Crane Operator Certification Meeting  -  April 2-3, 2013
The Agency's notes below provide a record of comments made at the stakeholder meetings. The Agency has not tried to characterize the comments, but to just reproduce what was said. The Agency is not evaluating or interpreting what was said; nor does the Agency necessarily agree with or approve any particular comment or point of view.
The Agency opened with ground rules of the meeting and clarified that it was not being held in support of rulemaking. A representative from the Office of the Solicitor for OSHA clarified that the meeting was not an advisory meeting and therefore did not have to meet requirements of the Federal Advisory Committee Act.
April 2, 2013- Morning Session
OSHA: What does Certification mean at the worksite?
Speaker: Representing an insurance company
   1. What options are under consideration by OSHA?

OSHA:  Nothing is ruled out at this point; a range of options are on the table. We can do some kind of interpretation, a directive, or rulemaking. We are not in rulemaking on the issue now.
Speaker: Representing a crane manufacturer
   1. The practical test is done without a load. It's for the end user to decide whether the operator is qualified to go to a larger or smaller capacity.
Speaker: Representing a union
   1. Certification would meet the minimum requirements for a qualified operator, but someone still has to qualify the individual to operate that specific crane.
Speaker: Representing a crane manufacturer
   1. Certification should not mean qualification. Certification is a foundation of knowledge that gets an operator in the door. It demonstrates his proficiency on a certain level. There needs to be a second step which involves familiarization with the exact crane he or she will operate.
Speaker: Representing a construction company
   1. It's important to remember that some of us, particularly with a transient workforce, depend on certification. It's like a driver's license. A license may be enough for a small WV car, but not for a semi. The certification needs some kind of relationship to the equipment that he will operate. If you certify on something small, you shouldn't be able to run something huge.
   2. Of course, close capacities don't make a lot of difference, but it cannot be carte blanch to run any size crane.
Speaker: Representing an insurance company
   1. There is no difference in crane operation between cranes at 60 and 90 tons of capacity.
   2. CDAC never intended for certification to mean qualification.
   3. Someone with a driver's license for a small vehicle isn't immediately qualified to operate any vehicle over any distance.
   4. The accreditation requirement for 3[rd] party testing organizations is meant to ensure some level of sophistication and consistency of the testing organizations.
   5. Operators need to be qualified by the employers for the specific equipment and job. If that's not what the rule says, it must be fixed.
   6. Older operators have trouble with the written portion, while younger operators have more difficulty with the practical.
OSHA: Certification equals qualification is in the regulation. And that's what it means in some states licensing schemes, too. It means qualification in the regulatory sense. Therefore, you're within the rules to operate the crane. But, we also appreciate that "qualification" means something else to employers on the worksite.
Speaker: Representing a crane rental company
   1. It's not practical to certify an operator on every crane he or she may operate. Our cranes go from 15 to 110 tons. If we need to move someone to a larger capacity crane, we provide additional training. A certification doesn't mean that I can just throw him onto a 120-ton crane. I wouldn't be doing my due diligence unless I trained him and knew he could run that specific machine.
Speaker: Representing an accreditation body
   1. Certification is based on a job analysis. A job analysis is a formal scientific study that should include what practitioners, owners, and employers think is the knowledge, skill, and ability someone needs to do the job.
   2. All certifications we've issued have a job analysis that includes the type of equipment used.
   3. Certification normally means the holder is ready to go work.
   4. Some industries, like physicians, are a two-step process. A licensed physician has to become certified as a specialty, like a cardiologist.
   5. Qualification normally means an evaluation of degrees held, work experience, and any certifications achieved. There needs to be some kind of standards and guidelines for the second stage of qualification, though we know the industry won't want a second certification.
Speaker: Representing a certification body
   1. Certification and qualification are not the same. The value of the equipment keeps employers from putting someone in who isn't qualified.
   2. Just certification is better than what we had before, which was nothing. Some small businesses will rely on it especially for smaller equipment. And these certifications are almost enough by themselves to indicate that an operator is qualified.
   3. But, on large equipment, there is more of a responsibility for the employer to make sure the operator is qualified. The capacity and type language is a good way to make sure the certification relates to the equipment used.
OSHA: We see a lot of incidents where someone wasn't given the additional training. They were just let loose. The rule used to call for the employer to make sure the operator is qualified to run the equipment. That language was removed. In its place is certification. Very few are using the employer audited program.
Speaker: Representing a crane rental company:
   1. Certification by a third party testing organization is the only one with the capacity and type language. I think it was a mistake. I think that CDAC meant to replace it, but that never happened. The options are incongruous.
Speaker: Representing an electrical contractor:
   1. We've always qualified our operators. Certification added an additional layer. We qualify everyone we train. Certification gives a license to operate. Now that certification is  the minimum, there is going to be a bidding war for crane operators.
Speaker: Representing a certification body
   1. A certification is a beginners' license. It is a test of the fundamentals, and it was never intended to be anything more than that.
   2. No test, however elaborate, could cover the multitude of situations that crane operators find themselves in.
   3. We would counsel employers that they have to take experience into account when deciding if an operator is qualified. They should also take into account the jobs he or she has done previously.
   4. The employer should evaluate the appropriateness of the certification for the job that he needs done.
   5. When OSHA first indicated back in 2010 that the horizontal requirements were going away, members of CDAC said that it was never their intent for it to work that way.
Speaker: Representing a manufacturer
   1. As written, an employee who is certified for the equipment is qualified. Regardless of what certification has meant in the past, that's what it means now according to OSHA.
   2. We're uncomfortable with that because it removes the employer from the equation.
   3. That increases the importance of type and capacity. Employers want more than a first step, but for something that gets the operator further down the road.
   4. We're here to prevent accidents, so it's important to look at boom length and not just capacity. The opportunity for tip over and electrocutions goes up at longer boom lengths.
   5. We need something more like what was the rule before we added certification. In the aerial device standard, we have the location of manuals, safety devices, functions of the controls, all operated for sufficient time to show familiarity. The operator must be familiar with the equipment.
Speaker: Representing a certification body
   1. We've been training people for a while. The certification demonstrates a specific level of proficiency.
   2. We should add back operator qualification in addition to certification.
   3. California and Ontario both saw decreases in accidents when certification was introduced.
   4. We're not going to start citing operators, but what you need is an employer obligation to qualify plus the certification.
Speaker: Representing a manufacturer
   1. One size doesn't fit all. There are 450 different models of cranes in different product groups. There is overlap in a lot of these product categories.
   2. Whether certification means qualification is the bigger point. Every manufacturer has different safety devices. Certification should not mean qualification.
Speaker: Representing a construction company
   1. We're being naïve here if we think that employers won't think an operator with the card is qualified to use a Manitowoc 4100.
   2. We had an accident where someone had taken a hydraulic certification and got into a tower crane.
   3. We have to have an additional employer obligation, or we have to enhance the certification so it relates to what they're going to do.
   4. I'll spend a full day with each operator at my company, but then I'll leave, and they'll start doing something totally different. If we want better safety, we need to enhance the certification.
Speaker: Representing an insurance company
   1. No certification is going to prevent all accidents. CDAC never intended for certification to mean qualification. That makes the industry less safe, and that's an absurd result.
   2. Certification is only one of multiple factors that go into qualification.
   3. Qualified means approved to do a specific task.
Speaker: Representing a certification company
   1. Our certifications are broken down by capacity levels. It takes more skill to run higher capacity cranes. The industry mainly had in mind the longer boom lengths that take more skill. If you break it down by capacity, you can have harder tests for larger cranes, even if certification isn't qualification, that gets you closer.
   2. It's important to remember that smaller employers will look at the card and think that the guy is qualified.
   3. Not all employers are qualified to evaluate operators.
Speaker: Representing a second manufacturer
   1. OSHA has a definition of qualified in its other regulations. Everyone understands this. Certification, as we've heard today, means something different.
   2. OSHA's relationship is with employers, so they cannot bind the certification agencies directly.
   3. I have a 15 year old certification, but no one would put me into a crane because I'm not qualified. The certification is expired anyway.
   4. If OSHA leaves the rule as it is, it has lost the ability to enforce operator qualifications and safety has taken a step backwards. Certification doesn't equal qualification by itself.
Speaker: Representing an electrical contractor
   1. I agree. We've investigated accidents where the operator was qualified. Everyone has a different opinion of how qualified an operator should be.
Speaker: Representing an accreditation body
   1. We need to be clearer about what certification is. If it means qualification, certification bodies have to go back and redo their job description so that it is more comprehensive and meets the end goal of providing an operator ready to work on day 1. That would be different than the job analysis as currently conceptualized.
   2. Certification cannot prevent all accidents. It reduces the potential by indicating that the operator has some of the knowledge and skill to perform.
   3. There should also be a responsibility to take away the certification if someone does something unethical or, after due process, the operator demonstrated that they did not have the competence. There would have to be a report to the certification body that there has been some kind of incident, so it could be revoked.
   4. There also needs to be some standardization of qualification as an additional step beyond the certification.
Speaker: Representing a large military employer
   1. Two years ago, they adjusted to the new regulation, and decided to go with third party certification.
   2. Some of our older operators accustomed to duty cycle work cannot pass the certification program.
   3. We start with certified operators and have an additional in-house program that qualifies them.
   4. We examine accidents and near misses to look for what happened.
   5. The configuration is often part of what happened, and capacity and boom length are a part of that. But, it has to be a two-step qualification process.
Speaker: Representing a crane rental company
   1. It's not practical to expect a certification to get someone all the way to qualification. The range of configurations that an operator can use is just too great. It would almost have to be model specific just because there is so much variance.
   2. An airline qualifies its pilots, while the FAA just gives a more generalized license. Another analogy is NYC's welding license that doesn't qualify a welder for every weld.
Speaker: Representing a large military employer
   1. We require annual, and soon bi-annual, testing with the equipment.
Speaker: Representing an insurance company
   1. There should be an additional step. The trouble is that OSHA doesn't have the rules to require that.
Speaker: Representing a crane rental company
   1. Is there some burden on a manufacturer? There are differences between different manufacturers of the same type of crane. It used to be that when they got new machines 10 years ago, the manufacturer would provide training. That doesn't happen anymore. Perhaps they need a training manual.
OSHA: We would like to address the issue now of crane operator certification by capacity and type.
Speaker: Representing a certification agency
   1. We think capacity and type is good language. Typically, capacity means a bigger and longer boom. It's not practical to have a boom length identifier. They use a range of capacities.
   2. The operator needs to show skill in controlling the load. Type and capacity are both needed to ensure that the crane the operator is certified for is close enough to what he'll use. A card not sufficient without type and capacity.
Speaker: Representing a second manufacturer
   1. One issue with capacity is that cranes are getting bigger all the time. Any capacity bands will become obsolete as time progresses. There are some higher capacity cranes with smaller booms, and vice versa.
   2. We believe it should be done by type and characteristic, such as conventional hydraulic vs. crawler, or luffing jib vs. fixed boom.
   3. There was one accident, in particular, where the operator thought the boom was at max angle and caused an accident.
   4. If you must do it in capacity ranges, pick those based on what are offered today based on the feature set.
   5. People always want stronger and lighter cranes, however. Capacity is going to create an archaic standard very quickly. Boom length and capacity are not always related.
Speaker: Representing a certification body
   1. What is important is control type.
   2. It's curious that the other three options for operator certification in 1926.1427 don't include "capacity and type."
Speaker: Representing a crane rental company
   1. Capacity and boom length don't always correlate. The main distinguishing factor is the attachments. Those come into play as you get to larger cranes. The boom length isn't relevant.
Speaker: Representing a manufacturer
   1. California did it on boom length or capacity. There are three sizes. Small cranes are less than 19 tons and generally have 3 sections of boom at 70 feet. Then there are 40 tonners with more boom. These aren't the same product. A 40 ton is definitely not a 400 ton. There does need to be some differentiation because of the size of the load and the things they're picking up.
Speaker: Representing an insurance company
   1. Why wasn't capacity included in the other 3 options?
   2. We're worried about requiring operators to get multiple certifications.
   3. The economic analysis was inadequate if capacity is required. Higher capacity tests cost more because of the setup costs on larger cranes.
   4. Old operators will no longer be qualified if capacity is required. Many of them do not have capacity on their certification.
Speaker: Representing a manufacturer:
   1. Capacity bands would be arbitrary.
   2. When California used them, we routinely got calls to de-rate cranes to try to fiddle with the capacity bands. It wasn't the big companies, but the city utilities who didn't want to recertify operators.
Speaker: Representing a crane rental company
   1. Often the instruction manual is the same at different capacities.
Speaker: Representing a certification agency
   1. Does control type mean there needs to be different certifications for different attachments? Even if the cab is the same in different cranes, it takes more skill to operate with a heavier load.
   2. The boom length is also a function of the attachments you put on it.
   3. Cranes are generally labeled by their capacity and attachments, and the certification needs to be understandable by people at the job site who are checking the cards the operators have.
Speaker: Representing a manufacturer
   1. There are a huge number of boom trucks being sold. Last year, 1,600 in North America, of which 1,300 were less than 30 tons. There is strong growth of 20 to 25% in this equipment. Most of these go to small business. How can we make it affordable for the small businesses using these trucks to get their operators certified? Any bands should reflect the quantities of different capacities out there.
Speaker: Representing a construction employer
   1. Capacity doesn't affect how it runs, but what does affect it is the configuration. It's way different with different booms and luffers.
   2. We don't know any certification bodies that address the different counterweights and luffers. Capacity should be a function of those things.
Speaker: Representing an electric contractor
   1. It's easier to refer to capacity than configuration.
Speaker: Representing a second crane rental company
   1. Emphasizes the importance of the lift plan. Capacity doesn't make a big difference. The center of gravity on a larger crane is different.
Speaker: Representing an accreditation body
   1. Emphasizes the need for formal research on effect of capacity.
   2. We need to know what certification means in relation to qualification.
Speaker: Representing a second certification body
   1. There is a higher perception of risk on larger cranes, so more planning goes into the lift frequently.
   2. OSHA needs to come up with some solution for the sixty thousand operators out there with certifications that don't reflect capacity.
   3. This also puts the economic analysis into question.
   4. The California study showed reductions in accidents after certification was introduced. Unlike the Ontario study, this one was just certification.
Speaker: Representing an insurance company
   1. You shouldn't put a 30 ton operator in a 300 ton, but if the test is all you have to do, he'll probably pass and get the certification.
   2. Creating more tests is just going to cost more money.
Speaker: Representing a manufacturer
   1. We shouldn't require small operators to have the additional expertise needed for larger cranes.
   2. The point about sixty thousand operators is a scare tactic, since OSHA could deal with that for most people via interpretation or enforcement.
Speaker: Representing a crane rental company
   1. Type and capacity matter a great deal when moving the crane. And, that is when a lot of accidents occur.
Speaker: Representing a certification body
   1. Cranes are colloquially referred to by their capacity. "Oh, I run the 300 ton..." But, boom length is always a part of this.
Speaker: Representing a crane rental company
   1. Suggests manufacturers provide more guidance on what new operators have to be trained on.
Speaker: Representing a large military employer
   1. Doesn't believe that capacity needs to be a part of the certification. Emphasizes the importance of the lift plan.
Speaker: Representing a crane inspection company
   1. Capacity not as big an issue as skill. Brakes on 40 ton American are the same as on a 105 ton.
   2. Again, emphasizes the lift plan. A test is to verify the skill level of the operator.
Speaker: Representing an accreditation body
   1. Not sure if capacity has to be accounted for in written, practical, or both.
Speaker: Representing a second certification body
   1. The point about sixty thousand operators was not a scare tactic. There are reasons to be scared.
   2. Invalidating these certifications brings the economic analysis into question.
Speaker: Representing an insurance company
   1. We need to figure out a way to make the rule fit what industry wants, that being employer responsibility to qualify.
   2. Industry will rebel if the capacity issue isn't fixed because the costs will be too high.
April 3, 2013- Morning Session
OSHA: What does Certification mean at the worksite?
Speaker: Representing a construction company
   1. The language to take care of this issue already exists in the ASME standard.
   2. Our in-house program is based on capacity and configurations. Some operators can operate a given crane, but if you add a luffer to it, he cannot. Any qualification needs to take attachments into account.
Speaker: Representing a crane rental company
   1. We have many operators with certifications from various bodies. But, the reality is that the certification doesn't qualify him or her to run a piece of equipment.
   2. Most violations are going to come from signal persons and riggers.
   3. You cannot qualify a guy to run a 21000 Manitowoc with a luffer based on capacity and type. How does one find a certified operator for a brand new piece of equipment? OSHA says to look at his operator certification card,  and if it's right, then he's qualified to run the machine. As a user and trainer, that is not enough.
Speaker: Representing a steel erection company:
   1. The intent of CDAC was to improve safety. The training and certification process is to ensure that employers provide a basic level of understanding for all crane operators.
   2. Beyond that basic threshold, it's up to employers.
   3. We note the certifications of all our operators, but just because someone is certified for a lattice boom crawler crane does not mean we put him in a 2250 with attachments.   Just having a certification doesn't qualify someone to run with a given set of attachments. Certification is not qualification. The employer still has to qualify people to run their machines.
Speaker: Representing a construction company
   1. We have a process to qualify our certified operators. We qualify them to run specific cranes in specific configurations on the site for the applications they will use them for. This includes clam bucket, pile driving work, and hook work.
   2. Certification, at best, will be a basic knowledge of the machine and its capabilities and limitations. It is our responsibility as owners to make sure they're qualified for a given situation.
   3. Our cranes have a lot of variety. We keep talking about 300 ft. lattice booms with luffing jibs. These are a small percentage of the cranes used. It would be difficult to get a large population to validate that particular test, psychometrically. The end user has the responsibility to make sure someone is qualified.
Speaker: Representing a crane rental company
   1. It's up to the employer to qualify an operator. We have to certify individual operators for what they're going to do, for contractual reasons. Each employee must be task trained for what they're going to do. This is reflected in other OSHA regulations.
   2. Certification is a great tool for learning load charts and foot tools.
   3. We have 7 different crane types from 8 manufacturers. Each one has multiple configurations. We have over 100 employees. You're looking at 34 million dollars to get a certification for each employee on each type and configuration of crane. It should be up to the employer to train and make sure they can run a specific crane. We're not going to put them on a valuable crane that they cannot use.
Speaker: Representing a crane operator training center
   1. It's a benefit to an employer, who has to evaluate an operator, to know what equipment they're certified on.
   2. There is a benefit to type, and there is a benefit to capacity. Generally we classify by capacity and not boom length.
   3. Having an endorsement on the card for a luffer, maxer, or other attachments would increase the utility for the employer.
   4. Whether certification works for larger machines--there isn't an easy answer for. It's partially taken into account in the "most similar" language in (b)(2).
   5. An electronic log for experience is something already done in British Columbia and Washington State.
   6. We have several more certification bodies now than when CDAC happened, so we should be mindful of changing the rule when some have acted in reliance upon it.
   7. Perhaps the 2014 deadline should be pushed back.
Speaker: Representing a certification agency
   1. We don't track operator experience. What we do is assess crane operators and their skill levels.
   2. If the general duty clause is still applicable, how can we deem someone qualified just by virtue of certification?
   3. There is a wide variety of configurations out there with new ones being added all the time. Even a later model of the same crane will have a lot of different things and take some time to become familiar with.
   4. We've seen people getting on cranes they weren't qualified to run because they want to keep a job going. Some operators are weak on the electronic aspects, so they put it in override and operate it that way.
   5. Every test has to be in writing which limits the ability to arbitrarily come up with new tests that reflect capacity.
   6. They have a process to decide what is necessary, including a job task analysis and subject matter experts to find what needs to be tested.
   7. They had capacity bands for a few years. After initial accreditation, differentiating between capacity was nothing more than a façade. There's no real difference between 50 and 70 tons or 50 and 120 tons. What really makes a crane different is the configuration.
   8. The reason for such a change would be because OSHA wants to see them perform a maximum capacity lift. All one can do at maximum load is pick something up, possibly swing down 12 to 15 degrees, and then put the load on the ground.
Speaker: Representing a certification agency
   1. Certification should not mean qualification. It qualifies someone to a minimum level.
   2. Our written tests have a large variety of cranes. It won't be the same load or crane when one gets to the practical.
   3. It would be difficult to do it by specific model in a way that is psychometrically sound due to a lack of data.
   4. A certification is like a driver's license and means they're minimally qualified.
Speaker: Representing a transport and rental company
   1. Certification implies a higher level of expertise than just qualified.
   2. We have to qualify our operators for a specific piece of equipment. The certification bodies do a great job, but it's just a first step. The manufactures provide some training, but that isn't job specific.
   3. There are four types of control systems: hydraulic, joystick, conventional friction, and remote controls. All of them are used on various types of cranes regardless of tonnage. By tying things to capacity, it creates a perception of a need for different tests--which isn't there.
   4. We need to add the employer responsibility back into the rule.
   5. There also needs to be some kind of standardization of employer qualification.
Speaker: Representing a manufacturer
   1. From our perspective, it's great to hear from employers that they want the responsibility to qualify operators. A certification shouldn't mean qualification.
   2. We don't want Subpart CC to supersede the requirements of the general duty clause. You should leave responsibility where it should be.
Speaker: Representing a construction firm
   1. The question isn't whether someone is certified, it's whether he or she is qualified.
   2. Configuration is what dictates whether someone is qualified. There is a challenge in doing this for small organizations.
Speaker: Representing an engineering and construction firm
   1. Whatever we do needs to be simple. There needs to be clear definitions of qualified and certified.
   2. Smaller companies we deal with get a certification card and don't have a professional who certifies them. Someone brings in an NCCCO card and the owner thinks they're qualified, but we know they're not. There needs to be clearer definitions.
OSHA: On to capacity.
Speaker: Representing a steel erection company
   1. I don't think our industry can support a nation-wide registry. OSHA is supposed to give a minimum standard. Our employees aren't responsible enough to input that kind of information. Would that burden be on them or the employer?
   2. Only the portable option mentions type and capacity.
   3. I wonder how OSHA will deal with certified operators who don't meet the current thresholds.
Speaker: Representing a union
   1. We asked for an exclusion for cranes up to 50 tons during the rulemaking process. Those operators have other standards that are stricter than what is found in the final rule. So, we questioned the need for certification when we have training requirements in other standards. In that context, paying for certification is a waste of money.
   2. If certification is going to bring with it qualification for the job site, it's valid. Otherwise we're forcing the employers to go through the certification process for nothing.
Speaker: Representing a crane rental company
   1. Two certification bodies do capacity, two do not. There are different ways of looking at capacity: gross, net, and rated capacity. There is a definition of rated capacity that varies by configuration and use. When someone tries to figure out the capacity they need, he looks at the net load, converts to gross load, then looks at the radius, then the size of the cranes based on net capacity. Capacity should mean that he can figure out the capacity by reading the load chart. To be a qualified operator, I have to understand the manual, ANSI, federal, and state standards. The capacity varies by how far I've got the boom out. Different configurations can change the capacity, and OSHA needs to clarify what they mean.
Speaker: Representing a certification agency
   1. It's possible to be a trainer without being certified. Should we call everyone a trainer to circumvent the rule?
   2. These certification programs are not designed to qualify operators, but to assess skills. To qualify someone for particular job conditions, that's on the employer. Certification doesn't qualify someone to work near power lines for Subpart V work, for instance.
Speaker: Representing a construction company
   1. A certification company can certify up to some minimum standard. They can certify knowledge of OSHA and ASME standards.
   2. An employer should have to qualify an operator with respect to boom length, attachment, and configuration.
   3. Anyone worth their salt is going to document the training it took to get here. We document for OSHA. We start by training someone to the minimum required for the cert, get the training, then through completion of the employer process.
   4. Some clients want certifications from specific organizations, so that poses challenges and causes us to have to double certify operators.
Speaker: Representing a training center
   1. OSHA might consider continuing to require operator certification, but adding an employer responsibility on top of that. The employer step will qualify the operator for the specific equipment. That keeps the onus on the employer to ensure qualification.
   2. It's not clear that all employers have the skill to do this.
Speaker: Representing a certification agency
   1. For two days now we've heard an emphasis on employer responsibility. That's the only place where it makes sense for it to be. We're not set up to train these operators or teach the skills necessary to pass the test. We just assess.
   2. Plenty of organizations are capable of providing training. The intent of certification is to stimulate training and verify by the card. We assess a minimum skill to use the crane, with everything beyond that resting on the employer.
Speaker: Representing a transport and rental company
   1. The capacity is a little misused in that it implies greater skill at higher capacity. The four different organizations have different standards for their tests. OSHA should develop the standards classifications.  You can break down type categories by capacity and boom length into small, medium, large, super, and unlimited. In addition, you could require attachment certification on long booms over 200 feet.
   2. Any capacity classifications would be arbitrary.
   3. Generally, you want the person who used the crane before, not someone only familiar with the attachments.
   4. It's on the owner to make sure we've got the right person in there.
Speaker: Representing a second certification agency
   1. We have capacity on our tests and can easily take it out.
   2. To do what the last speaker suggested would take way too long and cost too much.
   3. We're an avenue for an employer to verify a minimum level of ability of the operator.
   4. Configurations change, so the cert doesn't mean they can do anything. Certification could never keep up with new configurations and new cranes.
Speaker: Representing a training center:
   1. The different certification organizations are not all equally difficult. OSHA seems to assume they're all even, but they're not. That's another reason certification shouldn't mean qualification.
Speaker: Representing a manufacturer
   1. The Power Crane and Shovel Association wrote a letter in September recommending that OSHA follow the types specified in B30 standards.
   2. So, there is general agreement in industry that if you're certified for a 100-ton mobile telescopic, you can take that same person and put in 400-ton crane with just a main boom and no attachment. You're basically in the same configuration. The basics of running it safely haven't changed.
   3.  If I take that operator and put on 100 ton crane with luffing attachment, may not be certified or qualified for that attachment. We need to look at the type of crane, then examine whether we need specific endorsement for attachments. We can work with OSHA to determine categories. This means certification by type with endorsements for specific configurations.
Speaker: Representing a construction company
   1. Our exposure isn't with the larger cranes.
   2. Previously our operators were NCCCO certified, but now we're with CIC because we interpreted the standard to require capacity.
   3. We've heard a lot about putting duties back on the employer. But then, why are we certifying? Why not qualify our own operators?
   4. I don't know that the majority of crane users are being represented here. We would be greatly affected by that change.
   5. The owner's responsibility to qualify is a cost of doing business. OSHA sets minimum requirements for certification. I don't look at certification as a beginner's permit. It's a baseline that you can do something with.
   6. We rent from a lot of different contract yards. If we ask about the training of the operator, and they produce a certification card, not the training log. Yet, today we seem to be minimizing the card. We shouldn't minimize  how it's regarded. It's a license to operate the equipment.
   7. To me, type and capacity, for the majority of crane users, gives employers a baseline to tell the employer what they're familiar with.
   8. Type and capacity is a start, but does not solve all the issues. Some employers qualify and certify, and it's a cost of business. But from our point of view, with 70 certified operators, it's a baseline. We will qualify in a particular crane, but we're mostly on smaller equipment. A majority of crane operators are in that category.
Speaker: Representing a certification agency
   1. Doing capacity bands would require going through the accreditation process over again. We cannot simply modify what we're doing unless we're able to back it up with statistical data over the course of a year and apply.
Speaker: Representing a crane rental company
   1     Who is the qualified person who can resume operations when the operator safely stops under 1926.1418?
   2. (21)(b)(2) is still there. An employer has to provide a safe working environment.
Speaker: Representing a steel erection company
   1. It seems clear that most people here think that certification should not equal qualification.
   2. On capacity banding, I disagree with those who say we should have capacity bands.
   3. Some have mentioned the costs of such testing. We've studied it, and our costs would go from around 200,000 dollars per year to over a million. That does not include some things like assembly and disassembly. It's especially onerous for large crawler cranes with multiple attachments.
   4. Cannot support any solution that means that currently certified operators are no longer able to operate.
April 3, 2013- Afternoon Session
OSHA: What does Certification mean at the worksite?
Speaker: Representing safety consulting
   1. OSHA did not understand what CDAC meant by the word "qualified".
   2. "Certified" Operators means that they are allowed to run a crane. However, the employer has to decide who can run which cranes.
   3. A person can operate a crane successfully for years and yet not pass the written certification exam -- which means the law says he/she is not allowed to operate a crane even though he/she is qualified. Another operator can operate a crane poorly for years, but passes the test--which means he/she is compliant with the law, but is not qualified.
   4. In addition to seeing a certificate, the employer has to evaluate things about the operator like the type of work the operator has performed, the types of equipment operated, the demeanor of the operator, the extent of the operator's experience, etc.
   5. Qualified in Subpart CC only means the operator has passed the tests, but does not indicate anything else regarding the operator's qualifications to perform hoisting jobs at the worksite.
   6. Once the operator is certified, OSHA cannot cite the employer for not providing training or the operator not being qualified; but, the employer can be cited for any violations of many other requirements in Subpart CC.
   7. Recommends that OSHA not use the term "qualified" with respect to operators like it is used for riggers, signal persons, etc. and use the term "license" instead.

Speaker: Representing operator training
   1. Certification is a prerequisite to qualification
   2. The Big South crane incident is evidence that operators can be certified to run a crane, but still not be qualified to run it.
   3. Certification in the crane standard has been misidentified as an overall certification-- it is only an entry-level certification--a license to learn
   4. Misidentifying the certification is worse than having no certification at all because it can cause employers to improperly evaluate the skills of operators
   5. Thousands of operators have been tested and with those cards they can only get in the door based on my company's operator assessment process.
   6. My company provides operator training, and I estimate that 90% of those operators pass the test after taking our training.
   7. Those operators do basic knowledge things like calculate loads, read load charts, recognize power line hazards, determine the center of gravity of equipment, etc.
   8. Although operator certification is a great idea, calling those operators qualified is a mistake.
   9. Type and capacity is important but the employer must evaluate the operator and determine who has the skills and knowledge to run a bigger or smaller crane.
   10. Qualification takes further skills such as working with equipment with various outrigger configurations, counterweight, knowing boom modes, loads, etc.
   11. 90% of operators today operate cranes with telescoping booms versus lattice.

Speaker: Representing educational consulting

   1. Qualification is a personnel evaluation term; whereas certification is standards based--an operator is certified to meet minimum standards.
   2. The qualifications of an operator may change.  Do you want to use this term as being an equal to certification?

Speaker: Representing steel erection consulting

   1. During CDAC, accrediting was a detailed discussion.  He does not recall qualification equaling certification being discussed by CDAC.
   2. Certification is a different commitment than qualification.
   3. Certification is only a starting point, such as with a rigger.

Speaker: Representing a mining labor union
   1. Qualified is a tricky concept
   2. I have held many certifications for all sorts of tasks related to mining and that meant that I could not perform those tasks at the mine until I was certified to do them.
   3. In mining, I could not surface blast even though I was certified as an underground blaster and I learned that surface blasting was quite different and took a different set of skills.
   4. We certified a lot of operators in WV and MD. to get ahead of the certification due date and lost many operators who were safe operators that we trained and tested in preparation for the certification test. If those that already got certifications will not be grandfathered, based on our experience with certification of our operators, we are being penalized.

Speaker: Representing general contracting
   1. Certification is based on equipment
   2. Employers must be able to assess the operators at the site based on knowledge and experience.
   3. The operators should be required to get a card, but the employer should also be required to take operators out of the seats until they can operate the crane safely.
   4. Worked with MD OSHA on its operator certification codes.  The operator is qualified/certified by a third party tester, but the employer still has the last say.
   5. Operators need familiarization with big cranes with outriggers.
   6. Testers cannot certify operators to crane models because there are just too many models of cranes available.

Speaker: Representing an operators labor union
   1. Certification testing only gets the operator a driver's license.
   2. You get a license to drive a car, but that does not mean you can drive in a NASCAR race.
   3. The focus needs to be off of the testing because the employer qualifies its operators.
   4. The problem with certifying by type and capacity is that there is limited equipment with varied configurations available for operators to test on. Even if that approach is attempted the testing will not hit on every type of equipment and configurations that is out there.
   5. Based on the cost of certification, how long is that piece of string? Mom and pop companies must certify its operators. I did a small survey and some say certification is only a driver's license and some operators with certifications are not allowed to do things like critical lifts and such. Ultimately, the employer must know who is qualified.

Speaker: Representing a steel erector trade association
   1. It's difficult to get the money in steel erection to certify operators and keep them certified because it is ongoing.
   2. A question from my members to OSHA, Is operator certification merely considered an extra step to qualification?

OSHA: Based on the regulatory text of the crane standard, no.

Speaker: Representing safety consulting
   1. Employers must determine an operator's qualifications based on things like the operator's history and the types of equipment she/he operated.
   2. Employers often use equipment during break-in periods in the yard and 2-3 years of oiler apprenticeships to train and qualify operators.
   3. Many operators that can operate a 165-ton American hydraulic crane could past the test, but would have to gain more experience on a friction crane of similar type and lower capacity before being able to operate the friction crane safely.
   4. To limit certifications to cranes of under a 100-ton capacity would be doing so for only commercial reasons.
   5. Some level of testing is needed.  For example, New Mexico does not test by capacity, but does issue a license simply as a credential that I have been trained and tested.
   6. NCCCO was the only tester at first and there are at least three more now. I believe NCCCO has been the best and testing by capacity has not mattered a bit.
   7. Qualifying requires more knowledge of the crane, such as that simply lowering a boom with a luffing jib is hazardous; and electronic controls are complex, but operation of the crane may be safer.
   8. Operation of a small crane like a 25-ton friction is more complicated (because of the dexterity of the operator needed) which makes the situation paradoxical in that bigger cranes are considered to be more dangerous.
   9. The employer pulling an operator's card can be an incentive for the operator to learn the crane.
   10. The crane standard will always be behind in technology because there is always new technology, such as cranes that jackknife in the middle because they are so big and jackknifing helps them to get around tight corners.
   11. There was no definition for the crane used in the Big Blue incident. It was new technology that the employer had to determine who could operate it. That determination would not be based solely on what type or capacity of crane the operators were certified to run. It would be based on a lot of other factors, so size limits to certifications does not matter.

Speaker: Representing operator training
   1. Certifying operators on bigger cranes would be cheaper because an operator can also operate a lot of other smaller cranes.
   2. Certification tests the operator's ability to maneuver and control a load.  The hardest part of riding a bike is balancing it. A certified operator can fundamentally run a crane.
   3. The operator's ability to operate a friction/electronic/hydraulic crane with attachments needs to be evaluated at the work site.

Speaker: Representing general contracting

   1. Testers should also document the certified operators' history and experience.
   2. To my knowledge there are no requirements in the crane standard for taking a certification card away or reducing the card.

OSHA: Testing organizations have protocols for revoking certifications.
Speaker: Representing educational consulting
   1. Most certification organizations do not issue licenses unless they have the ability to take them away.
   2. Stay away from licensing unless there are methods of tracking and revoking the licenses in the programs of the issuer.
   3. There should be operators' special needs accommodations addressed by certifications.
   4. The larger issue of operators being able to operate a crane safely, but not being able to test well can be addressed through the use of technology.
   5. Certifications are entry-level, the peanut butter and jelly of certification is that the operator meets knowledge requirements, but is not necessarily qualified for operation of the crane at the worksite.
   6. Stay away from certifications if OSHA does not get into requirements for personnel evaluations.

Speaker: Representing an operators labor union
   1. Verified and explained the basic certification-revoking procedures of Local 150 and OECP- issue with operator brought before the board of the Union.
   2. Larger cranes have smaller margins of error due to their safety factors.
   3. It is difficult and costly to get larger cranes to the site and set up for testing of operators.

Speaker: Representing general contracting
   1. Asked OSHA to define what a large crane is.
   2. Just because you can run a larger crane does not mean that transfers directly to smaller cranes.
   3. Certain basic operating skills can be used to run most equipment.
   4. The cost for each training course for different certifications is great with no added benefit to the operator. In addition, recertification is a continuous process and costly.
   5. The crane industry is a small one. A bad operator's reputation is what will keep her/him from getting jobs.

Speaker: Representing operator training
   1. Minimal skills like being able to read load charts is a large part of an operator's knowledge needed to operator various types and capacities of cranes safely. For example, the load chart informs the operator of a crane's structural and stability tolerances. Knowing how to use the information is a skill the operator takes from crane to crane regardless of size and type.
   2. Perhaps a low level certification could be provided that gets into the use of outriggers and boom functions.
   3. Certifications test for minimal level skills. No one tests on 500-ton cranes because it is too expensive to do so. Capacity could be addressed in the written test.

Speaker: Representing an operators' labor union
   1. How does OSHA believe capacity limits should be determined?

Speaker: Representing OSHA
   1. We have already heard a few options during the course of these meetings.

OSHA: Is there uniformity on crane testing to match  what is being operated at the worksite?

Speaker: Representing an operators' labor union
   1. We cannot cover all types and sizes of cranes,  but Local 150 works with the employers to get different cranes of configurations typically used on jobsites.
   2. Chicago requires a crane operator's license that is only based on type.

Speaker: Representing a labor union
   1. The union train and qualify on the cranes that are used at the worksite.

Speaker: Representing safety consulting
   1. Forklift certification and training cover the basics and must also be particular to the hazards at the worksite. The employer endorses for, say, an extended reach forklift, and authorizes the operator to use the forklift. If the card says something different, it is a violation.
   2. Does capacity mean must be limited capacities?  No. However, if there are limits in the operator's training it must be on the cards. For example: all cranes but friction cranes.
   3. There are all kinds of welding certification required for welders...welding upside down, vertical, etc. because the employer needs to know what testing proves and if there are limits. However, it is inappropriate for OSHA to set limits in crane capacity with regards to operator certification. I'm not sure what we have; the card is good for 50 tons.

[A ten minute break was taken.]
OSHA: Does equipment capacity matter during operator certification testing?
Speaker: Representing educational consulting
   1. Are there any testing organizations that are in compliance with OSHA requirements?

OSHA: All I can say is that we are aware that two are not.
Speaker: Representing educational consulting
   1. What will operators be doing for the practical test? Will they be knocking a tennis ball off of a barrel? What are the tasks that are done in all cranes that do not vary by capacity? When you find differences, then draw the lines there.
   2. With regard to accreditation, if there are no differences in job hazard analysis, it would show up that all skills sets would be the same. Could the operators pass the test regardless of the type and capacity of crane?
   3. Is there research on this topic that can be referenced?
   4. What is the difference between qualified and certified?

Speaker: Representing educational consulting

   1. Job Task Analysis has been done by testing organizations about controlling the load. The written test captures different characteristics and capacities of cranes.  Practical testing on big cranes captures all three aspects for all cranes.

Speaker: Representing steel erection consulting
   1. Where did § 1926.1427(b)(2) come from?

OSHA: It was added by OSHA for clarity- to put what was described in the preamble of the proposed rule in the regulatory text of the final rule.
Speaker: Representing general contracting
   1. Information for critical lifts is on the load charts too, so anything off the chart is not allowed. Certification for generic capacity for particular types of cranes seems acceptable.
   2. We are losing focus, the employer does not have to put a particular operator in the seat, even when the operator is certified

Speaker: Representing operator training
   1. By making testing consistent, the market will correct itself.
   2. Requiring testing by capacity and characteristics of the cranes will level the playing field.
   3. OSHA should define parameters for the testing organizations.

Speaker: Representing safety consulting
   1. In the state of Washington, configuration of the crane is a small issue. What's staggering is the number of crane incidents involving certified/licensed operators.
   2. It is up to employers to train and qualify their operators regarding loads on a boom, leverage, ground support, maintenance, and set up.
   3. As chairman of A10.41, we are developing a standard for all mechanized/powered equipment  that covers 99% of the things that need to be known to operate the equipment safely. These standards cover job task analysis, limitations,, capacities, operations manual, managing people, etc. Like the forklift standard, it is performance based and for subgroups of bigger groups of equipment, the industry will take care of itself.

Speaker: Representing operator training
   1. The most confusing thing for operators during testing is understanding conflicting standards like ASME/ANSI/OSHA/ASTM. Hopefully the new rule will help with this.

OSHA: We can only enforce our own rules.
Speaker: Representing operator training
   1. Then make it clearer.

Speaker: Representing safety consulting
   1. Holding cards in 2014 that were issued now, is that going to be a problem? The industry tried to voluntarily comply, gone above and beyond-- allow grandfathering.

OSHA: The person on my mind right now is the one who gets a card today.
Speaker: Representing operator training
   1. Everyone knows what is written in the crane standard. Everyone knows what it says. Grandfathering invalid certifications would be defeating the safety of the rule.
   2. What is OSHA's reply to ASME standards?

OSHA: Statutorily, we must enforce our own rule.
Speaker: Representing an operator labor union
   1. We are not asking for grandfathering of everything -- they thought they were meeting the standard, the intent was there, trying to meet the demands of the contractors.

Speaker: Representing general contracting
   1. In 2011, I mandated that my company have all crane operators certified. Most of their certifications will be invalid as of 2014.

OSHA: Are you referring to your own employees?
Speaker: Representing general contracting
   1. Yes, my employees.
   2. What should I do now? I don't know what the final rule will say.

Speaker: Representing a steel erector trade association
   1. I don't know what types and classification/configurations will be available. How would you go about that?

OSHA: One option would be to have your operators get certifications that are available for equipment that is most similar.
Speaker: Representing a steel erector trade association
   1. Way on the other side of the argument, if you test on the biggest crane, you don't have to have a capacity limit.

Speaker: Representing a labor union
   1. We don't think capacity is relevant for crawler cranes.

Speaker: Representing operator training
   1. Clean up the language in the rules so that games can't be played with capacities among the certifiers.

Speaker: Representing operator training
   1. Does OSHA have any ideas for dealing with the operators who hold certifications that will become invalid?

OSHA: One solution to the operators who do not have capacity on their certifications is for the testers to issue them cards specifying the type and capacity of the crane on which the operators tested.
Speaker: Representing general contracting
   1. We got ahead of the rule and got everyone certified, soon we will no longer be certified even though we did the right thing.

Speaker:  Representing an operators labor union
   1. Think about what was the intent.  For example, in 1991, Chicago didn't require a written exam, now they have one. The intent is to meet the OSHA standard.

Speaker: Representing safety consulting
   1. I'm just clarifying that I'm talking about the grandfathering of people who already hold certifications. The market will figure out the capacity issue. People are waiting on OSHA to make a decision.

Speaker: Representing an operators' labor union
   1. There's a big cost for administering a 15 question additional exam. It is unnecessary to supplement the existing one.

OSHA: OSHA is now starting to do most of the talking which may mean that we do not have any more new ideas to share on the type and capacity. Does anyone else have anything else that they would like to offer on the topic?
[OSHA closed the meeting]


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79903-79905]
[FR Doc No: 2015-32247]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-1433; FDA-2013-E-1435; FDA-2013-E-1437]

Determination of Regulatory Review Period for Purposes of Patent
Extension; JETREA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for JETREA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 22, 2016. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 20,
2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2013-E-1433; FDA-2013-E-1435; and FDA-2013-E-1437 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; JETREA.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product JETREA
(ocriplasmin). JETREA is indicated for the treatment of symptomatic
vitreomacular adhesion. Subsequent to this approval, USPTO received
patent term restoration applications for JETREA (U.S. Patent Nos.
7,445,775; 7,547,435; and 7,914,783) from ThromboGenics NV, and the
USPTO requested FDA's assistance in determining these patents'
eligibility for patent term restoration. In a letter dated January 31,
2014, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of JETREA
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
JETREA is 2,171 days. Of this time, 1,987 days occurred during the
testing phase of the regulatory review period, while 184 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: November 9,
2006. The applicant claims November 11, 2006, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was November 9, 2006,
when the investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): April 17, 2012. FDA has verified the
applicant's claim that the biologics license application (BLA) for
JETREA (BLA 125422/0) was initially submitted on April 17, 2012.
    3. The date the application was approved: October 17, 2012. FDA has
verified the applicant's claim that BLA 125422/0 was approved on
October 17, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 2,169 days; 761 days; or 435 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested

person may petition FDA for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period. To meet its burden, the petition must be timely (see
DATES) and contain sufficient facts to merit an FDA investigation. (See
H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions
should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32247 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P