Citrus greening (known internationally as Huanglongbing disease of citrus and referred to below as HLB) is considered to be one of the most serious citrus diseases in the world. HLB is a bacterial disease caused by strains of the bacterial pathogens “CandidatusLiberibacter asiaticus”, “CandidatusLiberibacter africanus”, and “CandidatusLiberibacter americanus” that attack the vascular system of host plants. The pathogens are phloem-limited, inhabiting the food-conducting tissue of the host plant, and causes yellow shoots, blotchy mottling and chlorosis, reduced foliage, and tip dieback of citrus plants. HLB greatly reduces production, destroys the economic value of the fruit, and can kill trees. Once a tree is infected, there is no cure for HLB. In areas of the world where the disease is endemic, citrus trees decline and die within a few years and may never produce usable fruit. HLB was first detected in the United States in Miami-Dade County, FL, in 2005, and is only known to be present in the United States in the States of Florida and Georgia, Puerto Rico, two parishes in Louisiana, and two counties in South Carolina.

CVC is also a highly injurious disease of citrus. Caused by a strain of the bacteriumXylella fastidiosa,CVC causes severe chlorosis between veins on the leaves of affected plants. Leaves on affected plants frequently have discoloration of the upper leaf coupled with brown lesions underneath. CVC may reduce plant growth and lead to abnormal flowering and fruit production. CVC is currently not known to occur in the United States.

The regulations in 7 CFR part 319, “Foreign Quarantine Notices,” prohibit or restrict the importation of certain plants and plant products to prevent the introduction or dissemination of plant pests and noxious weeds into the United States. The regulations in “Subpart-Nursery Stock, Plants, Roots, Bulbs, Seeds, and Other Plant Products,” §§ 319.37 through 319.37-14 (referred to below as the regulations), restrict, among other things, the importation of seeds for propagation.

In an interim rule1 effective and published in theFederal Registeron April 6, 2010 (75 FR 17289-17295, Docket No. APHIS-2008-0052), we amended the regulations to prohibit the importation of propagative seed of several Rutaceae (citrus family) genera from certain countries where HLB or CVC is present, and to require propagative seed of these genera from all other countries to be accompanied by a phytosanitary certificate with an additional declaration that neither HLB nor CVC is known to occur in the country where the seed was produced.

Comments on the interim rule were required to be received on or before June 7, 2010. We received three comments by that date, from a citrus nursery, a company engaged in the commercial production, packing, and shipping of citrus products, and a State department of agriculture. The comments are addressed below, by topic.

One commenter stated that countries in which HLB or CVC is present would respond to the prohibitions of the interim rule by in turn prohibiting the importation of citrus articles from the United States. Because the loss of foreign markets would adversely impact the U.S. citrus industry, the commenter stated that the rule should be withdrawn.

On September 19, 2005, the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) reported the first two confirmed detections of HLB within the United States to the International Plant Protection Convention. Since that time, it has been at the discretion of foreign countries to promulgate regulations prohibiting or restricting the importation of host articles of HLB from the United States, based on an assessment of the potential risk to plants, plant parts, and plant products within those countries that could be associated with the introduction or dissemination of the disease. We note, however, that countries that are members of the World Trade Organization have committedthemselves to basing prohibitions or restrictions on the importation of articles (such as, in this case, citrus from the United States) on scientific evidence and risk assessment.

In the interim rule, our stated rationale for imposing prohibitions on the importation of seed of genera that are hosts of HLB was that emerging evidence suggested that such seed could transmit the disease. To that end, we cited a peer-reviewed article by Susan Halbert and Keremane Manjunath that detailed that, when seedlings are generated from seed that is infected with HLB, a small percentage of those seedlings have been found to be infected with HLB.2

All three commenters stated that the Halbert and Manjunath article did not provide an adequate scientific basis for considering seed to be a pathway for the transmission of HLB. Two of the commenters pointed out that Halbert and Manjunath did not conduct original research regarding seed transmission, but instead referenced a 1981 study. The same commenters also pointed out that researchers in the 1981 study collected only a small number of seeds, and did not test the seedlings derived from this seed for the disease, but rather determined them to have the same stunted, chlorotic appearance as infected plants. Both commenters concluded by citing Halbert and Manjunath's assessment that the 1981 experiment “bears repeating” as evidence that Halbert and Manjunath themselves had concerns about the study's findings. Finally, one commenter cited two more recent studies, published in 2009, that the commenter asserted conclude that HLB is not seed-borne. All three commenters stated that we should amend the interim rule to allow the importation of propagative seed from countries where only HLB is present.

We disagree with the commenters' interpretation of Halbert and Manjunath's assessment of the 1981 experiment; stating that an experiment bears repeating is not tantamount to stating that one has concerns with its findings, and is, in fact, consistent with the basic elements of the scientific method.

Moreover, the Halbert and Manjunath article was not our sole basis for taking regulatory action; we referenced it in order to illustrate some of the information that factored into our determination. We considered other evidence. For example, as we mentioned in an interim rule that established domestic quarantine regulations for HLB and that was published in theFederal Registerand effective on June 17, 2010 (75 FR 34322-34336, Docket No. APHIS-2008-0015), researchers at USDA's Agricultural Research Service (ARS) and APHIS' Center for Plant Health Science and Technology (CPHST) have recently undertaken extensive studies to determine the likelihood of seed transmission of HLB. Both the ARS and CPHST studies found that a percentage of seedlings from infected seed tested positive for HLB via polymerase chain reaction (PCR) analysis; in the ARS study, the infection rate varied, but was as great as 78.5 percent in certain instances.3 ARS researchers did note, however, that the bacterium causing HLB remained at a very low titer in affected plants, and that most infected seedlings remained largely or entirely asymptomatic several years after testing positive for the disease.

One of the 2009 articles4 referenced by the commenter does not contradict, and in fact is generally consistent with, the findings of the ARS study. The article details a 2007 study, conducted by Ute Albrecht and Kim Bowman, in which more than 15,000 seeds were obtained from symptomatic trees of the following species:Citrus macrophyllaWebster,Citrus vangasaybojer, XPoncirus trifoliata, Citrus reticulataBlanco,Citrus aurantiumL., andCitrus sinensis.Of the seedlings grown from these seeds, 769 were tested for HLB via PCR analysis at time periods ranging from 7 weeks to 9 months after sowing. Five of these 769 seedlings tested positive for the disease. However, titer levels of the bacterium were low, and the plants remained asymptomatic. In addition, repeated retesting of the positive plants several months after the initial test yielded negative PCR results.

The other article5 referenced by the commenter details an experiment that Hajivand Shokrollah conducted in order to determine the transmissibility of HLB through seed obtained from infectedCitrus reticulataplants. As part of the experiment, Shokrollah tested 20 seedlings grown from such seed by using PCR analysis. While each seedling tested negative for HLB, we do not consider 20 plants, all of the same species, to be a large enough or varied enough sample size to yield conclusive results regarding disease transmission.

We acknowledge that all the studies referenced above suggest that the transmission of HLB via propagative seed is fundamentally different than its transmission via other vectors, such as budwood or Asian citrus psyllid: The bacterium is present in infected seedlings at low concentration levels, plants remain largely asymptomatic, and plants may test negative for the disease after initially testing positive. However, it is well-documented that the bacterium associated with HLB may be unevenly distributed throughout an infected plant, that the latency period for expression of symptoms may be pronounced, and that the manner in which those symptoms are expressed is influenced by a multitude of factors. Accordingly, because of the severity of HLB, in order for us to deregulate propagative seed as a host of the disease, we would need clear evidence that the disease cannot be transmitted via propagative seed or that infected seedlings cannot serve as vectors of the disease. Such evidence does not currently exist. Hence we are making no change to the interim rule in response to these comments.

One commenter stated that hot water dips are effective in treating seed for HLB. However, the commenter failed to provide any evidence in support of this assertion.

In the preamble of the interim rule, our stated rationale for imposing prohibitions on the importation of seed of genera that are hosts of CVC was that there was also emerging evidence that propagative seed could transmit this disease. To that end, we cited a 2003 study6 by W.B. Liet al.(referred to below as Liet al.).

One commenter pointed out that Liet al.was conducted only on threesubspecies of sweet oranges, did not evaluate disease transmission from seeds taken from asymptomatic fruit, and was aborted before conclusive findings could be drawn. The commenter therefore asserted that seed should not be regulated as a host of CVC until further research is conducted.

The commenter is right in pointing out that Liet al.was aborted abruptly, because of a hurricane, and that only a study on three subspecies of sweet oranges was concluded by that time. However, CVC seed infection rates were greater than 22 percent for one subspecies evaluated in that study, and the transmission from seeds to seedlings was determined to be “efficient.” Moreover, research had begun on several other species, and was tending towards the results of the sweet orange study. Finally, we note that no studies have been conducted since 2003 that call into question the findings of Liet al.For these reasons, we have determined that Liet al.'s conclusion, that the study “demonstrated that [CVC] can be transmitted through seed to seedlings,” is correct, and constitutes a sufficient basis for the prohibitions in the interim rule.

Therefore, for the reasons given in the interim rule and in this document, we are adopting the interim rule as a final rule, without change.

This action also affirms the information contained in the interim rule concerning Executive Order 12988 and the Paperwork Reduction Act.

Further, this action has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

This rule affirms an interim rule that amended the regulations governing the importation of nursery stock to prohibit the importation of propagative seed of several Rutaceae (citrus family) genera from certain countries where citrus greening or citrus variegated chlorosis (CVC) is present. The interim rule also required propagative seed of these genera from all other countries to be accompanied by a phytosanitary certificate with an additional declaration that neither citrus greening nor CVC are known to occur in the country where the seed was produced. The action was necessary in order to prevent the introduction or dissemination of citrus greening or CVC within the United States.

We have prepared a final regulatory flexibility analysis addressing the economic effects of the interim rule on small entities, as required by the Regulatory Flexibility Act. The analysis identifies importers of citrus seed as entities potentially affected by the interim rule. The full analysis may be viewed on the Regulations.gov Web site (see ADDRESSESabove for instructions for accessing Regulations.gov) or obtained from the person listed underFOR FURTHER INFORMATION CONTACT.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in theFederal Registeron November 15, 2010 (75 FR 69609). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a Note within the AD.

We estimate that this AD will affect 628 products of U.S. registry. We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $53,380, or $85 per product.

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 AD will not have federalism implications under Executive Order 13132. This AD will 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 AD:

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); and

3. 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet athttp://www.regulations.gov;or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in theADDRESSESsection. Comments will be available in the AD docket shortly after receipt.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to the specified products. That NPRM published in theFederal Registeron November 9, 2010 (75 FR 68731). That NPRM proposed to require an inspection to determine the serial numbers of the auxiliary power unit (APU) generator and the left and right engine direct current (DC) generators, and related corrective actions if necessary. That NPRM also proposed to require revising the airplane flight manual.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal and the FAA's response to each comment.

The European Aviation Safety Agency (EASA) requested clarification regarding the applicability of the NPRM. The EASA noted that the applicability in paragraph (c) of the NPRM applies to Cessna Model 750 airplanes having serial numbers -0222 and -0225 and subsequent. The EASA noted that paragraph (i) of the NPRM states that no person may install any Pacific Scientific generators having part number 92841-1 (9914752-1) that has serial numbers 060 through 297 without suffix “C” on any airplane. The EASA asked if there is a chance that the affected generators could be installed on other Model 750 airplanes with serial numbers that are not identified in paragraph (c) of the NPRM.

We agree to clarify. Cessna Model 750 airplanes having lower serial numbers use only Goodrich generators, which are not affected by the identified unsafe condition. We have not changed the final rule in regard to this issue.

Cessna requested that we change the paragraph identifier in Note 1 of the NPRM to specify paragraph (h), not paragraph (g) of the NPRM, because paragraph (h) of the NPRM contained the AFM revisions.

We agree. We revised this AD as requested.

Cessna requested that we remove the compliance time of “before further flight” from the Relevant Service Information section and paragraph (g) of the NPRM. Cessna did not provide a reason for its request.

We partially agree. We agree that the information in the Relevant Service Information and the Cessna service letter should match; however, the Relevant Service Information section is not contained in the final rule. We do not agree with the request to change the compliance time in paragraph (g) of the final rule. By the time this AD is issued, there will not be an issue with parts availability and if an affected generator is found to be installed, it should be replaced immediately. However, operators may request approval of an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (j)(1) of this AD. We have not changed the final rule in regard to this issue.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the change described previously. We also determined that this change will not increase the economic burden on any operator or increase the scope of the AD.

We estimate that this AD affects 67 airplanes of U.S. registry. We also estimate that it takes up to 10 work-hours per product to comply with this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be up to $56,950, or $850 per product.

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.

This AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:

(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),

(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 amends 14 CFR part 39 as follows:

Discussion

The European Aviation Safety Agency (EASA), which is the aviation authority for the Member States of the European Community, has issued EASA Airworthiness Directive 2010-0036, dated March 8, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Airbus has issued A340 Airworthiness Limitation Items, Document AI/SE-M4/95A.0051/97, Issue 11, dated February 20, 2009. This document provides the mandatory time for maintenance tasks, structural inspection intervals, and related structural inspection procedures. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

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 the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

There are no products of this type currently registered in the United States. However, this rule is necessary to ensure that the described unsafe condition is addressed if any of these products are placed on the U.S. Register in the future.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a Note within the AD.

Since there are currently no domestic operators of this product, notice and opportunity for public comment before issuing this AD are unnecessary.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under theADDRESSESsection. Include “Docket No. FAA-2011-0040; Directorate Identifier 2010-NM-185-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

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 AD will not have federalism implications under Executive Order 13132. This AD will 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 AD:

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); and

3. 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

Discussion

The European Aviation Safety Agency (EASA), which is the aviation authority for the Member States of the European Community, has issued EASA Airworthiness Directives 2010-0131, dated June 28, 2010 and EASA AD 2009-0192, dated August 28, 2009 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI (EASA AD 2009-0192) states:

Airbus has issued A340 ALS Part 1, Safe Life Airworthiness Limitation Items Revision 05, dated July 29, 2010. This document provides for mandatory replacement times, structural inspection intervals, and related structural inspection procedures or other procedures (e.g.,modifications). The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

On April 20, 2006, we issued AD 2006-09-07, Amendment 39-14577 (71 FR 25919, May 3, 2006), for all Airbus Model A330-200 and -300, and A340-200 and -300 series airplanes, and A340-541 and -642 airplanes. That AD requires operators to revise the Airworthiness Limitations section of the Instructions for Continued Airworthiness to incorporate new information. That information includes, for all affected airplanes, decreased life limit values for certain components; and for Model A330-200 and -300 series airplanes, new inspections, compliance times, and new repetitive intervals to detect fatigue cracking, accidental damage, or corrosion in certain structures. That AD results from a revision to section 9-1 of the Airbus A330 and A340 maintenance planning documents (MPDs) for life limits/monitored parts, and section 9-2 of the Airbus A330 MPD for airworthiness limitations items. Accomplishing the revision in paragraph (g) of this AD eliminates the need for the revision required by paragraph (f)(2) of AD 2006-09-07 for Model A340 airplanes.

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 the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

There are no products of this type currently registered in the United States. However, this rule is necessary to ensure that the described unsafe condition is addressed if any of these products are placed on the U.S. Register in the future.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a Note within the AD.

Since there are currently no domestic operators of this product, notice and opportunity for public comment before issuing this AD are unnecessary.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under theADDRESSESsection. Include “Docket No. FAA-2011-0039; Directorate Identifier 2010-NM-184-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

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 AD will not have federalism implications under Executive Order 13132. This AD will 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 AD:

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); and

3. 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to certain Model 767 airplanes. That NPRM was published in theFederal Registeron April 8, 2010 (75 FR 17887). That NPRM proposed to require doing a detailed inspection for correct main track downstop assembly, thread protrusion, and damaged and missing parts of the main track downstop assemblies of the outboard slats, and related investigative and corrective actions if necessary. That proposed AD also proposed to require doing a detailed inspection for foreign objects debris and damage to the wall of the track housing of the outboard slats, and corrective actions if necessary.

The NPRM referred to Boeing Special Attention Service Bulletin 767-57-0118, dated October 8, 2009. We reviewed Boeing Special Attention Service Bulletin 767-57-0118, Revision 1, dated October 21, 2010. This service bulletin revision adds an option to inspect either the bolt or nut for looseness by applying torque to the main track downstop assembly nut or the bolt head, corrects a reference, and removes the references to slat numbers 6 and 7 in Appendix A. This service bulletin revision does not add any additional work for the affected airplanes.

We gave the public the opportunity to participate in developing this AD. We considered the comments received from the commenters.

American Airlines (AAL) requested that we specify that Boeing Document D-590 may be used as a source for acceptable fastener and materialsubstitution in a note in the General Information section of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 767-57-0118, dated October 8, 2009.

From this request, we infer that AAL asked that we include Boeing Document D-590 as a source for the acceptable fastener and material substitution in the NPRM. We disagree that adding this document to the requirements of the AD is necessary. Boeing Document D-590 is the collection of many Boeing standards and specifications. We have determined that this document is too broad for this AD. We have not changed the final rule in regard to this issue.

AAL requested that we clarify the fitting location. AAL stated that it believes the 114T2520 fitting located at outboard slat station (OSS) 426.997 should be removed to facilitate proper torque checking of the bolts. AAL stated that Boeing confirmed that it is acceptable to remove the stop fitting(s) as required for access and that it is safe to remove the stop fitting(s) without rigging the slats. AAL also stated that Boeing does not plan to revise Boeing Special Attention Service Bulletin 767-57-0118, dated October 8, 2009, to include removal or installation procedures for the stop fitting(s) for access purposes. AAL reported that Boeing does plan to add a note in the next revision of Boeing Special Attention Service Bulletin 767-57-0118, dated October 8, 2009, that states “if it is necessary to remove more parts for access, you can remove those parts. You must install all parts removed for access before the airplane is put back in service.” As a result, AAL requested that we revise the NPRM to incorporate a note providing steps to remove the up-stop fitting as required to facilitate the torque check, to reinstall the up-stop fitting in accordance with Boeing Drawing 114T2160, and to torque the nuts using Boeing Airplane Company (BAC) procedure 5009 or an equivalent operator procedure.

We agree that clarification might be necessary. Based on the best data available, the manufacturer provided the procedures necessary to do the required actions. Note 8 in Section A. “General Information” of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 767-57-0118, Revision 1, dated October 21, 2010, states, “If it is necessary to remove more parts for access, you can remove those parts. If you can get access without removing identified parts, it is not necessary to remove all of the identified parts.” The procedures in AD rulemaking actions, however, typically do not include procedures such as the steps required to gain access and close up. We have updated the final rule to refer to the latest issue of the service information.

AAL stated that a single torque check could be accomplished rather than the two distinct checks as specified in Steps 1 and 2 of Figures 2 and 5 of Boeing Special Attention Service Bulletin 767-57-0118, dated October 8, 2009. AAL stated that in these figures, the torque check is accomplished by first holding the bolt head and applying force to the nut to verify that it does not turn on the bolt threads. AAL stated that the torque is checked secondly by applying torque to the head and verifying that the bolt does not rotate. AAL stated that applying torque to the nut without holding the head will adequately test the same conditions. AAL stated that if the bolt and nut are loose and if torque is applied to the nut, either the nut will turn on the bolt or the bolt will turn with the nut. AAL stated that if neither turns, then they are tight. AAL asserted that this procedure would eliminate some work steps and simplify the task.

We agree with the reasons provided by the commenter. As stated previously Boeing has released Special Attention Service Bulletin 767-57-0118, Revision 1, dated October 21, 2010, which corrects that information. We have revised the final rule to refer to this service bulletin as the appropriate source of service information.

Continental Airlines (CAL) requested that Boeing Special Attention Service Bulletin 767-57-0118, dated October 8, 2009, be revised to correct the reference to the AMM section to 27-81-34, not 27-81-00.

We agree. As stated previously Boeing has released Special Attention Service Bulletin 767-57-0118, Revision 1, dated October 21, 2010, which corrects that information. We have revised the final rule to refer to this revision as the appropriate source of service information.

United Airlines (United) requested that we revise the Costs of Compliance section of the NPRM. United noted that the FAA estimated 8 work-hours to comply with the proposed requirements of the NPRM, and Boeing Special Attention Service Bulletin 767-57-0118, dated October 8, 2009, estimated 22 work-hours.

We disagree with the request to revise the Costs of Compliance section of this AD. The economic analysis is limited to the cost of actions actually required by the rule. It does not consider the costs of “on condition” actions (e.g.,“repair, if necessary”) because, regardless of AD direction, those actions would be required to correct an unsafe condition identified in an airplane and ensure operation of that airplane in an airworthy condition, as required by the Federal Aviation Regulations. We have made no change to this final rule regarding this issue.

Boeing requested that we clarify that if damage is found while inspecting the slat track housing, operators should contact the FAA for approval of an alternative method of compliance (AMOC) only when the damage exceeds the allowance contained in Boeing Special Attention Service Bulletin 767-57-0118. Boeing stated that this service bulletin contains damage blend-out allowances (0.015-inch blend-out depth on a 0.063-inch-thick wall) for the slat track housing in Figure 8. Boeing stated that the NPRM does not provide for the existing repair information contained in this service bulletin and requires that all repairs be submitted to the FAA for approval of AMOCs.

We agree with the request for the reasons the commenter provided, and we have revised paragraph (h) of this AD accordingly.

We added a new paragraph (k) to this final rule to provide information on the federal Paperwork Reduction Act. We have reidentified subsequent paragraphs accordingly.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We estimate that this AD affects 361 airplanes of U.S. registry. We also estimate that it will take about 8 work-hours per product to comply with this AD. The average labor rate is $85 per work-hour. Required parts will cost $0per product. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $245,480, or $680 per product.

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.

This AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:

(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) 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.

You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in theFederal Registeron October 21, 2010 (75 FR 64963). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

The European Aviation Safety Agency (EASA) requested that we update the NPRM to refer to EASA AD 2009-0221R1, dated June 30, 2010. This EASA AD corrects a typographical error, which was the source of a difference between the FAA NPRM and the EASA AD.

We agree with the EASA's request to update this final rule to refer to the latest EASA AD. We have also revised Note 1 of the final rule to state that there are no differences between the EASA AD and the FAA AD.

We reviewed the available data, including the comment received, and determined that air safety and thepublic interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a Note within the AD.

We estimate that this AD will affect 6 products of U.S. registry. We also estimate that it will take about 3 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,530 or $255 per product.

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 AD will not have federalism implications under Executive Order 13132. This AD will 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 AD:

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); and

3. 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet athttp://www.regulations.gov;or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in theADDRESSESsection. Comments will be available in the AD docket shortly after receipt.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2005-18-02, Amendment 39-14242 (70 FR 71610, November 29, 2005). That AD applies to the specified products. The NPRM published in theFederal Registeron August 18, 2010 (75 FR 50945). That NPRM proposed to modify the TLS of the manufacturer's engine manual and an air carrier's approved continuous airworthiness maintenance program to incorporate additional inspection requirements. PW has developed and the FAA has approved improved inspection procedures for the critical life-limited parts. The mandatory inspections are needed to identify those critical rotating parts with conditions which, if allowed to continue in service, could result in uncontained failures.

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the proposal and the FAA's response to the comment.

One commenter, American Airlines, requested that we change thecompliance time from within 30 days after the effective date of the AD, to within 180 days after the effective date of the AD. This change would give PW the time to revise fan hub inspection Alert Service Bulletin No. A6272, dated September 24, 1996, to obtain an Alternative Method of Compliance to fan hub inspection AD 97-17-04R1, and to allow automatic eddy current inspection per engine manual Section 72-33-31, Inspection No.-05.

We agree. Availability of the tooling will take about 6 months, and the risk will be negligible since a manual inspection is now in place. We revised this AD as requested.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the AD with the change described previously. We also determined that this change will not increase the economic burden on any operator nor increase the scope of the AD.

We estimate that this AD will affect 1,143 JT8D-209, -217, -217A, -217C, and -219 turbofan engines installed on airplanes of U.S. registry. We also estimate that it will take about 10 work-hours per engine to perform the actions, and that the average labor rate is $85 per work-hour. Since this is an added inspection requirement, included as part of the normal maintenance cycle, no additional part costs are involved. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $971,550.

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.

This AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:

(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),

(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 amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in theFederal Registeron November 15, 2010 (75 FR 69606). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a Note within the AD.

We estimate that this AD will affect 6 products of U.S. registry. We also estimate that it will take about 16 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $8,160, or $1,360 per product.

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 AD will not have federalism implications under Executive Order 13132. This AD will 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 AD:

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); and

3. 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet athttp://www.regulations.gov;or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in theADDRESSESsection. Comments will be available in the AD docket shortly after receipt.

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

History

On Monday, November 22, 2010, the FAA published a notice of proposed rulemaking in theFederal Registerto revise Class E airspace at Barrow, Alaska (75 FR 71046).

Interested parties were invited to participate in this rulemaking processby submitting written comments on the proposal to the FAA. No comments were received.

There was an error in the notice of proposed rulemaking regarding the E5 airspace coordinates for Wiley Post/Will Rogers Memorial Airport at Barrow, Alaska. This error has been corrected in the final rule.

The Class E airspace areas designated as 700/1,200 ft. transition areas are published in paragraph 6005 of FAA Order 7400.9U,Airspace Designations and Reporting Points,signed August 18, 2010 and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by revising Class E airspace at Wiley Post/Will Rogers Memorial Airport at Barrow, AK, to accommodate five amended RNAV SIAPs, and one ODP. This Class E airspace will provide adequate controlled airspace upward from 700 and 1,200 feet above the surface for safety and management of IFR operations at Wiley Post/Will Rogers Memorial Airport, Barrow, Alaska. With the exception of editorial changes, and the changes described above, this rule is the same as that proposed in the NPRM.

The FAA has determined that this 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. Because this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, 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 1, section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it creates Class E airspace sufficient in size to contain aircraft executing instrument procedures for the Wiley Post/Will Rogers Memorial Airport at Barrow, Alaska and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.

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

On Monday, December 13, 2010, the FAA published a notice of proposed rulemaking in theFederal Registerto amend Class E airspace at Savoonga, AK (75 FR 77574).

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA.One comment was received. The commenter suggested that the portion of the proposed Class E airspace overlaying Russian airspace should be excluded. The FAA has found merit in this and has adjusted the airspace area to exclude that area outside of U.S. airspace. The FAA also noted that the geographic coordinates for the Savoonga Airport cited in the NPRM were not rounded. This action corrects that error.

The Class E airspace areas designated as 700/1,200 ft. transition areas are published in paragraph 6005 of FAA Order 7400.9U,Airspace Designations and Reporting Points,dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by revising Class E airspace to accommodate three amended SIAPs and one new SIAP at the Savoonga Airport, Savoonga, AK. This Class E airspace will provide adequate controlled airspace upward from 700 feet and 1,200 feet above the surface for the safety and management of IFR operations at Savoonga Airport. The 1,200 foot controlled airspace will extend into the Norton Sound Low Offshore Airspace Area and that airspace will be redefined in a future rulemaking action. With the exception of editorial changes, and the changes described above, this rule is the same as that proposed in the NPRM.

The FAA has determined that this 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. Because this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, 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 1, section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it creates Class E airspace sufficient in size to contain aircraft executing instrument procedures for the Savoonga Airport and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.

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

History

On Monday, December 13, 2010, the FAA published a notice of proposed rulemaking in theFederal Registerto revise Class E airspace at Shungnak, AK (75 FR 77573).

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments were received.

The Class E airspace areas designated as 700/1,200 ft. transition areas are published in paragraph 6005 of FAAOrder 7400.9U,Airspace Designations and Reporting Points,signed August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by revising Class E airspace at the Shungnak Airport, AK, to accommodate amended SIAPs. This Class E airspace will provide adequate controlled airspace upward from 700 and 1,200 feet above the surface for safety and management of IFR operations at the Shungnak Airport.

The FAA has determined that this 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. Because this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, 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 1, section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it creates Class E airspace sufficient in size to contain aircraft executing instrument procedures for the Shungnak Airport and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.

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

On Monday, December 13, 2010, the FAA published a notice of proposed rulemaking in theFederal Registerto revise Class E airspace at Platinum AK (75 FR 77572).

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments were received.

Subsequent to the publications, the FAA noted that the geographic coordinates for the Platinum Airport cited in the NPRM were not rounded. This action corrects that error.

The Class E airspace areas designated as 700/1,200 ft. transition areas are published in paragraph 6005 of FAA Order 7400.9U,Airspace Designations and Reporting Points,signed August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by revising Class E airspace at the Platinum Airport, AK, to accommodate one new SIAP at the Platinum Airport. This Class E airspace will provide adequate controlled airspace upward from 700 and 1,200 feet above the surface for safety and management of IFR operations at the Platinum Airport. The 1,200 foot controlled airspace will extend into the Norton Sound Low Offshore Airspace Area and Control Area 1234L and those airspaces will be redefined in a future rulemaking action.With the exception of editorial changes, and the changes described above, this rule is the same as that proposed in the NPRM.

The FAA has determined that this 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. Because this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, 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 1, section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it creates Class E airspace sufficient in size to contain aircraft executing instrument procedures for the Platinum Airport and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.

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

On July 21, 2010, the final rule entitled Safe, Efficient Use and Preservation of the Navigable Airspace, was published in theFederal Register.1 In that rule, the FAA amended the regulations governing objects that may affect the navigable airspace to incorporate case law and legislative action, and to simplify the rule language.

In section III2 of the preamble to the final rule, the FAA noted that affected parties were not required to comply with the new information collection requirements until OMB approved the FAA's request to collect the information.

In accordance with the Paperwork Reduction Act, the FAA submitted a copy of the new information collection requirements to OMB for its review. On January 14, 2011, OMB approved the FAA's request under Control Number 2120-0745, which will expire January 31, 2013.

Today's notice is being published to inform affected parties of OMB's approval, and to announce that as of the effective date of this notice, affected parties must comply with the new information collection requirements in 14 CFR 77.7, 77.9, and 77.11.

As part of OMB's approval, it advised the FAA that because the form3 that will be used to collect the new information was previously approved under existing Control Number 2120-0001, the FAA must revise 2120-0001 to incorporate the new information collection requirements and submit the revision to OMB for approval. Accordingly, the FAA will prepare the revision and publish it in theFederal Registerfor public comment. The FAA will consider the comments it receives before finalizing the revision and sending it to OMB for approval. Meanwhile, affected parties must comply with the information collection requirements in the final rule, Safe, Efficient Use and Preservation of the Navigable Airspace, according to OMB's approval under Control Number 2120-0745.

The statute under which the Secretary of Transportation regulates commercial space transportation, 51 U.S.C. subtitle V, chapter 509, sections 50901-50923 (chapter 509), requires that, for each commercial space launch or reentry, the Department of Transportation (DOT) and, through delegation, the Federal Aviation Administration (FAA) enter into a reciprocal waiver of claims agreement with “the licensee or transferee, contractors, subcontractors, crew, space flight participants, and customers of the licensee or transferee, and contractors and subcontractors of the customers * * *” 51 U.S.C. 50914(b)(2). This requirement also applies to permittees under 51 U.S.C. 50906(i). This rule changes Title 14, Code of Federal Regulations (14 CFR) 440.17(c) to more clearly track Congress' requirement that the reciprocal waiver of claims include all “customersof the licensee or transferee * * *”Id.(emphasis added).

Enacted in 1998, § 440.17(c) requires that the U.S. Government, commercial space launch and reentry licensees, and the licensees' customers enter into a reciprocal waiver of claims agreement with the government.See Financial Responsibility Requirements for Licensed Launch Activities,63 FR 45592 (Aug. 26, 1998) (final rule); andFinancial Responsibility Requirements for Licensed Launch Activities,61 FR 38992 (Jul. 25, 1996) (notice of proposed rulemaking) (“Financial Responsibility NPRM”). The regulation was amended to require a waiver between the U.S. Government, permittees, and the permittees' customers.See Human Space Flight Requirements for Crew and Space Flight Participants,71 FR 75616 (Dec. 5, 2006) (final rule); andExperimental Permits for Reusable Suborbital Rockets,70 FR 77262 (Dec. 29, 2005) (notice of proposed rulemaking).

The FAA is required by 51 U.S.C. 50914(b)(2) and 50906(i) to enter into a reciprocal waiver of claims agreement with the customers of a licensee or permittee for commercial space flight. The pertinent part of the regulation for implementing this congressional requirement, § 440.17(c), currently mandates that the licensee or permittee and its customer enter into a three-party reciprocal waiver of claims agreement when conducting a licensed or permitted activity in which the federal government, any agency, or its contractors and subcontractors is involved. This requirement also applies to activities where property insurance is required under § 440.9(d).

Unfortunately, the FAA has found that this language has created confusion. The term “three-party reciprocal waiver,” in particular, has prompted some customers of commercial space launches to believe that only three parties were necessary to complete the waiver, even if there were multiple customers; and so, under this interpretation, only one customer was considered necessary to sign the waiver. Further, Appendix B and Appendix C of part 440 define, “Customer”as the above-named Customer on behalf of the Customer and any person described in § 440.3 of the regulations. Again, customers sometimes read this language to suggest that one customer could sign on behalf of the other customers.

However, a plain language reading of the statute makes it clear that Congress intended the government to enter into a reciprocal waiver of claims with all customers.See51 U.S.C. 50914(b)(2). Further, the notice of proposed rulemaking (NPRM) for § 440.17 shows that the regulation actually captures all customers within the reciprocal waiver requirement. As noted in the Financial Responsibility NPRM:

The changes to Appendix B and Appendix C of part 440 provide examples of waiver agreements for multiple-customer launches and reentries. These examples are included for the convenience of parties involved in commercial space activities. The FAA's intent with these examples is to clarify that each customer must waive claims against all other customers, the U.S. Government, and the licensee or permittee. Each customer is also required to indemnify these other parties against claims by the customer's own contractors and subcontractors.

Further, each customer must extend the reciprocal waiver of claims to its own contractors and subcontractors. However, in no case is any one customer required to indemnify against claims brought by another customer, or to extend the reciprocal waiver of claims to other customers or the contractors and subcontractors of any other customer. Thus, the definition of “customer” in the appendices has been clarified to ensure that one customer cannot sign on behalf of othercustomers. Again, these changes are consistent with the Financial Responsibility NPRM and FAA policy.

To maintain consistency, the FAA is also amending paragraph 5(b) of the reciprocal waiver of claims in the appendices. That paragraph addresses how a customer holds harmless and indemnifies the other parties to the waiver and their related entities against claims brought by the customer's contractors and subcontractors. The FAA is removing from 5(b) the statement that the customer indemnifies the other parties against claims brought by any person “on whose behalf” the customer entered into the waiver, namely, under the current but not the new appendix definition, another customer.

The FAA is making this change because the language is unnecessary and incorrect. It is unnecessary because of the FAA's policy and practice of requiring all customers to sign the required waivers; thus, a customer should not be signing on behalf of another customer. It is the licensee who is responsible for obtaining waivers from all customers. Additionally, the regulations do not require a customer to indemnify the other parties for claims made by other customers.See14 CFR 440.17(d). Accordingly, in keeping with this rulemaking's clarification that all customers sign a reciprocal waiver, the FAA is removing the statement that a customer must provide indemnification on behalf of another customer.

In consideration of the foregoing, the Federal Aviation Administration amends chapter II of title 14, Code of Federal Regulations as follows:

An MDDS is a device that is intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. An MDDS acts only as the mechanism by which medical device data can be transferred, stored, converted, or displayed. An MDDS does not modify the data or modify the display of the data. An MDDS by itself does not control the functions or parameters of any other medical device. An MDDS can only control its own functionality. This device is not intended to provide or be used in connection with active patient monitoring. Any product that is intended for a use beyond the uses (or functions) identified in this final classification rule is not an MDDS and is not addressed by this rule.

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301et seq.) 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) establishes three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). General controls include requirements for registration, listing, adverse event reporting, and good manufacturing practice (quality system requirements) (21 U.S.C. 360c(a)(1)(A)). Special controls are controls that, in addition to general controls, are applicable to a class II device to help provide reasonable assurance of that device's safety and effectiveness (21 U.S.C. 360c(a)(1)(B)).

Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendment devices, are classified automatically by statute into class III, without any FDA rulemaking (21 U.S.C. 360c(f)). Postamendment devices that are automatically classified into class III require premarket approval prior to marketing the device, unless the device is reclassified into class I or II.

Reclassification of postamendment devices into class I or class II is governed by section 513(f)(3) of the FD&C Act, formerly section 513(f)(2) of the FD&C Act. This section provides that FDA may initiate the reclassification of a device classified into class III under section 513(f)(1) of the FD&C Act, or the manufacturer or importer of a device may petition FDA for the issuance of an order classifying the device in class I or class II. To change the classification of the device, it is necessary that the proposed new classification have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. A medical device reclassified into class I or class II may require the submission of a premarket notification to assure safety and effectiveness, unless the device is exempt.

Premarket notifications are not required for certain class I and class II medical devices. Under section 510(l) of the FD&C Act (21 U.S.C. 360(l)), a class I device is exempt from the premarket notification requirements unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. FDA refers to these criteria as “reserved criteria.” An exemption permits manufacturers to introduce into commercial distribution generic types of devices without first submitting a premarket notification to FDA.

Products that are built with, or consist of, computer and/or software components are subject to regulation as devices if they meet the definition of a device contained in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). In 1989, FDA published a draft guidance document, “FDA Policy for the Regulation of Computer Products,” that explained how FDA planned to determine whether a computer-based product and/or software-based product is a device, and how FDA intended to regulate this device type. The document became known as the “Draft Software Policy.” Since 1989, however, the use of computer products and software products as medical devices has grown exponentially. Consequently, FDA determined that because of the history, complexity, and diversity of computer systems and controlling software, it would be impractical to adopt one “software” or “computer” policy to address all computer and software medical devices. The Draft Software Policy was withdrawn, official notice of which appeared in theFederal Registeron January 5, 2005 (70 FR 824 at 890).

An appropriate regulatory approach should depend primarily upon the risk the device poses to the patient should the device (software or hardware) fail to perform in accordance with its specifications. This principle, along with FDA's examination of modern medical device networks and computer infrastructures, informs this reclassification of a category of postamendment computer and software devices that can be regulated under a single classification. This medical device has been named a “Medical Device Data System” or “MDDS.” Because an MDDS does not provide new or unique algorithms or functions, FDA has determined that applying general controls, such as the Quality System regulation (QS regulation or QS requirements) (part 820 (21 CFR part 820)), to the design and development of these devices will provide sufficientregulatory control to mitigate any associated risks. Accordingly, FDA is classifying the MDDS into class I.

In theFederal Registerof February 8, 2008 (73 FR 7498), FDA issued a proposed rule (the proposed rule) to reclassify, upon its own initiative, MDDSs from class III (subject to premarket approval), to class I (subject to general controls). Further, in accordance with section 510(l) of the FD&C Act, the proposed rule set forth that an MDDS intended for use only by a health care professional and that does not perform irreversible data compression would be exempt from the premarket notification requirements, subject to the limitations on exemption in § 880.9 (21 CFR 880.9). Under the proposed rule, if an MDDS were indicated for use by anyone other than a health care professional, or performed irreversible data compression, a premarket notification would be required.

This regulation classifies as class I MDDS only data systems with specific intended uses and functions. Those device data systems that include any uses beyond, or that are for intended uses different from, those identified for an MDDS will remain class III devices. FDA has determined that MDDSs can be regulated as class I devices because general controls provide a reasonable assurance of safety and effectiveness for this device type. In making this determination, FDA has considered that the risks associated with MDDSs are generally from inadequate software quality and incorrect functioning of the device itself. These failures can lead to inaccurate or incomplete data transfer, storage, conversion according to preset specifications, or display of medical device data, resulting in incorrect treatment or diagnosis of the patient. Based on FDA's knowledge of, and experience with, MDDSs, FDA has determined that general controls will provide a reasonable assurance of safety and effectiveness of MDDSs, such that special controls and premarket approval are not necessary to provide such assurance.

The QS regulation is particularly important in our determination that general controls will provide a reasonable assurance of safety and effectiveness for the device. The QS regulation governs the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of devices and is intended to ensure that finished devices will be safe and effective (§ 820.1). Accordingly, as discussed in the proposed rule (73 FR 7498 at 7500 and 7501), the application of the QS regulation significantly reduces the risks of inadequate design and unreliable performance associated with an MDDS.

Specifically, the design control provisions (§ 820.30) that apply to the design of class I devices automated with computer software, especially the risk analysis required under § 820.30(g), will ensure that specified design requirements are met, thereby minimizing the risk of an MDDS inaccurately transferring, storing, converting according to preset specifications, or displaying medical device data.

Based on the preamble to the proposed rule, and the comments received in response to the proposed rule, FDA is now finalizing the reclassification of medical device data systems from class III to class I. This classification will be codified at 21 CFR 880.6310. To meet the definition of an MDDS under § 880.6310, a data system must be intended for the “transfer,” “storage,” “electronic conversion * * * in accordance with a preset specification,” or “electronic display” of medical device data, “without controlling or altering the functions or parameters of any connected devices.” This classification excludes any data systems with intended uses outside the scope of this rule, as further described in section III.B of this document.

FDA made some changes to the rule in response to the comments received. Specifically, FDA has revised the rule as follows:

Paragraph (a)(1) has been modified by moving the reference to “without altering the function or parameters of any connected devices” from paragraphs (a)(1)(i) through (a)(1)(iii) to introductory paragraph (a)(1) of the final rule. Furthermore, a reference to “controlling” was added, and “function” was revised as “functions.” These changes were made to avoid redundancy and to clarify that an MDDS can transfer data that controls a connected medical device not initiated by the MDDS.

Paragraph (a)(1)(i) has been modified to remove the reference to the “exchange” of medical device data by an MDDS. This reference was removed to clarify that the intended use of this medical device type is to act as a communication conduit through which medical device data can be transmitted. The word “exchange” could have implied a more active role in data generation or manipulation than that intended for this device type.

Paragraph (a)(1)(ii) has been modified to remove the reference to “retrieval.” FDA made this change because the role of an MDDS relating to data flow is adequately described by the reference to “transfer” functionality in paragraph (a)(1)(i). The MDDS can act as a communication conduit for sending and receiving medical device data.

Paragraphs (a)(1)(iii) and (a)(1)(iv) were reordered to place the conversion function before the display function. FDA undertook this organizational change to provide clarification of MDDS functionality and because this ordering is more logical and easier to follow. There is no substantive change intended from this reordering.

Paragraphs (a)(1)(ii) and (a)(1)(iii) have been modified to remove the words “from a medical device.” FDA removed these words to clarify that for purposes of the data storage and display functions, the direction the medical device data flows—to or from the MDDS—is not important.

Paragraph (a)(2), which in the proposed rule defined medical device data, has been modified. In response to requests for clarification concerning the acceptable system components of an MDDS, paragraph (a)(2) now provides a list of system components that may be included in an MDDS. FDA has determined that medical device data need not be defined in the rule itself. We are, however, providing clarification here regarding what constitutes medical device data. As stated in this final rule, an MDDS only communicates medical device data. For purposes of this rule, data that is manually entered into a medical device is not considered medical device data. However, if manually entered data is subsequently transmitted from a medical device as electronic data it will be considered medical device data. A device that then transmits that data or is intended to provide one of the other MDDS functions with regard to that data may be an MDDS. In response to requests for clarification, the use of “real time, active, or online patient monitoring” in the proposed rule has been replaced to indicate that an MDDS is not “intended to be used in connection with active patient monitoring.”

Paragraph (b) has been modified to exempt all MDDSs from premarket notification requirements (subject to the limitations on exemption in § 880.9). Based on comments received and a review of data compression features in MDDSs and similar device types, FDA has determined not to require premarket notification for MDDSs that feature irreversible data compression. In addition, the limitation on the scope ofthe premarket notification exemption to use by health care professionals has also been removed. Based on comments received and information FDA has gathered, FDA does not have reason to believe there is a potential unreasonable risk of illness or injury from an MDDS, even when used by someone other than a health care professional. Therefore, FDA is exempting MDDS devices from the premarket notification procedures in subpart E of part 807 (21 CFR part 807) (510(k) requirements), subject to the limitations in § 880.9.

The comment period for the MDDS proposed rule began on February 8, 2008, and remained open until May 8, 2008. The Agency received comments from 21 different organizations. Comments were received from device manufacturers and related companies; information technology companies and associations; trade organizations representing device manufacturers and other interested parties; professional associations and organizations representing health care practitioners; and health care and consumer advocacy organizations, including individual physicians and hospital/health care organizations.

In general, all the comments recognized the importance of regulating MDDSs as their own device type. The comments generally fell into the following four main categories: (1) Comments on the classification and exemption of the MDDS; (2) comments seeking additional explanation of the scope of the MDDS classification; (3) comments requesting clarification of terms used in the classification regulation; and (4) comments discussing other issues, such as the analysis of burdens and regulatory requirements.

(Comment 1) It was suggested that the MDDS should be classified as class II, rather than class I. The comment asserted that because MDDSs must send a signal to the medical device transmitting the data, this can increase the risks of the system. As such, this comment suggested that class II special controls, such as standardized formats and languages, in addition to general controls, were needed. One comment recommended that MDDSs be subject to performance standards related to data formats, interoperability, etc.

(Response) FDA disagrees that devices within the scope of this classification should be class II or that performance standards are required. The general controls, particularly the QS requirements, will provide a reasonable assurance of the safety and effectiveness of this device type. These are devices through which medical device data are passively transferred or communicated. In transferring or communicating the data, an MDDS by itself may not alter or control the functioning of any other medical device. Other devices with which an MDDS operates or to which an MDDS is connected may themselves be class I, II, or III devices, depending on their intended uses, and will need to comply with the controls and safeguards applicable to their classification. These controls will address any risks associated with the device's ability to function with data received from or sent to the MDDS. The information available to the Agency, including the comments provided, does not suggest that general controls are insufficient to provide a reasonable assurance of the safety and effectiveness of this device type or that special controls or performance standards are necessary. Because MDDS systems are so varied and these systems and their communication protocols change frequently, FDA believes that special controls would not be particularly effective. To emphasize the passive transfer or communication function of MDDS, however, the reference to the “exchange” function was removed from the rule. This term could imply that an MDDS may actively affect or manipulate the data of or from other devices. We believe the QS regulation and other general controls will provide a reasonable assurance of safety and effectiveness for this device type. The QS regulation requires that manufacturers ensure that devices perform as intended (through design, development, and other quality systems requirements) (part 820). The other general controls, such as labeling requirements and adverse event reporting, ensure that users have information necessary to use the MDDS, and that any problems that occur are reported to FDA (21 CFR parts 801 and 803).

(Comment 2) Comments were received seeking clarification of the term “health care professional” as used in reference to the premarket notification exemption for certain MDDSs in § 880.6310(b). Specific comments suggested that the term “health care professional” should not be limited to those performing medical treatment, but should also include managers, data entry clerks, and others who perform similar administrative tasks. Other related comments stated that the exemption from premarket notification should be extended to devices intended for all users, not just health care professionals, and to all prescription MDDSs. A few comments asked for clarification of whether use of a device to transmit medical device data from a patient device for physician review would be considered lay or professional use. One comment asked whether a system allowing lay users to view data at home, even when they cannot change the data and are not instructed to take any action, would require premarket notification.

(Response) FDA has reconsidered its position regarding requiring premarket notification for MDDSs when intended for use by someone other than a health care professional. FDA agrees that the exemption from premarket notification should be extended to an MDDS intended for any user, not just health care professionals. Under section 510(l) of the FD&C Act, a class I device may be exempt from the premarket notification requirements unless the device is intended for a use which is of substantial importance in preventing impairment of human health, or it presents a potential unreasonable risk of illness or injury. FDA refers to these criteria as “reserved criteria.” Based on the information received, FDA does not have reason to believe that an MDDS, when intended for use by someone other than a health care professional, would present an unreasonable risk of illness or injury. FDA bases this position on the absence of any reported adverse events or other data in the record to indicate that transferring, storing, converting from one format to another according to preset specifications, or displaying medical device data would pose an unreasonable risk when used by someone other than a health care professional. Therefore, we have determined that lay use of an MDDS, either to transmit data from a patient device or to present data to a patient (e.g.,for the patient to view the data from home), would not require premarket notification. However, FDA may decide to change the exempt status of MDDS in the future if, through normal reporting mechanisms or otherwise, FDA determines that the use of these devices by someone other than a health care professional poses an unreasonable risk of illness or injury. In response to the comments requesting clarification of the term “health care professional,” FDA is not defining this term because the term is no longer used in the regulation.

(Comment 3) Comments raised the question whether certain devices, such as glucose monitors, would be impacted by the exemption limitation under § 880.9(a), (b), and (c)(5).

(Response) This rule in not intended to change the regulation of glucose monitors, which would not be classified as MDDSs.

(Comment 4) Several comments asked for clarification on the intended uses of an MDDS. For example, one comment stated that the rule appeared to indicate there were two device types that fit under the MDDS classification: (1) Those that pass medical data from a source(s) to a destination(s); and (2) clinical user-focused devices that archive and/or display medical device data. Several comments recommended that particular devices, such as automatic backup systems, systems to automate workflow or provide workflow decision support, billing/claims systems, and systems that provide appointment scheduling, should be excluded from MDDS classification. One comment suggested that software functionality such as automating decision support protocols and guidelines, where the manufacturer provides the mechanism but the health care professional enters the detailed protocol information, should be excluded from MDDS classification. A few comments requested clarification with respect to “competent human intervention” from the 1989 Draft Software Policy in determining whether a device is an MDDS.

(Response) In response to these requests for clarification of the intended uses and functionality of an MDDS, FDA has revised the rule. Specifically, FDA has clarified that MDDSs are data systems that transfer, store, convert according to preset specifications, or display medical device data without controlling or altering the function or parameters of any connected medical device—that is, any other device with which the MDDS shares data or from which the MDDS receives data. A system that performs any other function or any additional function is not an MDDS. An MDDS acts only as the mechanism through which medical device data can be transferred, stored, converted, or displayed. An MDDS does not modify, interpret, or add value to the data or the display of the data. An MDDS does not add to or modify the intended uses or clinical functions that are already contained within the medical devices that provide data to (or receive data through) the MDDS. An MDDS by itself does not control the functioning of any other medical device. An example would be in the case of software that would alter the parameters on an infusion pump. The MDDS could pass that control signal to the infusion pump, but the MDDS could not initiate that signal. An MDDS can, however, control its own functionality. It can generate signals to establish and implement communication of medical device data. For example, if a system stores data and contains diagnostic functionality that allows it to perform clinical assessments or clinical monitoring, such as alarm functionality based on preset clinical parameters, that system is not an MDDS. At the same time, a device or system that does not transfer, store, convert, or display medical device data is also not an MDDS. Although we cannot determine, in the abstract, whether a particular workflow or billing system would be an MDDS, systems that do not receive or transmit data from a medical device (i.e., medical device data) would not meet the MDDS definition.

The 1989 Draft Software Policy was withdrawn as indicated in theFederal Registerof January 5, 2005 (70 FR 824 at 890). This final MDDS rule should be used for determining whether a device is an MDDS.

(Comment 5) Comments were received requesting clarification of the types of medical device data that can be transmitted via an MDDS. Specifically, one comment suggested that the type of medical device data transmitted via an MDDS be limited to the transmission of medical device data away from a medical device, so as to emphasize the Agency's position that the “report-writing functions of a computer system,” or manual entry of data, would not be considered an MDDS. Several comments suggested that an MDDS was only the device data system that interfaces directly with the device that generated the medical device data, whereas systems which receive the information subsequently would not be an MDDS. One comment suggested that software modules that retrieve, transmit, store, display, transfer, or exchange static representations of medical device data from an MDDS or other medical device are not medical devices.

(Response) FDA agrees that the term “medical device data” could be clarified with regard to the intended functionality of an MDDS. FDA considers medical device data to be any electronic data that is available directly from a medical device or that was obtained originally from a medical device. As FDA explained in the proposed rule, “It is FDA's long-standing practice to not regulate those manual office functions that are simply automated for the ease of the user (e.g.,office automation) and that do not include MDDS as described previously. For example, the report-writing functions of a computer system that allow for the manual (typewriter like) input of data by practitioners would not be considered as an MDDS, because these systems are not directly connected to a medical device” (73 FR 7498 to 7500). FDA agrees that any data manually entered into a medical device and not then electronically transmitted is not to be considered medical device data for purposes of this rule; MDDSs are not intended to capture report-writing functions of a computer system. If data that has been manually entered into a medical device is subsequently transmitted from the medical device as electronic data, however, this data will be considered medical device data. Medical device data can be communicated from any connected device, regardless of whether it is received directly from the originating medical device. For example, transmission of “static representations” of medical device data would not preclude a system (or device in that system) from being an MDDS. Accordingly, FDA has removed the words “from a medical device” from the proposed paragraph (a)(1) and has removed the language of proposed paragraph (a)(2) defining medical device data. This standard is not needed in the rule itself, and is being clarified in the preamble instead.

(Comment 6) One commenter asked FDA to clarify that an MDDS can exchange data between medical devices.

(Response) An MDDS is intended to be a communication conduit for medical device data. An MDDS does not create or generate any of its own data, including signals, to be sent to a medical device, other than data relating to the MDDS's own functioning (i.e., self-diagnosis or reports of malfunctioning). But, an MDDS may be used to transmit medical device data that originates from a source that is external to the MDDS either to, or away from, another medical device. To emphasize this intended function of an MDDS, the term “exchange,” in proposed § 880.6310(a)(1)(i) has been removed from the final rule. As stated in the final rule, an MDDS may transmit data between devices so long as it does not control or alter the functions or parameters of those devices.

(Comment 7) Several comments inquired whether Computerized Provider Order Entry (CPOE) systems and electronic prescribing systems would be regulated under the MDDS rule. Several comments also asked whether electronic health record products would be regulated under the MDDS rule. One comment suggested that electronic medical record productsused in the perioperative environment should be regulated as class II.

(Response) This rule is limited in scope to devices meeting the definition of an MDDS. It does not address, or consider, other device functionality or an intended use that is outside this definition. For instance, as noted in the proposed rule, “[t]his * * * regulation does not address software that allows a doctor to enter or store a patient's health history in a computer file” (73 FR 7498 at 7500). Moreover, as previously stated, manually entered data is not medical device data unless it is subsequently transmitted electronically. Thus, although we recognize that certain functions of an MDDS might be present in an electronic health record product, we expect electronic health record software generally falls outside the MDDS classification. Moreover, a device or system such as a CPOE system that, for instance, can order tests, medications, or procedures, would not meet the MDDS definition because its intended uses fall outside that definition's scope.

(Comment 8) Many comments asked whether systems already regulated under other specific device type regulations would fall under the MDDS regulation. Specifically, the comments inquired whether certain devices, such as a laboratory information system (LIS) classified as a calculator/data device processing module for clinical use under § 862.2100 (21 CFR 862.2100), or a picture archiving and communications system (PACS) classified under § 892.2050 (21 CFR 892.2050), would fall within the scope of the MDDS regulation.

(Response) FDA intends for the MDDS definition to be broad, to capture systems that feature the functions identified in this rule but that do not fall under another device type regulation. Numerous device classifications exist for products that perform data and information transfer, storage, display, conversion, and/or similar management functions. The MDDS classification only applies to devices that meet the MDDS definition and do not have additional functions that are outside the scope of an MDDS and that fall within an existing classification. An LIS and a PACS (§§ 862.2100 and 892.2050, respectively) are two device classifications that encompass functionality similar to an MDDS, but they have other specific intended uses or features that are outside the scope of the MDDS rule. A PACS may have similar functionality as an MDDS, but a PACS may perform digital processing, unlike an MDDS. Moreover, a PACS deals only with medical images, while an MDDS may deal with images and other medical data. A LIS, classified under the calculator/data processing module for clinical use regulation, may store clinical data; but a LIS is also able to process data, unlike an MDDS. Another device that is potentially similar to an MDDS is a medical image management system (MIMS), classified under the medical image communications device regulation (21 CFR 892.2020). But a MIMS transfers medical images, unlike an MDDS.

If a device meets the definition of a LIS or PACS or other already classified device, the device is within that device type and is regulated accordingly, even if one or more of its intended uses might overlap with the MDDS classification. FDA is not aware of any currently marketed PACS, LIS, or MIMS devices that have the intended use of an MDDS and no other intended uses. If a manufacturer believes its PACS, LIS, or MIMS device meets the definition of an MDDS, it should contact FDA.

(Comment 9) One comment requested clarification regarding the reference in the proposed rule to an MDDS not containing any “new or unique” algorithms, and asked whether a combination of existing algorithms or functions would be considered new or unique. Some comments inquired whether APACHE Medical Systems or Apgar scores would be considered a clinical decision support system.

(Response) For the purposes of this rule, any functionality or algorithms supporting intended uses that are not included in this rule's definition of MDDS would be considered “new or unique.” This MDDS rule does not address whether APACHE or Apgar Scoring would be considered clinical decision support systems. FDA expects that systems such as APACHE decision support systems and software-based Apgar scoring systems generally would perform functions that are outside the scope of an MDDS. MDDSs are intended to perform only certain functions: Transferring, storing, converting in accordance with a preset specification, or displaying medical device data. Any functionality such as processing, characterizing, categorizing, or analyzing the data would be outside the scope of an MDDS. Furthermore, systems that perform any clinical or medical diagnostic function are not considered MDDSs.

(Comment 10) Other comments raised questions regarding whether a database that flags certain data or prioritizes data, or a system that creates data plots or graphs, would be considered an MDDS. Another comment suggested that systems that trend raw data over time could still be an MDDS. One comment asked whether a system that emails a physician when medical data fits pathologic patterns or a system that presents medical data with analytic pattern fit statistics can be an MDDS.

(Response) An MDDS has intended uses that are limited to transmitting, storing, converting according to a preset specification, and displaying data. FDA considers flagging (via email or otherwise), analyzing, prioritizing, plotting, or graphing data to be additional uses that add value or knowledge to the existing data and thereby exceed the limited functionality of an MDDS. An MDDS with a display function is intended only to display data in the same form in which the data was received from a connected medical device. Use of an MDDS for conversion is limited to translation, so that data can be viewed or transmitted in the same form that it was received by the MDDS. An MDDS can convert data into different languages, so that devices or equipment from different vendors can share information. An MDDS cannot, however, interpret the data or change the form in which the data was received by the MDDS. For example, an MDDS could convert data to or from the HL7 format, so that data provided from a connected medical device in spreadsheet form could be displayed in spreadsheet form by the MDDS or another connected device. But numerical data from a medical device connected to an MDDS could not be displayed graphically by the MDDS, nor could the MDDS display graphic data in spreadsheet form or otherwise in a different graphic form.

(Comment 11) FDA received comments inquiring as to the scope of the phrase, “without altering the function or parameters of any connected devices,” in proposed § 880.6310(a). Commenters also asked whether a system that sends data to an infusion pump to control the flow rate, updates clock time on a connected device, sends software updates to, or updates database information embedded in, a connected device would be considered an MDDS.

(Response) As previously described, the language that is the subject of these comments has been slightly modified in the final rule, primarily by adding reference to not “controlling” such functions or parameters and moving this language up to the beginning of paragraph (a). A system that initiates the data or generates the control signal to an infusion pump to control the flow rate would not be an MDDS because, as the revised final rule indicates, generation of data is not an intended use for an MDDS and an MDDS performs itsintended uses without “controlling or altering the functions or parameters of any connected devices.” FDA considers a device to control or alter a connected device if, among other things, it generates a signal or other data that controls or alters the functioning of the connected device. Therefore, an MDDS could transfer a signal or other data from an initiating device to the infusion pump in the situation described in the comment. As the final rule states, an MDDS by itself cannot control or alter the parameters or functions of a connected medical device. Rather, the MDDS can be used to transfer data from a non-MDDS initiating device, which when received, will alter the parameters of a connected device. The product that initiates the alteration of the device function would be a medical device that is classified separately from the MDDS. Similarly, any software, or corresponding information technology (IT) system, that issues or creates data or system changes, including the clock time, or modifies any control parameters of any connected device, such as software updates or database information, is not an MDDS.

(Comment 12) Some comments asked whether generation of an email message, or conversion to Hypertext Markup Language (HTML), Portable Document Format (PDF), Health Level 7 (HL7), or similar format, would be considered equivalent to generating a printable format. As described in the proposed rule, “A medical device data system (MDDS) is a device intended to provide one or more of the following uses: * * * [t]he electronic conversion of medical device data from one format to another format in accordance with a preset specification. For example, this would include software that converts digital data generated by a pulse oximeter into a digital format that can be printed.” (73 FR 7498 at 7499 and 7500).

(Response) FDA agrees that an MDDS may convert medical data “from one format to another format in accordance with a preset specification” (§ 880.6310(a)(1)(iii)). A preset specification is a standardized translation of data from the format in which it was received from a medical device to another format in which the data are stored, displayed, or transferred by the MDDS. For example, this may include conversion of data to HTML, PDF, HL7, or similar format. An MDDS may not otherwise convert, alter, modify, or interpret the data that is received from a medical device, and may not change the form in which the data is stored, transferred, or displayed (e.g.,from a graph to a spreadsheet).

(Comment 13) FDA received several comments inquiring whether different formats met the definition of “display.” In one comment, FDA was asked to explain whether a “viewer,” which a practitioner can use to review and confirm clinical results for the purpose of patient treatment, would be considered a “display.” Other comments raised the question whether monitors and computer terminals that display medical device data would be considered MDDSs. Still other comments asked FDA to clarify that medical devices with display screens are not MDDSs.

(Response) As stated in this document, systems with display functioning can be considered an MDDS, so long as the device meets the other parts of the MDDS definition; devices would not qualify as an MDDS merely because they have a display screen. As identified in the proposed rule, and discussed elsewhere in this final rule, an MDDS does not include systems that have intended uses for clinical functioning or active patient monitoring. As long as a device with a viewer performs only those functions in the MDDS definition, it would be an MDDS.

(Comment 14) Another comment raised the question whether a device with a data display that overlaid, or superimposed, images would be considered an MDDS.

(Response) FDA cannot determine whether this would be an MDDS without additional information about the device. The device's classification would depend on whether its intended uses were limited to those of an MDDS, including the display of medical device data and converting medical device data according to preset specifications. FDA would also need to determine whether the display functionality provides an additional layer of diagnostic support to the health care professional, such as active patient monitoring, which is not an intended use for an MDDS.

(Comment 15) Many comments asked whether various system constructions and components, in general, would be regulated as MDDSs under § 880.6310. Several comments asked whether “off-the-shelf” software, wireless systems, backup systems, third party equipment, or interfaces would be considered MDDSs.

(Response) FDA has defined an MDDS as a system that transfers, stores, converts according to preset specifications, or displays medical device data. By themselves, any system, or component of a system, that is solely intended for use as general IT equipment (and that is not intended for a device use under section 201(h) of the FD&C Act), would not be considered a medical device.

FDA recognizes that an MDDS, as a system, can consist solely of software, or can feature additional components constructed in many different ways. Such a system can include software, hardware, and the intended architecture, as well as any interfaces and functions of connected devices. Due to the wide variations among these systems, FDA cannot ascertain based on the comments whether specific system constructions or components would meet the definition of an MDDS. To better convey the scope of what FDA considers an MDDS, however, FDA has clarified the rule to indicate that “[a] medical device data system (MDDS) may include * * * a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol” (§ 880.6310(a)(2)). When the system is validated under the QS regulation (§ 820.30(g)) and in assessing the safety and effectiveness of the device, the entire system, including all components, is considered.1

(Comment 16) Many comments requested clarification on whether a product used with medical devices, such as a glucose meter, blood pressure cuff, or spirometer, is an accessory to a previously classified device, an accessory to an MDDS, or a component of an MDDS. A few comments requested clarification on when software developed to operate with a specific device becomes an accessory to that device, regulated under the principal device's classification, and when it remains an MDDS subject to the MDDS rule. One comment noted that FDA has cleared medical device data software for devices such as glucose meters, blood pressure cuffs, and spirometers as accessories to those devices. One comment suggested that software developed to interface only with a particular device be regulated as an accessory to that particular device type, whereas a product intended to be used with generic/multiple types of devices be regulated as an MDDS. The comment further suggested that labeling for MDDS devices that support generic/multiple device types not be prohibited from specifying particular medicaldevices with which MDDS software is compatible.

(Response) As indicated in the classification regulation, an MDDS has limited intended uses. In general, these intended uses include the passive transfer or communication of medical device data without controlling or altering the functions or parameters of any connected medical devices. As such, any product that is a medical device, and that supports a function outside the scope of an MDDS intended use, would not be considered an MDDS. If the product meets the definition of an MDDS because it is limited to the intended uses of an MDDS, FDA will regulate such a product as an MDDS, not as an accessory to or component of another device, regardless of how many particular devices or device types the product supports. FDA recognizes that some devices that meet the definition of an MDDS may have been previously cleared as accessories to other device types. Through enactment of this regulation, devices that are considered MDDSs will now be classified as class I, Exempt, whether they are existing devices or new/modified devices that are now defined as MDDS. If some of the intended uses of a device fall outside the scope of the MDDS regulation, then the device would not meet the definition of or be regulated as an MDDS. Finally, the specific content of MDDS product labeling is outside the scope of this rule, and is governed by part 801.

(Comment 17) Several comments requested clarification of the term “irreversible data compression.” A few comments requested clarification on whether rounding errors, type conversions, or a loss of fidelity less than the margin of error in the data represented irreversible data compression. Another comment regarding exemption from premarket notification stated that FDA should require premarket notifications for MDDSs that perform “irreversible data compression” only when the MDDS performs irreversible data compressions that can lead to a patient safety risk.

(Response) After reviewing the comments and reviewing device classifications that are potentially similar to the MDDS, FDA has removed the distinction regarding irreversible data compression from the final rule. The safety and effectiveness concern with regard to irreversible data compression is that compressed output data is not an exact replica of the input data. Based on comments received and a review of data compression features in MDDSs and similar device types, FDA has determined not to require premarket notification on the basis of irreversible data compression. FDA has concluded that general controls are sufficient to ensure that any data compression features will not undermine the safety and effectiveness of the device in these circumstances.

(Comment 18) Some comments asked FDA to better define the term “sound an alarm” as used in the proposed rule to characterize a function that an MDDS cannot perform. Other related comments asked about the permissible scope of alarm capabilities of an MDDS. For example, it was suggested that the prohibited alarms be defined as alarms that require positive acknowledgement, cancellation, or clinical impact. Several comments suggested that the definition of an alarm in the MDDS regulations should be consistent with the International Electrotechnical Commission definition (IEC 60601-1-8). Other comments suggested that an MDDS should be permitted to create and detect alarms for low priority physiological conditions. Many comments also noted that if MDDSs could not include an alarm, that would mean an MDDS could not include a signal that the MDDS was malfunctioning. Several comments requested clarification on whether transmitting alarm conditions, including high-priority, real-time alarms, without providing any notification to the user, was acceptable for an MDDS. One comment asked whether displaying the content and timing of an alarm as part of a historical record would exclude a device from the MDDS classification.

(Response) After considering the comments, FDA has removed the term “sound an alarm” from the final regulation. FDA agrees with the comments that an MDDS should be able to include alarms related to its own operational status, such as an alarm announcing a malfunction. FDA recognizes that functions that allow an MDDS to monitor its own operational status are critical to mitigating the risks associated with this device type. Accordingly, FDA considers alarms that monitor the operational status of an MDDS to be an acceptable function within the definition of MDDS.

FDA has further clarified in the final rule that an MDDS excludes any system that does more than transfer, store, convert according to preset specifications, or display medical device data without controlling or altering the functions or parameters of a connected medical device. A device data system that facilitates clinical assessments or monitoring, such as alarm or alert functionality based on preset clinical parameters (including low priority physiological conditions) is not an MDDS. It is permissible for an MDDS to transfer any type of data, including alarms, without analysis or specific recognition of the intent or significance of that data. An MDDS may therefore display or store the content and timing of an alarm generated by a connected device, in the same format as the data was received from the originating device, as part of a historical record.

(Comment 19) Several comments asked FDA to define “real time, active, or online,” and recommended that the MDDS classification should exclude monitoring of data critical to the timely care of the patient, without regard to the time required to process data. Other comments suggested that “real time, active, or online patient monitoring” was confusing and would exclude from the MDDS classification devices intended to transmit medical device data to a physician for the purpose of performing remote patient examinations.

(Response) FDA agrees with the recommendation in the comments with reference to “real time, active, or online patient monitoring”. We have modified the rule to include the word “active” to represent any device that is intended to be relied upon in deciding to take immediate clinical action. A device intended to be used for active patient monitoring (or decision support) is not an MDDS. There are existing classifications for patient monitoring devices.2 The detection, measurement, or recording of patient data and other functions of a patient monitoring device are outside the scope of an MDDS. Moreover, as a class I device, an MDDS is not intended to be used in connection with active monitoring that depends on the timeliness of the data transmission, because an MDDS is not subject to controls relating to the speed of transmission and conversion. Any device that transmits, stores, converts, or displays medical device data that is intended to be relied upon in deciding to take immediate clinical action or that is to be used for continuous monitoring by a health care professional, user, or the patient is not an MDDS. Such devices are generally accessories to other devices. FDA has changed the final regulation to state that an MDDS“does not include devices intended to be used in connection with active patient monitoring.”

(Comment 20) Comments inquired how FDA would implement this regulation. These comments inquired as to the deadline for submitting premarket notifications and complying with registration and listing requirements. Several commenters requested an extension of 18 to 24 months for manufacturers to comply with the QS regulations and other controls, because many of the affected entities, such as hospitals acting as MDDS manufacturers, will be creating compliant processes and systems from scratch. Additional related questions pertained to the enforcement of the regulation. Specifically, comments expressed concern with how health care facilities would be regulated, and suggested that a longer period of time be permitted for these facilities to register and list the device, as well as to comply with the QS regulations. One comment requested clarification on how the term “legally marketed” would be interpreted by FDA in determining whether retrospective design controls would be required, given that no MDDS devices have received premarket approval (PMA), as would be required prior to issuance of this final rule in order to have been legally marketed. The comment further suggested that the limitations on 510(k) exemptions under § 880.9 are not applicable provided that the results from the connected device are not displayed to the user.

(Response) FDA recognizes that some MDDSs already on the market are not currently manufactured in accordance with QS and Medical Device Reporting (MDR) requirements. As further discussed in section IV of this document, all manufacturers of MDDSs, including any health care facilities acting as manufacturers, will be required to comply with this regulation, which will become effective 60 days after the date of publication in theFederal Register. FDA expects manufacturers of an MDDS to register and list the device by 90 days after the publication date of this final rule in theFederal Register. FDA expects that all MDDS manufacturers will have established a compliant quality system and MDR system for their devices within 12 months after the effective date of the final rule. Particularly, FDA expects all MDDS manufacturers to establish and maintain adequate design controls as part of their quality system. The Office of Compliance will use existing policies and procedures, such as Form FDA 483 “Inspectional Observations,” warning letters, and other established mechanisms in the regulation of MDDS manufacturers. FDA does not intend to enforce design control requirements retroactively to any currently marketed device that would be classified as an MDDS under this rule; however, FDA does intend to enforce design control requirements for design changes to a currently marketed device once there is a design change. See response to Comments 2 and 17 regarding premarket notification requirements. FDA does not agree that because an MDDS device cannot display results to the user it would always be exempt from 510(k) requirements (i.e.,would not be subject to the regulatory limitations on exemptions in § 880.9). MDDSs may be subject to premarket clearance requirements if they exceed the limitations on exemptions (§ 880.9).

(Comment 21) Comments were received from hospital systems and other organizations, inquiring whether certain entities would be subject to the MDDS regulation. Specifically, some comments asked FDA to exclude manufacturers from this regulation if they are not in the business of marketing or selling devices, software, or software components. Other comments asked whether a health care facility or other purchaser that modifies MDDS software or hardware purchased from a vendor would be considered a manufacturer. A few comments noted that it is the customer, and not the manufacturer, who often decides whether MDDSs are connected to other MDDSs or other medical devices, and how these systems interact.

(Response) This final rule establishes the classification and regulatory controls applicable to an MDDS. Manufacturers of MDDSs must comply with these regulatory controls. Manufacturers of software systems or other products that do not have intended uses covered by the MDDS classification would not be subject to this rule. A purchaser of an MDDS who has only used, configured, or modified the MDDS in accordance with the original manufacturer's labeling, instructions for use, intended use, original design, and validation would not be considered a manufacturer for purposes of this regulation. If, however, a user makes any modifications to the MDDS that are outside the parameters of the original manufacturer's specifications for the device, for purposes of the user's clinical practice or otherwise for commercial distribution, that user becomes a manufacturer under the MDDS rule, and as a result is subject to applicable device regulations, including registration and listing and the QS regulation. Likewise, if a user reconfigures any other product into an MDDS for such purposes, that user would also be a device manufacturer subject to applicable regulations. This is consistent with FDA's current definition of a “manufacturer” for purposes of the MDR system, establishment registration and device listing, reports of corrections and removals, and QS regulations (parts 803, 807, 820, and 21 CFR part 806).

(Comment 22) Some comments asked whether a health care facility or other purchaser that buys software or hardware that has not been labeled or otherwise denoted as an MDDS, and that then subsequently utilizes the software or hardware for functionalities within the scope of this MDDS regulation, will be considered a manufacturer. A few comments asked whether device communication protocols incorporated by third-party companies or custom interfaces developed by hospitals would fall within the scope of the MDDS classification.

(Response) For clarity, we interpret the comment to presume that the software or hardware is not modified after purchase. A health care facility or other purchaser that buys software or hardware that has not been labeled or otherwise denoted as an MDDS, but is used as an MDDS, is not considered to be a manufacturer. If, however, the purchaser adds to or modifies any hardware or software such that the software is intended to provide the transfer, storage, conversion according to preset specifications, or display of medical device data (or otherwise modifies the product to render it a medical device) and uses it in clinical practice, the purchaser becomes a device manufacturer in accordance with § 807.3(d). If a third-party company or hospital develops its own software protocols or interfaces that have an intended use consistent with an MDDS, or develops, modifies, or creates a system from multiple components of devices and uses it clinically for functions covered by the MDDS classification, then the entity would also be considered a device manufacturer.

(Comment 23) One comment sought clarification of the applicability of the QS regulation, specifically the applicability of design controls, to an MDDS. A few comments noted that upon issuance of the final rule on MDDS, § 820.30(a)(2)(ii) will need to be updated to add MDDSs.

(Response) The MDDS, at its most basic composition, could be softwarethat automates a system. Accordingly, even though many class I devices are exempt from the design control requirement, the MDDS is already subject to design controls under § 820.30(a)(2)(i) because MDDS devices are automated with software. Manufacturers of MDDSs therefore must comply with these design control requirements, as outlined in section IV of this document.

(Comment 24) A few comments inquired as to how to meet the MDR requirements for MDDSs. Specifically, one comment pertained to whether all MDDS problems should be reported, and asked whether a hospital is responsible for MDRs only for MDDS software problems, or also for problems that may be due to hardware on which MDDS software is running. The comment further asked whether MDDS problems related to malware or viruses should be reported. Another comment asked whether hospitals were responsible for reporting MDDS MDR events even when they cannot be sure which specific MDDS created the reportable event. This comment further referred to existing custom hospital software that meets the definition of an MDDS, and asked whether MDRs would be required for these systems and whether problems detected during upgrades to such systems would be reportable. One comment also recommended the development of a health IT complaint reporting system.

(Response) Manufacturers, including hospitals that develop custom systems that meet the definition of an MDDS, must comply with the MDR requirements in part 803. This reporting obligation applies to events in which a medical device has or may have caused or contributed to a death or serious injury, as well as certain device malfunctions. This rule does not affect a manufacturer's obligations under part 803. Additionally, a device user facility, as defined in § 803.3 to include hospitals, is required to report device-related deaths and serious injuries. This reporting should include all available information on the MDR event, including any information about the role that malware or viruses may have played in the event. As discussed previously, purchasers, including hospitals, are subject to MDR requirements applicable to manufacturers concerning an MDDS to which the hospital has added to or modified any hardware or software. The same requirements apply to hospitals that develop their own software protocols or interfaces that have an intended use consistent with an MDDS. Hospitals that use MDDSs without engaging in these manufacturing activities must report in accordance with the requirements for user facilities. FDA does not currently have any plans for specialized reporting systems for MDDSs.

(Comment 25) Several comments requested clarification on how multi-purpose or modular software and devices would be handled with regard to the MDDS rule. For example, one comment recommended that devices with both diagnostic/therapeutic functionality and MDDS functionality could be partitioned such that the MDDS functionality could be modified without having to submit for premarket review. One comment suggested that separable stand-alone software modules capable of independent operation should be regulated individually based on the intended use of that module, whereas modules that are not intended to operate independently, would be regulated based on the intended use of the entire software system. One comment suggested that devices that comprise a virtual system—for example, a blood pressure cuff that can transmit information used with a cell phone that can receive such information—be regulated independently, and that the combination of such devices should not result in a new device.

(Response) The MDDS regulation does not necessarily prevent modular implementation. Because of the various ways in which an MDDS may be configured and integrated with other medical devices and the potential effect of new configurations on functionality and intended use, it is not possible for FDA to make generalized determinations on whether an MDDS or related software module would require premarket review, nor can FDA determine whether the combination of multiple devices would result in a new device requiring premarket review absent further information about the specific devices. The previous responses to comments regarding accessories and components provide guidance on how particular parts of a system would be regulated under the MDDS rule. Manufacturers should contact FDA regarding questions about regulation of specific devices.

(Comment 26) One comment recommended that FDA provide education sessions and written materials on implementing the QS regulation for MDDSs. Another comment suggested revision to the 1989 Draft Software Policy or the development of new guidance specifying products excluded from MDDS classification, and a methodology for clarifying the regulatory status of products that are excluded.

(Response) FDA believes this final rule and preamble provide an adequate description of the MDDS classification, but FDA will consider providing training and other educational outreach to MDDS manufacturers and users. FDA provides numerous resources to entities seeking guidance on compliance with the QS regulation. The FDA Web site provides device advice and training modules specific to the QS regulation. In addition, manufacturers may contact the Division of Small Manufacturers, International and Consumer Assistance for assistance with QS regulation compliance questions. As previously indicated in section I.C of this document, the 1989 Draft Software Policy has been withdrawn.

(Comment 27) A few comments suggested that FDA hold public hearings/workshops on the proposed regulation to provide clarification on the definition of MDDS and what devices are excluded from the classification, as well as a public forum for discussing the benefits and risks of MDDS systems. A few comments suggested that the comment period for the proposed rule should be extended.

(Response) In issuing this regulation, FDA followed the required rulemaking process (§ 10.40 (21 CFR 10.40)). Through this process, we published a notice of the proposed rule and provided a 90-day public comment period, which is longer than the required 60-day timeframe (§ 10.40(b)(2)). In response, we received comments from 21 organizations, and made several changes to the rule, as noted. Having provided sufficient opportunity for public comment and having weighed those comments, FDA finds no basis for delaying implementation of this rule for an additional comment period. Furthermore, FDA has no plans for public hearings or public forums at this time. FDA is finalizing this rule without a public meeting based on the substantial substantive and constructive comments received during the comment period. As a result, we do not believe a public meeting would add any additional constructive input that would merit delaying implementation of the rule.

(Comment 28) One comment suggested that FDA should perform a study to identify those MDDS systems that present the greatest risk in order to more clearly define categories for possible regulation. The comment further suggested that the MDDS regulation should only apply to software that presents patient safety risk asidentified by the proposed study. Another comment suggested that FDA determine the potential impact associated with low-risk MDDS systems on patient safety before implementing the regulation.

(Response) FDA believes that all MDDS devices present some patient safety risk. FDA has determined that MDDSs can be regulated as class I devices, however, because general controls, particularly those contained in the QS regulations, provide sufficient regulatory safeguards to provide a reasonable assurance of safety and effectiveness for this device type. FDA did not receive information from the comments or other sources suggesting that there are other categories of MDDS that are high risk and, therefore, FDA does not believe that there is any need to conduct a more elaborate study or categorization of MDDSs for purposes of this regulation.

This rule will become effective 60 days after the date of publication of the final rule. All MDDS manufacturers will be expected to register electronically and list under part 807 within 90 days of the publication of this final rule in theFederal Register. FDA expects all manufacturers of MDDSs to develop and implement a compliant quality system and comply with Medical Device Report requirements within 12 months of the effective date of this regulation.

The Agency has determined under 21 CFR 25.34(b) that this reclassification 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.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action under the Executive order.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. As FDA explained in the proposed rule, FDA has been exercising enforcement discretion up to now with respect to class III requirements on MDDSs, but ongoing enforcement discretion may not be a viable long-term regulatory alternative (73 FR 7498 at 7501 and 7502). Because this rule is therefore deregulatory, creates no new burdens in addition to those that exist already under the FD&C Act, and will relieve manufacturers of the cost of complying with existing legal requirements applicable to Class III devices in the future, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $135 million, using the most current (2009) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

An MDDS is a device that electronically transfers, stores, converts according to preset specifications, or displays medical device data. It does not provide any diagnostic or clinical decisionmaking functions. It does not modify data or the display of data. The MDDS device is currently classified into class III, the highest level of regulatory oversight. The MDDS was initially placed in this classification by default.

We published a regulatory impact analysis as part of the proposed rule in theFederal Registerof February 8, 2008. In that analysis, we described that in the absence of continuing enforcement discretion, changing the classification for an MDDS from the default class III (premarket approval) to class I (general controls) would be deregulatory. The cost of complying with the requirements for general controls under class I is a small fraction of the cost of complying with the premarket approval requirements under class III. MDDS manufacturers, as makers of class III devices, bear all costs associated with premarket approval, including the cost of submitting the premarket approval application (PMA) and payment of user fees. The costs associated with the submission of the PMA are substantial, potentially reaching $1,000,000.

In the analysis accompanying the proposed rule, we requested information on the size of the MDDS industry, but received no comments on that issue. FDA did receive seven comments on the regulatory impact analysis.

(Comment 1) There were three comments asserting that the costs of compliance for large health care organizations could be greater than what had been estimated in the proposed rule and would be a burden to some of these organizations. One of these comments stated that if the definition of an MDDS was overly broad, compliance costs could be in excess of $100 million.

(Response) FDA believes the comments misinterpret the definition of an MDDS. The comments reference systems of Electronic Health Records (EHRs) and Personal Health Records (PHRs). Although an EHR or PHR system, or a portion of such a system, may constitute a medical device, these are explicitly excluded from this rulemaking. This rule only addresses those medical devices that meet the MDDS definition. Moreover, health care organizations purchasing off-the-shelf software and using this software according to the product labeling will not be subject to regulation. In any event, a narrower MDDS definition could render more devices subject to the more burdensome class III requirements.

(Comment 2) There were three comments citing published data to claim costs of compliance could be substantially greater than estimated in the proposed rule and that the burden could be expected to exceed the threshold amount of $135 million.

(Response) FDA believes the cited estimates do not apply to this rulemaking because the source analysis projects burdens associated with EHR, PHR, and radiology information systems (RISs). EHR and PHR systems are not included in this rulemaking, and RIS are already regulated and would not be affected by this final rule. Moreover, the burden of complying with class III requirements is significantly greater.

(Comment 3) A comment asked that FDA include in its Analysis of Impact an estimate of costs associated with developing and implementing the necessary systems to ensure compliancewith FDA's MDR requirements, as many MDDS manufacturers are non-traditional medical device manufacturers. The comment noted that IT companies could have products being used in both MDDS and non-MDDS applications.

(Response) In the analysis of impacts in the proposed rule, FDA estimated costs of complying with FDA's QS and MDR regulations. Although specific requirements may initially be unfamiliar to some manufacturers, FDA believes most manufacturers' existing quality systems would need only minimal modification to bring them into compliance, if they are not already. FDA notes that IT companies selling equipment marketed for general IT use and not marketed for MDDS intended uses would not be subject to MDDS regulation, whether or not the product may be used in an MDDS application. FDA reiterates that the cost of complying with QS and MDR regulations is not a burden imposed by this rulemaking. These are burdens that manufacturers already incurred, notwithstanding FDA's exercise of enforcement discretion with regard to manufacturers of MDDS devices.

FDA's initial estimate of a one-time cost to comply with FDA's QS and MDR regulations assumes that manufacturers already have quality practices in place, including complaint-handling systems. FDA is not aware of any MDDS manufacturers lacking good business practices, including quality systems. Nevertheless, FDA cannot be sure of the extent to which all manufacturers have in place quality systems that can be easily modified to meet the requirements of QS and MDR regulations. Costs to a manufacturer would depend on the state of its quality systems, but would likely be less than $20,000 for the manufacturer to bring its quality system into compliance. Total costs could exceed $20,000 if the manufacturer also needed to hire a full time employee to manage the quality system. If a firm does not have any quality system, FDA estimates it would incur a one-time cost of less than $20,000 to establish the appropriate procedures, and would then likely need to hire a full time employee to manage the quality system. Comments to the proposed rule estimated an additional employee with regulatory compliance subject matter expertise to cost $143,000 annually, including salary and benefits. The estimated cost to a firm without a quality system would therefore be an initial amount up to $20,000 to establish the system and then $143,000 annually thereafter. Of course, these would not be burdens associated with this rulemaking; they are existing burdens that a manufacturer already faces notwithstanding FDA's decision to exercise enforcement discretion up to this point.

(Comment 4) A comment claimed that the exclusion of decision support functionality from MDDSs would place a large number of devices into class II, increasing the regulatory cost to industry.

(Response) FDA disagrees with this comment. This final rule will not change the classification of any devices other than MDDSs, and serves only to reduce the statutory and regulatory burdens associated with devices in the MDDS classification.

(Comment 5) A comment asked that FDA conduct an analysis of the impact of the proposed rule on existing MDDS manufacturers, including an assessment of risks and benefits and the costs of compliance.

(Response) This analysis considers the impact of the rule on MDDS manufacturers, and we have considered the comments received on this topic. As previously discussed, this final rule will move MDDS devices from class III to class I, and thus to a less costly set of requirements. As a result, this action is relieving manufacturers of burdens they would otherwise bear.

Through this final rule, FDA will reclassify MDDS devices from the class III default to class I. The application of general controls, including the software design controls in part 820, will be consistent with the principle of applying the least degree of regulatory control necessary to provide reasonable assurance of safety and effectiveness. The application of this lowest level of regulatory oversight will be consistent with the treatment of other devices with similar risk profiles. Software used to store, transmit, and communicate patient medical data, such as LISs and Medical Image Communication Systems, is typically classified into class I.

FDA has already recognized that the class III requirements are not necessary for ensuring the safety and effectiveness of MDDS devices and has been exercising enforcement discretion with MDDS device manufacturers. These firms have not been required to submit PMAs or meet other requirements typically required of manufactures of class III devices. The Agency believes all or nearly all firms in this industry have in place good business practices, including quality systems. If FDA were to discontinue enforcement discretion, most firms would comply with the class I provisions.

This final rule is deregulatory. Device manufacturers currently subject to class III requirements will be subject to the less burdensome requirements for the makers of class I devices. Of course, changing the device classification may not have any financial impact on the practices of MDDS manufacturers if FDA were to continue its practice of enforcement discretion and to the extent such manufacturers are not already complying with the class III requirements. For the purposes of this analysis, however, we recognize that continued exercise of enforcement discretion will not be permanent. The regulatory alternatives are therefore the class III, class II, or class I controls, enforced by the Agency consistent with the FD&C Act. This final rule will re-classify MDDS devices as class I, which will reduce the applicable regulatory requirements.

Manufacturers of class I devices are required to follow general control requirements, which include: (1) Register and list their MDDS devices with the Agency, (2) conform to applicable medical device current good manufacturing practice requirements (part 820), and (3) comply with MDR requirements (part 803). This final rule exempts MDDS devices from premarket notification unless they exceed the limitations on 510(k) exemptions found in § 880.9.

The majority of MDDS manufacturers will incur a cost to register and list their devices with the Agency. We estimate this burden to be less than 1 hour per year for manufacturers familiar with this requirement, and up to 2 hours per year for manufacturers not currently producing any FDA-regulated devices (and therefore unfamiliar with the requirement). Manufacturers will also face user fees of $2,179 in fiscal year (FY) 2011 to register and list their devices with the Agency. These fees will rise to $2,364 in 2012. These fees do not represent a cost imposed by this final rule, but a cost that manufacturers may not have yet incurred because of FDA's practice of enforcement discretion with manufacturers of MDDS devices.

Based on experience with the MDDS and similar devices, FDA believes that most manufacturers of these devices already have quality systems in place as part of good business practices. Goodquality systems would include complaint-handling procedures. FDA's QS requirements are flexible and FDA believes that these manufacturers will be able to conform their systems to FDA requirements with little difficulty or cost. Manufacturers are already required to report to FDA whenever they learn that their device may have caused or contributed to a death or serious injury to a patient. The costs of complying with these requirements will be relatively small, but will vary depending on the number and nature of the devices manufactured and the state of the firm's existing quality system. Based on our understanding that the industry generally has in place measures to ensure quality, we believe most firms will be able to adapt their systems to meet FDA's QS and MDR regulations for not more than $20,000. This cost would not be imposed by this final rule; it is an existing burden that manufacturers may not have fully incurred because of FDA's exercise of enforcement discretion with manufacturers of MDDSs.

Because manufacturers have not been required to register and list, we cannot be positive all firms have existing measures to ensure quality, and we cannot rule out the possibility that some manufacturers will face greater costs. If a manufacturer has no quality system in place, we estimate that it would cost less than $20,000 to establish a quality system plus the annual cost of a full-time employee to manage such a system. Comments to the proposed rule estimated the cost of such an employee, including benefits, to be $143,000 per year.

With the issuance of this final rule and the classification of MDDSs into class I, a manufacturer of an MDDS would not need to comply with the PMA requirement that applies to class III devices or submit a premarket notification. For those MDDSs that exceed the limitations on 510(k) exemptions found in § 880.9, the required premarket notification for an MDDS will be far less complex than submission of a PMA. The cost of preparing and submitting such a notification would be several thousand dollars. The user fees for a premarket notification would be $4,348 for FY 2011, increasing to $4,717 in 2012. In contrast, the cost of submitting a PMA can reach $1,000,000, plus user fees of an additional $236,298 in FY 2011, increasing to $256,384 in FY 2012.

In summary, this device reclassification final rule will substantially reduce an existing legal burden on the manufacturers of MDDSs. The burden of compliance with the general controls provisions applicable to the manufacturers of all class I devices is attributable to statutory requirements that already apply but in the past have not been enforced for MDDSs. Because continued exercise of enforcement discretion may not be a viable long-term regulatory alternative, this final rule reduces the ultimate regulatory burden for manufacturers of MDDSs. Considering the cost of submitting a PMA plus the relevant user fees, the reduction could be $1,000,000 per device.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because reclassification of the affected devices from class III to class I will relieve manufacturers of the cost of complying with the premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e), the Agency certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects 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. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows:

PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974.

PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for March 2011.1

The March 2011 interest assumptions under the benefit payments regulation will be 2.50 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for February 2011, these interest assumptions are unchanged.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during March 2011, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply.See5 U.S.C. 601(2).

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because immediate action is needed to provide for the safety of life and property on navigable waters. Because of the dangers posed by the surf conditions during the Mavericks Surf Competition, the special local regulation is necessary to provide for the safety of event participants, spectators, spectator craft, and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. Any delay in the effective date of this rule would expose mariners to the dangers posed by the surf conditions during the Mavericks Surf Competition.

The Mavericks Surf Competition is a one day “Big Wave” surfing competition consisting of the top 24 big wave surfers and only occurs when 15-20 foot waves are sustained for over 24 hours and are combined with mild easterly winds of no more than 5-10 knots. Because weather conditions are integral to the occurrence of the Maverick Surf Competition, the exact date of the event cannot be determined in advance. The rock and reef ridges that make up the sea floor of the Pillar Point area combined with just the right weather conditions create the large waves that Mavericks is known for. Due to the treacherous terrain and un-navigable areas surrounding Pillar Point, the Coast Guard is establishing a special local regulation within a 1,000 yard radius of Pillar Point that restricts navigation near the surf competition area and neighboring treacherous terrain and identifies the safest area for spectator viewing on the water.

The Coast Guard is establishing a special local regulation within a 1,000 yard radius of Pillar Point in Half Moon Bay. The Mavericks Surf Competition will occur in the vicinity of Pillar Point in the navigable waters of Half Moon Bay, and the spectator viewing area will be located inside the following coordinates: 37°29.265′ N 122°30.165′ W, 37°29.248′ N 122°29.978′ W, and 37°29.406′ N 122°30.081′ W (NAD 83). Competitors, participating agencies (Coast Guard, San Mateo Police Marine Patrol, Pillar Point Harbor Patrol, San Mateo Fire Marine Patrol) and the public (to include but not restricted to: Commercial sightseeing vessels, photographer platforms and recreational boaters) will be given 48 hours notice prior to the start of the one day competition. This action is necessary to ensure the safety of participants and spectators during the event. During the enforcement period, unauthorized persons (persons not classified as spectators, participants or participating agencies) or vessels are prohibited from transiting through, anchoring, blocking, or loitering in the regulated area without permission of the Captain of the Port (COTP) or their designated representative.

The effect of the temporary special local regulation will be to regulate navigation in the vicinity of Pillar Point while the Mavericks Surf Competition is taking place. Except for persons or vessels authorized by the Coast Guard Patrol Commander (persons classified as spectators, participants or participating agencies), no person or vessel may transit within the bounds of the regulated area. These regulations are needed to keep spectators and vessels a safe distance away from the event participants and the un-navigable waters surrounding Pillar Point and to ensure the safety of participants, spectators, and transiting vessels.

The Coast Guard will enforce the temporary special local regulation from 8 a.m. to 3 p.m. on a date to be determined. Notification of the enforcement of the special local regulation will be provided to the public via broadcast notice to mariners, as well as through advertising on local media.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management andBudget has not reviewed it under that Order.

Although this rule regulates navigation in the waters encompassed by the regulated area, the effect of this rule will not be significant. The entities most likely to be affected are pleasure craft engaged in recreational activities. In addition, the rule will only regulate navigation for a limited time. Finally, the Public Broadcast Notice to Mariners will notify the users of local waterway to ensure that the regulated area will result in minimum impact.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this 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.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: owners and operators of pleasure craft engaged in recreational activities and sightseeing intending to transit the area during the period of enforcement. This rule will not have a significant economic impact on a substantial number of small entities for several reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time; (ii) vessel traffic can pass safely around the area; (iii) vessels engaged in recreational activities and sightseeing have ample space outside of the affected areas of Half Moon Bay, CA to engage in these activities; and (iv) the maritime public will be advised in advance of this regulated area via Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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). 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.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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 rule under Executive Order 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 Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, 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 rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 0023.1 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the humanenvironment. This rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction. This rule involves establishing a temporary special local regulation.

An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

In order to perform necessary maintenance, the Louisiana Department of Transportation and Development has requested a temporary deviation from the published regulation for the SR 39 (Judge Seeber/Claiborne Avenue) vertical lift bridge across the Inner Harbor Navigational Canal, mile 0.9, (GIWW mile 6.7 EHL). The bridge provides 40 feet of vertical clearance when closed above mean high water, and 156 feet above MHW in the open-to-navigation position. Currently, under 33 CFR 117.458(a), the draw of the bridge shall open on signal; except that, from 6:30 a.m. to 8:30 a.m. and 3:30 p.m. to 5:45 p.m. Monday through Friday, the draw need not be open for the passage of vessels. The draw shall open at any time for a vessel in distress.

This deviation allows the bridge to remain closed to navigation from 6:30 a.m. until 5:45 p.m. from April 2, 2011 through May 21, 2011. However, during these times, the bridge will open for the passage of vessels at 10 a.m. and 2 p.m. daily. From 5:45 p.m. until 6:30 a.m., the bridge will remain in the open-to-navigation position or will open on signal. Exact times and dates for the closures will be published in the Local Notice to Mariners and broadcast via the Coast Guard Broadcast Notice to Mariners system.

Navigation on the waterway consists mainly of tugs with tows and ships. The Coast Guard has coordinated the closure with waterway users, industry, and other Coast Guard units. These dates and this schedule were chosen to minimize the significant effects on vessel traffic; however, vessels that can pass under the bridge in the closed-to-navigation position can do so any anytime. The bridge will not be able to open for emergencies.

The bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

On December 10, 2010, we published a notice of proposed rulemaking (NPRM) entitled “Regulated Navigation Area; Hudson River South of the Troy Locks, NY” in theFederal Register(75 FR 76943). We received no comments on the proposed rule. A public meeting was not requested and none was held.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. The 30-day delay would be contrary to the public interest. As of January 20, 2011, ice formations in the Hudson River require the commencement of Coast Guard icebreaking operations. Without immediate implementation of this rule, the Coast Guard will not be able to prevent underpowered tugs from transiting through identified, unsafe ice conditions. This could lead to these tugs with barges becoming beset in the ice and further delaying the delivery of home heating oil to communities along the Hudson River and within the region, as well as posing a safety threat to the environment and a potential hazard to navigation.

The legal basis for this rule is 33 U.S.C. 1221-1236; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define RNAs.

Historically ice has been an impediment to navigation during certain times of the year on the navigable waters of the Hudson River south of the Troy Locks. West Point, Crum Elbow, Esopus Meadows, Stuyvesant Anchorage, Hudson Anchorage, Silver Point, and Hyde Park are all natural choke points on the Hudson River where ice buildup has the potential to severely restrict vessel traffic.

There are several situations faced by vessels during severe winter conditions that can place the vessels, passengers, and crew in great danger including being beset in the ice and ice accretion, where ice forms on the superstructure and decks of transiting vessels thereby affecting the vessel's stability. Ice may also cause significant damage to propellers, rudders, and hull plating.

The formation of ice on the Hudson River is subject to many variables and is not consistent from year to year. During a moderate or severe winter, the frozen waterways may impede a vessel's ability to maneuver. Once ice build-up begins it can affect the transit of vessels on the navigable waterways. In addition a vessel's watertight integrity may also be compromised by ice abrasion and ice pressure on the vessel's hull.

Ice floes on the navigable waterways may also cause visual aids to navigation to become submerged, destroyed, or moved off station. Ice conditions on the navigable waterways may create hazardous conditions in which the operations of certain vessels become unsafe.

Previous ice seasons have shown that vessels with less than 3000 horsepower, while engaged in towing operations, have significant difficulty transiting the Hudson River in locations where ice thickness is on average eight inches or greater. This difficulty in transiting the Hudson River during ice buildup poses a safety threat to the environment and a potential hazard to navigation.

It sometimes becomes necessary to impose operating restrictions to ensure the safe navigation of vessels. During the 2009-2010 ice navigation season the Coast Guard promulgated a Temporary Final Rule that established an RNA for that period. That rule established restrictions similar to those that the Coast Guard establishes in this rule. This rule allows the Coast Guard to restrict and manage vessel movement when hazardous ice conditions exist within a specified area of the Hudson River.

The Regulated Navigation Area is intended to restrict vessels with less than 3000 horsepower (HP) engaged in towing operations from operating on the Hudson River south of the Troy Locks when ice thickness is on average eight inches or greater, unless authorized by the Captain of the Port (COTP) New York or a designated representative.

The COTP New York will notify mariners of the location and thickness of the ice as well as any restrictions via marine broadcast, Local Notices to Mariners, and VTS New York. For the purpose of this rule, the definition of horsepower in 46 CFR 10.107 applies.

When the ice thickness reaches an average of eight inches or greater on the Hudson River along reported routes, vessels of less than 3,000 HP engaged in towing operations will not be authorized to transit unless in conjunction with scheduled Coast Guard icebreaking operations in thearea, or operating with an assist tug or as part of a convoy, or specifically authorized by the COTP New York.

Operators of vessels that do not meet the criteria of the operating restrictions, but who believe that they have the capability to operate in ice safely, may seek a waiver from the COTP New York to continue operating. Waivers may be requested by calling telephone number (718) 354-4356 or on VHF channel 13 or 16.

The Coast Guard received no comments on the proposed rulemaking. No changes were made to the Final Rule.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

The Coast Guard's implementation of the Regulated Navigation Area will only be enforced at the location on the navigable waters of the Hudson River south of the Troy Locks where ice conditions on average are eight inches or greater, and only restrict vessels that are less than 3,000 horsepower while engaged in towing operations.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this 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.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners and operators of tugs with engines below 3,000 total horsepower attempting to transit the Hudson River in cold weather months when ice thickness is on average eight inches or greater.

This RNA will not have a significant economic impact on a substantial number of small entities for the following reasons: Tugs with less than 3,000 total horsepower have historically been unable to transit the Hudson River when ice thickness is on average eight inches or greater. Operators have generally taken these vessels out of service or use vessels that are capable of operating in such conditions.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

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). 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.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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 rule under Executive Order 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 Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in theirregulatory activities unless the agency provides Congress, through the Office of Management and Budget, 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 rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this 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 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing a Regulated Navigation Area restricting tugs with less than 3,000 total horsepower from transiting the Hudson River when ice thickness is on average eight inches or greater. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

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

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a)of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive notice of the triathlon with sufficient time to publish an NPRM and to receive public comments prior to the triathlon. Any delay in the effective date of this rule would be contrary to the public interest because immediate action is needed to minimize the potential danger to triathlon participants as well as the general public.

On March 20, 2011, Paramount Productions LLC is hosting the Miami International Triathlon. This triathlon includes a 0.9 mile swim, which will take place in the waters east of Bayfront Park in Miami, Florida. Approximately 1,500 individuals are scheduled to compete in the triathlon. This safety zone is necessary to protect triathlon participants, participant vessels, and the general public during the effective period.

The safety zone encompasses certain navigable waters east of Bayfront Park in Miami, Florida. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless specifically authorized by the Captain of the Port Miami or a designated representative. The safety zone will be in effect from 7 a.m. until 9:30 a.m. on March 20, 2011.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

We expect the economic impact of this rule to be so minimal that a full regulatory evaluation is unnecessary. This rule may have some impact on the public, but these potential impacts will be minimal for the following reasons: (1) The rule will be in effect for less than three hours; (2) vessel traffic in the area during the effective period will be minimal; (3) although persons and vessels will not be able to enter, transit through, anchor in, or remain within the safety zone without authorization from the Captain of the Port Miami or a designated representative, they will be able to operate in the surrounding area during the effective period; (4) persons and vessels may still enter, transit through, anchor in, or remain within the safety zone if authorized by the Captain of the Port Miami or a designated representative; (5) advance notification will be made to the local maritime community via broadcast notice to mariners; and (6) the triathlon host will distribute informational materials in advance of the triathlon.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this 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.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within the waters east of Bayfront Park that are encompassed within the safety zone from 7 a.m. until 9:30 a.m. on March 20, 2011. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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). 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.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental HealthRisks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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 rule under Executive Order 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 Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, 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 rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this 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 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment.

This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing a temporary safety zone, as described in paragraph (34)(g), that will be in effect for less than three hours. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

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

On January 1, 2011, compliance with the IMSBC Code became mandatory for all vessels subject to the International Convention for the Safety of Life at Sea (SOLAS), 1974, as amended, that carry bulk solid cargoes other than grain. The final rule (75 FR 64586) allows use of the IMSBC Code as an alternate form of compliance with 46 CFR part 148, subject to conditions and limitations. The rule reduces the need for the current Special Permits for the carriage of certain solid hazardous materials in bulk.

The Coast Guard issues Special Permits as part of its mission to ensure maritime safety and facilitate U.S. commerce. To ensure that the carriage requirements imposed by the Special Permit are sufficient and that the permit holder is complying with the terms of the permit, the Coast Guard requires the submission of information concerning the history of shipments made under the terms of the Special Permit.

With the exception of this collection of information, the Bulk Solid Hazardous Materials: Harmonization With the International Maritime Solid Bulk Cargoes (IMSBC) Code rule became effective on January 1, 2011. Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), an agency may not conduct or sponsor a collection of information until the collection is approved by OMB. Accordingly, the preamble to the final rule stated that the Coast Guard would not enforce the collection of information requirements occurring under 46 CFR part 148 until the collection of information request was approved by OMB, and also stated that the Coast Guard would publish a notice in theFederal Registerannouncing that OMB approved and assigned a control number for the requirement.

The Coast Guard submitted the information collection request to OMB for approval in accordance with the Paperwork Reduction Act of 1995. On January 28, 2011, OMB approved the collection of information and assigned the collection OMB Control Number 1625-0025 entitled “Carriage of Bulk Solids Requiring Special Handling—46 CFR 148”. The approval for this collection of information expires on January 31, 2014. A copy of the OMB notice of action is available in our online docket (USCG-2009-0091) athttp://www.regulations.gov.

This document announces that, on January 27, 2011, OMB approved, for a period of three years, the information collection requirements contained in the Commission'sOrder,FCC 10-88, published at 75 FR 39859, July 13, 2010. The OMB Control Number is 3060-1145. The Commission publishes this notice as an announcement of the effective date of the rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street, SW., Washington, DC 20554. Please include the OMB Control Number, 3060-1145, in your correspondence. The Commission will also accept your comments via e-mail; please send them toPRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail tofcc504@fcc.govor call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on January 27, 2011, for the information collection requirements contained in the Commission's rules at 47 CFR 64.604 (c)(5)(iii)(I).

Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act, that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1145.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number:3060-1145.

OMB Approval Date:January 27, 2011.

OMB Expiration Date:January 31, 2014.

Title:Structure and Practices of the Video Relay Service Program, CG Docket No. 10-51.

Form Number:N/A.

Respondents:Business or other for-profit entities.

Number of Respondents and Responses:13 respondents; 169 responses.

Estimated Time per Response:.017 hours (1 minute average per response).

Frequency of Response:Annual and monthly reporting requirements.

Obligation to Respond:Required to obtain or retain benefits. The statutory authority for this information collection is found at sections 1, 4, 225, and 303(r)of the Communications Act of 1934, as amended (Act), 47 U.S.C. 151, 154, 225, and 303(r).

Total Annual Burden:3 hours.

Total Annual Cost:None.

Nature and Extent of Confidentiality:An assurance of confidentiality is not offered because this information collection does not require the collection of personally identifiable information (PII) from individuals.

Needs and Uses:In document FCC 10-88 the Commission finds good cause to adopt an interim rule requiring the Chief Executive Officer, Chief Financial Officer, or other senior executive of a Telecommunications Relay Service (TRS) provider submitting minutes to the Interstate TRS Fund (Fund) administrator for compensation on a monthly basis to certify, under penalty of perjury, that the submitted minutes were handled in compliance with section 225 of the Act and the Commission's rules and orders. Also in this document, the Commission requires such an executive to certify, under penalty of perjury, that cost and demand data submitted to the Fund administrator on an annual basis related to the determination of compensation rates or methodologies are true and correct. The explosive growth in the Fund in recent years and evidence of fraud against the Fund, as evidenced by recent indictments and guilty pleas from call center managers and employees admitting to defrauding the Fund of tens of millions of dollars, require the Commission to take immediate steps in preserving the Fund to ensure the continued availability of TRS. By requiring providers to be more accountable for their submissions, the Commission takes necessary, affirmative steps to preserve the TRS Fund.