (Ref. 1) and a Clinical Reminder (Ref. 35), respectively, warning that the use of blood lancets to obtain blood from more than one patient risks the transmission of bloodborne pathogen infections from one patient to other patients. Both FDA and CDC recommended that blood lancets should never be used to obtain blood from more than one patient. In addition, the Centers for Medicare and Medicaid Services issued a Survey and Certification Memorandum for Point of Care Devices and Infection Control in Nursing Homes identifying the use of blood lancet devices for more than one patient as an infection control standards deficiency (Ref. 36). On November 29, 2010, FDA issued “Guidance for Industry and Food and Drug Administration Staff: Blood Lancet Labeling”, which provided guidance for lancet manufacturers on the labeling of all blood lancets, including those capable of reuse, as “single patient use only” devices (Ref. 2).

In 2012, another outbreak of acute HBV was reported in an ALF in Virginia (Ref. 37). The source patient had been recently transferred from another ALF where she had acquired nosocomial HBV infection from the shared use of blood lancets for multiple patients (Ref. 31). This ALF also reused blood lancets to obtain blood from multiple patients for glucose monitoring. This dangerous practice resulted in two new nosocomial HBV infections in this ALF.

Outbreaks of hepatitis transmission due to use of blood lancets to draw blood from more than one patient for blood glucose monitoring have not been limited to the United States. In 2001, Desenclos et al. described an outbreak of nosocomial hepatitis C transmission in an inpatient ward for children with cystic fibrosis and diabetes in a French hospital in 1994-1995 (Ref. 38). Blood glucose monitoring was done by the nursing staff for the patients with cystic fibrosis as well as for the patients with diabetes using a spring-loaded lancet with a disposable platform to stabilize the finger. These devices were shared among patients between 1986 and 1992 during repeated admissions to the inpatient unit. After 1992, patients were supposed to use only their own lancet devices for blood glucose monitoring. The retrospective prevalence of prior hepatitis C infection was found to be 58 percent in patients with cystic fibrosis and 17 percent in patients with diabetes in 1994. At the time (1994), the prevalence of antibody to hepatitis C in the general public in France was 1.1 percent. The patients with cystic fibrosis had more frequent and longer admissions to the inpatient ward, and more of the exposed cystic fibrosis patients (66.7 percent) were screened for hepatitis C infection than were the patients with diabetes admitted to the inpatient ward during the exposure period (39.5 percent). These factors may have influenced the apparent difference in hepatitis C transmission in these two groups of exposed patients.

In 2005, De Schrijver et al. described an outbreak of acute HBV infection in a nursing home in Antwerp (Ref. 39). The initial report of a fulminant case of acute HBV infection in an 83-year-old resident of the home resulted in an investigation that identified acute hepatitis B infection in another four patients there. Four of the five acutely infected patients had diabetes and received assisted blood glucose sampling by the nursing home staff. The two blood lancet models used in the facility (one each in two sections) were used to obtain blood from multiple patients. The device platforms were not disposable. The lancets were washed only when blood was visible on the device and were not disinfected. Nurses did not routinely wash their hands or wear gloves when obtaining blood. Two of the five patients with acute nosocomial hepatitis B died of their infections.

In 2008, Gotz et al. reported the investigation of two cases of acute HBV infection among patients at a nursing home in the Netherlands (Ref. 40). The nursing home stay of these two patients overlapped with that of a patient with known chronic HBV infection. Early in this time period, the nursing home changed the lancet device used for glucose monitoring from a spring-loaded device with a disposable platform (used for multiple patients) to a device with a rotating drum dispensing new lancet blades, which was also used to draw blood from multiple patients, although it was labeled for single patient use only. This device was used for about a month until the staff realized that active rotation of the drum was occasionally forgotten, resulting in the reuse of a lancet blade on more than 1 patient. The new device was then removed from the facility and the spring-loaded lancet was returned to use. The two patients with acute HBV received blood glucose monitoring as did the source patient with chronic HBV, sometimes on the same day. Two other patients who also received blood glucose monitoring escaped infection. The investigators stated that they believed the rotating lancet drum device was likely the means of transmission of HBV infection between patients.

In 2011, Duffell et al. reported on the investigations of five reports of HBV transmission in community health care settings in the United Kingdom (Ref. 4). All of the nine initially reported patients with HBV had diabetes and were receiving blood glucose monitoring. Further investigation identified another 12 patients with acute HBV infection. The care settings in which hepatitis transmission occurred were described as a “private residential home” (1 patient), nursing and residential home (1 patient), “private nursing and residential” (1 patient) and “local care home” (2 patients). Eleven of the 21 acutely infected patients had symptomatic HBV; seven of these patients died, five due to the HBV infection. All of the care sites in which acute HBV transmission occurred were using blood lancets designed intended for single patient use only; these devices were either routinely or occasionally used for multiple patients. One facility also used a single glucometer for multiple patients and did not clean or disinfect it between patients. The authors also noted that information reported on patients found to have acute HBV infection between 1990 and 2003 identified only four patients with blood glucose monitoring as a possible risk factor; one of these patients was infected as a result of in-hospital transmission from another patient on the same ward, although details were not provided. Between 2004 and 2006, the 9 patients described previously in this document were reported and investigation led to the discovery of an additional 12 cases of health care-related HBV transmission due to the improper use of blood lancets during patient blood glucose monitoring.

A blood lancet is used to puncture the skin to obtain small blood specimens for testing blood glucose, hemoglobin, and other blood components. Some blood lancets are used with POC blood testing devices, such as blood glucose meters and Prothrombin Time and International Normalized Ratio (PT/INR) anticoagulation meters. Today, probably the most common use for a blood lancet is in diabetes monitoring. These devices are used in both home and professional health care settings. Only a small blood sample is needed for testing of blood glucose level. The blood sample is dropped onto a test strip and inserted into a blood glucose meter for results.

Some blood lancets are also used with PT/INR anticoagulation meters. These devices are used in both home and professional health care settings. The PT and INR are used to monitor the effectiveness of the anticoagulant warfarin. Warfarin helps inhibit the formation of blood clots. The formation of blood clots may be associated with atrial fibrillation, the presence of artificial heart valves, deep venous thrombosis, and some cases of pulmonary embolism. Because the use of warfarin may cause excessive bleeding, patients are monitored, typically by PT/INR.

Because newborns have relatively small amounts of blood compared to adults, it is usually preferred to use as small amount of blood as possible for any screening or other laboratory tests for newborns. Blood lancets may be used to perform heel sticks in newborns. Heel stick is a minimally invasive way of obtaining capillary blood samples. In newborns, heel sticks are the preferred collection method for small volumes of blood.

The possible benefit of multiple use blood lancets for multiple patient use is that acute care hospitals may consider reusing a single device or using one device with multiple blades to have benefits, in that doing so may expedite procedures.

FDA has evaluated the risks to health associated with use of multiple use blood lancets for multiple patient use. In doing so, FDA considered information from the reports and recommendations of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee from the meeting of June 26, 2013, the adverse event reports for these devices in FDA's Manufacturer and User Facility Device Experience (MAUDE) database, and the published scientific literature, which is discussed in FDA's executive summary for the June 26, 2013, panel. Based on this information, FDA has determined the following risks:

Bloodborne pathogens such as HBV, hepatitis C virus, and potentially any other pathogen present in the bloodstream of a patient can be transmitted from one patient to another by the following mechanisms:

• Reuse of the same lancet blade to draw blood from more than one patient or

• Failure/inability to adequately clean the base of a multiple use blood lancet resulting in the blood contamination of the next “new” lancet blade when blood is drawn from more than one patient.

The blade of a lancet device is designed to pierce the skin and draw blood. Except when the used lancet blade is immediately and automatically covered by a sharps safety feature, which renders the blade inaccessible, the exposed sharp blade of a blood lancet presents a puncture hazard to anyone coming in contact with it. Blade exposure can result due to either the lack of a sharps safety feature or device breakage.

Human skin always carries a population of bacteria and often fungi (normal skin flora), which causes no problem for the host when skin is intact. However, puncture injuries to the skin by sharp objects such as lancet blades can carry these microbes into the normally sterile tissue below the skin. Such injuries have the potential to cause local skin/soft tissue infections.

Skin contact with some materials, metals and material colorants can cause skin inflammation, irritation or exanthems (rashes). These reactions may be due to either hypersensitivity to a specific compound/metal or to a non-specific reaction.

FDA believes multiple use blood lancets for multiple patient use should be reclassified from class I to class III. The Panel held on June 26, 2013, discussed and made recommendations regarding the regulatory classification of blood lancets to reclassify multiple use blood lancets for multiple patient use to class III under 513(e) of the FD&C Act. The Panel strongly agreed with FDA that based on the available scientific evidence, multiple use blood lancets for multiple patient use should be reclassified to class III because multiple use blood lancets for multiple patient use present a potential unreasonable risk of illness or injury. They also agreed that insufficient information exists to establish special controls for multiple use blood lancets for multiple patient use, because there is no evidence that these devices can be adequately cleaned and disinfected and that there is no proven method of doing so. Therefore, it is appropriate to regulate them in class III.

FDA agrees with the Panel's recommendation that these devices present a potential unreasonable risk of illness or injury due to the inherent and significantly increased risk of bloodborne pathogen transmission risk as compared to single use only or single patient only blood lancets. FDA does not believe existing valid scientific evidence, as defined in § 860.7 (21 CFR 860.7), supports a reasonable assurance that the device can be adequately reprocessed between uses on different patients. FDA also believes sufficient information does not exist to establish special controls for blood lancets intended for multiple patient use. Given the availability of safer single patient use blood lancet devices, FDA further believes that the probable benefits to health from use of the device do not outweigh the probable risks. Currently FDA is unaware of technology or other controls that would adequately mitigate against the inherent and significantly increased risk of blood borne pathogen transmission in multiple use blood lancets for use in multiple patients. Therefore, the safety and effectiveness of the multiple use blood lancets for multiple patients, particularly the effectiveness of their reprocessing instructions/methods to render the device safe for use on more than one patient and the ability of health care providers to follow these instructions completely should be independently demonstrated for each device of this type via a PMA application. FDA is proposing to require an individual demonstration that a reasonable assurance of safety and effectiveness exists for each device within this type. The manufacturer of each individual device will have the opportunity to demonstrate the safety and effectiveness of the device for its intended use by submitting a PMA.

A PMA for this device must include the information required by section 515(c)(1) of the FD&C Act. Such a PMA should also include a detailed discussion of the risks identified previously in this document, as well as a discussion of the effectiveness of the device for which premarket approval is sought. In addition, a PMA must include all data and information on: (1) Any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.

A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use (§ 860.7(c)(2)). FDA defines valid scientific evidence in § 860.7(c)(2)).

To present reasonable assurance of safety and effectiveness of multiple use blood lancets for multiple patient use, FDA believes manufacturers should submit performance testing, including clinical trials of their device, in order to support PMA approval. Existing published clinical literature may also be leveraged as part of the PMA submission.

Before requiring the filing of a PMA, FDA is required by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for interested persons to request a change in the classification of the device based on new information relevant to the classification. Any proceeding to reclassify the device will be under the authority of section 513(e) of the FD&C Act.

A request for a change in the classification of this device is to be in the form of a reclassification petition containing the information required by 21 CFR 860.123, including new information relevant to the classification of the device.

We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This proposed order refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814, subparts B and E, have been approved under OMB control number 0910-0231. The collections of information in part 807, subpart E, have been approved under OMB control number 0910-0120. The collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.

FDA is proposing that any final order based on this proposal become effective on the date of its publication in the Federal Register or at a later date if stated in the final order.

Prior to the amendments by FDASIA, section 515(b) of the FD&C Act provided for FDA to issue regulations to require approval of an application for premarket approval for preamendments devices or devices found substantially equivalent to preamendments devices. Section 515(b) of the FD&C Act, as amended by FDASIA, provides for FDA to require approval of an application for premarket approval for such devices by issuing a final order, following the issuance of a proposed order in the Federal Register. FDA will continue to codify the requirement for an application for premarket approval, resulting from changes issued in a final order, in the Code of Federal Regulations (CFR). Therefore, under section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in the proposed order, we are proposing to require approval of an application for premarket approval for multiple use blood lancets for multiple patient use and, if this proposed order is finalized, we will make the language in 21 CFR 878.4850(d) consistent with the final version of this proposed order.

The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 878, as proposed to be amended elsewhere in this issue of the Federal Register, be further amended as follows:

Temporary regulations in the Rules and Regulations section of this issue of the Federal Register amend 26 CFR part 1. The temporary regulations provide a special rule for a renewable-source utility arrangement in which the building owner does not pay a local utility company for the utility consumed by the tenant. The text of those regulations also serves as the text of these regulations. The preamble to the temporary regulations explains the temporary regulations and these proposed regulations.

Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to this regulation, and because the regulation does not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Internal Revenue Code, this notice of proposed rulemaking has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

Before these proposed regulations are adopted as final regulations, consideration will be given to any written comments (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS as prescribed in this preamble under the “ADDRESSES” heading. The IRS and the Treasury Department request comments on all aspects of the proposed regulations. All comments that are submitted by the public will be available for public inspection and copying at www.regulations.gov or upon request. A public hearing will be scheduled if requested in writing by any person that timely submits comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the Federal Register.

The principal author of these regulations is David Selig, Office of the Associate Chief Counsel (Passthroughs and Special Industries), IRS. However, other personnel from the IRS and the Treasury Department participated in their development.

Accordingly, 26 CFR part 1 is proposed to be amended as follows:

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

On February 8, 2016, Set Up Events notified the Coast Guard that it will be sponsoring the Xterra Myrtle Beach Swim from 7:15 a.m. to 9:15 a.m. on April 24, 2016. The legal basis for the proposed rule is the Coast Guard's Authority to establish a safety zone: 33 CFR part 165. The purpose of the proposed rule is to ensure safety of life on the navigable water of the United States during the swim portion of the Xterra Myrtle Beach Triathlon.

The Coast Guard proposes to establish a temporary safety zone on the Atlantic Intracoastal Waterway in Myrtle Beach, South Carolina during the Xterra Myrtle Beach Triathlon, on April 24, 2016. Approximately 75 swimmers are anticipated to participate in the race. Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the safety zone by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

We developed this proposed rule after considering numerous statutes and Executive Orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and executive orders.

E.O.s 12866 (“Regulatory Planing and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O.13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This proposed rule is not a significant regulatory action under section 3(f) of E.O. 12866, as supplemented by E.O. 13563, and does not require an assessment of potential costs and benefits under section 6(a)(3) of E.O. 12866. The Office of Management and Budget (OMB) has not reviewed it under E.O. 12866.

The economic impact of this proposed rule is not significant for the following reasons: (1) The temporary safety zone would be enforced for only two hours; (2) although persons and vessels would not be able to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port Charleston or a designated representative, they would be able to operate in the surrounding area during the enforcement periods; (3) persons and vessels would still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the Captain of the Port Charleston or a designated representative; and (4) the Coast Guard would provide advance notification of the regulated area to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

This rule may affect the following entities, some of which may be small entities: The owner or operators of vessels intending to enter, transit through, anchor in, or remain within the regulated area during the enforcement period. However, for the reasons discussed in Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult Lieutenant John Downing using the contact information given in FOR FURTHER INFORMATION CONTACT. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This proposed rule would not cause a taking of private property or otherwise have taking implications under E.O. 12630 (“Governmental Actions and Interference with Constitutionally Protected Property Rights”).

This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, (“Civil Justice Reform”), to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this proposed rule under E.O. 13045 (“Protection of Children from Environmental Health Risks and Safety Risks”). This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

This proposed rule does not have tribal implications under E.O. 13175 (“Consultation and Coordination with Indian Tribal Governments”), because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this proposed rule under E.O. 13211 (“Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under E.O. 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

The National Technology Transfer and Advancement Act, codified as a note to 15 U.S.C. 272, directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a temporary safety zone issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:

The Semipostal Authorization Act, Pub. L. 106-253, grants the Postal Service discretionary authority to issue and sell semipostal stamps to advance such causes as it considers to be “in the national public interest and appropriate.” See 39 U.S.C. 416(b). On June 12, 2001, the Postal Service published a final rule establishing the regulations in 39 CFR part 551 for the discretionary Semipostal Stamp Program (66 FR 31826). Minor revisions were made to these regulations to implement Pub. L. 107-67, 115 Stat. 514 (2001), and to reflect minor organizational changes in the Postal Service (67 FR 5215 (February 5, 2002)). On February 19, 2004, the Postal Service published a final rule clarifying the cost-offset policy for semipostal stamps (69 FR 7688), and on February 9, 2005, the Postal Service also published an additional minor clarifying revision to these cost-offset regulations (70 FR 6764).

Most recently, on January 22, 2016, the Postal Service published a proposed amendment to 39 CFR 551.5 to remove certain restrictions on the commencement date for the discretionary Semipostal Stamp Program, and clarify how many semipostal stamps issued under that program may be on sale at any one time (81 FR 3762).

Upon further consideration, however, it was determined that a further revision of the rules concerning the discretionary Semipostal Stamp Program was necessary to facilitate its smooth and efficient operation. Accordingly, the Postal Service now proposes and invites comments upon a more detailed revision of 39 CFR part 551. This proposal supersedes (but incorporates) the amendments previously published on January 22, 2016. The proposed changes are summarized below.

The proposed revision of § 551.3 streamlines and simplifies the selection process for the causes to receive funds raised through the sale of semipostal stamps, and states the Postal Service's intention to issue five such stamps over the statutory ten-year period. It also notifies the public that no further consideration will be given to previously submitted proposals but that such proposals may be resubmitted under the revised regulations. The paragraph relating to proposals regarding the same subject and proposals for the sharing of funds between two agencies is edited for clarity and moved to § 551.4, concerning submission requirements and criteria, where it more appropriately belongs.

The proposed revision of § 551.4 sharpens the submission requirements and, among other things, makes Postal Service employees ineligible to submit proposals for semipostal stamps.

The proposed revision of § 551.5(a) would remove certain restrictions on the commencement date of the discretionary Semipostal Stamp Program. Under current regulations, the 10-year period for the discretionary semipostal stamp program commences on a date determined by the Office of Stamp Services, but that date must be after the sales period of the Breast Cancer Research stamp (BCRS) is concluded. Most recently, Public Law 114-99 (December 11, 2015) extended that sales period to December 31, 2019. Under the proposed revision, the 10-year period will commence on a date determined by the Office of Stamp Services, but the date need not be after the BCRS sale period concludes.

The proposed revision of § 551.5(b) would clarify that although only one semipostal stamp under the discretionary Semipostal Stamp Program under 39 U.S.C. 416 (a “discretionary program semipostal stamp”) will be offered for sale at any one time, other semipostal stamps required to be issued by Congress (such as the BCRS) may be on sale when a discretionary program semipostal stamp is on sale. Current regulations state that the Postal Service will offer only one semipostal stamp for sale at any given time during the 10-year period (not specifying whether it is a discretionary program semipostal stamp or a semipostal stamp required by Congress). Under the proposed revision, the one-at-a-time limitation on the sale of semipostal stamps would apply only to discretionary program semipostal stamps.

To minimize confusion regarding applicable postage rates, the proposed revision of § 551.6 specifies that for purposes of calculating the price of a semipostal, the First-Class Mail® single-piece stamped first-ounce rate of postage will be considered “the rate of postage that would otherwise regularly apply.”

In accordance with 39 U.S.C. 416(e)(2), the Postal Service invites public comment on the following proposed amendments to the Code of Federal Regulations. For the reasons stated in the preamble, the Postal Service proposes to revise 39 CFR part 551 as follows:

The Gulf reef fish fishery, which includes gag and black grouper, is managed under the FMP. The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

The Magnuson-Stevens Act requires NMFS and regional fishery management councils to achieve on a continuing basis the optimum yield from federally managed fish stocks. This mandate is intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, while also protecting marine ecosystems.

The 2014 Southeast Data, Assessment and Review (SEDAR 33) benchmark stock assessment indicates that the Gulf gag stock is not overfished or undergoing overfishing as of 2012, the last year of data used in SEDAR 33. However, as described in the framework action, the Council's Reef Fish Advisory Panel, the Council's Science and Statistical Committee (SSC), and public testimony, all suggested that the Council use caution when setting the gag annual catch limits (ACL) and annual catch targets (ACT). Therefore, the Council decided not to modify the Gulf gag ACL or ACT in this framework action.

Additionally, the 2010 SEDAR 19 benchmark assessment for black grouper found that the Gulf black grouper stock was neither overfished nor undergoing overfishing.

This rule would revise the recreational closed season for gag and the recreational minimum size limits for gag and black grouper in the Gulf.

The current closed season for the gag recreational sector is January 1 through June 30 and December 3 through December 31, annually. This closed season was established in Amendment 32 to the FMP to help prevent the gag recreational ACL from being exceeded (77 FR 6988, February 10, 2012).

This rule would revise the gag recreational closed season to be from January 1 to May 31, annually. The intent of this revised closed season would be to reduce the amount of dead discards of gag that occur during the Gulf's recreational season for red snapper that begins on June 1, annually, and to extend the gag recreational fishing season beyond the current December closure date to provide the opportunity for the recreational sector to harvest the recreational ACL. The gag recreational ACT was only exceeded once, and the recreational ACL has never been exceeded since ACLs and ACTs were established for gag in 2011.

The current gag and black grouper recreational minimum size limits in Gulf Federal waters are both set at 22 inches (55.9 cm), total length (TL). The current gag and black grouper minimum size limit in South Atlantic Federal waters is 24 inches (61.0 cm), TL for both species and for both the commercial and recreational sectors. For the state of Florida, in state waters off Monroe County in the Gulf, the recreational minimum size limit for gag and black grouper is 24 inches (61.0 cm), TL. This proposed rule would increase the recreational minimum size limit for both species to 24 inches (61.0 cm), TL, to be consistent with the Federal waters of the South Atlantic and state waters off Monroe County, Florida. The Council decided that the benefits of having a size limit for these species that is consistent with both the South Atlantic and the state size limits for the waters off Monroe County, Florida, will outweigh any impacts of increased discard rates for these species. Furthermore, gag are sometimes misidentified as black grouper and having the same recreational minimum size limit for gag and black grouper may assist the public in complying with the applicable regulations for gag and black grouper. Additionally, increasing the recreational minimum size limit for these species is expected to provide the opportunity for more gag and black grouper to become sexually mature and spawn.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the framework action, the FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows:

A description of this proposed rule, why it is being considered, and the objectives of this proposed rule are contained in the preamble and in the SUMMARY section of the preamble. The Magnuson-Stevens Act provides the statutory basis for this proposed rule.

This proposed rule, if implemented, would not be expected to directly affect any small entities. This proposed rule would modify the gag and black grouper recreational minimum size limits and the gag recreational season in the Gulf. Only recreational anglers, who may fish from shore, man-made structures, private, rental, or charter vessels, and headboats, are allowed a bag or possession limit of grouper species in the Gulf. Captains or crew members on charter vessels or headboats, as well as commercial vessels, cannot harvest or possess gag or black grouper under the recreational bag limits. As a result of only recreational anglers being allowed a bag or possession limit, only recreational anglers would be directly affected by the proposed changes to the gag and black grouper recreational minimum size limits and the gag recreational season dates. Recreational anglers, however, are not considered to be small entities under the RFA and the economic effects of this proposed rule on these anglers are outside the scope of the RFA.

Charter vessels and headboats (for-hire vessels) sell fishing services to recreational anglers. Because the proposed change in the gag and black grouper minimum size limits and the change to the gag recreational season would not directly alter the services sold by these vessels, this proposed rule would not directly apply to or regulate their operations. Any change in demand for these fishing services, and associated economic effects, as a result of changing the minimum size limits and recreational season would be a consequence of behavioral change by anglers, secondary to any direct effect on anglers and, therefore, an indirect effect of the proposed rule. Because the effects on for-hire vessels would be indirect, they fall outside the scope of the RFA.

The information provided above supports a determination that this rule would not have a significant economic impact on a substantial number of small entities. Because this rule, if implemented, is not expected to have a significant economic impact on any small entities, an initial regulatory flexibility analysis is not required and none has been prepared.

No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this proposed rule. Accordingly, this rule does not implicate the Paperwork Reduction Act.

For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

We are proposing to increase recreational fishing opportunities for Gulf of Maine (GOM) cod and haddock starting May 1, 2016. The proposed changes would allow anglers to retain one cod per day during the months of August and September and keep up to 15 haddock per day for most of the fishing year. Table 1, below, summarizes the proposed measures compared to the fishing year 2015 measures.

The Northeast Fishery Science Center (Center) conducted operational stock assessments for all 20 groundfish stocks in September 2015. The assessment concluded that the GOM haddock stock biomass continues to increase, and as a result, a substantial catch-limit increase (150 percent) is anticipated for the 2016 fishing year. The assessment also concluded that, although GOM cod remains overfished and subject to overfishing, biomass has increased slightly. A 30-percent increase to the catch limit for GOM cod is expected for 2016.

These catch limit increases will be proposed in a separate rulemaking for Framework Adjustment 55 to the Northeast Multispecies Fishery Management Plan (FMP) which is expected to be published in the Federal Register in the next few weeks. Final approval of the recreational measures proposed in this action is contingent upon approval of the catch limit increases proposed in Framework 55. Framework 55 also proposes to remove the GOM cod retention prohibition in the recreational fishery. If catch limits or management measures other than those to be proposed in Framework 55 rulemaking are implemented, we will adjust recreational measures as necessary to ensure that catch from the recreational fishery will remain within the final catch limits implemented for fishing year 2016.

A peer-reviewed bioeconomic model, developed by the Center, was used to estimate 2016 recreational GOM cod and haddock mortality under various combinations of minimum sizes, possession limits, and closed seasons. Catch data and model projections suggest that the recreational fleet is not expected to exceed its fishing year 2015 catch limits for GOM cod or haddock. Based on the Framework 55 catch limits recommended by the Council for the 2016 fishing year, analyses indicate that recreational catch for both GOM cod and haddock could be increased (Table 2).