The Federal Election Commission is making permanent a program to afford respondents in pending enforcement matters the opportunity to participate in hearings (generally through counsel) and present oral arguments directly to the Commissioners, prior to any Commission determination of whether to find probable cause to believe respondents violated FECA. 1

On June 11, 2003, the Commission held a hearing concerning its enforcement procedures. The Commission received comments from those in the regulated community, many of whom argued for increased transparency in Commission procedures and expanded opportunities to contest allegations. 2 In response to issues raised at the hearing, the Commission has made a number of changes and clarifications. These changes and clarifications include allowing respondents to have access to their deposition transcripts, See Statement of Policy Regarding Deposition Transcripts in Nonpublic Investigations, 68 FR 50688 (August 22, 2003), and clarifying questions concerning treasurer liability for violations of the FECA, See Statement of Policy Regarding Treasurers Subject to Enforcement Proceedings, 70 FR 3 (January 3, 2005).

On December 8, 2006, the Commission published a proposal for a pilot program for probable cause hearings, and sought comments from the regulated community. See Proposed Policy Statement Establishing Pilot Program for Probable Cause Hearings, 71 FR 71088 (Dec. 8, 2006). The comment period on the proposed policy statement closed on January 5, 2007. The Commission received four comments, all of which endorsed the proposed pilot program for probable cause hearings. These comments are available at http://www.fec.gov/law/policy.shtml#proposed under the heading “Pilot Program for Probable Cause Hearings.”

On February 8, 2007, the Commission decided by a vote of 6-0 to institute the pilot program. The program went into effect on February 16, 2007. The pilot program was designed to remain in effect for at least eight months, after which time a vote would be scheduled on whether the program should continue. The Commission finds that the pilot program has been successful and hence, is issuing this notice to announce that the Commission has determined to make the program permanent.

A respondent may request a probable cause hearing when the enforcement process reaches the probable cause determination stage (see 11 CFR 111.16-111.17) and the respondent submits a probable cause response brief to the Office of General Counsel. The General Counsel will attach a cover letter to its probable cause brief to inform the respondent of the opportunity to request an oral hearing before the Commission. See 11 CFR 111.16(b). Hearings are voluntary and no adverse inference will be drawn by the Commission based on a respondent's request for, or waiver of, such a hearing. The respondent must include a written request for a hearing as a part of the respondent's filed reply brief under 11 CFR 111.16(c). Each request for a hearing must state with specificity why the hearing is being requested and what issues the respondent expects to address. Absent good cause, to be determined at the sole discretion of the Commission, late requests will not be accepted. Respondents are responsible for ensuring that their requests are timely received. All requests for hearings, scheduling and format inquiries, document submissions, and any other inquiries related to the probable cause hearings should be directed to the Office of General Counsel.

The Commission will grant a request for an oral hearing if any two Commissioners agree that a hearing would help resolve significant or novel legal issues, or significant questions about the application of the law to the facts. The Commission will inform the respondent whether the Commission is granting the respondent's request within 30 days of receiving the respondent's brief.

The purpose of the oral hearing is to provide a respondent an opportunity to present the respondent's arguments in person to the Commissioners before the Commission makes a determination as to whether there is “probable cause to believe” that the respondent violated the Act or Commission regulations. Consistent with current Commission regulations, a respondent may be represented by counsel, at the respondent's own expense, or may appear pro se at a probable cause hearing. See 11 CFR 111.23. Respondents (or their counsel) will have the opportunity to present their arguments, and Commissioners, the General Counsel, and the Staff Director will have the opportunity to pose questions to the respondent, or respondent's counsel, if represented.

At the hearing, respondents are expected to raise only issues that were identified in the respondent's hearing request. Such issues must have been previously presented during the enforcement process, either in the response, during the investigation or pre-probable cause conciliation, or in the reply brief. Respondents may discuss any issues presented in the enforcement matter, including potential liability and calculation of a civil penalty, and should be prepared to address questions related to the complaint, their initial response, and any other material they have submitted to the Commission. The reply brief should include specific citations to any authorities (including prior Commission actions) on which the respondent is replying or intends to cite at the hearing. If respondents discover new information after submission of the reply brief, or need to raise new arguments for similarly extenuating circumstances, they should notify the Commission as soon as possible prior to the hearing. Commissioners may ask questions on any matter related to the enforcement proceedings and respondents are free to raise new issues germane to any response.

Hearings are confidential and not open to the public; generally only respondents and their counsel may attend. Attendance by any other parties must be approved by the Commission in advance.

The Commission will determine the format and time allotted for each hearing at its discretion. Among the factors that the Commission may consider are agency time constraints, the complexity of the issues raised, the number of respondents involved, and the extent of Commission interest. The Commission will determine the amount of time allocated for each portion of the hearing, and each time limit may vary from hearing to hearing. The Commission anticipates that most hearings will begin with a brief opening statement by respondent or respondent's counsel, followed by questioning from the Commissioners, General Counsel, and Staff Director. Hearings will normally conclude with the respondent or respondent's counsel's closing remarks.

Third party witnesses or other co-respondents may not be called to testify at a respondent's oral hearing, nor may a respondent's counsel call the respondent to testify. However, the Commission may request that the respondent submit supplementary information or briefing after the probable cause hearing. The Commission discourages voluminous submissions. Supplementary information may be submitted only upon Commission request and no more than ten days after such a request from the Commission, unless the Commission's request for information imposes a different, Commission-approved deadline. Materials requested by the Commission, and materials considered by the Commission in making its “probable cause to believe” determination, may be made part of the public record pursuant to the Commission's Statement of Policy Regarding Disclosure of Closed Enforcement and Related Files, 68 FR 70426 (Dec. 18, 2003).

The Commission will have transcripts made of the hearings. The transcripts will become a part of the record of the enforcement matter and may be relied upon for determinations made by the Commission. Respondent may be bound by any representations made by respondent or respondent's counsel at a hearing. The Commission will make the transcripts available to the respondent as soon as practicable after the hearing, and the respondent may purchase copies of the transcript. Transcripts will be made public after the matter is closed in accordance with Commission policies on disclosure. 3

In cases involving multiple respondents, the Commission will decide on a case-by-case basis whether to structure any hearings separately or as joint hearings for all respondents. Respondents are encouraged to advise the Commission of their preferences. Co-respondents may request joint hearings if each participating co-respondent provides an unconditional waiver of confidentiality with respect to other participating co-respondents and their counsel and a nondisclosure agreement. If separate hearings are held, each respondent will have access to the transcripts from the hearing of that respondent, but transcripts of other co-respondents' hearings will not be made available unless co-respondents specifically provide written consent to the Commission granting access to such transcripts.

The Commission will seek to hold the hearing in a timely manner after receiving respondents' request for a hearing. The Commission will attempt to schedule the hearings at a mutually acceptable date and time. However, if a respondent is unable to accommodate the Commission's schedule, the Commission may decline to hold a hearing. The Commission reserves the right to reschedule any hearing. Where necessary, the Commission reserves the right to request from a respondent an agreement tolling any upcoming deadline, including any statutory deadline or other deadline found in 11 CFR part 111.

Probable cause hearings are optional and no negative inference will be drawn if respondents do not request a hearing. Currently, the majority of the Commission's cases are settled through pre-probable cause conciliation. Proceeding to probable cause briefing requires a substantial investment of the Commission's limited resources. Consistent with the goal of expeditious resolution of enforcement matters, the Commission encourages pre-probable cause conciliation. The Commission has a practice in many cases of reducing the civil penalty it seeks through its opening settlement offer in pre-probable cause conciliation. However, once pre-probable cause conciliation has been terminated, this reduction (normally 25%) is no longer available and the civil penalty will generally increase.

This notice establishes rules of agency practice or procedure. This notice does not constitute an agency regulation requiring notice of proposed rulemaking, opportunities for public participation, prior publication, and delay effective under 5 U.S.C. 553 of the Administrative Procedures Act (“APA”). The provisions of the Regulatory Flexibility Act, 5 U.S.C. 605(b), which apply when notice and comment are required by the APA or another statute, are not applicable.

On September 6, 2006, the Drug Enforcement Administration (DEA) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) (71 FR 52724) proposing to amend its regulations to allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of that controlled substance.

DEA received 264 comments regarding the NPRM. Two hundred thirty-one commenters supported the NPRM, 33 commenters opposed the rulemaking. Commenters supporting the NPRM included six physician associations, including those representing anesthesiologists, pediatricians, and psychiatrists, and three state level licensing organizations; five nursing associations, including several nursing specialty associations; 3 pharmacy associations and 6 state boards of pharmacy; 17 organizations focusing on the treatment of pain and end of life issues; 8 other organizations; and individual commenters including 73 pain patients, 65 physicians or physicians' offices, 31 parents of children with attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD), 30 individual citizens, 16 pharmacists, 5 nurses, and 2 physician's assistants. Commenters opposing the NPRM included 1 organization focusing on the treatment of pain; 17 individual citizens; 8 physicians; 3 pharmacists or pharmacy workers; 2 parents of pain patients; 1 nurse; and 1 physician's assistant.

The vast majority of commenters supported the rulemaking as proposed, although some commenters suggested various changes or requested clarification of certain issues. DEA has carefully considered all comments received. An in-depth discussion of the issues raised by commenters and DEA's responses to those comments follows.

Of the 264 comments DEA received, 166 expressed approval of the proposed rule without change. The remainder of the comments either objected to the proposed rule or suggested modifications thereto. The major issues raised by the commenters are addressed below.

Comments expressing approval of the proposed rule without change: Commenters who expressed support for this rule represented a broad variety of interest groups, medical professionals, pharmacists, and patients. General comments regarding the support for this rule and the benefits commenters believed it will have appear below.

Patients being treated for pain: Commenters who described themselves as patients who receive controlled substances for the treatment of pain were very supportive of implementation of the rule as proposed. These commenters noted that the allowance for multiple prescriptions would reduce the number of visits they would need to make to practitioners, which would be beneficial financially. Many of these patients indicated they are unemployed or underemployed due to their medical conditions, and each additional visit to practitioners for the purpose of receiving another prescription takes a financial toll on them.

Among the patients who commented in support of the rule were those who indicated that they live in rural areas. These commenters explained that, currently, they must either drive to their practitioners, which is difficult for them, or must find someone to drive them because they cannot drive themselves due to their condition. They noted that arranging rides is often difficult and that the drive to a practitioner may be several hours each way. Some also stated that the trip is expensive and that the length of the trip exacerbates their conditions. According to these commenters, implementation of the proposed rule would enable them to visit their prescribing practitioners less frequently, thereby lessening the foregoing difficulties.

Parents of children receiving controlled substances: Commenters who described themselves as parents of children with ADD or ADHD welcomed the proposed rule. In their view, if the proposed rule is implemented, they no longer will have to take their children to their prescribing practitioners every month. As a result, they indicated they will be able to take less time off from work and their children will have fewer absences from school. Many of these commenters also noted that having to make monthly visits to practitioners is especially burdensome to single parents. These commenters also identified reduced costs as a reason for their support of the proposed rule.

Prescribing practitioners: Commenters who identified themselves as practitioners who prescribe controlled substances were, for the most part, strongly supportive of the proposed rule. Many of these commenters expressed the view that allowing the issuance of multiple sequential prescriptions for schedule II controlled substances will drastically reduce the work of the practitioners' offices and free up valuable practitioner-patient time. Many also expressed the view that for some of their patients whom they characterized as “stable” (including certain patients with chronic pain and ADD or ADHD), they believe there is no medical need to see such patients every month. In such cases, some of these commenters added they believe having to make monthly visits to the practitioner is a hardship to patients who are already suffering. It should be noted that some commenters who identified themselves as practitioners expressed a sharply contrasting view, asserting that patients who receive schedule II controlled substances should be seen in person at least once a month to ensure proper medical supervision and to lessen the likelihood of drug addiction and abuse. This latter perspective of some commenting practitioners is addressed further below.

Pharmacists: Commenters who identified themselves as pharmacists were, for the most part, supportive of the proposed rule. These commenters stated that issuing multiple prescriptions for sequential filling for schedule II controlled substances would reduce the quantity of those controlled substances dispensed to a patient at any one time. They argued that this reduced quantity could reduce the potential for abuse or diversion of these controlled substances. Some pharmacists indicated they would be more comfortable dispensing these prescriptions because of the more limited quantities dispensed.

90-day supply at one time: Sixteen commenters who supported the NPRM, and six commenters who disagreed with the NPRM, believed that the entire 90-day supply of controlled substances was available at one time instead of in sequential prescriptions. Commenters who supported the rule but believed that DEA is advocating the dispensing of a 90-day supply of controlled substances at one time cited the ease of filling prescriptions and obtaining reimbursement as reasons for their support. Those who objected to the rule on this ground believed it would be more difficult to monitor patients.

DEA response: In view of these comments, DEA wishes to make clear that the NPRM did not advocate that physicians prescribe a 90-day supply of controlled substances with a single prescription. Rather, the NPRM stated that if a physician determines it is medically appropriate to issue multiple schedule II prescriptions, the physician may provide for up to a 90-day supply through the use of multiple schedule II prescriptions under the conditions specified in the proposed rule.

As to the comment that DEA should allow multiple schedule II prescriptions for unlimited days' worth of schedule II controlled substances, as DEA explained in the NPRM, for the proposed rule to be legally permissible, it must be consistent with the text, structure, and purposes of the Controlled Substances Act (CSA). In this regard, 21 U.S.C. 829(a) states: “No prescription for a controlled substance in schedule II may be refilled.” By comparison, subsection 829(b) states that, for a schedule III or IV controlled substance, a prescription may be refilled up to five times within six months after the date the prescription was issued. Thus, Congress clearly mandated greater prescription controls for schedule II substances than for schedule III and IV substances. For example, a physician may—consistent with the statute—issue a prescription for a schedule III or IV controlled substance and indicate on the prescription a certain number of refills. In this manner, a physician may provide a patient with up to a six-month supply of a schedule III or IV controlled substance with a single prescription indicating five refills. The same cannot be done with a schedule II controlled substance since section 829(a) prohibits refills. The statute requires a separate prescription if the physician wishes to authorize a continuation of the patient's use of a schedule II drug beyond the amount specified on the first prescription. Thus, if DEA were to allow multiple prescriptions for an unlimited days' worth of schedule II controlled substances, the controls for prescribing schedule II controlled substances would be less stringent than for schedule III and IV controlled substances—a result that would conflict with the purpose and structure of the CSA. DEA believes that the 90-day limit, under the terms specified in the proposed rule, strikes a fair balance that takes into account the limitation imposed by Congress under section 829 as well as the general structure of the statute, which imposes greater controls for schedule II substances than those in lower schedules.

Sequential filling of prescriptions, “refills”: One commenter opposed the NPRM because the commenter believed that sequential prescriptions were “refills” which are not permitted by law. Two commenters suggested writing all sequential prescriptions, which the commenters referred to as “refills,” on one prescription. They believed this would prevent the patient from changing the dates or using multiple pharmacies to fill the prescriptions. Commenters also believed this would eliminate the possibility of the patient claiming that the original prescription had been lost and requesting replacement prescriptions. Two commenters recommended allowing 90-day sequential prescriptions on one prescription blank, but allowing the practitioner to prescribe the intervals at which it would be filled, rather than only permitting 30-day interval sequential fillings.

One commenter suggested writing a single prescription with two “refills” with the annotation “Do not fill more frequently than once a month.” One commenter suggested permitting not more than two “refills” of a schedule II prescription, but requiring the use of triplicate prescription blanks with one copy being sent to the state and the second copy being sent to DEA. The commenter then suggested that if a practitioner chose not to agree to this system, then the practitioner would not be permitted to sequentially prescribe any schedule II prescription. The commenter believed that this system would prevent theft and loss.

DEA response: As discussed above, DEA believes that the proposed rule takes into account the CSA prohibition on refilling prescriptions for schedule II controlled substances in a manner consistent with the overall framework of the Act. The use of multiple prescriptions for the dispensing of schedule II controlled substances, under the conditions set forth in this Final Rule, ensures that the prescriptions are treated as separate dispensing documents, not refills of an original prescription. As this Final Rule indicates, each separate prescription must be written for a legitimate medical purpose by a practitioner acting in the usual course of professional practice, and the practitioner must provide written instructions on each separate prescription regarding the filling of that prescription.

Regarding the comment that suggested allowing the writing of a single prescription with two “refills” with the annotation “Do not fill more frequently than once a month,” this would conflict with the CSA, which, as explained above, disallows the refilling of schedule II prescriptions. As indicated in this Final Rule, when issuing multiple prescriptions for a schedule II controlled substance, each of the prescriptions to be filled sequentially must be written on a separate prescription blank and must contain the information specified in this Final Rule.

As for the suggestion that DEA require the use of triplicate prescription blanks, DEA has never required triplicate prescription blanks for prescriptions and believes, at this time, that the requirements contained in this Final Rule provide adequate safeguards against diversion, which render unnecessary the use of triplicate prescription blanks. However, as with all newly promulgated regulations, DEA will continue to monitor the situation to determine whether additional modifications are needed to safeguard against diversion. DEA recognizes that some states require the use of triplicate prescriptions for some or all controlled substances. DEA supports the efforts of states to take the specific action they deem necessary to prevent the diversion of controlled substances within their jurisdictions. This Final Rule expressly requires practitioners to comply with all applicable provisions of state law when issuing multiple schedule II prescriptions.

Federal law and schedule II controlled substances: Five commenters requested written clarification that this rule is not intended to change existing Federal law which does not limit the length of time for which an individual prescription may be written or the total quantity, including the number of dosage units, that may be prescribed at one time. Further, two commenters suggested that DEA state, in the Final Rule, that federal law does not address how frequently a practitioner must see his patient, and that it remains within the practitioner's reasonable medical judgment as to how frequently the practitioner sees a patient.

Commenters requested that DEA clarify that the practitioner is not required to see the patient every 30 days or at the end of 90 days. One commenter requested that DEA clarify whether a practitioner is required to see a patient after 90 days. Alternatively, the commenter inquired as to whether the practitioner is permitted to write a new prescription with “Do not fill until” and mail it to the patient or have the patient pick it up if, in the prescribing practitioner's medical judgment, the patient does not need to see the practitioner. One commenter recommended DEA clarify whether it is DEA's intent to limit any schedule II controlled substance prescription to only a 90-day supply or, alternatively, to limit sequential schedule II prescriptions written on the same day to a 90-day supply. One commenter requested clarification as to whether the regulation limits the supply to 90 days when only a single schedule II controlled substance prescription is issued.

DEA response: As the NPRM made clear, the proposed rule in no way changes longstanding federal law governing the issuance of prescriptions for controlled substances. As stated in the NPRM: “What is required, in each instance where a physician issues a prescription for any controlled substance, is that the physician properly determine there is a legitimate medical purpose for the patient to be prescribed that controlled substance and that the physician be acting in the usual course of professional practice.” (71 FR 52725, September 6, 2006). Further, this Final Rule itself contains the following statement:

This Final Rule does not change any of the foregoing principles of the CSA and DEA regulations.

Effective date of prescription: Two commenters requested that DEA clarify the effective date of a sequential prescription for a schedule II controlled substance. Some commenters pointed out that some states stipulate “effective dates” for prescriptions, noting that these states have laws which require that, to be valid, prescriptions must be filled within a certain time after they are written, and that these time limits differ by state. Some commenters noted that if the time limit starts on the date all the sequential prescriptions are written, then it cannot be used in some states. If the effective date starts on the “Do not fill until” date on the second and third prescriptions, then it will be valid in many more states.

Three commenters requested clarification as to whether it is legally permissible for a practitioner to issue a single prescription with “Do not fill before [date],” in which the “Do not fill” date is, for example, 7-10 days in the future.

DEA response: Neither the CSA nor the DEA regulations use the term “effective date” for a prescription. The DEA regulations require that all prescriptions for controlled substances “be dated as of, and signed on, the day when issued.” 21 CFR 1306.05(a). This Final Rule does not amend the regulations regarding the date of issuance of a prescription.

Under longstanding federal law and DEA regulations, there is no express requirement that a prescription be filled within a certain time after it was issued. The proposed rule likewise contained no such express requirement, as DEA believes that the requirements contained in the proposed rule provided adequate safeguards against diversion. At the same time, the proposed rule made clear that the issuance of multiple prescriptions is permissible only if “the individual practitioner complies fully with all other applicable requirements under the [CSA] and [DEA] regulations as well as any additional requirements under state law.” (71 FR 52726). To make this point unambiguous, the NPRM also stated that “nothing in this proposed rule changes the requirement that physicians must also abide by the laws of the states in which they practice and any additional requirements imposed by their state medical boards with respect to proper prescribing practices and what constitutes a bona fide physician-patient relationship.” (71 FR 52725).

The proposed rule did not address whether a single prescription with “Do not fill before [date]” instructions is permissible. Nor does any existing provision of the CSA or DEA regulations address this type of prescribing. Accordingly, there is no prohibition on doing so under the CSA or DEA regulations, provided the practitioner otherwise complies fully with all applicable requirements of federal and state law.

Insurance reimbursement considerations: Four commenters requested further relaxation of the regulations to allow a 90-day supply of schedule II controlled substances to be dispensed at one time because, these commenters asserted, this would significantly decrease the cost of the medications to the patients through their health insurance. One commenter also recommended permitting the pharmacy to dispense a 90-day supply on one prescription, making it available in 30-day intervals, but allowing the patient to pay for the entire supply at one time to save on the cost of the medication.

DEA response: It is beyond the scope of DEA's authority under the CSA to take regulatory action for the specific purpose of affecting the manner in which patients pay for the medications or the manner in which insurance providers reimburse patients for such costs. As mentioned previously, the CSA and DEA regulations contain no specific limit on the number of days' worth of a schedule II controlled substance that a practitioner may authorize per prescription.

Limitations regarding certain medications: Three commenters supported the use of sequential prescriptions specifically for schedule II controlled substances used to treat ADD or ADHD, but disagreed with the use of sequential prescriptions for schedule II controlled substances used in the treatment of pain. Commenters believed pain patients should be seen and evaluated every 30 days and have medications prescribed at that time. One commenter requested that DEA include explicit language indicating that this regulation is applicable to all patients being treated for ADHD with stimulant medications.

Conversely, one commenter supported the use of sequential prescriptions only for narcotic schedule II controlled substances, or pain medications.

Another commenter suggested rescheduling methylphenidate and amphetamines, except methamphetamine, to separate them from pain medications because the two populations for ADHD medications and pain medications are different.

DEA response: This rule pertains to all schedule II controlled substances, not just those substances intended or approved to treat certain conditions. As DEA stated in the September 6, 2006, Policy Statement published in conjunction with the Notice of Proposed Rulemaking (71 FR 52716), it is certainly appropriate for prescribing practitioners and medical oversight boards to explore questions regarding appropriate treatment regimens for particular categories of controlled substances. Moreover, it might indeed be beneficial toward preventing diversion and abuse of controlled substances for prescribing practitioners to see patients at regular intervals when prescribing certain controlled substances for certain medical conditions. However, as the Policy Statement made clear, DEA does not regulate the general practice of medicine and the agency lacks the authority to issue guidelines that constitute advice on the general practice of medicine. DEA wishes to reiterate the general principle that the prescribing practitioner must properly determine there is a legitimate medical purpose for the patient to be prescribed the controlled substance and must be acting in the usual course of professional practice. Similarly, a pharmacy has a corresponding responsibility in this regard.

Regarding the comment suggesting the rescheduling of certain schedule II controlled substances based on the conditions and populations which they are intended to treat, DEA notes that scheduling of controlled substances is based on scientific determinations regarding the substance's potential for abuse, its potential for psychological and physical dependence, and whether the substance has a currently accepted medical use in treatment in the United States (21 U.S.C. 812(b)). DEA may not reschedule a substance merely based on the population it is intended or approved to treat.

Language on sequential prescriptions: Two commenters suggested not limiting the language on the prescription to “Do not fill before [date].” These commenters suggested other alternatives including “Do not fill until xx/xx/xxxx,” and “Fill on xx/xx/xxxx.” Five commenters requested that DEA provide examples of acceptable language in the Final Rule. One commenter suggested requiring a standardized method for dating prescriptions, and considering prescriptions void if that standard is not adhered to. Another commenter recommended that specific indication should be provided regarding sequential prescriptions by including “1 of 3,” “2 of 3,” and “3 of 3” on the prescriptions.

DEA response: The Final Rule states that the individual practitioner must “[provide] written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription.” The commenters have correctly observed that this provision does not mandate that the practitioner use any particular language in the instructions on the sequential prescriptions, so long as such instructions make clear what is the earliest date on which the pharmacy may fill each prescription. DEA believes this is a sufficiently clear rule that practitioners will be able to understand and carry it out and, therefore, it is unnecessary to insist on a particular scripted approach. Likewise, under this Final Rule, a practitioner may—but is not required to—do as the commenter suggested and write on the sequential prescriptions, “1 of 3,” “2 of 3,” and “3 of 3”, so long as each prescription complies fully with all the requirements of this Final Rule, including that it contains specific instructions regarding the earliest date on which the sequential prescription may be filled.

One commenter recommended that the practitioner write in his/her own handwriting in blue ink “Do not fill until [date].”

DEA response: DEA appreciates that the underlying intent of this comment is to ensure that the “Do not fill until [date]” instructions were actually written by the practitioner, as opposed to being the result of forgery. While DEA supports all efforts of practitioners to take steps to prevent forgery in the context of prescriptions, the agency believes it is unnecessary to adopt the particular added requirement suggested by this commenter.

One commenter recommended that certain diagnostic codes, known as ICD-9 codes, should be written by the practitioner in their own handwriting on the face of the prescription.

DEA response: DEA has not previously required that prescriptions contain such diagnostic information, and the agency does not believe that such requirement is necessary to prevent diversion and abuse of controlled substances when issuing multiple prescriptions in accordance with the rule being issued today.

Post-dating of prescriptions: One commenter recommended allowing post-dated prescriptions so the practitioner does not have to use space on the prescription blank for the phrase “Do not fill before [date].”

DEA response: The DEA regulations have always required that all prescriptions for controlled substances “be dated as of, and signed on, the day when issued.” 21 CFR 1306.05(a). This requirement is essential to monitor compliance with all provisions of the CSA and DEA regulations relating to the prescribing and dispensing of controlled substances, including (but not limited to) the requirement that a controlled substance be dispensed, including prescribed, only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Accordingly, it would be inappropriate to allow post-dating of prescriptions under any circumstance, including when issuing multiple prescriptions under the Final Rule being issued today.

Return of unfilled prescriptions: One commenter suggested that a patient return to the practitioner unfilled prescriptions (if issued for sequential dispensing) if the practitioner changes the medication and before the patient can receive a new prescription, as compared with simply destroying the previous prescriptions. The commenter asserted this would help to ensure that the previously-issued prescriptions will not be filled and diverted.

DEA response: Neither the CSA nor the DEA regulations address what a patient should do with an unfilled prescription for a controlled substance. Thus, regardless of whether the practitioner writes a single prescription or issues multiple prescriptions at the same time under the Final Rule being issued today, there is no mandatory procedure for handling unfilled prescriptions. In all situations, however, practitioners should use common sense in determining what steps are appropriate to prevent diversion in view of the particular patient's circumstances. While not required under the CSA or DEA regulations, it would be acceptable—and may even be the preferred practice—for a practitioner to ask the patient to return unfilled prescriptions for controlled substances, or for a patient to voluntarily do so.

Pharmacies and dispensing of sequential prescriptions: One commenter recommended that DEA clarify what a pharmacy is permitted to do if a prescription is written for 30 days and the month has 31 days (e.g., a prescription for 30 days with “Do not fill” before dates of 10/18/yy, 11/18/yy, 12/18/yy, but October has 31 days). The commenter also asked whether a pharmacist who fills a sequential prescription a day before the date stated because the pharmacy will be closed on the date the sequential prescription may be filled (e.g., Sunday) would be violating the regulation. Other commenters asked similar questions as to whether a pharmacist may fill sequential prescriptions earlier than the date specified by the prescribing practitioner. One commenter requested that DEA allow some language for a pharmacist's “good judgment” rather than having as an absolute that sequential prescriptions cannot be filled before the “Do not fill” date. At the very least, the commenter recommended that DEA include a statement of its intent to use enforcement discretion in these cases. Two commenters recommended that DEA clarify whether pharmacists can fill a sequential prescription before the “Do not fill” date (1) if the practitioner has not been contacted and (2) if the practitioner has been contacted. Three commenters requested that DEA clarify whether pharmacies are held accountable for filling the sequential prescriptions before the indicated date. Two commenters suggested that the Final Rule clarify any implications or responsibilities for the dispensing pharmacy.

DEA response: As explained in the NPRM, the requirements contained in the proposed rule were included to ensure that the rule can be reconciled with the text, purpose, and structure of the CSA. This includes, but is not limited to, adherence to the principles of requiring a written prescription for a schedule II controlled substance, maintaining clear accountability by practitioners when prescribing controlled substances, and ensuring adequate safeguards to prevent diversion and abuse. The Final Rule being issued today states expressly that, where a practitioner has issued multiple prescriptions in accordance with the rule, no pharmacist may fill any prescription before the date specified by the practitioner. The rule contains no exceptions to this requirement. In addition, because the CSA states that prescriptions for schedule II controlled substances must be written (21 U.S.C. 829(a)), the essential elements of the prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed, and—in the case of multiple prescriptions under this Final Rule—the earliest date on which the prescription may be filled) may not be modified orally.

Section 1306.12: Some commenters suggested revising the proposed rule to state that multiple prescriptions do not constitute refills.

DEA response: DEA believes such a revision is unnecessary as it is clear from the text of the rule that it is permissible to issue multiple prescriptions in the manner specified in the rule.

Use of the term “properly”: Section 1306.12(b)(1)(i) of the proposed rule read: “The individual practitioner properly determines there is a legitimate medical purpose for the patient to be prescribed that controlled substance and the individual practitioner is acting in the usual course of professional practice.” Several commenters suggested removing the word “properly” here, asserting that the use of the word “properly” in this context is unclear or modifies the meaning of the longstanding requirement that a controlled substance be dispensed for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

DEA response: Although the language of the proposed rule was meant simply to reiterate (and not modify) the meaning of the longstanding requirement that a controlled substance be dispensed for a legitimate medical purpose by a practitioner acting in the usual course of professional practice, DEA has decided to revise section 1306.12(b)(1)(i) in view of the comments. Specifically, DEA has revised this paragraph to more closely track the pertinent language contained in the longstanding regulation 21 CFR 1306.04(a). The paragraph being finalized today reads: “Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.”

Section 1306.12(b)(1)(iii): Section 1306.12(b)(1)(iii) of the proposed rule stated: “The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.” Several commenters objected to this provision, asserting that its meaning is unclear or that it imposes an undue burden on practitioners to prevent diversion and abuse. One commenter requested that DEA state whether this imposes a new standard on practitioners.

Eleven commenters recommended deleting the paragraph in its entirety. Commenters believed that the practitioner cannot account for all possible scenarios in making this conclusion. Commenters stated that the potential liability problem for practitioners is that their conclusions and prescribing actions could come into question any time a patient was implicated in abuse or diversion. Commenters believed that practitioners will waste valuable patient time documenting why issuing sequential prescriptions does not cause undue risk. Commenters believed it could also cause the unintended consequences of practitioners avoiding prescribing a medication the patient needs for fear of liability in court. Commenters argued that sequential prescriptions, in limiting the quantity of controlled substances prescribed at one time, supposedly decrease the potential for abuse/diversion.

DEA response: Since the inception of the CSA, it has always been a requirement that all DEA registrants (manufacturers, distributors, practitioners, pharmacies, researchers, importers and exporters) take reasonable steps to prevent their DEA registrations from being used in a manner that results in an undue risk of diversion. This requirement is inherent in the CSA registration provisions (21 U.S.C. 823) as well as the DEA regulations. For example, 21 CFR 1301.71 states: “All * * * registrants shall provide effective controls to guard against theft and diversion of controlled substances.” It bears emphasis that the Final Rule being issued today in no way changes this requirement. Under this Final Rule, practitioners who prescribe controlled substances are subject to the same standard in preventing diversion as they always have been under the CSA and DEA regulations. Section 1306.12(b)(1)(iii) of this Final Rule is intended to make clear that a practitioner may not simply comply with the other requirements of this Final Rule while turning a blind eye to circumstances that might be indicative of diversion. Thus, section 1306.12(b)(1)(iii) merely underscores that the longstanding requirement of providing effective controls against diversion remains in effect when issuing multiple schedule II prescriptions in accordance with this Final Rule.

Further, as DEA stated in the Policy Statement (71 FR 52716), published alongside the NPRM, “one cannot provide an exhaustive and foolproof list of ‘dos and don'ts’ when it comes to prescribing controlled substances for pain or any other medical purpose.” Just as DEA cannot provide an exhaustive list of “dos and don'ts” to elaborate on the phrase “legitimate medical purpose in the usual course of professional practice,” the agency cannot expand upon the general requirement that practitioners take reasonable steps to prevent diversion by setting forth a list of every hypothetical scenario a practitioner might encounter along with specific instructions on how the practitioner should handle the situation. DEA has an obligation to carry out all regulatory requirements in a reasonable manner, consistent with the governing statutes enacted by Congress, and to take into account all circumstances of the particular case at issue. The agency will do so with regard to all aspects of this Final Rule, including section 1306.12(b)(1)(iii) .

Section 1306.12(b)(2): Section 1306.12(b)(2) of the proposed rule contained the statement:

DEA response: The requirement that a prescription for a controlled substance be issued in accordance with established medical standards has been an integral part of federal law for decades and has been upheld by the United States Supreme Court. 1 This requirement applies to all controlled substances and applies regardless of whether a practitioner issues a single prescription or multiple prescriptions in accordance with this Final Rule.

Pharmacies and dispensing of sequential prescriptions: In section 1306.14, Labeling of substances and filling of prescriptions, DEA proposed the following new paragraph (e): “Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date.”

One commenter suggested the following additional language to section 1306.14(e): “No pharmacist or pharmacy including mail order operations may auto-fill any additional prescriptions for schedule II drugs before verifying that the patient is still in need of each prescription refill.”

DEA response: It has always been the case under the CSA and DEA regulations that a pharmacist who fills a prescription for a controlled substance has a corresponding responsibility to ensure that the prescription was issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. This requirement, which is set forth in 21 CFR 1306.04(a), is one of the primary legal bases upon which pharmacists are held accountable under the CSA. DEA believes it is not necessary to modify or expand upon this longstanding requirement in the context of multiple schedule II prescriptions, so long as the prescribing and filling of such prescriptions takes place in accordance with all the provisions of this Final Rule.

Electronically transmitted prescriptions: Four commenters recommended DEA allow electronically transmitted prescriptions for controlled substances.

DEA response: DEA notes that the electronic prescribing of controlled substances is outside the scope of this rulemaking. DEA intends to address electronic prescribing of controlled substances in a separate future rulemaking.

Authorization to use sequential prescriptions prior to publication of Final Rule: Two commenters requested that DEA allow practitioners to begin issuing multiple schedule II prescriptions based on the issuance of the NPRM (without waiting for a Final Rule to be published and to take effect).

DEA response: Under the Administrative Procedure Act (APA), when an agency seeks to impose a new substantive rule that modifies legal obligations of members of the public, the agency must first engage in notice-and-comment rulemaking (5 U.S.C. 553(b)). The APA further provides that substantive rules may not take effect until at least 30 days after publication of the final rule (5 U.S.C. 553(d)). Exceptions to these procedural requirements can be made only “when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest” (5 U.S.C. 553(b)(B)). DEA has not found that there is such a legal justification to exempt this Final Rule from the basic procedural requirements of the APA. Accordingly, this Final Rule does not take effect until the effective date indicated herein (December 19, 2007).

Long Term Care Facilities: One commenter asked if this rule will apply to patients in long term care facilities.

DEA response: The DEA regulations contain a variety of provisions relating to the dispensing of controlled substances at long term care facilities. These provisions are unaltered by this Final Rule. This Final Rule may be utilized in the context of a long term care facility, provided such activity complies with any other applicable provisions of the DEA regulations.

Miscellaneous: One commenter recommended that DEA make one federal rule regarding prescriptions to supersede the many different state laws.

DEA response: Under the CSA, Congress envisioned that the Federal and State Governments would work in tandem to regulate activities relating to controlled substances. This is reflected in 21 U.S.C. 903, which indicates that Congress did not intend to preempt state controlled substance laws, so long as such state laws do not conflict with federal law. Thus, each state may enact controlled substance laws that go beyond the requirements of the CSA, provided such laws do not conflict with the CSA. Given this aspect of the CSA, it would not be appropriate for DEA to seek to preempt or supersede state laws relating to the prescribing of controlled substances, provided such laws do not conflict with the CSA or DEA regulations.

One commenter suggested DEA work with other federal agencies and national professional medical societies to be certain doctors are screening for alcoholism and drug addiction in their private medical practices as they are prescribing schedule II controlled substances in the treatment of legitimate medical illnesses.

DEA response: DEA firmly supports all efforts of practitioners to screen for factors that might be indicative of whether the patient may be likely to seek controlled substances for purposes of abuse or to satisfy an addiction. However, such a consideration is beyond the scope of this Final Rule. Persons interested in such considerations might wish to review the Policy Statement, which was published in the Federal Register alongside the NPRM (71 FR 52716).

Three commenters recommended that DEA explain existing law and the impact of the new rule to health care professionals, state attorneys general, drug control officials, and professional licensing and regulatory boards.

DEA response: DEA works cooperatively with a wide variety of organizations who have an interest in the CSA and DEA regulations and policies, including, but not limited to: State Boards of Medicine and Boards of Pharmacy; law enforcement; regulatory and professional licensing authorities and agencies; the pharmaceutical industry; and professional organizations representing prescribing and dispensing practitioners. DEA meets regularly with these organizations to discuss matters of mutual concern. Included in these meetings are discussions of DEA legal and regulatory activities.

One commenter suggested allowing partial filling of schedule II prescriptions so as not to constitute a refill.

DEA response: The DEA regulations delineate the circumstances under which the partial filling of a prescription for a controlled substance in schedule II is permissible (21 CFR 1306.13). Adherence to this aspect of the DEA regulations serves a critical function in preventing diversion of schedule II controlled substances. Accordingly, this Final Rule does not modify the requirements of the DEA regulations relating to the partial filling of prescriptions.

Treatment of Pain Patients: Nineteen commenters opposed the NPRM because they believed that, for a patient who is receiving controlled substances for the treatment of pain, the practitioner should see the patient more than once every 90 days to properly monitor the patient's condition and whether that patient is responding well to the medication. These commenters asserted that such a patient should see the practitioner every 30 days because treatment for pain does not consist of medication alone.

One commenter stated that he had a family member who became addicted to schedule II controlled substances that were prescribed for pain and whose quality of life diminished significantly as a result. This commenter therefore objected to “slackening the restrictions on these highly addictive and destructive drugs.”

DEA response: DEA recognizes, as these comments reflect, that some practitioners believe that seeing a patient who is receiving controlled substances only once every 90 days is inadequate. However, the CSA does not expressly address how frequently a practitioner must see a patient when prescribing controlled substances. At the same time, practitioners who prescribe controlled substances must see their patients in an appropriate time and manner so as to meet their obligation to prescribe only for a legitimate medical purpose in the usual course of professional practice and to thereby minimize the likelihood that patients will abuse, or become addicted to, the controlled substances. In this regard, section 1306.12(b)(2) of this Final Rule states:

Diversion: One commenter opposed the NPRM, asserting that a practitioner cannot always tell whether he or she is “getting scammed” by a patient seeking drugs for abuse. This commenter suggested that, if a practitioner is being deceived by such a patient, the harm will be less if the prescription is only for a 30-day supply of a controlled substance (rather than a 90-day supply). Another commenter opposed the NPRM because the commenter believed that drug abusers will change the dates on the multiple prescriptions and have all the multiple prescriptions filled at once by different pharmacies. Another commenter, who indicated she worked in a pharmacy, expressed the view that drug addicts will see multiple practitioners in a 90-day period to obtain overlapping 90-day supplies of schedule II controlled substances.

DEA response: It is true that, other factors being equal, the diversion of a 90-day supply of controlled substances causes greater harm than the diversion of a 30-day supply. Likewise, the adverse effects of any improper conduct on the part of a drug-seeking patient (such as “doctor shopping” or seeing multiple prescribing practitioners) will be magnified if the patient is receiving a 90-day supply of a schedule II controlled substance as opposed to a 30-day supply. However, for the reasons provided in responding to the preceding comments, DEA believes it is appropriate to allow for up to a 90-day supply of schedule II controlled substances under the conditions set forth in this Final Rule—with the understanding that 90 days is the upper limit and by no means mandatory. To the contrary, as this Final Rule indicates, the practitioner must determine on his/her own, on a case-by-case basis, based on sound medical judgment, and in accordance with established medical standards, the appropriate amounts of schedule II controlled substances to prescribe.

Possibility of increased pressure on prescribing practitioners: Some commenters expressed the view that implementation of the proposed rule will result in practitioners receiving an increased number of “demands” by patients to receive a 90-day supply of controlled substances. As a result, these commenters asserted practitioners might feel undue pressure to prescribe a 90-day supply of controlled substances at each office visit.

DEA response: Given this important concern, DEA repeats for emphasis the following statement in this Final Rule:

It is indeed essential that practitioners adhere to the above-quoted provision and not simply—based on pressure from patients or any other improper reason—feel obligated to provide multiple prescriptions totaling a 90-day supply of schedule II controlled substances. Toward this end, practitioners may wish to refer their patients to the above-quoted provision if they believe doing so will be beneficial.

Appropriateness of this rule in view of the extent of prescription controlled substance abuse in the United States: Among those commenters who objected to the proposed rule, many pointed to the alarming increase in prescription controlled substance abuse in the United States and resulting deaths and harm to the public welfare. Such commenters expressed the view that the proposed rule—or any other lessening of drug controls—will exacerbate the problem.

DEA response: DEA shares the concerns of those who are deeply troubled by the increasing levels of prescription controlled substance abuse in the United States and the resulting detriment to the public health and welfare of the American people. DEA addressed these concerns in depth in the September 6, 2006, Policy Statement that was published in conjunction with the proposed rule, and the agency encourages those interested in this topic to review that document. To minimize the likelihood that this Final Rule will exacerbate the extensive problem of prescription controlled substance abuse in the United States, DEA has reiterated in the text of the regulation several important and longstanding legal principles. Among these are the requirements that “Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice” and that “The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.” In addition, as stated repeatedly above, nothing in this Final Rule shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing schedule II controlled substances; rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so. It is with the understanding that adherence to all of these principles is essential that DEA has concluded that implementation of this Final Rule is consistent with the overall structure of the CSA and DEA's mission.

Methadone: Among the commenters who objected to the proposed rule, several mentioned the prescribing of methadone in particular and the significant number of deaths that have resulted from methadone abuse. These commenters expressed concern that the proposed rule would lead to even more deaths from methadone abuse.

DEA response: DEA shares the concerns of those commenters who pointed to the unique and significant problems associated with methadone abuse. In view of these concerns, DEA repeats the following statement from the September 6, 2006, Policy Statement that was published in conjunction with the proposed rule:

Since 2003, the FDA has issued revised labeling for methadone analgesic products, and physician education and training curricula have been developed for methadone treatment. 3 In 2007, SAMHSA convened an expert panel to consider the implications of methadone mortality.

As DEA discussed at the beginning of this document, the vast majority of comments received regarding this rulemaking were supportive of its adoption. Two hundred thirty-one of the 264 comments received supported this action. As DEA noted previously, this rulemaking was supported by a wide variety of individuals and organizations—medical professionals, patient advocacy organizations, and patients themselves. To reiterate, the majority of commenters believed this Final Rule would be beneficial from both physical and financial perspectives, citing the time and money saved due to less frequent visits to prescribing practitioners, and the reduced physical toll resulting from the reduced visits. While many commenters sought clarification regarding various aspects of this rulemaking, it is important to reiterate the overwhelmingly positive reaction this rule generated.

DEA, state authorities, practitioners, and pharmacists all share a common interest in ensuring that controlled substances are prescribed for legitimate medical purposes by prescribing practitioners acting in the usual course of professional practice. As discussed throughout this document, DEA, through its enforcement of the CSA and its implementing regulations, must prevent the diversion and abuse of controlled substances while ensuring that there is an adequate supply for legitimate medical purposes. DEA supports the intent of this Final Rule to address patients' needs for schedule II controlled substances while preventing the diversion of those substances. DEA believes that this Final Rule provides an option for practitioners to treat their patients, which is legally permissible and consistent with the text, structure, and purposes of the CSA.

The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), has reviewed this regulation, and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. This rule provides an additional option that practitioners may utilize when prescribing schedule II controlled substances under certain circumstances. The rule will not mandate any new procedures. Therefore, a regulatory flexibility analysis is not required for this rule.

The Deputy Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866, Regulatory Planning and Review, Section 1(b). This rule has been deemed a “significant regulatory action.” Accordingly, this rule has been reviewed by the Office of Management and Budget.

This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

This rule does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Department published a proposed rule, with a request for comments, amending and updating numerous sections of Part 51 of Title 22 of the Code of Federal Regulations. The rule was discussed in detail in Public Notice 5712, as were the Department's reasons for changes in the regulation ( Federal Register , March 7, 2007, 72 FR 10095). The comment period closed on May 7, 2007. The Department of State is now promulgating its final rule. Some of the more notable changes in the regulations include: Changes regarding minors, extending the two-parent consent and personal appearance requirements to minors under the age of 16; changes regarding Passport Agents and Passport Acceptance Agents, codifying the definitions and clarifying their qualifications and responsibilities, including the requirement that they be U.S. citizens or U.S. nationals respectively; changes on denial, revocation and restriction of passports to permit the Department to deny a passport, for example, to applicants who are the subject of an outstanding State, local, or foreign warrant of arrest for a felony, intended to enhance U.S. law enforcement and cooperation; and changes regarding change of names on passports, intended to clarify what is required of an applicant whose name has changed and to reflect more accurately Department practice in this regard.

Subpart F remains under review and may be addressed in a future rulemaking. Public Notice 5712 further advised that a separate rulemaking was underway to amend Part 51 to introduce the passport card and that comments regarding the passport card would be considered in that separate rulemaking, which is ongoing. The final rule for the passport card will include any necessary renumbering of its sections for compatibility with the numbering of this overall revision, as well as language modifications to take into account the changes made in this Final Rule.

Analysis of Comments: The Department received four (4) comments. One comment expressed support of the change to increase the maximum age requiring two-parent consent for minors from under 14 to under 16. A second comment, addressed in detail below, underscored the importance of competent adjudicators, recommended the Department always require applicants to appear in person (rather than permit mail-in procedures), and suggested passport fees should be considerably increased. The two remaining comments concerned passport fees and the proposed passport card. Because issues regarding passport fees and the passport card are addressed in a separate rulemaking, the Department will respond to these comments at a later time.

One comment suggested that the Department should always require that a passport application be executed personally rather than allowing renewals by mail. The comment also seemed to misunderstand the role of the U.S. Postal Service and clerks of court, who act as passport acceptance agents but do not have the ability to adjudicate and issue passports. The commenter also opined that the passport application process should be made more difficult because passports are “as easy to get as turning on a water faucet.”

The passport application process for first time passport applicants is designed to verify the citizenship and identity of the applicant. A U.S. passport is, by definition, a citizenship and identity document. U.S. citizens may apply for subsequent passports by mail within certain parameters described in the regulations. This is an acceptable practice because the Department has previously thoroughly reviewed and verified the applicant's citizenship and ensured that the applicant's identity is genuine. Furthermore, fraud prevention measures allow the Department to instantly retrieve the previous version of the applicant's passport record, and quickly compare the submitted passport information and photograph with the previously issued, imaged passport record. Further, the lack of personal appearance by the applicant has no negative effect on the automated checks, which are performed on all passport applications before approval. In addition, necessary criminal and other checks performed during the passport review process do not require the applicant to appear in person. Finally, imposing such a requirement would place an unacceptable burden on applicants, passport acceptance facilities, and passport agencies.

Passport acceptance agents throughout the country provide an invaluable customer service on behalf of the State Department by enabling citizens to apply for passports anywhere in the country rather than exclusively at passport agencies. Acceptance agents are responsible for accepting the applications and administering the oath contained in the application. They also ensure that the required evidence of citizenship and identity accompany the application. Acceptance agents do not adjudicate applications or issue passports. Those functions are performed exclusively by the State Department.

The Department published this rule as a proposed rule, with 60 days for public comments and review.

These changes to the regulations are hereby certified as not expected to have a significant impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act, 5 U.S.C. 301-612, and Executive Order 13272, section 3(b) as the rule governs only individuals.

This rule is not a major rule, as defined by 5 U.S.C. 804, for purposes of congressional review of agency rulemaking under the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121. This rule would not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UFMA), Public Law 104-4, 109 Stat. 48, 2 U.S.C. 1532 generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $120 million or more by State, local, or tribal governments, or by the private sector. This final rule does not result in any such expenditure nor will it significantly or uniquely affect small governments.

This regulation does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Nor will the rule have federalism implications warranting the application of Executive Orders No. 12372 and No. 13132.

The Department of State reviewed this final rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866 and determined that the benefits of the final rule justify its costs. The Department does not consider the final rule to be an economically significant regulatory action within the scope of section 3(f)(1) of the Executive Order since it is not likely to have an annual effect on the economy of $100 million or more or to adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities.

The Department has reviewed the regulations in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. , Federal agencies must obtain approval from OMB for each collection of information they conduct, sponsor, or require through regulation. The Department of State has determined that this proposal does not contain new collection of information requirements for the purposes of the PRA.

Passports.

This final regulation amends the Employment Tax Regulations (26 CFR part 31) by providing guidance relating to section 3121(a)(5)(D). The Federal Insurance Contributions Act (FICA) imposes taxes on employees and employers equal to a percentage of the wages received with respect to employment. Section 3121(a) defines wages for FICA tax purposes as all remuneration for employment unless otherwise excepted. Section 3121(a)(5)(D), added by the Social Security Amendments of 1983 (Public Law 98-21 (97 Stat. 65)), generally excepts from wages payments made by an employer for the purchase of an annuity contract described in section 403(b). However section 3121(a)(5)(D) expressly excludes from the exception payments made by reason of a salary reduction agreement (whether evidenced by a written instrument or otherwise). Thus, payments made under a salary reduction agreement to purchase a section 403(b) annuity contract are included in wages for FICA purposes. A temporary and proposed regulation defining the term “salary reduction agreement” for purposes of section 3121(a)(5)(D) was published in the Federal Register (69 FR 67054) on November 16, 2004.

For income tax purposes, contributions made by an employer to a section 403(b) contract, including contributions made pursuant to a cash or deferred election or other salary reduction agreement, are generally excluded from income. § 403(b); see also section 1450(a) of the Small Business Job Protection Act of 1996 (Pub. L. 104-188 (110 Stat. 1755)). Conversely, for FICA tax purposes, contributions made by an employer to a section 403(b) contract pursuant to a cash or deferred election or other salary reduction agreement are included in wages. § 3121(a)(5)(D); see also S. Rep. No. 98-23, at 40-41, 98th Cong., 1st Sess. (1983).

This regulation finalizes the temporary and proposed regulation without change. The final regulation provides that the term “salary reduction agreement” includes (1) a plan or arrangement whereby a payment will be made if the employee elects to reduce his or her compensation pursuant to a cash or deferred election as defined at § 1.401(k)-1(a)(3) of the Income Tax Regulations, (2) a plan or arrangement whereby a payment will be made if the employee elects to reduce his or her compensation pursuant to a one-time irrevocable election made at or before the time of initial eligibility to participate in such plan or arrangement (or pursuant to a similar arrangement involving a one-time irrevocable election), and (3) a plan or arrangement whereby a payment will be made if the employee agrees as a condition of employment (whether such condition is set by statute, contract, or otherwise) to make a contribution that reduces the employee's compensation.

Comments were submitted with respect to the definition of the term “salary reduction agreement” for purposes of section 3121(a)(5)(D) and with respect to the applicability date of the temporary and proposed regulation.

Commentators asserted that Congress intended the term “salary reduction agreement” in section 3121(a)(5)(D) to apply only to voluntary reductions in salary and not to salary reductions required as a condition of employment. In support of this view, commentators cited the legislative history underlying section 3121(a)(5)(D), particularly the following language from the Senate Report:

Commentators maintained that Revenue Ruling 65-208 distinguishes between voluntary and mandatory salary reduction contributions and that the legislative history reflects Congress’ intent to treat only voluntary salary reduction contributions as having been made by reason of a salary reduction agreement. While the Senate Report indicates a Congressional intent to “codify the holding of Revenue Ruling 65-208,” the revenue ruling does not address any distinction between voluntary and mandatory reductions in salary. The critical distinction drawn in Revenue Ruling 65-208 is between situations “where an organization uses its own funds for the purchase of an annuity contract” (a supplemental contribution) and situations “where the employee takes a voluntary reduction in salary to provide the necessary funds” (a salary reduction contribution). At the time Revenue Ruling 65-208 was issued the statutory standard under section 3121(a)(2) for determining whether to include contributions to section 403(b) annuity contracts in wages for FICA purposes was whether the contributions had been paid by the employer or by the employee. Thus, in determining whether the employer or the employee has paid the contribution, the revenue ruling distinguishes between supplemental contributions funded by the employer and salary reduction contributions funded by the employee. Whether a salary reduction contribution was voluntary or mandatory is irrelevant in establishing that the employee funded the contribution through a reduction in salary.

Several courts have discussed Revenue Ruling 65-208 and confirmed that it addresses the distinction between salary supplements and salary reductions. See Temple University v. United States , 769 F.2d 126, 130 (3d Cir. 1985), discussing the distinction drawn by Revenue Ruling 65-208 between supplemental contributions and salary reduction contributions, and Canisius College v. United States , 799 F.2d 18, 20-21 (2d Cir. 1986), distinguishing between “salary supplement plans” and “salary reduction plans.” See also University of Chicago v. United States , No. 06 C 3452, 2007 U.S. Dist. LEXIS 61632, at *8 (N.D. Ill. Aug. 21, 2007) concluding that “the distinction that was being drawn in [Revenue Ruling 65-208] was between annuity purchase funds that come from employee contributions and those that come from employer contributions.” The Treasury Department and the Internal Revenue Service (IRS) continue to believe that it is consistent with the legislative history of section 3121(a)(5)(D) and with the codification of Revenue Ruling 65-208 to treat both voluntary salary reductions and salary reductions to which the employee agrees as a condition of employment as payments made pursuant to a salary reduction agreement.

Commentators suggested that the term “salary reduction agreement” for purposes of section 3121(a)(5)(D) should mean an elective deferral within the meaning of section 402(g)(3)(C), which defines the term elective deferral for purposes of the section 402(g)(3) limit on the exclusion of elective deferrals from gross income. In their view, because salary reduction contributions made pursuant to a one-time irrevocable election or as a condition of employment are not elective deferrals under section 402(g)(3)(C) and its accompanying regulations, such contributions are not made pursuant to a salary reduction agreement and, consequently, are excluded from wages under section 3121(a)(5)(D).

Section 402(g)(3)(C) provides that the term “elective deferral” includes “any employer contribution to purchase an annuity contract under section 403(b) under a salary reduction agreement (within the meaning of section 3121(a)(5)(D)).” However, when enacting section 402(g)(3), Congress made the following statement about the relationship among mandatory salary reduction contributions, elective deferrals, and salary reduction agreements: “if an employee is required to contribute a fixed percentage of compensation to a tax-sheltered annuity as a condition of employment, the contributions are not treated as elective deferrals.” H.R. Rep. No. 99-841 at II-405 (1986). Similarly, in 1988 Congress added the flush language of 402(g)(3) providing that a one-time irrevocable election will not be treated as an elective deferral. Congress added the flush language to clarify that the term “elective deferral” excludes contributions “made pursuant to a one-time election to participate in the tax-sheltered annuity even though such contribution would be considered made under a salary reduction agreement under section 3121(a)(5)(D).”

S. Rep. No. 100-445, at 151, 100th Cong., 2d Sess. (1988). Congress explained the clarification to section 402(g)(3) as follows:

Thus, as reflected in both the statutory language of section 402(g) and in its legislative history, Congress intended the definition of salary reduction agreement for purposes of section 3121(a)(5)(D) to be distinct from the definition of elective deferral for purposes of section 402(g)(3)(C).

Furthermore, Congress intended that the term wages would have different meanings for income tax withholding and FICA tax purposes. The broader scope of the term for FICA tax purposes is consistent with the general policy underlying the FICA. See S. Rep. No. 98-23, at 39, 98th Cong., 1st Sess. (1983) relating to the Social Security Amendments of 1983 (Pub. L. 98-21 (97 Stat. 65)). Moreover, the legislative history to section 3121(a)(5)(D) cited in this preamble describes Congress's intent to codify the holding in Revenue Ruling 65-208 (see § 601.601(d)(2)(ii)( b )), which provides that certain amounts included in income and amounts included in wages with respect to contributions used to purchase a 403(b) annuity contract are not the same. Based on the statutory language and the legislative history of section 3121(a)(5)(D) and related provisions, including section 3121(v)(1)(B) as discussed in this preamble, the Treasury Department and the IRS continue to believe that the term “salary reduction agreement” in section 3121(a)(5)(D) includes salary reduction contributions made pursuant to a one-time irrevocable election or as a condition of employment.

The term “salary reduction agreement” is used not only in section 3121(a)(5)(D) but also in another subsection of section 3121, specifically section 3121(v)(1)(B), which provides that wages include “any amount treated as an employer contribution under section 414(h)(2) where the pickup referred to in such section is pursuant to a salary reduction agreement (whether evidenced by a written instrument or otherwise).” Commentators contended that the term “salary reduction agreement” should be interpreted differently for purposes of sections 3121(a)(5)(D) and 3121(v)(1)(B) because section 3121(v)(1)(B) applies only to salary reduction contributions made under a section 414(h) pick-up plan established by a State or local government employer. By definition, the salary reductions that fund these employer contributions are mandatory whereas contributions to section 403(b) annuity plans may be mandatory or voluntary. While it is correct that salary reductions in connection with section 414(h) pick-up plans are mandatory, we see no evidence in the statute or legislative history that Congress intended to interpret the same language differently or to treat similarly situated employees differently for FICA purposes. Both section 3121(a)(5)(D) and section 3121(v)(1)(B) include salary reduction contributions in wages for FICA tax purposes. Neither the statute nor the legislative history gives a basis for concluding that mandatory salary reductions made in connection with a section 414(h) pick-up plan should be included in wages for FICA purposes while mandatory salary reductions made in connection with a section 403(b) annuity plan should be excluded from wages. Thus, the Treasury Department and the IRS continue to believe that it is appropriate to give a consistent interpretation to identical language in two subsections of the same statutory section enacted only one year apart.

Similarly, as discussed in the preamble to the temporary and proposed regulation, the Tenth Circuit's decision in Public Employees' Retirement Board v. Shalala, 153 F.3d 1160 (10th Cir. 1998) supports the view that a mandatory salary reduction contribution nonetheless requires the employee's agreement. In Public Employees' Retirement Board the Court of Appeals held that the term “salary reduction agreement” includes mandatory salary reduction contributions made as a condition of employment. As the Court said, “[A]n employee's decision to go to work or continue to work * * * constitutes conduct manifesting assent to a salary reduction.” 153 F.3d at 1166. The employment relationship itself is a voluntary relationship, and the employee manifests his or her agreement with the terms and conditions of the employment relationship by accepting employment. See University of Chicago v. United States, No. 06 C 3452, 2007 U.S. Dist. LEXIS 61632, at *7 (N.D. Ill. Aug. 21, 2007) citing Public Employees' Retirement Board for the proposition that “a salary reduction agreed to as a condition of employment constitutes a salary reduction agreement because ‘the employee has “agreed” to the salary reduction by continuing employment.’ ” The temporary and proposed regulations, and now the final regulations, read the term “agreement” for purposes of section 3121(a)(5)(D) as the Tenth Circuit read it for purposes of section 3121(v)(1)(B), as both an agreement to accept employment subject to a mandatory salary reduction and an agreement to a specified salary reduction.

Accordingly, the final regulation adopts the definition of salary reduction agreement as proposed.

Commentators asked the IRS to confirm that the definition of salary reduction agreement provided in the temporary and proposed regulation would apply prospectively only and, therefore, would not affect contributions to a section 403(b) plan made prior to November 16, 2004, the date the temporary and proposed regulation went into effect. As explicitly set forth in § 31.3121(a)(5)-2T the temporary and proposed regulation was applicable to contributions to section 403(b) annuity plans made on or after November 16, 2004. Therefore, the Internal Revenue Service will not apply the temporary and proposed regulation to contributions made to any section 403(b) plan prior to November 16, 2004, for purposes of determining whether such contributions were subject to FICA tax. The final regulation will apply only to contributions made to any section 403(b) plan on or after November 15, 2007.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) and (d) of the Administrative Procedure Act (5 U.S.C. chapter 5) do not apply to this regulation, and because the regulation does not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply.

The principal author of this regulation is Neil D. Shepherd, Office of Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and Treasury Department participated in its development.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior (Secretary) conditionally approved the Texas program effective February 16, 1980. You can find background information on the Texas program, including the Secretary's findings, the disposition of comments, and the conditions of approval, in the February 27, 1980, Federal Register (45 FR 12998). You can find later actions on the Texas program at 30 CFR 943.10, 943.15, and 943.16.

The Abandoned Mine Land Reclamation Program was established by Title IV of the Act (30 U.S.C. 1201 et seq. ) in response to concerns over extensive environmental damage caused by past coal mining activities. A reclamation fee on each ton of coal supports the abandoned mine land reclamation program. The money collected is used to finance the reclamation of abandoned coal mines and for other authorized activities. Section 405 of the Act allows States and Indian Tribes to assume exclusive responsibility for reclamation activity within the State or on Indian lands if they develop and submit to the Secretary for approval, a program (often referred to as a plan) for the reclamation of abandoned coal mines. On the basis of these criteria, the Secretary approved the Texas plan on June 23, 1980. You can find background information on the Texas plan, including the Secretary's findings, the disposition of comments, and the approval of the plan in the June 23, 1980, Federal Register (45 FR 41937). You can find later actions concerning the Texas plan and amendments to the plan at 30 CFR 943.25.

By letter dated February 14, 2007 (Administrative Record No. TX-662), Texas sent us amendments to the Texas program and the Texas plan, at its own initiative, under SMCRA (30 U.S.C. 1201 et seq. ). We announced receipt of the proposed amendments in the April 30, 2007, Federal Register (72 FR 21185). We did not receive any public comments. We did receive comments from two Federal agencies.

During our review of the amendment to the Texas program, the Railroad Commission of Texas notified us that the Texas legislators capped the State's administrative penalty at $10,000 instead of the $13,000 as proposed in the amendment to the Texas program submitted to us on February 14, 2007 (Administrative Record No. TX-662). On May 7, 2007, Texas sent us this revision to its regulatory program statutes regarding administrative penalty for violations of permit conditions along with corresponding revisions to its regulations regarding determination of amount of penalty (Administrative Record No. TX-662.03).

Also, during our review of the Texas program amendment, we identified concerns about informal public hearings and assessment of separate violations for each day. By email dated June 5, 2007 (Administrative Record No. TX-662.07) we notified Texas of these concerns. Texas sent us revisions to this amendment by e-mail dated June 7, 2007 (Administrative Record No. TX-662.08).

Based on Texas' revisions to its amendment, we reopened the public comment period in the June 11, 2007, Federal Register at 72 FR 32049. The public comment period ended on June 26, 2007. We did not receive any public comments.

Following are the findings we made concerning the amendments under SMCRA and the Federal regulations at 30 CFR 732.15, 732.17, 884.14, and 884.15. We are approving the amendments as described below.

Texas revised its requirements at section 134.150(c) pertaining to who may not be subject to liens as a result of the reclamation of abandoned mine lands. Currently, persons who owned property before May 2, 1977, and who did not consent to, or participate in, or exercise control over the mining operation that necessitated the reclamation are exempt from liens. Texas removed the date requirement at section 134.150(c)(1) so that persons who did not consent to, or participate in, or exercise control over the mining operation (that necessitated the reclamation) are exempt from liens regardless of when they acquired the property.

We are approving the change because this date requirement of May 2, 1977, was also removed from section 408(a) of SMCRA effective December 20, 2006, and because the change will not make Texas' plan less stringent than SMCRA.

Texas proposed to revise subsection (b) by increasing its penalty cap from $5,000 to $10,000 for each violation at surface coal mining operations.

Section 518(i) of SMCRA requires that the civil penalty provisions of each State program contain, at a minimum, penalties which are “no less stringent than” those set forth in SMCRA. Section 518(a) of SMCRA assesses a maximum penalty of $5,000 for each violation. Texas proposed a maximum penalty of $10,000 for each violation. We are approving Texas' change at section 134.174(b) because it is no less stringent than SMCRA.

Texas' regulations listed in the table below contain language that is the same as or similar to the corresponding sections of the Federal regulations or statute.

Because the above State regulations contain language that is the same as or similar to or have the same meaning as the corresponding Federal regulations or statute, we find that they are no less stringent than SMCRA and/or no less effective than the Federal regulations.

In section 12.337(a), Texas added topsoil substitutes to the list of materials to be redistributed after final grading during surface mining reclamation. The counterpart Federal regulation at 30 CFR 816.22(d)(2) includes topsoil substitutes as one of the materials being redistributed after the land is regraded during surface mining reclamation. We are approving this addition because it is no less affective than the above Federal regulation.

Texas added the word, informal, to the section heading. Texas also revised paragraph (g) by changing “public hearing” to “informal public hearing” and by changing “review” to “formal review.” The revised paragraph (g) reads as follows:

The counterpart Federal regulation at 30 CFR 843.15(g) refers to “hearings” and “reviews” under enforcement procedures as “informal hearings” and “formal reviews.” We are approving the above revisions because they simply clarify that under Texas' enforcement procedures, public hearings are “informal public hearings” and reviews are “formal reviews” and because the revisions are no less effective than the Federal regulations at 30 CFR 843.15(g).

Texas' current regulation regarding administrative penalties was promulgated in 1979. Texas proposed to increase these penalties to reflect the decreased value in the dollar since 1979. The current penalties begin with $20 increments for each penalty assessment point and increase to a maximum penalty of $5,000. The revised penalties begin with $550 and increase to $10,000.

Section 518(i) of SMCRA requires that the civil penalty provisions of each State program contain penalties which are “no less stringent than” those set forth in SMCRA. Our regulations at 30 CFR 840.13(a) specify that each State program shall contain penalties which are no less stringent than those set forth in section 518 of the Act and shall be consistent with 30 CFR part 845. However, in a 1980 decision on OSM's regulations governing civil monetary penalties (CMPs), the U.S. District Court for the District of Columbia held that because section 518 of SMCRA fails to enumerate a point system for assessing civil penalties, the imposition of this requirement upon the States is inconsistent with SMCRA. In response to the Secretary's request for clarification, the Court further stated that it could not uphold requiring the States to impose penalties as stringent as those appearing in 30 CFR 845.15. Instead, section 518(i) of the Act requires only the incorporation of penalties and procedures explained in section 518. The system proposed by the State must incorporate the four criteria of section 518(a) of SMCRA: (1) History of previous violations, (2) seriousness of the violation, (3) negligence of the permittee, and (4) good faith of the permittee in attempting to achieve compliance. As a result of the litigation, 30 CFR 840.13(a) was suspended in part on August 4, 1980 (45 FR 51548) by suspending the requirement that penalties shall be consistent with 30 CFR part 845. Consequently, we cannot require that the CMP provisions contained in a State's regulatory program mirror the point system and resulting dollar amounts specified in our regulations.

We are approving Texas' revised penalties because the penalties are no less stringent than those specified in SMCRA and the procedural requirements are the same or similar to the procedures specified in SMCRA and the Federal regulations.

We asked for public comments on the Texas program and Texas plan amendments, but did not receive any.

On March 16, 2007 (Administrative Record No. TX-662.01) and May 31, 2007 (Administrative Record No. TX-662.06), under 30 CFR 732.17(h)(11)(i), 884.14(a)(2), and 884.15(a), and section 503(b) of SMCRA, we requested comments on the amendments from various Federal agencies with an actual or potential interest in the Texas program and Texas plan. On March 22, 2007, the Natural Resources Conservation Service stated that it had no comments pertaining to the proposed changes (Administrative Record No. TX-662.02). The U.S. Army Corps of Engineers responded on April 20, 2007 (Administrative Record No. TX-662.04), that both its Southwestern Division representatives and its Regulatory Branch in its Headquarters office had no additional comments at this time to the proposed changes to the Texas abandoned mine land reclamation plan.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the Texas program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Texas proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment.

On March 16, 2007 (Administrative Record No. TX-662.01) and July 10, 2007 (Administrative Record No. TX-662.06), under 30 CFR 732.17(h)(11)(i), 884.14(a)(2), and 884.15(a), we requested comments on the Texas program and Texas plan amendments from the EPA. The EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on State regulatory program amendments that may have an effect on historic properties. On March 16, 2007 (Administrative Record No. TX-662.01) and May 31, 2007 (Administrative Record No. TX-662.06), we requested comments on the Texas program amendment, but neither responded to our request.

Based on the above findings, we approve the amendments to the Texas program and the Texas plan that Texas sent us on February 14, 2007, and as revised on May 7, 2007, and June 7, 2007.

To implement this decision, we are amending the Federal regulations at 30 CFR part 943, which codify decisions concerning the Texas program and Texas plan. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this rule effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. This determination is based on the fact that the Texas program does not regulate coal exploration and surface coal mining and reclamation operations on Indian lands. Therefore, the Texas program has no effect on federally-recognized Indian tribes.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rule rescissions we are approving with the dates that they were adopted by the Antelope Valley Air Quality Management District (AVAQMD) and submitted by the California Air Resources Board (CARB).

These rule submittals were found to meet the completeness criteria in 40 CFR part 51, Appendix V, which must be met before formal EPA review on September 17, 2007 and October 24, 2006, respectively.

A version of Rule 1158 adopted December 2, 1983 was approved into the SIP on January 15, 1987. A version of Rule 1186 adopted September 10, 1999 was approved into the SIP on June 10, 2000.

Section 110(a) of the CAA requires states to submit regulations that control VOC emissions, oxides of nitrogen, particulate matter, and other air pollutants which harm human health and the environment. These rules were originally developed as part of the South Coast Air Quality Management District's (SCAQMD) program to control particulate matter (PM). At the time, SCAQMD's jurisdiction included the portion of Los Angeles County located in the Mojave Desert Air Basin, known as the Antelope Valley. On July 1, 1997 the AVAQMD was formed, pursuant to statute and assumed the duties and powers of the SCAQMD in the Antelope Valley. The AVAQMD subsequently rescinded Rules 1158 and 1186 after determining that there are no sources regulated by these rules within the jurisdiction of the AVAQMD. EPA's technical support document (TSD) has more information about these rules.

EPA has evaluated all the appropriate background and submittal documentation and has determined that the rescission of Rules 1158 and 1186 are approvable. The AVAQMD has identified that the sources regulated by these rules are not present in the AVAQMD. Further, the AVAQMD also stated that they do not anticipate these types of sources in the future.

The rule rescissions are consistent with the CAA, EPA regulations and EPA policy.

We believe these rule rescissions are consistent with the relevant policy and guidance. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rule rescissions because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rule rescissions. If we receive adverse comments by December 19, 2007, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on January 18, 2008. This will incorporate these rule rescissions into the federally enforceable SIP.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission; to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 18, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On September 25, 2007 (72 FR 54390), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed approval of Pennsylvania's redesignation request and maintenance plan SIP revisions for the Scranton/Wilkes-Barre Area that provide for continued attainment of the 8-hour ozone NAAQS for at least 10 years after redesignation. The NPR also proposed approval of a 2002 base year emissions inventory for the Area. The formal SIP revisions were submitted by PADEP on June 12, 2007. Other specific requirements of Pennsylvania's redesignation request and maintenance plan SIP revisions, and the rationales for EPA's proposed actions, are explained in the NPR and will not be restated here. No public comments were received on the NPR.

However, on December 22, 2006, the U.S. Court of Appeals for the District of Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-hour Ozone Standard. (69 FR 23591, April 30, 2004). South Coast Air Quality Management Dist. v. EPA , 472 F.3d 882 (D.C.Cir. 2006). On June 8, 2007, in South Coast Air Quality Management Dist. v. EPA, Docket No. 04-1201, in response to several petitions for rehearing, the D.C. Circuit clarified that the Phase 1 Rule was vacated only with regard to those parts of the rule that had been successfully challenged. Therefore, the Phase 1 Rule provisions related to classifications for areas currently classified under subpart 2 of Title I, part D of the Act as 8-hour nonattainment areas, the 8-hour attainment dates and the timing for emissions reductions needed for attainment of the 8-hour ozone NAAQS remain effective. The June 8 decision left intact the Court's rejection of EPA's reasons for implementing the 8-hour standard in certain nonattainment areas under subpart 1 in lieu of subpart 2. By limiting the vacatur, the Court let stand EPA's revocation of the 1-hour standard and those anti-backsliding provisions of the Phase 1 Rule that had not been successfully challenged. The June 8 decision reaffirmed the December 22, 2006 decision that EPA had improperly failed to retain measures required for 1-hour nonattainment areas under the anti-backsliding provisions of the regulations: (1) Nonattainment area New Source Review (NSR) requirements based on an area's 1-hour nonattainment classification; (2) Section 185 penalty fees for the 1-hour severe or extreme nonattainment areas; and (3) measures to be implemented pursuant to section 172(c)(9) or 182(c)(9) of the CAA, on the contingency of an area not making reasonable further progress toward attainment of the 1-hour NAAQS, or for failure to attain NAAQS. In addition, the June 8 decision clarified that the Court's reference to conformity requirements for anti-backsliding purposes was limited to requiring the continued use of the 1-hour motor vehicle emissions budgets until 8-hour budgets were available for 8-hour conformity determinations, which is already required under EPA's conformity regulations. The Court thus clarified the 1-hour conformity determinations are not required for anti-backsliding purposes.

For the reasons set forth in the proposal, EPA does not believe that the Court's rulings alter any requirements relevant to this redesignation action so as to preclude redesignation, and do not prevent EPA from finalizing this redesignation. EPA believes that the Court's December 22, 2006 and June 8, 2007 decisions impose no impediment to moving forward with redesignation of this area to attainment, because even in the light of the Court's decisions, redesignation is appropriate under the relevant redesignation provisions of the CAA and longstanding policies regarding redesignation requests.

EPA is approving the Commonwealth of Pennsylvania's redesignation request, maintenance plan, and 2002 base year emissions inventory SIP revisions because they satisfy the requirements for approval. EPA has evaluated Pennsylvania's redesignation request that was submitted on June 12, 2007 and determined that it meets the redesignation criteria set forth in section 107(d)(3)(E) of the CAA. EPA believes that the redesignation request and monitoring data demonstrate that the Scranton/Wilkes-Barre Area has attained the 8-hour ozone standard. The final approval of this redesignation request will change the designation of the Scranton/Wilkes-Barre Area from nonattainment to attainment for the 8-hour ozone standard. EPA is approving the maintenance plan for the Scranton/Wilkes-Barre Area submitted on June 12, 2007 as a revision to the Pennsylvania SIP. EPA is also approving the MVEBs submitted by PADEP in conjunction with its redesignation request. In addition, EPA is approving the 2002 base year emissions inventory submitted by PADEP on June 12, 2007 as a revision to the Pennsylvania SIP. In this final rulemaking, EPA is notifying the public that we have found that the MVEBs for NO X and VOCs in the Scranton/Wilkes-Barre Area for the 8-hour ozone maintenance plan are adequate and approved for conformity purposes. As a result of our finding, the Scranton/Wilkes-Barre Area must use the MVEBs from the submitted 8-hour ozone maintenance plan for future conformity determinations. The adequate and approved MVEBs are provided in the following table:

The Scranton/Wilkes-Barre Area is subject to the CAA's requirement for the basic nonattainment areas until and unless it is redesignated to attainment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves State law as meeting Federal requirements and imposes no additional requirements beyond those imposed by State law. Redesignation is an action that affects the status of a geographical area and does not impose any new regulatory requirements on sources. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This final rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Because this action affects the status of a geographical area, does not impose any new requirements on sources, or allows the state to avoid adopting or implementing other requirements, this action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard.

In reviewing SIP submissions, EPA’s role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Redesignation is an action that affects the status of a geographical area and does not impose any new requirements on sources. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 18, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This action, approving the redesignation of the Scranton/Wilkes-Barre Area to attainment for the 8-hour ozone NAAQS, the associated maintenance plan, the 2002 base year emission inventory, and the MVEBs identified in the maintenance plan, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

A list of potentially affected entities is provided in the Federal Register of September 19, 2007 (72 FR 53470) (FRL-8135-8). If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In the Federal Register of September 19, 2007 (72 FR 53470), EPA issued several direct final Significant New Use Rules (SNURs), including SNURs for the two chemical substances that are the subject of this withdrawal. These direct final rules were issued pursuant to the procedures in 40 CFR part 721, subpart D. In accordance with 40 CFR 721.170(d)(4)(i)(B), EPA is withdrawing the rules issued for dodecandioic acid, 1, 12-dihydrazide (CAS No. 4080-98-2; PMNs P-01-759 and P-05-555) and thiophene, 2, 5-dibromo-3-hexyl- (CAS No. 116971-11-0; PMN P-07-283) (see § 721.10057 and § 721.10088, respectively) because the Agency received a notice to submit adverse comments. EPA intends to propose SNURs for these two substances via notice and comment rulemaking in a future Federal Register document.

For further information regarding EPA's expedited process for issuing SNURs, interested parties are directed to 40 CFR part 721, subpart D and the Federal Register of July 27, 1989 (54 FR 31314). The record for the direct final SNUR for these substances which is being withdrawn was established at EPA-HQ-OPPT-2006-0898. That record includes information considered by the Agency in developing this rule and one of the notices of intent to submit adverse comments. The other notice of intent to submit adverse comments was claimed as Confidential Business Information by the commenter and therefore is not in the public docket.

To access the electronic docket, please go to http://www.regulations.gov and follow the online instructions to access Docket ID No. EPA-HQ-OPPT-2006-0898. Additional information about the docket facility is provided under ADDRESSES in the Federal Register document of September 19, 2007 (72 FR 53470). If you have questions, consult the person listed under FOR FURTHER INFORMATION CONTACT .

This final rule revokes or eliminates an existing regulatory requirement and does not contain any new or amended requirements. As such, the Agency has determined that this withdrawal will not have any adverse impacts, economic or otherwise. The statutory and executive order review requirements applicable to the direct final rule were discussed in the Federal Register document of September 19, 2007 (72 FR 53470). Those review requirements do not apply to this action because it is a withdrawal and does not contain any new or amended requirements.

The Congressional Review Act, 5 U.S.C. 801 et seq. generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Regulations governing the spiny dogfish fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota, which is allocated into two quota periods based upon percentages specified in the fishery management plan. The commercial quota is distributed to the coastal states from Maine through Florida, as described in § 648.230.

The initial total commercial quota for spiny dogfish for the 2007 fishing year is 4 million lb (1.81 million kg) (71 FR 40436, July 17, 2006 ). The commercial quota is allocated into two periods (May 1 through October 31, and November 1 through April 30). Vessel possession limits are intended to preclude directed fishing, and they are set at 600 lb (272 kg) for both quota Periods 1 and 2. Quota Period 1 is allocated 2.3 million lb (1.05 million kg), and quota Period 2 is allocated 1.7 million lb (763,849 kg) of the commercial quota. The total quota cannot be exceeded, so landings in excess of the amount allocated to quota Period 1 have the effect of reducing the quota available to the fishery during quota Period 2.

The Administrator, Northeast Region, NMFS (Regional Administrator) monitors the commercial spiny dogfish quota for each quota period and, based upon dealer reports, state data, and other available information, determines when the total commercial quota will be harvested. NMFS is required to publish a notification in the Federal Register advising and notifying commercial vessels and dealer permit holders that, effective upon a specific date, the Federal spiny dogfish commercial quota has been harvested and no Federal commercial quota is available for landing spiny dogfish for the remainder of that quota period.

Section 648.4(b) provides that Federal spiny dogfish permit holders agree, as a condition of the permit, not to land spiny dogfish in any state after NMFS has published notification in the Federal Register that the commercial quota has been harvested and that no commercial quota for the spiny dogfish fishery is available. Therefore, effective 0001 hr local time, November 16, 2007, landings of spiny dogfish in coastal states from Maine through Florida by vessels holding commercial Federal fisheries permits are prohibited through April 30, 2008, 2400 hr local time. The 2008 Period 1 quota will be available for commercial spiny dogfish harvest on May 1, 2008. Effective November 16, 2007, federally permitted dealers are also advised that they may not purchase spiny dogfish from vessels issued Federal spiny dogfish permits that land in coastal states from Maine through Florida.

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

The temporary rule also is accessible via the Internet at the Office of the Federal Register 's website at http:// www.gpoaccess.gov/fr/index.html . Background information and documents, including the EA, are available at the Council's website at http://www.pcouncil.org .

On May 17, 2007, NMFS published a temporary rule (72 FR 27759) to prohibit any vessel from participating in either the mothership, catcher-processor, or shoreside delivery sector of the directed whiting fishery off the West Coast in 2007 if it did not have a history of sector-specific participation in the whiting fishery between January 1, 1997 and January 1, 2007 (72 FR 27759.) The Council had requested that NMFS implement this rule in order to prevent new entrants from accelerating the pace of the fishery and potentially increasing the rate at which bycatch species are taken in the fishery. The Council had requested this emergency rule in order to prevent conservation and management problems in the 2007 fishery while it worked to develop a vessel license limitation program for the whiting fishery in 2008 and beyond. The emergency rule published on May 17, 2007, went into effect on May 14, 2007, and was made effective for 180 days, or until November 13, 2007. Under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) at section 305(c), an emergency rule may be made effective for up to 180 days and may be extended for up to 186 additional days. In most fishing years, the whiting fishery has taken its full allocation and the whiting fishery is closed by mid-November. As of publication of this document, however, 2007 whiting quota remains available and the fishery remains open. In order to prevent the “race for fish” that the Council had feared for the 2007 whiting fishery, and to ensure that the accelerated race for fish does not occur in the early 2008 whiting season, the emergency rule must be extended through the additional allowable 186 days to May 13, 2008. NMFS anticipates that Amendment 15, if approved, will be implemented by that time.

NMFS notes that the May 17, 2007 temporary rule included a provision (amendment to § 660.333) allowing disaggregation of permits that had been aggregated in early 2007, and did not specify the end of the effective date for this disaggregation provision. NMFS has determined that it was an oversight to leave the provision effective indefinitely. NMFS is leaving the disaggregation in place and effective through the effective date of the extension of the emergency rule as originally planned to provide parties time to complete any desired disaggregation. If Amendment 15 to the Groundfish FMP is approved and implemented, NMFS intends to consider, through notice and comment rulemaking, termination of the option to disaggregate.

Further background information for this action is provided in the preamble text of the May 17, 2007 emergency rule and in the supporting documents for this action, and is not repeated here.

During the comment period on the initial emergency action, which ended on June 18, 2007, NMFS received one letter and eight emails of comment. All of the comments addressed the same subject and are summarized and addressed here:

Comments: When the Council requested that NMFS take emergency action to prohibit participation in the 2007 whiting fishery by vessels without sector-specific participation prior to January 1, 2007, it had not requested that NMFS set a beginning date for the vessel qualification period. NMFS first implemented sector-specific allocations to the non-tribal whiting sectors that operate today in 1997 (62 FR 27519, May 20, 1997). Therefore, in the emergency rule, NMFS implemented the Council's request for sector-specific participation history as a history of whiting catch between December 31, 1996 and January 1, 2007. Eight of the commenters wrote to state that they did not believe the Council had intended to exclude from the 2007 fisheries those vessels with fishery participation history prior to December 31, 1996. These commenters identified two vessels that would be excluded from participating in the shorebased whiting sector and which had already made financial arrangements to participate in the 2007 fishery based on their interpretation that the Council's request had been intended to include any vessels with whiting harvest prior to January 1, 2007, regardless of how far into the past that history had occurred. A dissenting commenter wrote to oppose revising the emergency rule to allow 2007 participation for vessels only with participation history prior to 1997 when the emergency rule was continuing to prohibit 2007 participation by vessels with limited entry permits but without a history of participation in the whiting fishery.

Response: NMFS reviewed the comments received and agreed that, although the Council's request did speak to sector-specific history, it did not set a start date for the qualification period for participation in 2007. Because NMFS did not have time to revise the emergency rule prior to the June 15, 2007 start date of the shorebased whiting fishery, NMFS instead revised the exempted fishing permits (EFPs) issued to the two affected vessels so that they were permitted to participate in the 2007 shorebased whiting sector. Both of the affected vessels had long and consistent history participating as catcher vessels in the mothership whiting fishery; therefore, NMFS believed that the vessels could be expected to participate in the shorebased sector without causing conservation concerns. In contrast to these two vessels, there were other vessels that were also excluded by the emergency rule to which NMFS did not issue revised EFPs. They did not receive EFPs because they did not have any history in the whiting fishery between 1997 and 2007, and thus NMFS was concerned about their ability to participate in the fishery without causing conservation concerns.

This emergency rule extension is published under the authority of the Magnuson-Stevens Act.

This action has been determined to be not significant for the purposes of Executive Order 12866.

Because no general notice of proposed rulemaking is required to be published in the Federal Register for this emergency rule extension by 5 U.S.C. 553 or by any other law, the analytical requirements of the Regulatory Flexibility Act do not apply; thus, no Regulatory Flexibility Analysis was prepared.

The Assistant Administrator finds it is unnecessary and contrary to the public interest to provide for prior notice and an opportunity for public comment on this emergency rule extension. In the initial emergency rule published on May 17, 2007 (72 FR 27759), NMFS requested, and subsequently received, comments on the rulemaking. Therefore, the agency has the authority to extend the emergency action for up to 186 days beyond the November 13, 2007, expiration of the initial emergency action, which is May 13, 2008.

The measures of this emergency rule extension remain unchanged from the measures contained in the initial emergency rule that prohibited participation in the 2007 whiting fishery by vessels without sector-specific participation history prior to January 1, 2007. This extension must be in place by November 14, 2007 because the 2007 whiting fishery is still underway and failing to extend the emergency rule would be counter to the Council's efforts to constrain whiting fishery participation in 2007 in order to constrain bycatch of co-occurring species within the whiting fishery. Extending the provisions of the emergency rule without notice and comment rule will ensure that the 2007 whiting fishery continues to operate with the same pool of participants that have been permitted to operate throughout the season, thereby preventing disruption of the fishery and unnecessary adverse economic impacts to fishery participants.

NMFS solicited public comment during the 30-day post-promulgation comment period on the measures contained in the initial emergency action and extended by this action. The comments received were considered and are addressed in the preamble to this rule; however, no change to the emergency action measures were enacted as a result of the comments received. The Council developed a vessel license limitation program for 2008 and beyond under Amendment 15 to the FMP, which would be considered and implemented through notice and comment rulemaking. Therefore, for the reasons outlined above, the Assistant Administrator finds it is unnecessary and contrary to the public interest to provide any additional notice and opportunity for public comment under 5 U.S.C. 553(b)(B) prior to publishing the emergency rule extension.

Fisheries, Fishing, Indian fisheries.