" Hunt, Tim" < Tim_ Hunt@ afandpa To: Mary Kissell/ RTP/ USEPA/ US@ EPA . org> cc: Ken Hustvedt/ RTP/ USEPA/ US@ EPA, Sally Shaver/ RTP/ USEPA/ US@ EPA 10/ 27/ 03 06: 17 PM Subject: Wood MACT Mary Tom,

As you know, we have been examining ways to increase the use of pollution prevention as a real compliance alternative in Wood MACT. The PBELs are a start and the use of add on controls with them would really help ( subject of 10/ 30 meeting). Another approach is to give facilities more time to comply if they adopt P2 given the complexities to ensure sufficient reductions. This approach originated from discussions with OGC.

We would like to talk about this idea on Thursday during our meeting along with the more traditional one year compliance extension.

Let me know if you have any questions in advance.

<< Compliance extension for P2 10 27 03. doc>>

Timothy Hunt Senior Director, Air Quality Programs American Forest and Paper Association Suite 800 1111 19th St., NW Washington, DC 20036 phone: 202 463 2588 fax: 202 463 2423 Tim_ Hunt@ afandpa. org ( See attached file: Compliance extension for P2 10 27 03. doc) Importance of a Pollution Prevention Compliance Extension In the Plywood and Composite Wood Panel MACT The proposed Plywood and Composite Wood Panel ( Wood) MACT rule ( 40 C. F. R. § 63.2233), requires an existing source to come into compliance three years after its promulgation. AF& PA recommends an additional 4 year compliance extension for process units that intend to implement pollution prevention as their primary compliance strategy. The concept of pollution prevention has long since been legitimized as the best way to utilize limited resources and protect the environment from unwanted collateral emissions produced by the use of add on controls. The life cycle inventory ( LCI) commissioned by AF& PA and provided as part of AF& PA's comments on the proposed rule shows that the widespread use of combustion devices such as RTOs and RCOs will have, at best, a questionable net benefit to the environment. Especially significant in the LCI analysis was the impact of emissions related to the off site electrical generation needed to power the large horsepower fans required by add on controls. AF& PA believes, however, that, if the recommended compliance extension cannot be accommodated, industry wide implementation of innovative pollution prevention options may be precluded due to the significant time required to develop, implement, and assess the success of innovative approaches.

Pollution prevention projects have several attributes in common that lead to their being more complex, time consuming, and potentially more capital intensive than simply installing add on controls. The use of add on controls is a brute force approach which encourages operations to run hot, hard, and dirty in order to justify the control cost. For existing facilities, implementing pollution prevention projects may involve substantial investment and modification of the existing processes in an iterative process that achieves incremental reductions, identifies roadblocks to further progress, addresses those roadblocks, and moves on to the next issue. The time commitment to pursue this strategy can be substantial.

In other instances, fundamental changes in process technology may be needed. For example, one commonly studied approach for reducing emissions is to dry the wood fiber or chips at a substantially lower temperature and/ or to a higher final moisture set point. Maintaining that higher moisture set point at the dryers on a consistent basis without excursions on the high side which threaten product quality or excursions on the low side which threaten noncompliance is likely to require process refinements in wood preparation, wood screening, wood flow control to the dryers, dryer temperature control, wood moisture measurement, etc. Accommodating the higher moisture content in the board manufacturing process is likely to require resin reformulation, blender modifications, forming line refinements, and other measures as determined during the process of feasibility trials. Implementing such an approach could ultimately involve replacing the whole dryer system, with capital costs that are an order of magnitude greater than the add on control systems, but with substantially lower overall operating costs, energy use, and collateral emissions.

It would seem to be highly appropriate to permit additional compliance time for facilities to allow sufficient time to plan, coordinate, and implement the best 1 combination of process changes to facilitate pollution prevention in conjunction with a rational business model. Prior MACT standards provide precedent for such an approach. Additional justification for this request is provided below.

Widespread implementation of pollution prevention options would be precluded Pollution prevention approaches for complying with the Wood MACT rule should be strongly encouraged, as they can avoid or minimize the environmental disbenefits associated with using add on, incineration based control systems. However, because many of the envisioned pollution prevention approaches have either not been fully researched nor field tested, an additional 4 year window is necessary to foster, develop and implement these approaches, and to assure continuous compliance. In addition, facility managers must have complete confidence that pollution prevention approaches will meet continuous compliance requirements. Continuously certifiable compliance can be threatened by process variables such as seasonality of raw materials. A four year compliance extension serves to provide an incentive to innovate by providing additional R& D time that will serve to protect against noncompliance action during the crucial new technology development and implementation process.

Avoid environmental disbenefits As discussed in § II of the AF& PA comments on the proposed rule, incineration based add on control systems have significant environmental disbenefits. These include large increases in fossil fuel energy use, electric power consumption, greenhouse gas emissions, and emissions of other criteria pollutants including SO2 and NOx. For example, at many wood products facilities, the burning of fossil fuels in an RTO/ RCO may be the only significant source of greenhouse gas emissions ( CO2). Moreover, since RTO/ RCOs will be fired exclusively with natural gas or propane, this will diminish our national strategic supply used for home heating, electric utilities, and vital industrial production, for little or no environmental benefit. The electrical requirements of RTO/ RCO technology will provide additional demands on scarce electrical generation/ transmission resources as well as generation related emissions.

Additional time is needed for the implementation of pollution prevention options In the preamble of the proposed Wood MACT rule, EPA acknowledges the difficulties in implementing pollution prevention options with the following quote:

Although we believe that the potential for pollution prevention exists for some facilities in the PCWP industry, we are not aware of any demonstrated pollution prevention techniques that can be universally applied across the industry. Furthermore, we have no information on the degree of emissions reduction that can be achieved through pollution prevention measures. The PCWP facilities use add on control devices because there currently are no feasible pollution prevention measures. 2 While AF& PA believes that there are pollution prevention options that hold significant promise for successfully reducing emissions to the ranges required by the proposed rule, the industry also agrees that these options have neither been widely commercialized nor demonstrated. This is not for lack of effort or research on the part of the PCWP industry. Industry wide efforts as part of the AF& PA Agenda 2020 and company specific projects have placed a high priority on commercial applications for these technologies. Companies typically consider these pollution prevention efforts to be business confidential projects, meaning that a detailed description of candidate projects is not appropriate. However, general types of pollution prevention projects being developed and their generic attributes are described in the following paragraphs. As noted above, these pollution prevention approaches are most likely to be implemented in conjunction with one or more other elements leading to a need for the development of additional levels of integration. This integration can only be accomplished with adequate time.

1) Low Temperature/ High Moisture Drying & Pressing It is widely acknowledged that a degree of HAP reduction can be accomplished by drying fiber at a lower temperature. However, lowering the drying temperature also has the unwanted effect of reducing the rated capacity of wood drying/ pressing equipment. Additional research time is required to develop methods for panel construction that include a higher moisture specification that will still meet consumer quality demands and maintain the production viability of the plant. As noted above, implementation of this approach at an existing facility is, of necessity, an iterative, diagnostic exercise involving virtually all aspects of the manufacturing process and is likely to involve elements described in items 3, 4, 5, and 6 below. While the fundamental feasibility of the approach has been studied at a few facilities, each plant has a unique combination of wood species, wood refining equipment ( flakers, chippers, refiners, etc.), wood screening equipment, dryers, burners, etc. which must be assessed.

Revamping the dryer and the press process at an existing plant to reduce emissions is significantly more costly and time consuming than merely placing an end of pipe air pollution control system on the process. To maintain the existing capacity of the plant, the revamping project would typically entail the replacement of the dryers and significant modifications to the remainder of the forming line, the press and perhaps the other combustions systems. And even with such a project, some air pollution control system may still be necessary.

The revamping project is estimated to have a capital cost of two to four times the cost of the installation of an end of pipe air pollution control systems. The project development and installation schedule for the revamping project is estimated to take two to two and a half times as long. Note, the revamping project has additional costs as well, including a significant increase in lost production. The tie in and startup of an end of pipe air pollution control system can be accomplished with little or no disruption to production, typically from two days to a week. The revamping project can easily lead to a lost production equivalent of a month, which could amount to several million dollars in lost revenue. 3 The post installation process is also more involved in the revamping project. An initial baseline is required including determination of issues such as seasonal/ wood species related variability. This process can easily require a year of detailed effort. Then follows a period of study to determine what moisture levels will assure consistent compliance. Next is a variability study to determine refinements needed to assure consistent maintenance of those moisture levels across a reasonable range of process operations including seasonal variations. Next is a process study to determine measures needed to assure adequate production quality, quantity, and cost at the new moisture levels. A period of implementation of process refinements would then be necessary followed by a period of assessment of the potential for maintenance of continuing compliance along with the needed production attributes. Given the number of variable involved, it is unlikely that all issues will be resolved within the first effort requiring additional work to tie up loose ends. It is this process of assess, refine, and reassess that is anticipated to require the requested extension of time for demonstration of compliance.

2) Conveyor Drying Conveyor drying is a relatively new concept that mechanically conveys the wood furnish through the dryer and achieves partial control by routing exhaust gases from the first dryer hot zone into a burner section or a boiler and recycling the latent heat back into the dryer. Since airflow is not relied upon to move the furnish through the dryer ( as is the case with most rotary dryers), conveyor dryers can carefully regulate temperatures on a zoned basis and provide additional emissions reductions. The burner or boiler provides the requisite heat for the drying process ( and possibly other plant heating needs). At present, there are few commercial applications, and even fewer vendors. At this time, conveyor dryers are very capital intensive and have a significantly higher cost than implementing the control technology. Additional compliance time is warranted so that companies can replace existing dryers when they are beyond their useful life ( average 10 to 15 years) with lower HAP emitting conveyor dryers. While a four year compliance extension ( resulting in a total compliance time of seven years) does not extend to the full useful life of existing dryers, the extension would allow a sufficient portion of the useful life of existing dryers to be expended such that it would be economically viable for companies to invest the significantly higher capital that is required to replace current dryers with conveyor dryers, rather than simply installing incinerators.

3) Species Control/ Substitution Some facilities may have the ability to utilize lower HAP emitting raw material species or combinations of such. Other facilities are performing research on agricultural substitutes that may have lower HAP emissions. This process of substitution of raw materials gives rise to all the process considerations described for the low temperature/ high moisture drying and pressing described above plus additional material handling issues based on the nature of the new furnish characteristics. Additional difficulties can be encountered locating and consolidating a new supply chain for new lower HAP emitting species. The requested four year 4 extension will be easily consumed in working through these issues in an orderly fashion.

4) Resin Reformulation At present there are three major suppliers of resin to the panel industry. All the major suppliers have initiated research and development of lower HAP resins. Research has also been initiated on types of resins, such as powdered resins, that can be utilized in conjunction with lower temperature drying to provide a high quality product with a higher level of moisture remaining the panel. This pollution prevention option is still in its formative stages. While some preliminary research has been conducted, another 3 to 5 years is likely to be needed before lower HAP resins become commercially viable.

5) Reducing Moisture Variability/ Precision Process Control By using precision process control either in the dryer or prior to the dryer, facilities can limit high moisture variability in boards and flakes that contribute to overdrying and high HAP emissions. By reducing this variability, target moistures can be increased and wood fiber temperatures can be reduced during the drying process. This can provide substantial reductions in HAP formation in the dryer. While some aspects of this approach are currently available and demonstrated, this approach alone will not yield sufficient HAP emission reductions by itself to meet the requirements of the rule. Thus, this option needs to be used in conjunction with other developed and un developed pollution prevention options described in this paper.

6) Green Screening HAP release is directly related to wood tissue temperature during drying. Because of their small surface areas, fines can release significant quantity of HAPs when they become overheated/ overdryed. When these small particles are removed prior to drying, significant HAP reductions can be accomplished. Green screening is a substantial capital expense potentially affecting all downstream processes. Retrofit of this equipment at an existing facility requires interruption of the existing line of process flow in order to integrate the screening process ahead of the furnish dryers. Costs for retrofit application can easily approach $ 1.0 million.

Since green fines tend to stick to green flakes, their separation is difficult without subjecting the flakes to excessive agitation which produces additional fine particles. This technology has not widely been applied in the Wood Products industry; therefore, research needs to move forward on optimum screening techniques and screen sizes in relation to HAP emissions. Additionally, alternative uses and markets for the material rejected by the screening also need to be developed.

7) Reduction of Temperature Stratification As with green screening, HAP reduction can be accomplished by reducing the temperature stratification within flake dryers and lowering the overall dryer operating 5 temperatures. Accomplishing these reductions will require an iterative process of equipment modification and raw material flow control that will demand time for development. This technology option, along with several other options we have described could potentially be construed as physical changes or changes in the method of operation requiring NSR permitting delays from 4 months to more than 1 year. Additionally, this technology has not been fully developed and, in all likelihood would require combinations of technologies to ensure compliance.

8) Oxidation in Existing Combustion Devices The industry feels strongly that the use of an existing on site combustion device such as process boilers or thermal oil heaters should be considered as an environmentallypreferable pollution prevention technique. For example, part of the emission unit exhaust could be used as combustion air for an existing boiler. In most cases, the process boiler could not utilize all of the large volume of air from multiple dryer stacks. It could, however, utilize part of the exhaust. Using this approach in conjunction with one or several of the other pollution prevention techniques that are not yet fully developed, a facility could comply with a production based emission limit. The availability of this option would preclude the need for RTO technology and would provide a net benefit to the environment with the reduction in collateral emissions. The success of this option is at least partially tied to further research on airflow reduction. In addition, the introduction of a hot, moist, VOC laden air stream into an existing combustion device often requires extensive re engineering of systems originally designed for ambient combustion air. These sorts of re engineering and retrofit projects require far more time and effort than a simple installation of an addon control but can accomplish significant HAPs reductions ( in many instances, equal to that of an RTO) with no additional combustion of fossil fuels. Accordingly, all possible incentives should be provided to maximize the implementation of this option.

9) Combination of Pollution Prevention Techniques Plants may ( and likely will) find that the only method to achieve compliance with reliable and adequate safety margins is with a combination of the techniques cited above and perhaps others not yet developed. Necessarily, that would create complexities. Extra time would be required to give plant managers confidence that they could implement these pollution prevention strategies into their plant operating procedures/ processes and still meet continuous compliance certification constraints.

The industry is committed to the goals of the MACT rule, and believes that a pollution prevention approach ultimately will result in lower overall compliance costs, energy use, and collateral emissions generation while still providing environmental and human health protection consistent with the goals of this rule. However, there are unique compliance and timing issues that the Wood MACT rule may create. Specifically, to meet the 3 year compliance deadline, only the add on control system approach is viable on a widespread basis. Its environmental disbenefits, however, 6 warrant allowing additional compliance time for other approaches to fully realize the goals of this rule. Since pollution prevention projects take longer to implement, the facilities would be faced with installing add on control systems and then taking them out or substantially modifying them. AF& PA believes that additional compliance time would ensure that the maximum degree of overall pollution reduction is achieved, without requiring unnecessary compliance costs. Further, AF& PA believes that EPA should encourage the use of these pollution prevention technologies, but recognizes that the evaluation and implementation of these technologies would add time and capital expense to the compliance activities for these sources.

EPA established the precedent for extending compliance deadlines on such grounds when it granted an eight year compliance deadline for kraft mills in the Pulp & Paper Cluster Rule. 63 Fed. Reg. 18504 ( Apr. 15, 1998). There, EPA declined to impose a three year compliance window on grounds that it would prevent the achievements of greater cost savings and environmental benefits associated with the combined use of two control technologies: brownstock washers and oxygen delignification units (" OD"). See id. at 18521 22 ( adopting rationale stated in proposed rule for five year extension of compliance term). EPA established a five year global extension to encourage sources to install ODs, which reduce the need for chlorinated chemical application in the bleaching process resulting in reduced loadings of chlorinated pollutants in the air and water. 61 Fed. Reg. 9383, 9394 ( Mar. 8, 1996). To gain the maximum benefit, sources would have had to upgrade brownstock washers and install new gas collection systems, but both could not be completed within three years. If EPA had required sources to spend time and money to retrofit their washers with a vent gas collection system to meet the three year deadline, they would have likely postponed or foregone installation of OD later. Explaining why a five year extension was warranted, EPA stated:

EPA believes the additional time would ensure that the maximum degree of overall multi media pollution reduction is achieved, without requiring unnecessary compliance costs. . . . EPA encourages the implementation of these pollution prevention technologies, but recognizes the evaluation and implementation of these technologies would add time and expense to the compliance activities for these sources.

Id. EPA concluded that an eight year compliance window would " allow sufficient time for a complete evaluation of all pollution control options." See id. at 9395. Notably, EPA questioned seriously " whether imposition of a standard that result[ ed] in foregoing substantial cross media environmental benefits could be MACT." Id.

Similarly, EPA extended the compliance deadline for imposition of MACT on storage tanks at oil refineries, noting that a three year deadline would result in increased HAP emissions. Specifically, EPA reasoned that, if pollution control upgrades were mandated for tanks at unscheduled times relative to their 10 year cleaning cycle, the amount of HAPs released in the process would exceed the amount of emissions reduced through earlier installation of controls. EPA stated: 7 The EPA determined that substantial HAP emissions occur when storage vessels are degassed and cleaned. Typically, storage vessels are inspected and maintained on a 10 year schedule, at which time tanks are degassed and cleaned. If a 3 year compliance schedule were required, storage vessels would be degassed and cleaned prematurely, resulting in substantial HAP emissions caused by the rule. These HAP emissions could not be balanced in less than 5 years for floating roof tanks by the emission reduction achieved from complying with the rule. By changing the proposed rule to allow floating roof tanks to comply with the storage vessel requirements 10 years after promulgation of the rule or at the next scheduled inspection, the EPA estimates that 3,000 Mg/ yr ( 2,700 tpy) of HAP, or 8,000 Mg ( 7,200 tpy) of HAP over 3 years, would be prevented from being emitted.

60 Fed. Reg. 43244, 43248 ( August 18, 1995).

A similar situation exists here. As discussed above, and in more detail in AF& PA's comments on the proposed rule, the incineration devices that otherwise would be required by Wood MACT have significant corollary environmental disbenefits, such that it is not clear whether their use would result in any net benefit to the environment. In contrast, several promising pollution prevention options exist for the wood products industry; these options could allow many sources to meet the HAP reductions mandated by the rule without any of the environmental disbenefits associated with these RTOs and RCOs. Yet as the above discussion demonstrates, if sources must comply within three years, their only viable option will be installation of RTOs or RCOs. Thus, as in the Pulp & Paper Cluster Rule and the Petroleum Refining MACT, allowing an extended compliance period provides an opportunity for significantly greater environmental benefits than could otherwise be achieved. Moreover, as EPA correctly noted in the Pulp & Paper Cluster Rule, here it is arguable " whether imposition of a standard that result[ ed] in foregoing substantial cross media environmental benefits could be MACT." For these reasons, a four year pollution prevention compliance extension represents sound public policy and is supported by prior precedent.

Recommended Approach In order to address the challenges with implementing pollution prevention options, AF& PA suggests adding 4 years to the compliance deadline, for a total of seven years. The facilities that implement this approach would be required to provide a commitment to do so within two years after promulgation of the rule, and also provide annual progress reports to identify progress towards those goals.


[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]
[Page 76807]
[DOCID:fr28de05-98]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2630-004]

PacifiCorp; Notice of Extension of Time To File Comments

December 19, 2005.
    On November 18, 2005, the Federal Energy Regulatory Commission
(Commission) issued a Notice of Availability of Draft Environmental
Assessment (EA) for the Prospect Nos. 1, 2, and 4 Hydroelectric Project
(Project No. 2630). The Notice requested that comments regarding the
Draft EA be filed with the Commission by no later than 45 days from the
date of the Notice, which is January 2, 2006. Please take notice that
the deadline for comments is now extended to January 20, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E5-7921 Filed 12-27-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 22, 2009 (Volume 74, Number 203)]
[Proposed Rules]
[Page 54534]
[DOCID:fr22oc09-23]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2009-0599; FRL-8971-5]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Revision to Clean Air Interstate Rule Sulfur Dioxide Trading
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the Commonwealth of Virginia for the purpose of
changing the timing of the first phase of the sulfur dioxide
(SO2) trading budget under the Commonwealth's approved
regulations that implement the requirements of the Clean Air Interstate
Rule (CAIR). In the Final Rules section of this Federal Register, EPA
is approving the Commonwealth's SIP submittal as a direct final rule
without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action,
no further activity is contemplated. If EPA receives adverse comments,
the direct final rule will be withdrawn and all public comments
received will be addressed in a subsequent final rule based on this
proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time.

DATES: Comments must be received in writing by November 23, 2009.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2009-0599 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2009-0599, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2009-0599. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://
www.regulations.gov or in hard copy during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
State submittal are available at the Virginia Department of
Environmental Quality, 629 East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Marilyn Powers,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action for the approval of the
Virginia revision to the CAIR SO2 trading program, with the
same title, that is located in the ``Rules and Regulations'' section of
this Federal Register publication.

     Dated: October 13, 2009.
James W. Newsom,
Acting Regional Administrator, Region III.
[FR Doc. E9-25353 Filed 10-21-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 142 (Tuesday, July 24, 2012)]
[Notices]
[Pages 43337-43342]
[FR Doc No: 2012-18015]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-1975-N-0336 (Formerly 75N-0184), FDA-1975-N-0355
(Formerly 75N-0185), FDA-1976-N-0272 (Formerly 76N-0056), FDA-1976-N-
0344 (Formerly 76N-0057), FDA-1978-N-0701 (Formerly 78N-0070), FDA-
1979-N-0224 (Formerly 79N-0169), FDA-1983-N-0297 (Formerly 83N-0030),
and FDA-1988-N-0004 (Formerly 88N-0242); DESI 597, 1626, 3265, 10837,
12283, and 50213, and Hydrocortisone Acetate and Pramoxine
Hydrochloride]

Drugs for Human Use; Drug Efficacy Study Implementation; Certain
Prescription Drugs Offered for Various Indications; Opportunity To
Affirm Outstanding Hearing Request

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is offering an
opportunity to affirm outstanding hearing requests pertaining to
several dockets. FDA will assume that companies with outstanding
hearing requests that do not respond to this notice are no longer
interested in pursuing their requests, and will deem the requests
withdrawn.

DATES: Effective Date: This notice is effective August 23, 2012.
    Hearing Requests: Hearing requests must be affirmed by notifying
FDA by August 23, 2012. Hearing requests not affirmed within that
timeframe will be deemed withdrawn.

ADDRESSES: Requests to affirm or withdraw outstanding hearing requests,
as well as all other communications in response to this notice, should
be identified with the appropriate docket number, and directed to
Pamela Lee, Office of Unapproved Drugs and Labeling Compliance, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 5173, Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Pamela Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 5173, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is
offering an opportunity to affirm outstanding hearing requests
pertaining to FDA Docket Nos. FDA-1975-N-0336 (formerly 75N-0184) (DESI
597); FDA-1976-N-0272 (formerly 76N-0056), FDA-1976-N-0344 (formerly
76N-0057), and FDA-1978-N-0701 (formerly 78N-0070) (DESI 1626); FDA-
1975-N-0355 (formerly 75N-0185) (DESI 3265); FDA-1975-N-0336 (formerly
75N-0184) (DESI 10837); FDA-1979-N-0224 (formerly 79N-0169) (DESI
12283); FDA-1983-N-0297 (formerly 83N-0030) (DESI 50213); and FDA-1988-
N-0004 (formerly 88N-0242).

I. Background

    When initially enacted in 1938, the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) required that ``new drugs'' (see 21 U.S.C.
321(p)) be approved for safety by FDA before they could legally be sold
in interstate commerce. To this end, the FD&C Act made it the sponsor's
responsibility, before marketing a new drug, to submit a new drug
application (NDA) to FDA to prove that its drug was safe. Between 1938
and 1962, if a drug obtained approval, FDA considered drugs that were
identical, related, or similar (IRS) (see (21 CFR 310.6(b)(1)) to the
approved drug to be ``covered'' by that approval, and allowed those IRS
drugs to be marketed without independent approval.
    In 1962, Congress amended the FD&C Act to require that new drugs be
proven effective for their labeled indications, as well as safe, to
obtain FDA approval. This amendment also necessitated that FDA conduct
a retrospective evaluation of the effectiveness of the drug products
that FDA had approved as safe between 1938 and 1962. FDA contracted
with the National Academy of Sciences/National Research Council (NAS/
NRC) to make an initial evaluation of the effectiveness of over 3,400
products that had been approved only for safety between 1938 and 1962.
The NAS/NRC reports for these drug products were submitted to FDA in
the late 1960s and early 1970s. The Agency reviewed and reevaluated the
reports and published its findings in Federal Register notices. FDA's
administrative implementation of the NAS/NRC reports was called the
Drug Efficacy Study Implementation (DESI). DESI covered the
approximately 3,400 products specifically reviewed by the NAS/NRC, as
well as the even larger number of IRS products that entered the market
without FDA approval.
    All drugs covered by the DESI review are ``new drugs'' under the
FD&C Act. If FDA's final DESI determination classifies a drug product
as lacking substantial evidence of effectiveness for one or more
indications, that drug product and those IRS to it may no longer be
marketed for the indications and are subject to enforcement action as
unapproved new drugs. If FDA's final DESI determination classifies the
drug product as effective for one or more of its labeled indications,
the drug can be marketed for those indications, provided it is the
subject of an application approved for safety and effectiveness.
Sponsors of drug products that have been found to be effective for one
or more indications through the DESI process may rely on FDA's
effectiveness determinations, but typically must update their labeling
to conform to the indications found to be effective by FDA and to
include any additional safety information required by FDA. Those drug
products with NDAs approved before 1962 for safety therefore require
approved supplements to their original applications if found to be
effective under DESI; IRS drug products require an approved NDA or
abbreviated new drug application (ANDA), as appropriate. Furthermore,
labeling for drug products classified as effective may contain only
those indications for which the review found the product effective
unless the firm marketing the product has received an approval for the
additional indication(s).

II. Outstanding Hearing Requests Pertaining to Docket Nos. FDA-1975-N-
0336 (Formerly 75N-0184) (DESI 597); FDA-1976-N-0272 (Formerly 76N-
0056), FDA-1976-N-0344 (Formerly 76N-0057), and FDA-1978-N-0701
(Formerly 78N-0070) (DESI 1626); FDA-1975-N-0355 (Formerly 75N-0185)
(DESI 3265); FDA-1975-N-0336 (Formerly 75N-0184) (DESI 10837); FDA-
1979-N-0224 (Formerly 79N-0169) (DESI 12283); FDA-1983-N-0297 (Formerly
83N-0030) (DESI 50213); and FDA-1988-N-0004 (Formerly 88N-0242)

    In 2006, FDA announced a new drug safety initiative to address
unapproved drugs currently being marketed in the United States, and to
facilitate a rational process to bring all such unapproved drugs into
the approval process. As part of the Unapproved Drugs Initiative, the
Office of Compliance of the Center for Drug Evaluation and Research is
reviewing proceedings that remain open under DESI. According to FDA's
records, the dockets discussed in this document contain pending hearing
requests.
    This Federal Register notice identifies the products that are the
subjects of hearing requests to the extent possible based on the
information contained in the hearing requests. In some cases, the
companies requesting hearings identified the product that was the
subject of the hearing request by name. In other cases, the company
simply identified the subject of its hearing request as a product that
is IRS to one of the products reviewed under DESI. In yet other cases,
there is no information provided by the requester about the product
that is the subject of its hearing request.
    In cases where FDA was able to obtain current contact information
for a company (or its successor-in-interest) or its representative, FDA
sent letters directly to the companies (or their successors-in-
interest) and/or their representatives requesting that outstanding
hearing requests be withdrawn or affirmed within a specified timeframe.
In some cases, however, FDA was unable to find current contact
information for the companies that requested hearings. Because many of
the products that are the subjects of these hearing requests may no
longer be marketed and some of the companies that requested hearings
may no longer be in business, FDA is seeking to determine whether there
is continued interest in pursuing these outstanding hearing requests.
It should be noted that the discussion of DESI dockets does not provide
a comprehensive historical record of each docket and, therefore, will
not identify every request that had been previously addressed.
    Through this Federal Register notice, FDA seeks to have any company
with an outstanding hearing request covered by this notice that has not
already responded to a direct communication from FDA either withdraw or
affirm its hearing request. FDA will assume that companies with
outstanding hearing requests that do not respond to this notice are no
longer in business and/or do not have a continuing interest in the
hearings, and FDA will deem their requests withdrawn.
    To withdraw an outstanding hearing request, a company (or its
successor-in-interest) or its representative should send a letter
stating its intention to do so to Pamela Lee (see ADDRESSES). The
letter should include the docket number of the proceeding, as well as
the name

and National Drug Code (NDC) number of the product that is the subject
of the hearing request.
    To affirm an outstanding hearing request, a company (or its
successor-in-interest) or its representative should send a letter
stating its intention to do so to Pamela Lee (see ADDRESSES). The
letter should include the docket number of the proceeding, as well as
the name and NDC number of the product that is the subject of the
hearing request. Letters affirming outstanding hearing requests must be
postmarked or emailed by the date specified in this notice (see DATES).
Only currently outstanding hearing requests may be affirmed; this
notice does not provide a new opportunity to request a hearing under
any of these dockets.

A. Certain Drug Products Containing an Anticholinergic in Combination
With a Barbituate; Docket No. FDA-1975-N-0336 (Formerly 75N-0184) (DESI
597)

    Under Docket No. FDA-1975-N-0336 (formerly 75N-0184), FDA
determined that certain drug products containing an anticholinergic in
combination with a barbiturate lacked substantial evidence of
effectiveness for various gastrointestinal disorders, and offered an
opportunity for hearing regarding its conclusion (48 FR 20495, May 6,
1983). In response to the May 1983 notice, the following companies
filed timely hearing requests: A.H. Robins Co. (now part of Pfizer,
Inc., 235 East 42nd St., New York, NY 10017), regarding Donnatal
Tablets (ANDA 86-676), Capsules (ANDA 86-677), and Elixir (ANDA 86-
661); B.F. Ascher & Co., Inc., 15501 W. 109th St., Lenexa, KS 66219,
regarding Anaspaz-PB; Bay Laboratories, Inc., 3654 West Jarvis, Skokie,
IL 60076, regarding Bay-Ase Elixir (ANDA 86-673); Beecham Laboratories,
a Division of Beecham, Inc. (now part of Glaxo SmithKline, 200 N 16th
St., 1, Philadelphia, PA 19102), regarding Hybephen (ANDA 86-
573); Carter-Wallace, Inc. (now part of Meda Pharmaceuticals, Inc., 265
Davidson Ave., Suite 300, Somerset, NJ 08873-4120), regarding
Barbidonna Tablets (ANDA 86-589), Barbidonna Elixir (ANDA 86-590), and
Barbidonna No. 2 Tablets (ANDA 87-572); Ferndale Laboratories, Inc.
(now part of Ferndale Pharma Group, Inc., 780 W. Eight Mile Rd.,
Ferndale, MI 48220), regarding Bellkatal Tablets and Pheno-Bella
Tablets; Halsey Drug Co., Inc. (now part of Acura Pharmaceuticals,
Inc., 616 N. North Court, Suite 120, Palatine, IL 60067), regarding
Susano Elixir (ANDA 86-587) and Susano Tablets (ANDA 86-588); Kremers-
Urban Co. (now part of Kremers-Urban Pharmaceuticals, Inc., 902
Carnegie Center, Suite 360, Princeton, NJ 08540), regarding Levsin with
Phenobarbital Tablets (ANDA 86-640); Lemmon Co. (now part of Teva
Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA
19454-1090), regarding Belladonna Alkaloids and Phenobarbital Tablets
(ANDA 86-591); McNeil Pharmaceutical (now part of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., P.O. Box 200,
Titusville, NJ 08568), regarding Butibel Tablets and Butibel Elixir
(ANDA 86-664); National Pharmaceutical Manufacturing Co. (now part of
Actavis US, 60 Columbia Rd., Bldg. B, Morristown, NJ 07960), regarding
Barophen Elixir (ANDA 86-546) and Butabar Belladonna Elixir (ANDA 86-
561); Purepac Pharmaceutical (now part of Actavis US, 60 Columbia Rd.,
Bldg. B, Morristown, NJ 07960), regarding Belladonna Alkaloids with
Phenobarbital Tablets and Elixir; Reid-Provident Laboratories, Inc.
(now part of Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL
60064-3500), regarding Spalix Elixir (ANDA 86-652) and Spalix Tablets
(ANDA 86-653); Richlyn Laboratories, Inc. (now part of Impax
Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544), regarding
Bellophen (ANDA 86-687) and Spasmolin (ANDA 86-655); Sandoz, Inc., 506
Carnegie Center, Suite 400, Princeton, NJ 08540, regarding Belladenal
Tablets (ANDA 86-668) and Belladenal S Tablets (ANDA 87-198); Stuart
Pharmaceuticals, Division of ICI Americas, Inc. (now part of
AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, P.O. Box 15437,
Wilmington, DE 19850-5437), regarding Kinesed Tablets; Vale Chemical
Co., Inc., 1201 Liberty St., Allentown, PA 18102, regarding Barbeloid
Tablets, Green (NDA 85-532) and Barbeloid Tablets, Yellow (NDA 86-549);
West-ward Pharmaceutical Corp., 401 Industrial Way West, Eatontown, NJ
07724-2206, regarding Belladonna Alkaloid with Phenobarbital Tablets;
William P. Poythress & Co., Inc., 16 N. 22nd St., P.O. Box 26946,
Richmond, VA 23261, regarding unidentified products composed of
atropine sulfate 0.195 milligrams (mg) in combination with
phenobarbital 16 mg; William Rorer, Inc. (now part of Sanofi-Aventis
U.S., 55 Corporate Dr., Bridgewater, NJ 08807), regarding Chardonna-2
Tablets (ANDA 86-585); and Wharton Laboratories, Inc., 48th Ave., Long
Island City, NY 11101, regarding Bellastal Capsules (ANDA 86-657).
    In May, June, and July 2011, FDA sent letters to the following
companies requesting that they withdraw or affirm their outstanding
hearing requests under this docket within 30 days: Pfizer, Inc.; B.F.
Ascher & Co., Inc.; Glaxo SmithKline; Meda Pharmaceuticals, Inc.;
Ferndale Pharma Group, Inc.; Acura Pharmaceutical Co.; Kremers-Urban
Pharmaceuticals, Inc.; Teva Pharmaceuticals; Ortho-McNeil-Janssen
Pharmaceuticals, Inc.; Actavis US; Abbott Laboratories; Impax
Laboratories, Inc.; Sandoz, Inc.; AstraZeneca Pharmaceuticals LP; West-
ward Pharmaceutical Corp.; and Sanofi-Aventis U.S.
    On May 24, 2011, Actavis US withdrew the hearing request filed by
National Pharmaceutical Manufacturing Co. On May 26, 2011, Teva
Pharmaceuticals and Impax Laboratories, Inc., withdrew the hearing
requests filed by Lemmon Co. and Richlyn Laboratories, Inc.,
respectively. On June 2, 2011, Ferndale Pharma Group, Inc., withdrew
its hearing request. On June 3, 2011, AstraZeneca Pharmaceuticals, LP,
withdrew the hearing request filed by Stuart Pharmaceuticals. On June
6, 2011, Acura Pharmaceutical Co. withdrew the hearing request filed by
Halsey Drug Co., Inc. On June 7, 2011, Johnson & Johnson Pharmaceutical
Research & Development, LLC, responded to the letter sent to Ortho-
McNeil-Janssen Pharmaceuticals, Inc., stating that the rights to
Butibel Elixir had been transferred to Carter Wallace in 1982. On June
20, 2011, B.F. Ascher & Co., Inc., withdrew its hearing request. On
June 22, 2011, Novartis Pharmaceuticals Corp., the successor-in-
interest by merger to Sandoz, Inc., withdrew Sandoz, Inc.'s hearing
request. On July 7, 2011, Meda Pharmaceuticals, Inc., withdrew the
hearing request filed by Carter-Wallace, Inc., as well as the hearing
request filed by McNeil Pharmaceutical for Butibel Tablets and Elixir.
On July 27, 2011, Kremers-Urban Co. withdrew its hearing request. On
August 11, 2011, GlaxoSmithKline withdrew the hearing request filed by
Beecham Laboratories. On August 24, 2011, Abbott Laboratories withdrew
the hearing request filed by Reid-Provident Laboratories, Inc.
    On July 6, 2011, West-ward Pharmaceutical Corp. affirmed its
hearing request and PBM Pharmaceuticals, Inc., affirmed the hearing
request filed by A.H. Robins Co., as the asserted successor-in-interest
to A.H. Robins Co.'s hearing request. A Federal Register notice issued
on June 8, 2011 (76 FR 33310), withdrew the approval of 70 NDAs and 97
ANDAs. This included the withdrawal of the approval for Donnatal
Capsules and

withdrawal of the conditional approval for the Donnatal Tablets and
Elixir. This withdrawal notice was subsequently corrected to note that
the approval and conditional approvals for these products were still in
effect, because PBM Pharmaceuticals, Inc., had acquired the rights to
the ANDAs and had informed FDA before the withdrawal would have become
effective that it did not want the ANDAs withdrawn (76 FR 79701,
December 22, 2011).
    As of April 1, 2012, Actavis U.S. (with respect to the hearing
request filed by Purepac Pharmaceutical) and Sanofi-Aventis U.S. had
not responded to FDA. FDA was unable to find current contact
information for Bay Laboratories, Inc.; Vale Chemical Co., Inc.;
William P. Poythress & Co., Inc.; and Wharton Laboratories, Inc. If any
of these companies, or any successor-in-interest, continues to have an
interest in pursuing its hearing request under this docket, the
companies (or their successors-in-interest) must affirm their hearing
requests in writing by the date specified in this notice (see DATES).
FDA will assume that hearing requests that are not affirmed within that
timeframe are no longer being pursued, and will deem them withdrawn.

B. Combination Drugs Containing a Xanthine Derivative; Docket No. FDA-
1976-N-0272 (Formerly 76N-0056), FDA-1976-N-0344 (Formerly 76N-0057),
and FDA-1978-N-0701 (Formerly 78N-0070) (DESI 1626)

    In 1972, FDA classified certain combination drug products
containing a xanthine derivative as less than effective for some
labeled indications and possibly effective for other labeled
indications (37 FR 14895, July 26, 1972). As described in a Federal
Register notice of February 29, 1984, FDA subsequently handled these
products in three groups: (1) Combinations containing more than 2
grains of xanthine derivative, more than 8 mg of phenobarbital, and/or
an ingredient not considered as part of the over-the-counter (OTC) drug
review (Docket No. FDA-1976-N-0272 (formerly 76N-0056)); (2)
combinations containing 2 grains or less of a xanthine derivative,
ephedrine, and 8 mg or less of phenobarbital (Docket No. FDA-1976-N-
0344 (formerly 76N-0057)); and (3) combinations containing
theophylline, ephedrine, and hydroxyzine hydrochloride (HCl) (Docket
No. FDA-1978-N-0701 (formerly 78N-0070)) (49 FR 7454, February 29,
1984).
    In 1976, FDA reclassified certain combination preparations
containing a xanthine derivative to lacking substantial evidence of
effectiveness, proposed withdrawing associated NDAs, and offered an
opportunity for hearing regarding its proposal (41 FR 15051, April 9,
1976). The group of products addressed in the April 1976 notice
contained more than 2 grains of xanthine derivative, a barbiturate in
higher strength than the equivalent of 8 mg of phenobarbital, and/or an
ingredient not considered as part of the OTC drug review (Docket No.
FDA-1976-N-0272 (formerly 76N-0056)) (id.). The holders of the NDAs
listed in the April 1976 notice did not request hearings, and those
NDAs were withdrawn in October 1977 (42 FR 54620, October 7, 1977).
However, in response to the April 1976 notice, the following companies
filed timely hearing requests: Knoll Pharmaceutical Co. (now part of
Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL 60064-3500),
regarding Quadrinal Tablets and Suspension, and Mead Johnson
Laboratories (now Mead Johnson Nutrition, 4th Floor, 2701 Patriot
Blvd., Glenview, IL 60026), regarding Quibron Plus Capsules and Elixir.
    In 1984, FDA amended the April 1976 notice to include its analysis
of new information regarding combination products containing a xanthine
derivative (49 FR 7454, February 29, 1984). Based on its analysis of
the new information, FDA concluded that there is a lack of substantial
evidence that: (1) Each ingredient contributes to the claimed effect of
such combination drug products, and (2) the dosage of each component is
such that the combinations are safe and effective for a significant
patient population (id.). Therefore, FDA proposed in the 1984 notice to
withdraw approval of the applications for combination products
containing a xandine derivative, and offered an opportunity for hearing
regarding its proposal. In response to the February 1984 notice, the
following companies filed timely hearing requests: National
Pharmaceutical Manufacturing Co. (now part of Actavis US, 60 Columbia
Rd., Bldg. B, Morristown, NJ 07960), regarding Brondelate Elixir,
Ferdinal Suspension, Guiaphed Elixir, Hydroxyzine Compound Syrup,
Iophylline Elixir, Isolate Compound Elixir, and Theofed Suspension and
Liquid; Warner Lambert Co. (now part of Pfizer, Inc., 235 East 42nd
St., New York, NY 10017), regarding Tedral SA; and William P. Poythress
& Co., Inc., 16 N. 22nd St., P.O. Box 26946, Richmond, VA 23261,
regarding an unidentified product containing a xanthine derivative,
ephedrine, and 8 mg or less of phenobarbital.
    In March and April 2011, FDA sent letters to Abbott Laboratories,
Actavis US, Mead Johnson Nutrition, and Pfizer, Inc., requesting that
these companies withdraw or affirm their outstanding hearing requests
under this docket within 30 days.
    On April 25, 2011, Mead Johnson Nutrition withdrew the hearing
request filed by Mead Johnson Laboratories. On May 3, 2011, Pfizer,
Inc. withdrew the hearing request filed by Warner Lambert Co. On May 9,
2011, Actavis US withdrew the hearing request filed by National
Pharmaceutical Manufacturing Co. On June 21, 2011, Abbott Laboratories
withdrew the hearing request filed by Knoll Pharmaceutical Co.
    FDA was unable to find current contact information for William P.
Poythress & Co. If this company, or its successor-in-interest,
continues to have an interest in pursuing its hearing request under
this docket, the company (or its successor-in-interest) must affirm its
hearing request in writing by the date specified in this notice (see
DATES). FDA will assume that hearing requests that are not affirmed
within that timeframe are no longer being pursued, and will deem them
withdrawn.

C. Certain Single Entity Antispasmodic Drugs; Docket No. FDA-1975-N-
0355 (Formerly 75N-0185) (DESI 3265)

    In 1971, FDA published DESI efficacy findings for single-ingredient
anticholinergic drugs for oral or injectable use containing dicyclomine
HCl and piperidolate HCl, among other ingredients (36 FR 11754, June
18, 1971). In a notice published on November 11, 1975 (40 FR 52644),
FDA determined that the June 18, 1971, Federal Register notice should
not have included drugs containing certain specified ingredients,
including dicyclomine HCl and piperidolate HCl, because the drugs
containing those ingredients were not anticholinergic drugs. Also on
November 11, 1975, FDA published a notice of opportunity for hearing
regarding these drugs (40 FR 52649). In response to the November 1975
notice, the following companies filed timely hearing requests: Carnrick
Laboratories, Inc., 65 Horsehill Rd., Cedar Knolls, NJ 07927, regarding
Midrin, and Merrell-National Laboratories, 110 Amity Rd., Cincinnati,
OH 45215, regarding Bentyl Capsules (NDA 7-409), Bentyl Injection (NDA
8-370), Bentyl Syrup (NDA 7-961), and Dactil Tablets (NDA 8-907).
    In September 2011, FDA sent letters to counsel for Carnrick
Laboratories, Inc., which FDA believed operated as a subsidiary of Elan
Corporation PLC, and

to Sanofi-Aventis U.S., which FDA believes to be the successor-in-
interest to Merrell-National Laboratories. In September 2011, Carnrick
Laboratories, Inc.'s former counsel informed FDA that it did not
represent Carnrick Laboratories, Inc., or Elan Corporation PLC with
respect to the hearing request under DESI 3265. In October 2011, FDA
sent a letter to Sun Pharmaceutical Industries, Inc., believing it to
be the successor-in-interest to Carnrick Laboratories, Inc.'s hearing
request. On November 3, 2011, a representative from Sun Pharmaceutical
Industries, Inc., verbally informed FDA that it was withdrawing the
hearing request filed by Carnrick Laboratories, Inc., and stated they
would be submitting their withdrawal of the hearing request in writing.
    As of April 1, 2012, Sanofi-Aventis U.S. has not responded to FDA.
If this company, or the successor-in-interest, continues to have an
interest in pursuing the hearing request filed by Merrell-National
Laboratories under this docket, the company (or its successor-in-
interest) must affirm the hearing request in writing by the date
specified in this notice (see DATES). FDA will assume that hearing
requests that are not affirmed within that timeframe are no longer
being pursued, and will deem them withdrawn.

D. Certain Anticholinergics/Antispasmodics in Combination With a
Sedative, and Single-Entity Antispasmodics, in Conventional Dosage
Form; Docket No. FDA-1975-N-0336 (Formerly 75N-0184) (DESI 10837)

    Through DESI review, FDA determined that two products, Pathibamate
and Milpath Tablets, both containing tridihexethyl chloride and
meprobamate, were possibly effective as adjunctive therapy in peptic
ulcer and in the irritable bowel syndrome, functional diarrhea, drug-
induced diarrhea, ulcerative colitis, urinary bladder spasm, and
urethral spasm (36 FR 11875, June 22, 1971). In 1981, FDA reclassified
these products to lacking substantial evidence of effectiveness,
proposed withdrawing associated NDAs, and offered an opportunity for
hearing regarding its proposal (46 FR 3977, January 16, 1981). In
response to the January 1981 notice, the following companies filed
timely hearing requests: Cord Laboratories (now part of Sandoz, Inc.,
2555 West Midway Blvd., Broomfield, CO 80020), regarding Chlordinium
Capsules (ANDA 86-667); Roche Laboratories (now part of Genentech,
Inc., 1 DNA Way, South San Francisco, CA 94080-4990), regarding Librax;
and Premo Pharmaceutical Laboratories, Inc. (now part of Teva
Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA
19454-1090), regarding Meprohex 200 (ANDA 86-674), Meprohex 400 (ANDA
86-658), and chlordinium capsules (ANDA 86-667).
    FDA sent letters to Genentech, Inc., in November 2010, and to
Sandoz, Inc., and counsel of record for Premo Pharmaceutical
Laboratories, Inc., in January 2011, requesting that these companies
withdraw or affirm their outstanding hearing requests under this docket
within 30 days. At the time, FDA was unable to find a current address
for Premo Pharmaceutical Laboratories, Inc., and did not know that the
company is part of Teva Pharmaceuticals.
    On February 4, 2011, Genentech, Inc., informed FDA that it was no
longer interested in pursuing the hearing request filed by Roche
Laboratories, but noted that it had sold the rights of the product that
was the subject of the hearing request to Valeant Pharmaceuticals
International, Inc. On February 28, 2011, Sandoz, Inc., withdrew the
hearing request filed by Cord Laboratories. On March 15, 2011, Teva
Pharmaceuticals withdrew the hearing request filed by Premo
Pharmaceutical Laboratories, Inc.
    In March 2011, FDA sent a letter to Valeant Pharmaceuticals
International, Inc., requesting that the company withdraw or affirm the
outstanding hearing request filed by Roche Laboratories under this
docket within 30 days. As of April 1, 2012, Valeant Pharmaceuticals
International, Inc., had not responded to FDA. If this company, or its
successor-in-interest, continues to have an interest in pursuing its
hearing request under this docket, the company (or its successor-in-
interest) must affirm its hearing request in writing by the date
specified in this notice (see DATES). FDA will assume that hearing
requests that are not affirmed within that timeframe are no longer
being pursued, and will deem them withdrawn.

E. Chlorthalidone; Docket No. FDA-1979-N-0224 (Formerly 79N-0169) (DESI
12283)

    In 1979, as part of the DESI review, FDA announced its conclusions
regarding the effectiveness of chlorthalidone for the treatment of
hypertension and certain types of edema (44 FR 54124, September 18,
1979). Specifically, FDA determined that there was substantial evidence
to support the effectiveness of the 25- and 50-mg strengths for use in
hypertension, but that there was no longer justification for the 100-mg
dosage form of chlorthalidone because of safety concerns at that dosage
level (id. at 54126). The 1979 notice proposed to withdraw approval of
the 100-mg strength and offered an opportunity for hearing regarding
its proposal. In response to the 1979 notice, the following companies
filed timely hearing requests: Generics International Division of
Apotex, Inc., 2400 North Commerce Pkwy., suite 400, Weston, FL 33326,
regarding Chlorthalidone, and USV Pharmaceutical Corp. (now part of
Sanofi-Aventis U.S., 55 Corporate Dr., Bridgewater, NJ 08807),
regarding Hygroton (NDA 12-283).
    FDA sent letters to Sanofi-Aventis U.S. and Apotex, Inc., in May
2011 and July 2011, respectively, requesting that the companies
withdraw or affirm their outstanding hearing requests under this docket
within 30 days.
    On August 12, 2011, Sanofi-Aventis U.S. withdrew the outstanding
hearing request filed by USV Pharmaceutical Corp. As of April 1, 2012,
Apotex, Inc., had not responded to FDA. If this company, or its
successor-in-interest, continues to have an interest in pursuing its
hearing request under this docket, the company (or its successor-in-
interest) must affirm its hearing request in writing by the date
specified in this notice (see DATES). FDA will assume that hearing
requests that are not affirmed within that timeframe are no longer
being pursued, and will deem them withdrawn.

F. Chlortetracycline and Tetracycline; Docket No. FDA-1983-N-0297
(Formerly 83N-0030) (DESI 50213)

    Through DESI review, FDA determined that certain fixed-combination
drugs containing antibiotics and sulfonamides lack substantial evidence
of effectiveness (34 FR 6008, April 2, 1969). The April 1969 Federal
Register notice proposed to revoke provisions for certification of
these products and offered interested persons 30 days to submit data
concerning the proposal. Data submitted in response to the April 1969
notice did not provide substantial evidence of effectiveness, so FDA
amended the antibiotic regulations on June 30, 1970, by revoking
provisions for the certification of these drugs (35 FR 10587, June 30,
1970). The order was to become effective in 40 days, and allowed 30
days for interested persons to file objections and request a hearing.
The time for responding to the June 1970 order was subsequently
extended until August 17, 1970 (35 FR 12653, August 8, 1970).
    In response to the June 1970 order, Pfizer, Inc., submitted data
regarding its

affected product, Urobiotic 250 Capsules, and requested a hearing.
Despite the filing of timely objections, the amendments were
inadvertently not stayed, and succeeding codifications of the
antibiotic regulations did not explicitly provide for certification of
Urobiotic 250 Capsules. However, FDA permitted Pfizer, Inc., to
continue distribution of its product pending resolution of the firm's
hearing request. In July 2010, Pfizer, Inc., voluntarily withdrew its
application for Urobiotic (see 75 FR 42455, July 21, 2010), but its
hearing request remains pending.
    In October 2010, FDA sent Pfizer, Inc., a letter requesting that it
withdraw or affirm its outstanding hearing request under this docket
within 30 days. As of April 1, 2012, Pfizer, Inc., had not responded to
FDA. If Pfizer, Inc. (or its successor-in-interest), continues to have
an interest in pursuing its hearing request under this docket, the
company (or its successor-in-interest) must affirm its hearing request
in writing by the date specified in this notice (see DATES). FDA will
assume that hearing requests that are not affirmed within that
timeframe are no longer being pursued, and will deem them withdrawn.

G. Hydrocortisone Acetate and Pramoxine HCl; Docket No. FDA-1988-N-0004
(Formerly 88N-0242)

    Through DESI review, FDA determined that topical corticosteroids,
including hydrocortisone acetate, were effective for symptomatic relief
and adjunctive management of various steroid-responsive dermatoses (36
FR 7982, April 28, 1971). In the mid-1970s, FDA approved several
products under ANDAs listing hydrocortisone acetate as their sole
active ingredient. Subsequently, FDA determined that these products
also contained an anesthetic active ingredient, pramoxine HCl. FDA
evaluated the effectiveness of the fixed-combination and found no
evidence that the pramoxine HCl component contributes an effect to the
combination drug (53 FR 25013, July 1, 1988). Thus, FDA proposed to
withdraw the ANDAs for these products and offered an opportunity for
hearing on its proposal (id).
    In response to the July 1988 notice, the following companies filed
timely hearing requests: Copley Pharmaceutical, Inc., 398 West Second
St., Boston, MA 02127, regarding a topical aerosol foam hydrocortisone
and pramoxine HCl product (ANDA 89-440); Ferndale Laboratories, Inc.
(now part of Ferndale Pharma Group, Inc., 780 W. Eight Mile Rd.,
Ferndale, MI 48220), regarding Pramosone lotion (0.5% hydrocortisone
acetate) (ANDA 83-213), Pramosone cream (0.5% hydrocortisone acetate)
(ANDA 83-778), Pramosone cream (1.0% hydrocortisone acetate) (ANDA 85-
368), Pramosone lotion (1.0% hydrocortisone acetate) (ANDA 85-979),
Pramosone lotion (2.5% hydrocortisone acetate) (ANDA 85-980), Pramosone
ointment (1% hydrocortisone acetate), Pramosone ointment (2.5%
hydrocortisone acetate), Pramosone cream (2.5% hydrocortisone acetate),
Enzone cream, Zone-A lotion, Zone-A Forte lotion, Zone-A cream, FEP
cream, Dibucort cream, and Procto-cream HC; and Reed & Carnrick (now
part of Meda Pharmaceuticals, Inc., 265 Davidson Ave., suite 300,
Somerset, NH 08873-4120), regarding its topical aerosol foam
hydrocortisone and pramoxine HCl products (ANDAs 86-195 and 86-457).
    In November 2010, FDA sent letters to Copley Pharmaceutical, Inc.;
Ferndale Pharma Group, Inc.; and Meda Pharmaceuticals, Inc., requesting
that these companies (or their successors-in-interest) withdraw or
affirm their outstanding hearing requests under this docket within 30
days. On January 3, 2011, counsel for Ferndale Laboratories, Inc., and
Meda Pharmaceutical, Inc., sent a letter affirming the hearing requests
made by both companies.
    As of April 1, 2012, Copley Pharmaceutical, Inc., had not responded
to FDA. If this company (or its successor-in-interest) continues to
have an interest in pursuing its hearing request under this docket, the
company (or its successor-in-interest) must affirm its hearing request
in writing by the date specified in this notice (see DATES). FDA will
assume that hearing requests that are not affirmed within that
timeframe are no longer being pursued, and will deem them withdrawn.
    This notice is issued under the Federal Food, Drug, and Cosmetic
Act (sections 502 and 505 (21 U.S.C. 352 and 355)).

    Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18015 Filed 7-23-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Notices]
[Page 8719]
[DOCID:fr27fe07-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL06-80-003]

Midwest Independent Transmission System Operator, Inc.; Notice of
Filing

February 21, 2007.
    Take notice that on February 9, 2007, Midwest Independent
Transmission System Operator, Inc. filed a refund report in compliance
to the Commission's August 11, 2006 Order on Complaint.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 2, 2007.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-3344 Filed 2-26-07; 8:45 am]

BILLING CODE 6717-01-P