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Unknown. Rule of Agency Procedure

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--- schema: federal-register doc_type: fedreg source_file: FR-2007-11-19.xml --- 72 222 Monday, November 19, 2007 Contents Agency Agency for Healthcare Research and Quality NOTICES Agency information collection activities; proposals, submissions, and approvals, 65031-65032 07-5734 Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service See Natural Resources Conservation Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 64986-64988 E7-22563 E7-22565 E7-22566 07-5720 Animal Animal and Plant Health Inspection Service RULES Plant-related quarantine, domestic:
Citrus canker, 65172-65204 E7-22549 Antitrust Antitrust Division NOTICES Competitive impact statements and proposed consent judgments: AT&T Inc. and Dobson Communications Corp., 65060-65076 07-5719 Army Army Department NOTICES Environmental statements; notice of intent: Base realignments and closures— Fort McPherson, GA, 65016-65017 07-5702 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 65032-65033 E7-22637 Coast Guard Coast Guard PROPOSED RULES Ports and waterways safety; regulated navigation areas, safety zones, security zones, etc.:
Cape Cod, MA; North Atlantic right whales; port access route study of potential vessel routing measures to reduce vessel strikes, 64968-64970 E7-22557 Commerce Commerce Department See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See Patent and Trademark Office Corporation Corporation for National and Community Service PROPOSED RULES AmeriCorps national service program; technical amendments, 64970-64979 E7-22298 Defense Defense Acquisition Regulations System NOTICES Agency information collection activities; proposals, submissions, and approvals, 65017 E7-22591 Defense Defense Department See Army Department See Defense Acquisition Regulations System Drug Drug Enforcement Administration RULES Schedule of controlled substances:
Schedule II controlled substances; multiple prescriptions, 64921-64930 E7-22558 Energy Energy Department RULES Consumer products; energy conservation program: Energy conservation standards— Residential furnaces and boilers, 65136-65170 E7-22216 EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States: California, 64946-64948 E7-22447 Air quality implementation plans; approval and promulgation; various States; air quality planning purposes; designation of areas:
Pennsylvania, 64948-64951 E7-22446 Toxic substances: Significant new uses— Dodecandioic acid, 1, 12-dihydrazide, etc.; withdrawn, 64951 E7-22614 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: California, 64970 E7-22449 NOTICES Agency information collection activities; proposals, submissions, and approvals, 65018-65019 07-5709 Air programs: State implementation plans; adequacy status for transportation conformity purposes— Washington, 65019 E7-22589 Committees; establishment, renewal, termination, etc.:
Good Neighbor Environmental Board, 65019-65020 07-5708 Meetings: Scientific Counselors Board, 65020-65021 E7-22598 Executive Executive Office of the President See Presidential Documents See Trade Representative, Office of United States Export Export-Import Bank NOTICES Meetings: Advisory Committee, 65021 07-5717 FAA Federal Aviation Administration PROPOSED RULES Aircraft: Automatic dependent surveillance-broadcast; out performance requirements to support air traffic control service, 64966-64968 E7-22544 Airworthiness directives:
ATR, 64960-64961 E7-22546 Boeing, 64955-64957 E7-22542 E7-22543 64961-64966 E7-22548 McDonnell Douglas, 64957-64960 E7-22547 NOTICES Environmental statements; availability, etc.: Greater Peoria Regional Airport, IL, 65126 07-5722 Meetings: RTCA, Inc., 65126-65127 07-5721 07-5723 FCC Federal Communications Commission PROPOSED RULES Common carrier services: Satellite communications— Ancillary terrestrial components, 64979-64980 E7-22567 NOTICES Common carrier services: Wireless telecommunications services— 700 MHz band licenses; auction procedures, 65022-65023 E7-22501 Meetings:
Diversity for Communications in the Digital Age Advisory Committee, 65023 07-5745 *Applications, hearings, determinations, etc.:* Atlantic Coast Radio, LLC, et al., 65021-65022 E7-22602 Federal Election Federal Election Commission RULES Compliance procedures: Probable cause hearings, 64919-64921 E7-22524 Federal Highway Federal Highway Administration NOTICES Federal agency actions on proposed highways; judicial review claims: Riverside County, CA; State Route 91highway project, 65127-65128 E7-22580 Federal Railroad Federal Railroad Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 65128-65131 E7-22593 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:
Change in bank control, 65023-65024 E7-22551 FTC Federal Trade Commission NOTICES Premerger notification waiting periods; early terminations, 65024-65026 07-5727 Fish Fish and Wildlife Service PROPOSED RULES Migratory bird permits: Import and export regulations; revisions, 64981-64985 E7-22182 NOTICES Endangered and threatened species: Recovery plans— Attwater's prairie chicken, 65058-65059 07-5705 Survival enhancement permits— Marin County, CA; California red-legged frog; safe harbor agreement, 65056-65058 07-5703 Food Food and Drug Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 65033-65042 E7-22480 E7-22489 E7-22492 E7-22495 E7-22586 E7-22587 E7-22588 Food additive petitions:
ARCH Chemicals, Inc.; withdrawn, 65042 E7-22536 Memorandums of understanding: Association of American Feed Control Officials; feed ingredients definition, disputes resolution, etc.; responsibilities clarification, 65042-65046 07-5748 Reports and guidance documents; availability, etc.: Voting Procedures for Advisory Committee Meetings, 65046-65047 07-5751 Foreign Foreign Assets Control Office NOTICES Sanctions; blocked persons, specially-designated nationals, terrorists, narcotics traffickers, and foreign terrorist organizations:
Belarus; additional designations, 65132-65133 E7-22559 Forest Forest Service NOTICES Appealable decisions; legal notice: Alaska Region, 64988 07-5704 Environmental statements; notice of intent: Stanislaus National Forest, CA, 64988-64991 E7-22571 National Forest System timber; sale and disposal: Contract extensions; finding of substantial overriding public interest, 64991-64994 E7-22534 GSA General Services Administration NOTICES Federal Management Regulation: Lease acquisition authority delegations; notification, usage, and reporting requirements, 65026-65030 E7-22530 Privacy Act; systems of records, 65030-65031 E7-22531 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Food and Drug Administration See National Institutes of Health NOTICES Special Exposure Cohort; employee class designations:
Kellex/Pierpont, NJ, 65031 E7-22527 Homeland Homeland Security Department See Coast Guard See Transportation Security Administration Housing Housing and Urban Development Department RULES Public and Indian housing: Project-Based Voucher Program; low-income housing tax credit rent provisions, 65206-65207 E7-22526 NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-22525 65055-65056 E7-22610 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Surface Mining Reclamation and Enforcement Office IRS Internal Revenue Service RULES Employment taxes:
Payments made by reason of a salary reduction agreement, 64939-64942 07-5730 NOTICES Agency information collection activities; proposals, submissions, and approvals, 65133 E7-22579 International International Trade Administration NOTICES Antidumping: Pasta from— Italy, 65010-65011 E7-22554 Steel concrete reinforcing bars from— Turkey, 65011-65012 E7-22556 International International Trade Commission NOTICES Import investigations: Glycine from— Various countries, 65060 E7-22538 Justice Justice Department See Antitrust Division See Drug Enforcement Administration Labor Labor Department See Mine Safety and Health Administration Land Land Management Bureau NOTICES Committees; establishment, renewal, termination, etc.:
North Slope Science Initiative Technical Advisory Panel; correction, 65059 E7-22568 Legal Legal Services Corporation NOTICES Grant and cooperative agreement awards: Civil legal services to eligible low-income clients; various States, 65078-65082 E7-22539 Maritime Maritime Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 65131 E7-22188 Mine Mine Safety and Health Administration NOTICES Petitions for safety standards modification; application, processing, disposition, etc., 65076-65078 E7-22561 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings:
Humanities Panel, 65082 E7-22569 National Institute National Institute of Standards and Technology NOTICES Reports and guidance documents; availability, etc.: Help America Vote Act; voting equipment evaluations; Phase II, 65012-65013 E7-22570 NIH National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 65047-65050 E7-22592 E7-22594 E7-22597 Committees; establishment, renewal, termination, etc.: Emerging Neuroscience and Training Integrated Review Group, 65050-65051 07-5744 Meetings:
National Heart, Lung, and Blood Institute, 65051 07-5739 National Institute of Child Health and Human Development, 65052 07-5738 National Institute of Environmental Health Sciences, 07-5736 65051-65053 07-5741 National Institute of General Medical Sciences, 65053 07-5743 National Institute of Mental Health, 65052 07-5740 National Institute on Aging, 65051-65052 07-5737 National Institute on Deafness and Other Communication Disorders, 65053 07-5742 Patent licenses; non-exclusive, exclusive, or partially exclusive:
Enlyton, Ltd., 65053-65054 E7-22595 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: Northeastern United States fisheries— Spiny dogfish, 64952 07-5731 West Coast States and Western Pacific fisheries— Pacific Coast groundfish, 64952-64954 07-5732 NOTICES Meetings: South Atlantic Fishery Management Council, 65013-65015 E7-22516 National Park National Park Service NOTICES National Register of Historic Places; pending nominations, 65059-65060 E7-22528 National Science National Science Foundation NOTICES Agency information collection activities; proposals, submissions, and approvals, 65082-65084 07-5707 Antarctic Conservation Act of 1978; permit applications, etc., E7-22504 65084 E7-22514 NRCS Natural Resources Conservation Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 64994-65010 07-5747 Nuclear Nuclear Regulatory Commission NOTICES Meetings:
Reactor Safeguards Advisory Committee, E7-22537 65109 E7-22540 *Applications, hearings, determinations, etc.:* Dominion Nuclear Connecticut, 65084-65087 E7-22428 Energy Department, Idaho Operations Office, 65087-65094 E7-22573 E7-22575 Foster Wheeler Environmental Corp., 65094-65098 E7-22572 General Electric Co., 65098-65101 E7-22578 Portland General Electric Co., 65101-65105 E7-22577 Private Fuel Storage LLC, 65105-65109 E7-22574 Office of U.S. Trade Office of United States Trade Representative See Trade Representative, Office of United States Overseas Overseas Private Investment Corporation NOTICES Agency information collection activities; proposals, submissions, and approvals, 65111 07-5728 Patent Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 65015-65016 E7-22541 Presidential Presidential Documents PROCLAMATIONS *Special observances:* America Recycles Day (Proc. 8203), 65209-65212 07-5768 Thanksgiving Day (Proc. 8204), 65213-65214 07-5769 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals, 65111-65112 E7-22582 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-22510 65112-65113 E7-22511 Joint Industry Plan:
American Stock Exchange LLC et al., 65113 E7-22533 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 65113-65116 E7-22482 International Securities Exchange, LLC, 65116-65117 E7-22552 New York Stock Exchange LLC, 65117-65119 E7-22509 Philadelphia Stock Exchange, Inc., 65119-65121 E7-22481 E7-22484 State State Department RULES Nationality and passports: Passport regulations reorganization, restructuring, and update, 64930-64939 E7-22461 PROPOSED RULES Acquisition regulations:
Common identification standard and personal identity verification of Federal employees and contractors; Federal information processing standards, 64980-64981 E7-22460 NOTICES Arms Export Control Act: Commercial export licenses; congressional notifications, 65121-65125 E7-22564 Meetings: Overseas Buildings Operations Industry Advisory Panel, 65125-65126 E7-22562 Surface Surface Mining Reclamation and Enforcement Office RULES Permanent program and abandoned mine land reclamation plan submissions:
Texas, 64942-64946 E7-22555 Trade Trade Representative, Office of United States NOTICES Reports and guidance documents; availability, etc.: Telecommunications trade agreements; compliance, 65109-65111 E7-22583 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Railroad Administration See Maritime Administration Transportation Transportation Security Administration NOTICES Maritime and land transportation security:
Transportation Worker Identification Credential; enrollment— Lake Charles, LA, 65054-65055 E7-22584 Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-22600 65131-65132 E7-22601 Separate Parts In This Issue Part II Energy Department, 65136-65170 E7-22216 Part III Agriculture Department, Animal and Plant Health Inspection Service, 65172-65204 E7-22549 Part IV Housing and Urban Development Department, 65206-65207 E7-22526 Part V Executive Office of the President, Presidential Documents, 65209-65214 07-5768 07-5769 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 222 Monday, November 19, 2007 Rules and Regulations FEDERAL ELECTION COMMISSION 11 CFR Part 111 [Notice 2007-21] Procedural Rules for Probable Cause Hearings AGENCY: Federal Election Commission. ACTION: Rule of Agency Procedure.
SUMMARY: The Federal Election Commission (“Commission”) is making permanent a program that allows respondents in enforcement proceedings under the Federal Election Campaign Act, as amended (“FECA”), to have a hearing before the Commission. Hearings will take place prior to the Commission's consideration of the General Counsel's recommendation on whether to find probable cause to believe that a violation has occurred. The Commission will grant a request for a probable cause hearing if any two commissioners agree to hold a hearing.
The program will provide respondents with the opportunity to present arguments to the Commission directly and give the Commission an opportunity to ask relevant questions. Further information about the procedures for the program is provided in the supplementary information that follows. DATES: Effective November 19, 2007. FOR FURTHER INFORMATION CONTACT: Mark D. Shonkwiler, Assistant General Counsel, 999 E Street, NW., Washington, DC 20463,
(202)694-1650 or
(800)424-9530. SUPPLEMENTARY INFORMATION: 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 1 The Commission is appending to this statement a general description of its enforcement procedures (“Basic Commission Enforcement Procedure”). These procedures are prescribed by statute and regulation. See 2 U.S.C. 437g; 11 CFR part 111. I. Background 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). 2 The comments from these 2003 proceedings are available online at *http://www.fec.gov/agenda/agendas2003/notice2003-09/comments.shtml.* 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. II. Procedures for Probable Cause Hearings A. Opportunity To Request a Hearing 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. B. Hearing Procedures 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 3 The Commission's *Statement of Policy Regarding Disclosure of Closed Enforcement and Related Files,* 68 FR 70426 (Dec. 18, 2003) is hereby amended to include disclosure of transcripts from probable cause hearings. C. Cases Involving Multiple Respondents 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. D. Scheduling of Hearings 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. E. Conclusion 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. Dated: November 5, 2007. Robert D. Lenhard, Chairman, Federal Election Commission. Note: The following Appendix will not appear in the Code of Federal Regulations. Appendix: Basic Commission Enforcement Procedure The Commission's enforcement procedures are set forth at 11 CFR part 111. An enforcement matter may be initiated by a complaint or on the basis of information ascertained by the Commission in the normal course of carrying out its supervisory responsibilities. 11 CFR 111.3. If a complaint substantially complies with certain requirements set forth in 11 CFR 111.4, within five days of receipt the Office of General Counsel notifies each party determined to be a respondent that a complaint has been filed, provides a copy of the complaint, and advises each respondent of Commission compliance procedures. 11 CFR 111.5. A respondent then has 15 days from receipt of the notification from the Office of General Counsel to submit a letter or memorandum to the Commission setting forth reasons why the Commission should take no action on the basis of the complaint. 11 CFR 111.6. Following receipt of such letter or memorandum, or expiration of the 15-day period, the Office of General Counsel may recommend to the Commission whether or not it should find “reason to believe” that a respondent has committed or is about to commit a violation of the Act or Commission regulations. 11 CFR 111.7(a). 4 With respect to internally-generated matters ( *e.g.* , referrals from the Commission's Audit or Reports Analysis Divisions), the Office of General Counsel may recommend that the Commission find “reason to believe” that a respondent has committed or is about to commit a violation of the Act or Commission regulations on the basis of information ascertained by the Commission in the normal course of carrying out its supervisory responsibilities, or on the basis of a referral from an agency of the United States or any state. If the Commission determines by an affirmative vote of four members that it has “reason to believe” that a respondent violated the Act or Commission regulations, the respondent must be notified by letter of the Commission's finding(s). 11 CFR 111.9(a). 5 The Office of General Counsel will also provide the respondent with a Factual and Legal Analysis, which will set forth the bases for the Commission's finding of reason to believe. 4 The Office of General Counsel may also recommend that the Commission find no “reason to believe” that a violation has been committed to is about to be committed, or that the Commission otherwise dismiss a complaint without regard to the provisions of 11 CFR 111.6(a). 11 CFR 111.7(b). 5 If the Commission finds no “reason to believe,” or otherwise terminates its proceedings, the Office of General Counsel shall advise the complainant and respondent(s) by letter. 11 CFR 111.9(b). After the Commission makes a “reason to believe” finding, an investigation is conducted by the Office of General Counsel, in which the Commission may undertake field investigations, audits, and other methods of information-gathering. 11 CFR 111.10. Additionally, the Commission may issue subpoenas to order any person to submit sworn written answers to written questions, to provide documents, or to appear for a deposition. 11 CFR 111.11-111.12. Any person who is subpoenaed may submit a motion to the Commission for it to be quashed or modified. 11 CFR 111.15. Following a “reason to believe” finding, the Commission may attempt to reach a conciliation agreement with the respondent(s) prior to reaching the “probable cause” stage of enforcement (i.e., a pre-probable cause conciliation agreement). See 11 CFR 111.18(d). If the Commission is unable to reach a pre-probable cause conciliation agreement with the respondent, or determines that such a conciliation agreement would not be appropriate, upon completion of the investigation referenced in the preceding paragraph, the Office of General Counsel prepares a brief setting forth its position on the factual and legal issues of the matter and containing a recommendation on whether or not the Commission should find “probable cause to believe” that a violation has occurred or is about to occur. 11 CFR 111.16(a). The Office of General Counsel notifies the respondent(s) of this recommendation and provides a copy of the probable cause brief. 11 CFR 111.16(b). The respondent(s) may file a written response to the probable cause brief within fifteen days of receiving said brief. 11 CFR 111.16(c). After reviewing this response, the Office of General Counsel shall advise the Commission in writing whether it intends to proceed with the recommendation or to withdraw the recommendation from Commission consideration. 11 CFR 111.16(d). If the Commission determines by an affirmative vote of four members that there is “probable cause to believe” that a respondent has violated the Act or Commission regulations, the Commission authorizes the Office of General Counsel to notify the respondent by letter of this determination. 11 CFR 111.17(a). Upon a Commission finding of “probable cause to believe,” the Commission must attempt to reach a conciliation agreement with the respondent. 11 CFR 111.18(a). If no conciliation agreement is finalized within the time period specified in 11 CFR 111.18(c), the Office of General Counsel may recommend to the Commission that it authorize a civil action for relief in the appropriate court. 11 CFR 111.19(a). Commencement of such civil action requires an affirmative vote of four members of the Commission. 11 CFR 111.19(b). The Commission may enter into a conciliation agreement with respondent after authorizing a civil action. 11 CFR 111.19(c). [FR Doc. E7-22524 Filed 11-16-07; 8:45 am] BILLING CODE 6715-01-P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1306 [Docket No. DEA-287F] RIN 1117-AB01 Issuance of Multiple Prescriptions for Schedule II Controlled Substances AGENCY: Drug Enforcement Administration (DEA), Department of Justice ACTION: Final rule. SUMMARY: The Drug Enforcement Administration
(DEA)is finalizing a Notice of Proposed Rulemaking published on September 6, 2006 (71 FR 52724). In that document, DEA proposed 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. DATES: *Effective Date:* This rule is effective December 19, 2007. FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone
(202)307-7297. SUPPLEMENTARY INFORMATION: Background 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. Comments Received 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. Discussion of Comments 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: Nothing in this subsection 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. In addition, in the August 26, 2005, “Clarification of Existing Requirements Under the Controlled Substances Act for Prescribing Controlled Substances” (70 FR 50408), DEA stated the following: The CSA and DEA regulations contain no specific limit on the number of days worth of a schedule II controlled substance that a physician may authorize per prescription. Some states, however, do impose specific limits on the amount of a schedule II controlled substance that may be prescribed. Any limitations imposed by state law apply in addition to the corresponding requirements under Federal law, so long as the state requirements do not conflict with or contravene the Federal requirements. 21 U.S.C. 903. Again, the essential requirement under Federal law is that the prescription for a controlled substance be issued for a legitimate medical purpose in the usual course of professional practice. In addition, physicians and pharmacies have a duty as DEA registrants to ensure that their prescribing and dispensing of controlled substances occur in a manner consistent with effective controls against diversion and misuse, taking into account the nature of the drug being prescribed. 21 U.S.C. 823(f). 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. Changes to Regulatory Text *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: Nothing in this paragraph
(b)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. In this context, two commenters suggested deleting the words “in accordance with established medical standards.” The commenters indicated they were not aware of any standards that a practitioner could use to determine whether it is appropriate to issue multiple prescriptions. *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. 1 *United States* v. *Moore* , 423 U.S. 122, 139-142 (1975). *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. Other Issues *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. Objections to Notice of Proposed Rulemaking *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: Nothing in this section 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. *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: 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 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: Methadone, a schedule II controlled substance, has been approved by the [Food and Drug Administration (FDA)] as an analgesic. While a physician must have a separate DEA registration to dispense methadone for maintenance or detoxification, no separate registration is required to prescribe methadone for pain. However, in a document entitled “Methadone-Associated Mortality: Report of a National Assessment,” [The Department of Health and Human Services, Substance Abuse and Mental Health Services Administration] recently recommended that “physicians need to understand methadone's pharmacology and appropriate use, as well as specific indications and cautions to consider when deciding whether to use this medication in the treatment of pain.” 2 This recommendation was made in light of mortality rates associated with methadone. 2 CSAT Publication No. 28-03. Available at *http://dpt.samhsa.gov/medications/methreports.aspx* . 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. 3 The FDA health advisory can be found at *http://www.fda.gov/cder/drug/advisory/methadone.htm* and the package insert can be found at *http://www.fda.gov/cder/foi/label/2006/006134s028lbl.pdf* . Conclusion 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. Regulatory Certifications Regulatory Flexibility Act 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. Executive Order 12866 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. Executive Order 12988 This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Executive Order 13132 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. Unfunded Mandates Reform Act of 1995 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. Congressional Review Act 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. List of Subjects in 21 CFR Part 1306 Drug traffic control, Prescription drugs. Pursuant to the authority vested in the Attorney General under sections 201, 202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 871(b)), delegated to the Deputy Administrator pursuant to section 501(a) (21 U.S.C. 871(a)) and as specified in 28 CFR 0.100 and 0.104, Appendix to Subpart R, the Deputy Administrator hereby orders that Title 21 of the Code of Federal Regulations, Part 1306, be amended as follows: PART 1306—PRESCRIPTIONS 1. The authority citation for part 1306 continues to read as follows: Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted. 2. Section 1306.12 is revised to read as follows: § 1306.12 Refilling prescriptions; issuance of multiple prescriptions.
(a)The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. (b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:
(i)Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
(ii)The individual practitioner provides 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;
(iii)The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv)The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
(v)The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
(2)Nothing in this paragraph
(b)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. 3. Section 1306.14 is amended by adding a new paragraph
(e)to read as follows: § 1306.14 Labeling of substances and filling of prescriptions.
(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. Dated: November 7, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7-22558 Filed 11-16-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF STATE 22 CFR Part 51 [Public Notice: 5991] RIN 1400-AC28 Passports AGENCY: Department of State. ACTION: Final rule. SUMMARY: This rule reorganizes, restructures, and updates passport regulations in order to make them easier for users to access information, to better reflect current practice and changes in statutory authority, and to remove outdated provisions. In general, the revisions do not mark a departure from current policy. Rather, the Department's intent is to bring greater clarity to current passport policy and practice and to present it in a less cumbersome way. DATES: This rule becomes effective February 1, 2008. FOR FURTHER INFORMATION CONTACT: Consuelo Pachon, Office of Passport Policy,
(202)663-2662. Hearing- or speech-impaired persons may use the Telecommunications Devices for the Deaf
(TDD)by contacting the Federal Information Relay Service at 1-800-877-8339. SUPPLEMENTARY INFORMATION: 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. Regulatory Findings Administrative Procedure Act The Department published this rule as a proposed rule, with 60 days for public comments and review. Regulatory Flexibility Act/Executive Order 13272: Small Business 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. The Small Business Regulatory Enforcement Fairness Act of 1996 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. The Unfunded Mandates Reform Act of 1995 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. Executive Orders 12372 and 13132: Federalism 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. Executive Order 12866: Regulatory Review 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. Executive Order 12988: Civil Justice Reform 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. Paperwork Reduction Act of 1995 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. List of Subjects in 22 CFR Part 51 Passports. Accordingly, for the reasons set forth in the preamble, 22 CFR part 51 is revised to read as follows: PART 51—PASSPORTS Sec. 51.1 Definitions. Subpart A—General 51.2 Passport issued to nationals only. 51.3 Types of passports. 51.4 Validity of passports. 51.5 Adjudication and issuance of passports. 51.6 Verification of passports and release of information from passport records. 51.7 Passport property of the U.S. Government. 51.8 Submission of currently valid passport. 51.9 Amendment of passports. 51.10 Replacement passports. Subpart B—Application 51.20 General. 51.21 Execution of passport application. 51.22 Passport agents and passport acceptance agents. 51.23 Identity of applicant. 51.24 Affidavit of identifying witness. 51.25 Name of applicant to be used in passport. 51.26 Photographs. 51.27 Incompetents. 51.28 Minors. Subpart C—Evidence of U.S. Citizenship or Nationality 51.40 Burden of proof. 51.41 Documentary evidence. 51.42 Persons born in the United States applying for a passport for the first time. 51.43 Persons born outside the United States applying for a passport for the first time. 51.44 Proof of resumption or retention of U.S. citizenship. 51.45 Department discretion to require evidence of U.S. citizenship or non-citizen nationality. 51.46 Return or retention of evidence of U.S. citizenship or non-citizen nationality. Subpart D—Fees 51.50 Form of payment. 51.51 Passport fees. 51.52 Exemption from payment of passport fees. 51.53 Refunds. 51.54 Replacement passports without payment of applicable fees. 51.55 Execution fee not refundable. 51.56 Expedited passport processing. Subpart E—Denial, Revocation, and Restriction of Passports 51.60 Denial and restriction of passports. 51.61 Denial of passports to certain convicted drug traffickers. 51.62 Revocation or limitation of passports. 51.63 Passports invalid for travel into or through restricted areas; prohibition on passports valid only for travel to Israel. 51.64 Special validation of passports for travel to restricted areas. 51.65 Notification of denial or revocation of passport. 51.66 Surrender of passport. Subpart F—Procedures for Review of Certain Denials and Revocations 51.70 Request for hearing to review certain denials and revocations. 51.71 The hearing. 51.72 Transcript and record of the hearing. 51.73 Privacy of hearing. 51.74 Final decision. Authority: 8 U.S.C. 1504; 22 U.S.C. 211a, 212, 213, 213n (Pub. L. 106-113 Div. B, Sec. 1000(a)(7) [Div. A, Title II, Sec. 236], 113 Stat. 1536, 1501A-430); 214, 214a, 217a, 218, 2651a, 2671(d)(3), 2705, 2714, 2721; 26 U.S.C. 6039E; 31 U.S.C. 7701, 7901; 42 U.S.C. 652(k) [Div. B, Title V of Pub. L. 103-317, 108 Stat. 1760]; E.O. 11295, Aug. 6, 1966, FR 10603; Sec. 1 of Pub. L. 109-210, 120 Stat. 319; Sec. 2 of Pub. L. 109-167, 119 Stat. 3578; Sec. 5 of Pub. L. 109-472, 120 Stat. 3554; Pub. L. 108-447, Div. B, Title IV, Dec. 8, 2004, 118 Stat. 2896. § 51.1 Definitions. The following definitions are applicable to this part:
(a)*Department* means the United States Department of State.
(b)*Electronic passport* means a passport containing an electronically readable device, an electronic chip encoded with the bearer's personal information printed on the data page, a digitized version of the bearer's photograph, a unique chip number, and a digital signature to protect the integrity of the stored information.
(c)*Minor* means an unmarried, unemancipated person under 18 years of age.
(d)*Passport* means a travel document regardless of format issued under the authority of the Secretary of State attesting to the identity and nationality of the bearer.
(e)*Passport acceptance agent* means a U.S. national designated by the Department to accept passport applications and to administer oaths and affirmations in connection with such applications.
(f)*Passport agent* means a U.S. citizen employee of the Department of State, including consular officers, diplomatic officers and consular agents abroad, and such U.S. citizen Department of State employees or contractors as the Assistant Secretary for Consular Affairs may designate for the purpose of administering oaths and affirmations for passport applications.
(g)*Passport application* means the application form for a United States passport, as prescribed by the Department pursuant to 22 U.S.C. 213 and all documents, photographs, and statements submitted with the form or thereafter in support of the application.
(h)*Passport authorizing officer* means a U.S. citizen employee who is authorized by the Department to approve the issuance of passports.
(i)*Secretary* means the Secretary of State.
(j)*United States* when used in a geographical sense means the continental United States, Alaska, Hawaii, Puerto Rico, Guam, and the Virgin Islands of the United States.
(k)*U.S. citizen* means a person who acquired U.S. citizenship at birth or upon naturalization as provided by law and who has not subsequently lost such citizenship.
(l)*U.S. national* means a U.S. citizen or a U.S. non-citizen national.
(m)*U.S. non-citizen national* means a person on whom U.S. nationality, but not U.S. citizenship, has been conferred at birth under 8 U.S.C. 1408, or under other law or treaty, and who has not subsequently lost such non-citizen nationality. Subpart A—General § 51.2 Passport issued to nationals only.
(a)A passport may be issued only to a U.S. national.
(b)Unless authorized by the Department, no person may bear more than one valid passport of the same type. § 51.3 Types of passports.
(a)*Regular passport* . A regular passport is issued to a national of the United States.
(b)*Official passport* . An official passport is issued to an official or employee of the U.S. Government traveling abroad to carry out official duties. When authorized by the Department, spouses and family members of such persons may be issued official passports. When authorized by the Department, an official passport may be issued to a U.S. government contractor traveling abroad to carry out official duties on behalf of the U.S. government.
(c)*Diplomatic passport* . A diplomatic passport is issued to a Foreign Service officer or to a person having diplomatic status or comparable status because he or she is traveling abroad to carry out diplomatic duties on behalf of the U.S. Government. When authorized by the Department, spouses and family members of such persons may be issued diplomatic passports. When authorized by the Department, a diplomatic passport may be issued to a U.S. Government contractor if the contractor meets the eligibility requirements for a diplomatic passport and the diplomatic passport is necessary to complete his or her mission. § 51.4 Validity of passports.
(a)*Signature of bearer* . A passport is valid only when signed by the bearer in the space designated for signature, or, if the bearer is unable to sign, signed by a person with legal authority to sign on his or her behalf.
(b)*Period of validity of a regular passport* .
(1)A regular passport issued to an applicant 16 years of age or older is valid for 10 years from date of issue unless the Department limits the validity period to a shorter period.
(2)A regular passport issued to an applicant under 16 years of age is valid for five years from date of issue unless the Department limits the validity period to a shorter period.
(3)A regular passport for which payment of the fee has been excused is valid for a period of 5 years from the date issued unless limited by the Department to a shorter period.
(c)*Period of validity of an official passport* . The period of validity of an official passport, unless limited by the Department to a shorter period, is five years from the date of issue, or so long as the bearer maintains his or her official status, whichever is shorter. An official passport which has not expired must be returned to the Department upon the termination of the bearer's official status or at such other time as the Department may determine.
(d)*Period of validity of a diplomatic passport* . The period of validity of a diplomatic passport, unless limited by the Department to a shorter period, is five years from the date of issue, or so long as the bearer maintains his or her diplomatic status, whichever is shorter. A diplomatic passport which has not expired must be returned to the Department upon the termination of the bearer's diplomatic status or at such other time as the Department may determine.
(e)*Limitation of validity* . The validity period of any passport may be limited by the Department to less than the normal validity period. The bearer of a limited passport may apply for a new passport, using the proper application and submitting the limited passport, applicable fees, photographs, and additional documentation, if required, to support the issuance of a new passport.
(f)*Invalidity* . A United States passport is invalid as soon as:
(1)The Department has sent or personally delivered a written notice to the bearer stating that the passport has been revoked; or
(2)The passport has been reported as lost or stolen to the Department, a U.S. passport agency or a diplomatic or consular post abroad and the Department has recorded the reported loss or theft; or
(3)The passport is cancelled by the Department (physically, electronically, or otherwise) upon issuance of a new passport of the same type to the bearer; or
(4)The Department has sent a written notice to the bearer that the passport has been invalidated because the Department has not received the applicable fees; or
(5)The passport has been materially changed in physical appearance or composition, or contains a damaged, defective or otherwise nonfunctioning chip, or includes unauthorized changes, obliterations, entries or photographs, or has observable wear or tear that renders it unfit for use as a travel document, and the Department either takes possession of the passport or sends a written notice to the bearer. § 51.5 Adjudication and issuance of passports.
(a)A passport authorizing officer may adjudicate applications and authorize the issuance of passports.
(b)A passport authorizing officer will examine the passport application and all documents, photographs and statements submitted in support of the application in accordance with guidance issued by the Department. § 51.6 Verification of passports and release of information from passport records.
(a)*Verification.* When required by a foreign government, a consular officer abroad may verify a U.S. passport.
(b)*Release of information.* Information in passport records is subject to the provisions of the Freedom of Information Act
(FOIA)and the Privacy Act. Release of this information may be requested in accordance with Part 171 or Part 172 of this title. § 51.7 Passport property of the U.S. Government.
(a)A passport at all times remains the property of the United States and must be returned to the U.S. Government upon demand.
(b)Law enforcement authorities who take possession of a passport for use in an investigation or prosecution must return the passport to the Department on completion of the investigation and/or prosecution. § 51.8 Submission of currently valid passport.
(a)When applying for a new passport, an applicant must submit for cancellation any currently valid passport of the same type.
(b)If an applicant is unable to produce a passport under paragraph
(a)of this section, he or she must submit a signed statement in the form prescribed by the Department setting forth the circumstances regarding the disposition of the passport.
(c)The Department may deny or limit a passport if the applicant has failed to provide a sufficient and credible explanation for lost, stolen, altered or mutilated passport(s) previously issued to the applicant, after being given a reasonable opportunity to do so. § 51.9 Amendment of passports. Except for the convenience of the U.S. Government, no passport may be amended. § 51.10 Replacement passports. A passport issuing office may issue a replacement passport without payment of applicable fees for the reasons specified in § 51.54. Subpart B—Application § 51.20 General.
(a)An application for a passport, a replacement passport, extra visa pages, or other passport related service must be completed using the forms the Department prescribes.
(b)The passport applicant must truthfully answer all questions and must state every material matter of fact pertaining to his or her eligibility for a passport. All information and evidence submitted in connection with an application is considered part of the application. A person providing false information as part of a passport application, whether contemporaneously with the form or at any other time, is subject to prosecution under applicable Federal criminal statutes. § 51.21 Execution of passport application.
(a)*Application by personal appearance.* Except as provided in § 51.28, to assist in establishing identity, a minor, a person who has never been issued a passport in his or her own name, a person who has not been issued a passport for the full validity period of 10 years in his or her own name within 15 years of the date of a new application, or a person who is otherwise not eligible to apply for a passport by mail under paragraphs
(b)and
(c)of this section, must apply for a passport by appearing in person before a passport agent or passport acceptance agent (see § 51.22). The applicant must verify the application by oath or affirmation before the passport agent or passport acceptance agent, sign the completed application, provide photographs as prescribed by the Department, provide any other information or documents requested and pay the applicable fees prescribed in the Schedule of Fees for Consular Services (see 22 CFR 22.1).
(b)*Application by mail—persons in the United States.* A person in the United States who previously has been issued a passport valid for 10 years in his or her own name may apply for a new passport by filling out, signing and mailing an application on the form prescribed by the Department if:
(1)The most recently issued previous passport was issued when the applicant was 16 years of age or older;
(2)The application is made not more than 15 years following the issue date of the previous passport, except as provided in paragraph
(e)of this section; and
(3)The most recently issued previous passport of the same type is submitted with the new application. Note to paragraph (b): The applicant must also provide photographs as prescribed by the Department and pay the applicable fees prescribed in the Schedule of Fees for Consular Services (22 CFR 22.1).
(c)*Application by mail—persons abroad.* A person in a foreign country where the Department has authorized a post to receive passport applications by mail who previously has been issued a passport valid for 10 years in his or her own name may apply for a new passport in that country by filling out, signing and mailing an application on the form prescribed by the Department if:
(1)The most recently issued previous passport was issued when the applicant was 16 years of age or older;
(2)The application is made not more than 15 years following the issue date of the previous passport, except as provided in paragraph
(e)of this section; and
(3)The most recently issued previous passport of the same type is submitted with the new application. Note to paragraph (c): The applicant must also provide photographs as prescribed by the Department and pay the applicable fees prescribed in the Schedule of Fees for Consular Services (22 CFR 22.1).
(d)Nothing in this Part shall prohibit or limit the Department from authorizing an overseas post to accept a passport application or applications from persons outside the country or outside the person's country of residence in circumstances which prevent provision of these services to the person where they are located or in other unusual circumstances as determined by the Department.
(e)A senior passport authorizing officer may authorize acceptance of an application by mail where the application is made more than 15 years following the issue date of the previous passport as appropriate and in accordance with guidance issued by the Department. § 51.22 Passport agents and passport acceptance agents.
(a)*U.S. citizen employees of the Department authorized to serve as passport agents.* The following employees of the Department are authorized by virtue of their positions to serve as passport agents unless the Department in an individual case withdraws authorization:
(1)A passport authorizing officer;
(2)A consular officer, or a U.S. citizen consular agent abroad;
(3)A diplomatic officer specifically authorized by the Department to accept passport applications; and
(4)Such U.S. citizen Department of State employees and contractors as the Assistant Secretary for Consular Affairs may designate for the purpose of administering oaths and affirmations for passport applications.
(b)*Persons designated by the Department to serve as passport acceptance agents.* When designated by the Department, the following persons are authorized to serve as passport acceptance agents unless the Department in an individual case withdraws authorization.
(1)An employee of the clerk of any Federal court;
(2)An employee of the clerk of any state court of record;
(3)A postal employee at a United States post office that has been selected to accept passport applications;
(4)An employee of the Department of Defense at a military installation that has been authorized to accept passport applications;
(5)An employee of a federal agency that has been selected to accept passport applications; and
(6)Any other person specifically designated by the Department.
(c)*Qualifications of persons designated by the Department to serve as passport acceptance agents.* Before the Department will designate a person described in § 51.22(b) as a passport acceptance agent, his or her employer must certify that the person:
(1)Is a U.S. citizen or a U.S. non-citizen national;
(2)Is 18 years of age or older;
(3)Is a permanent employee, excluding ad hoc, contractual, and volunteer employees; and
(4)Does not have a record of either:
(i)A Federal or State felony conviction; or
(ii)A misdemeanor conviction for crimes involving moral turpitude or breach of trust, including but not limited to embezzlement, identity theft, misappropriation, document fraud, drug offenses, or dishonesty in carrying out a responsibility involving public trust.
(d)*Training.* A passport acceptance agent described in § 51.22(b) must be trained to apply procedures and practices as detailed in guidance provided by the Department. Training must be successfully completed before accepting passport applications.
(e)*Responsibilities.* The responsibilities of a passport acceptance agent described in § 51.22(b) include but are not limited to the following:
(1)Certifying the identity of each applicant. Passport acceptance agents must certify that they have personally witnessed the applicant signing his or her application, and that the applicant has:
(i)Personally appeared;
(ii)Presented proper identification, as documented on the application;
(iii)Submitted photographs that are a true likeness; and
(iv)Taken the oath administered by the acceptance agent.
(2)Safeguarding passport application information under the Privacy Act of 1974. Passport acceptance agents described in § 51.22(b) must not retain copies of executed applications, nor release passport application information to anyone other than the applicant and the Department.
(3)Avoiding conflict of interest. Passport acceptance agents described in § 51.22(b) must not participate in any relationship that could be perceived as a conflict of interest, including but not limited to providing commercial services related to the passport process.
(f)*Documentation.* Passport acceptance facilities within the United States must maintain a current listing of all passport acceptance agents designated under § 51.22(b) working at its facility. This list must be updated at least annually and a copy provided to the officer specified by the Department at the appropriate passport issuing office.
(1)The current listing of all designated passport acceptance agents must include the passport acceptance agents':
(i)Names; and
(ii)Signatures.
(2)Any addition to or deletion from the current listing of designated passport acceptance agents is subject to prior approval by the Department. § 51.23 Identity of applicant.
(a)The applicant has the burden of establishing his or her identity.
(b)The applicant must establish his or her identity by the submission of a previous passport, other state, local, or federal government officially issued identification with photograph, or other identifying evidence which may include an affidavit of an identifying witness.
(c)The Department may require such additional evidence of identity as it deems necessary. § 51.24 Affidavit of identifying witness.
(a)An identifying witness must execute an affidavit in the form prescribed by the Department before the person who accepts the passport application.
(b)A person who has received or expects to receive a fee for his or her services in connection with executing the application or obtaining the passport may not serve as an identifying witness. § 51.25 Name of applicant to be used in passport.
(a)The passport shall be issued in the full name of the applicant, generally the name recorded in the evidence of nationality and identity.
(b)The applicant must explain any material discrepancies between the name on the application and the name recorded in the evidence of nationality and identity. The name provided by the applicant on the application may be used if the applicant submits the documentary evidence prescribed by the Department.
(c)A name change will be recognized for purposes of issuing a passport if the name change occurs in one of the following ways.
(1)Court order or decree. An applicant whose name has been changed by court order or decree must submit with his or her application a copy of the order or decree. Acceptable types of court orders and decrees include but are not limited to:
(i)A name change order;
(ii)A divorce decree specifically declaring the return to a former name;
(2)Certificate of naturalization issued in a new name.
(3)Marriage. An applicant who has adopted a new name following marriage must present a copy of the marriage certificate.
(4)Operation of state law. An applicant must present operative government-issued legal documentation declaring the name change or issued in the new name.
(5)Customary usage. An applicant who has adopted a new name other than as prescribed in paragraphs (c)(1) through
(4)of this section must submit evidence of public and exclusive use of the adopted name for a long period of time, in general five years, as prescribed in guidance issued by the Department. The evidence must include three or more public documents, including one government-issued identification with photograph and other acceptable public documents prescribed by the Department. § 51.26 Photographs. The applicant must submit with his or her application photographs as prescribed by the Department that are a good likeness of and satisfactorily identify the applicant. § 51.27 Incompetents. A legal guardian or other person with the legal capacity to act on behalf of a person declared incompetent may execute a passport application on the incompetent person's behalf. § 51.28 Minors.
(a)*Minors under age 16.*
(1)Personal appearance. Minors under 16 years of age applying for a passport must appear in person, unless the personal appearance of the minor is specifically excused by a senior passport authorizing officer, pursuant to guidance issued by the Department. In cases where personal appearance is excused, the person(s) executing the passport application on behalf of the minor shall appear in person and verify the application by oath or affirmation before a person authorized by the Secretary to administer oaths or affirmations, unless these requirements are also excused by a senior passport authorizing officer pursuant to guidance issued by the Department.
(2)Execution of passport application by both parents or by each legal guardian. Except as specifically provided in this section, both parents or each of the minor's legal guardians, if any, whether applying for a passport for the first time or for a renewal, must execute the application on behalf of a minor under age 16 and provide documentary evidence of parentage or legal guardianship showing the minor's name, date and place of birth, and the names of the parent or parents or legal guardian.
(3)Execution of passport application by one parent or legal guardian. A passport application may be executed on behalf of a minor under age 16 by only one parent or legal guardian if such person provides:
(i)A notarized written statement or affidavit from the non-applying parent or legal guardian, if applicable, consenting to the issuance of the passport, or
(ii)Documentary evidence that such person is the sole parent or has sole custody of the minor. Such evidence includes, but is not limited to, the following:
(A)A birth certificate providing the minor's name, date and place of birth and the name of only the applying parent;
(B)A Consular Report of Birth Abroad of a Citizen of the United States of America or a Certification of Report of Birth of a United States Citizen providing the minor's name, date and place of birth and the name of only the applying parent;
(C)A copy of the death certificate for the non-applying parent or legal guardian;
(D)An adoption decree showing the name of only the applying parent;
(E)An order of a court of competent jurisdiction granting sole legal custody to the applying parent or legal guardian containing no travel restrictions inconsistent with issuance of the passport; or, specifically authorizing the applying parent or legal guardian to obtain a passport for the minor, regardless of custodial arrangements; or specifically authorizing the travel of the minor with the applying parent or legal guardian;
(F)An order of a court of competent jurisdiction terminating the parental rights of the non-applying parent or declaring the non-applying parent or legal guardian to be incompetent.
(G)An order of a court of competent jurisdiction providing for joint legal custody or requiring the permission of both parents or the court for important decisions will be interpreted as requiring the permission of both parents or the court, as appropriate. Notwithstanding the existence of any such court order, a passport may be issued when compelling humanitarian or emergency reasons relating to the welfare of the minor exist.
(4)Execution of passport application by a person acting in loco parentis.
(i)A person may apply in loco parentis on behalf of a minor under age 16 by submitting a notarized written statement or a notarized affidavit from both parents or each legal guardian, if any, specifically authorizing the application.
(ii)If only one parent or legal guardian provides the notarized written statement or notarized affidavit, the applicant must provide documentary evidence that an application may be made by one parent or legal guardian, consistent with § 51.28(a)(3).
(5)Exigent or special family circumstances. A passport may be issued when only one parent, legal guardian or person acting in loco parentis executes the application, in cases of exigent or special family circumstances.
(i)“Exigent circumstances” are defined as time-sensitive circumstances in which the inability of the minor to obtain a passport would jeopardize the health and safety or welfare of the minor or would result in the minor being separated from the rest of his or her traveling party. “Time sensitive” generally means that there is not enough time before the minor's emergency travel to obtain either the required consent of both parents/legal guardians or documentation reflecting a sole parent's/legal guardian's custody rights.
(ii)“Special family circumstances” are defined as circumstances in which the minor's family situation makes it exceptionally difficult for one or both of the parents to execute the passport application; and/or compelling humanitarian circumstances where the minor's lack of a passport would jeopardize the health, safety, or welfare of the minor; or, pursuant to guidance issued by the Department, circumstances in which return of a minor to the jurisdiction of his or her home state or habitual residence is necessary to permit a court of competent jurisdiction to adjudicate or enforce a custody determination. A passport issued due to such special family circumstances may be limited for direct return to the United States in accordance with § 51.60(e).
(iii)A parent, legal guardian, or person acting in loco parentis who is applying for a passport for a minor under age 16 under this paragraph must submit a written statement with the application describing the exigent or special family circumstances he or she believes should be taken into consideration in applying an exception.
(iv)Determinations under § 51.28(a)(5) must be made by a senior passport authorizing officer pursuant to guidance issued by the Department.
(6)Nothing contained in this section shall prohibit any Department official adjudicating a passport application filed on behalf of a minor from requiring an applicant to submit other documentary evidence deemed necessary to establish the applying adult's entitlement to obtain a passport on behalf of a minor under the age of 16 in accordance with the provisions of this regulation.
(b)*Minors 16 years of age and above.*
(1)A minor 16 years of age and above applying for a passport must appear in person and may execute the application for a passport on his or her own behalf unless the personal appearance of the minor is specifically excused by a senior passport authorizing officer pursuant to guidance issued by the Department, or unless, in the judgment of the person before whom the application is executed, it is not advisable for the minor to execute his or her own application. In such case, it must be executed by a parent or legal guardian of the minor, or by a person in loco parentis, unless the personal appearance of the parent, legal guardian or person in loco parentis is excused by the senior passport authorizing officer pursuant to guidance issued by the Department.
(2)The passport authorizing officer may at any time require a minor 16 years of age and above to submit the notarized consent of a parent, a legal guardian, or a person in loco parentis to the issuance of the passport.
(c)*Rules applicable to all minors* —(1) Objections. At any time prior to the issuance of a passport to a minor, the application may be disapproved and a passport may be denied upon receipt of a written objection from a parent or legal guardian of the minor, or from another party claiming authority to object, so long as the objecting party provides sufficient documentation of his or her custodial rights or other authority to object.
(2)An order from a court of competent jurisdiction providing for joint legal custody or requiring the permission of both parents or the court for important decisions will be interpreted as requiring the permission of both parents or the court as appropriate.
(3)The Department will consider a court of competent jurisdiction to be a U.S. state or federal court or a foreign court located in the minor's home state or place of habitual residence.
(4)The Department may require that conflicts regarding custody orders, whether domestic or foreign, be settled by the appropriate court before a passport may be issued.
(5)Access by parents and legal guardians to passport records for minors. Either parent or any legal guardian of a minor may upon written request obtain information regarding the application for and issuance of a passport to a minor, unless the requesting parent's parental rights have been terminated by an order of a court of competent jurisdiction, a copy of which has been provided to the Department. The Department may deny such information to a parent or legal guardian if it determines that the minor objects to disclosure and the minor is 16 years of age or older or if the Department determines that the minor is of sufficient age and maturity to invoke his or her own privacy rights. Subpart C—Evidence of U.S. Citizenship or Nationality § 51.40 Burden of proof. The applicant has the burden of proving that he or she is a U.S. citizen or non-citizen national. § 51.41 Documentary evidence. The applicant must provide documentary evidence that he or she is a U.S. citizen or non-citizen national. § 51.42 Persons born in the United States applying for a passport for the first time.
(a)*Primary evidence of birth in the United States.* A person born in the United States generally must submit a birth certificate. The birth certificate must show the full name of the applicant, the applicant's place and date of birth, the full name of the parent(s), and must be signed by the official custodian of birth records, bear the seal of the issuing office, and show a filing date within one year of the date of birth.
(b)*Secondary evidence of birth in the United States.* If the applicant cannot submit a birth certificate that meets the requirement of paragraph
(a)of this section, he or she must submit secondary evidence sufficient to establish to the satisfaction of the Department that he or she was born in the United States. Secondary evidence includes but is not limited to hospital birth certificates, baptismal certificates, medical and school records, certificates of circumcision, other documentary evidence created shortly after birth but generally not more than 5 years after birth, and/or affidavits of persons having personal knowledge of the facts of the birth. § 51.43 Persons born outside the United States applying for a passport for the first time.
(a)*General.* A person born outside the United States must submit documentary evidence that he or she meets all the statutory requirements for acquisition of U.S. citizenship or non-citizen nationality under the provision of law or treaty under which the person is claiming U.S. citizenship or non-citizen nationality.
(b)*Documentary Evidence.*
(1)Types of documentary evidence of citizenship for a person born outside the United States include:
(i)A certificate of naturalization.
(ii)A certificate of citizenship.
(iii)A Consular Report of Birth Abroad.
(2)An applicant without one of these documents must produce supporting documents as required by the Department, showing acquisition of U.S. citizenship under the relevant provisions of law. § 51.44 Proof of resumption or retention of U.S. citizenship. An applicant who claims to have resumed or retained U.S. citizenship must submit with the application a certificate of naturalization or evidence that he or she took the steps necessary to resume or retain U.S. citizenship in accordance with the applicable provision of law. § 51.45 Department discretion to require evidence of U.S. citizenship or non-citizen nationality. The Department may require an applicant to provide any evidence that it deems necessary to establish that he or she is a U.S. citizen or non-citizen national, including evidence in addition to the evidence specified in 22 CFR 51.42 through 51.44. § 51.46 Return or retention of evidence of U.S. citizenship or non-citizen nationality. The Department will generally return to the applicant evidence submitted in connection with an application for a passport. The Department may, however, retain evidence when it deems it necessary for anti-fraud or law enforcement or other similar purposes. Subpart D—Fees § 51.50 Form of payment. Passport fees must be paid in U.S. currency or in other forms of payments permitted by the Department. § 51.51 Passport fees. The Department collects the following passport fees in the amounts prescribed in the Schedule of Fees for Consular Services (22 CFR 22.1):
(a)An application fee, which must be paid at the time of application, except as provided in § 51.52, and is not refundable, except as provided in § 51.53.
(b)An execution fee, except as provided in § 51.52, when the applicant is required to execute the application in person before a person authorized to administer oaths for passport purposes. The execution fee is collected at the time of application and is not refundable (see § 51.55). When execution services are provided by an official of a State or local government or of the United States Postal Service (USPS), the State or local government or USPS may retain the fee if authorized to do so by the Department.
(c)A fee for expedited passport processing, if applicable (see § 51.56).
(d)A surcharge in the amount of twenty dollars ($20) on the filing of each application for a passport in order to cover the costs of meeting the increased demand for passports as a result of actions taken to comply with section 7209(b) of the Intelligence Reform and Terrorism Prevention Act of 2004 (8 U.S.C. 1165 note). The surcharge will be recovered by the Department of State from within the passport fee reflected in the Schedule of Fees for Consular Services.
(e)An enhanced border security surcharge on the filing of each application for a regular passport in an amount set administratively by the Department and published in the Schedule of Fees for Consular Services.
(f)Any other fee that the Department is authorized or required by law to charge for passport services.
(g)The foregoing fees are applicable regardless of the validity period of the passport. § 51.52 Exemption from payment of passport fees. The following persons are exempt from payment of passport fees except for the passport execution fee, unless their applications are executed before a federal official, in which case they are also exempt from payment of the passport execution fee:
(a)An officer or employee of the United States traveling on official business and the members of his or her immediate family. The applicant must submit evidence of the official purpose of the travel and, if applicable, authorization for the members of his or her immediate family to accompany or reside with him or her abroad.
(b)An American seaman who requires a passport in connection with his or her duties aboard a United States flag vessel.
(c)A widow, widower, child, parent, brother or sister of a deceased member of the U.S. Armed Forces proceeding abroad to visit the grave of such service member or to attend a funeral or memorial service for such member.
(d)Other persons whom the Department determines should be exempt from payment of passport fees for compelling circumstances, pursuant to guidance issued by the Department; or
(e)Other categories of persons exempted by law. § 51.53 Refunds.
(a)The Department will refund the passport application fee and the security surcharge to any person exempt from payment of passport fees under 22 CFR 51.52 from whom the fee was erroneously collected.
(b)The Department will refund an expedited passport processing fee if the Department fails to provide expedited passport processing as provided in 22 CFR 51.56.
(c)For procedures on refunds of $5.00 or less, see 22 CFR 22.6(b). § 51.54 Replacement passports without payment of applicable fees. A passport issuing office may issue a replacement passport for the following reasons without payment of applicable fees:
(a)To correct an error or rectify a mistake of the Department;
(b)When the bearer has changed his or her name or other personal identifier listed on the data page of the passport, and applies for a replacement passport within one year of the date of the passport's original issuance.
(c)When the bearer of an emergency full fee passport issued for a limited validity period applies for a full validity passport within one year of the date of the passport's original issuance.
(d)When a passport is retained by U.S. law enforcement or judiciary for evidentiary purposes and the bearer is still eligible to have a passport.
(e)When a passport is issued to replace a passport with a failed electronic chip for the balance of the original validity period. § 51.55 Execution fee not refundable. The fee for the execution of a passport application is not refundable. § 51.56 Expedited passport processing.
(a)Within the United States, an applicant for passport service (including issuance, replacement or the addition of visa pages) may request expedited processing. The Department may decline to accept the request.
(b)Expedited passport processing shall mean completing processing within the number of business days published on the Department's website, consistent with the purposes of expedited processing, commencing when the application reaches a Passport Agency or, if the application is already with a Passport Agency commencing when the request for expedited processing is approved. The processing will be considered completed when the passport is ready to be picked up by the applicant or is mailed to the applicant, or a letter of passport denial is transmitted to the applicant.
(c)A fee is charged for expedited passport processing (see 22 CFR 51.51(c)). The fee does not cover any costs of mailing above the normal level of service regularly provided by the Department. The cost of expedited mailing must be paid by the applicant.
(d)The Department will not charge the fee for expedited passport processing if the Department's error, mistake or delay caused the need for expedited processing. Subpart E—Denial, Revocation, and Restriction of Passports § 51.60 Denial and restriction of passports.
(a)The Department may not issue a passport, except a passport for direct return to the United States, in any case in which the Department determines or is informed by competent authority that:
(1)The applicant is in default on a loan received from the United States under 22 U.S.C. 2671(b)(2)(B) for the repatriation of the applicant and, where applicable, the applicant's spouse, minor child(ren), and/or other immediate family members, from a foreign country (see 22 U.S.C. 2671(d)); or
(2)The applicant has been certified by the Secretary of Health and Human Services as notified by a state agency under 42 U.S.C. 652(k) to be in arrears of child support in an amount determined by statute.
(b)The Department may refuse to issue a passport in any case in which the Department determines or is informed by competent authority that:
(1)The applicant is the subject of an outstanding Federal warrant of arrest for a felony, including a warrant issued under the Federal Fugitive Felon Act (18 U.S.C. 1073); or
(2)The applicant is subject to a criminal court order, condition of probation, or condition of parole, any of which forbids departure from the United States and the violation of which could result in the issuance of a Federal warrant of arrest, including a warrant issued under the Federal Fugitive Felon Act; or
(3)The applicant is subject to a U.S. court order committing him or her to a mental institution; or
(4)The applicant has been legally declared incompetent by a court of competent jurisdiction in the United States; or
(5)The applicant is the subject of a request for extradition or provisional request for extradition which has been presented to the government of a foreign country; or
(6)The applicant is the subject of a subpoena received from the United States pursuant to 28 U.S.C. 1783, in a matter involving Federal prosecution for, or grand jury investigation of, a felony; or
(7)The applicant is a minor and the passport may be denied under 22 CFR 51.28; or
(8)The applicant is subject to an order of restraint or apprehension issued by an appropriate officer of the United States Armed Forces pursuant to chapter 47 of title 10 of the United States Code; or
(9)The applicant is the subject of an outstanding state or local warrant of arrest for a felony; or
(10)The applicant is the subject of a request for extradition or provisional arrest submitted to the United States by a foreign country.
(c)The Department may refuse to issue a passport in any case in which:
(1)The applicant has not repaid a loan received from the United States under 22 U.S.C. 2670(j) for emergency medical attention, dietary supplements, and other emergency assistance, including, if applicable, assistance provided to his or her child(ren), spouse, and/or other immediate family members in a foreign country; or
(2)The applicant has not repaid a loan received from the United States under 22 U.S.C. 2671(b)(2)(B) or 22 U.S.C. 2671(b)(2)(A) for the repatriation or evacuation of the applicant and, if applicable, the applicant's child(ren), spouse, and/or other immediate family members from a foreign country to the United States; or
(3)The applicant has previously been denied a passport under this section or 22 CFR 51.61, or the Department has revoked the applicant's passport or issued a limited passport for direct return to the United States under 22 CFR 51.62, and the applicant has not shown that there has been a change in circumstances since the denial, revocation or issuance of a limited passport that warrants issuance of a passport; or
(4)The Secretary determines that the applicant's activities abroad are causing or are likely to cause serious damage to the national security or the foreign policy of the United States.
(d)The Department may refuse to issue a passport in a case in which the Department is informed by an appropriate foreign government authority or international organization that the applicant is the subject of a warrant of arrest for a felony.
(e)The Department may refuse to issue a passport, except a passport for direct return to the United States, in any case in which the Department determines or is informed by a competent authority that the applicant is a minor who has been abducted, wrongfully removed or retained in violation of a court order or decree and return to his or her home state or habitual residence is necessary to permit a court of competent jurisdiction to determine custody matters. § 51.61 Denial of passports to certain convicted drug traffickers.
(a)A passport may not be issued in any case in which the Department determines or is informed by competent authority that the applicant is subject to imprisonment or supervised release as the result of a felony conviction for a Federal or state drug offense, if the individual used a U.S. passport or otherwise crossed an international border in committing the offense, including a felony conviction arising under:
(1)The Controlled Substances Act (21 U.S.C. 801 *et seq.* ) or the Controlled Substances Import and Export Act (21 U.S.C. 951 *et seq.* ); or
(2)Any Federal law involving controlled substances as defined in section 802 of the Controlled Substances Act (21 U.S.C. 801 *et seq.* ); or
(3)The Bank Secrecy Act (31 U.S.C. 5311 *et seq.* ) or the Money Laundering Act (18 U.S.C. 1956 *et seq.* ) if the Department is in receipt of information that supports the determination that the violation involved is related to illicit production of or trafficking in a controlled substance; or
(4)Any state law involving the manufacture, distribution, or possession of a controlled substance.
(b)A passport may be refused in any case in which the Department determines or is informed by competent authority that the applicant is subject to imprisonment or supervised release as the result of a misdemeanor conviction of a Federal or state drug offense if the individual used a U.S. passport or otherwise crossed an international border in committing the offense, other than a first conviction for possession of a controlled substance, including a misdemeanor conviction arising under:
(1)The Federal statutes described in § 51.61(a); or
(2)Any State law involving the manufacture, distribution, or possession of a controlled substance.
(c)Notwithstanding paragraph
(a)of this section, the Department may issue a passport when the competent authority confirms, or the Department otherwise finds, that emergency circumstances or humanitarian reasons exist. § 51.62 Revocation or limitation of passports.
(a)The Department may revoke or limit a passport when
(1)The bearer of the passport may be denied a passport under 22 CFR 51.60 or 51.61; or 51.28; or any other provision contained in this part; or,
(2)The passport has been obtained illegally, fraudulently or erroneously; was created through illegality or fraud practiced upon the Department; or has been fraudulently altered or misused;
(b)The Department may revoke a passport when the Department has determined that the bearer of the passport is not a U.S. national, or the Department is on notice that the bearer's certificate of citizenship or certificate of naturalization has been canceled. § 51.63 Passports invalid for travel into or through restricted areas; prohibition on passports valid only for travel to Israel.
(a)The Secretary may restrict the use of a passport for travel to or use in a country or area which the Secretary has determined is:
(1)A country with which the United States is at war; or
(2)A country or area where armed hostilities are in progress; or
(3)A country or area in which there is imminent danger to the public health or physical safety of United States travelers.
(b)Any determination made and restriction imposed under paragraph
(a)of this section, or any extension or revocation of the restriction, shall be published in the **Federal Register** .
(c)A passport may not be designated as valid only for travel to Israel. § 51.64 Special validation of passports for travel to restricted areas.
(a)A U.S. national may apply to the Department for a special validation of his or passport to permit its use for travel to, or use in, a restricted country or area. The application must be accompanied by evidence that the applicant falls within one of the categories in paragraph
(c)of this section.
(b)The Department may grant a special validation if it determines that the validation is in the national interest of the United States.
(c)A special validation may be determined to be in the national interest if:
(1)The applicant is a professional reporter or journalist, the purpose of whose trip is to obtain, and make available to the public, information about the restricted area; or
(2)The applicant is a representative of the International Committee of the Red Cross or the American Red Cross traveling pursuant to an officially-sponsored Red Cross mission; or
(3)The applicant's trip is justified by compelling humanitarian considerations; or
(4)The applicant's request is otherwise in the national interest. § 51.65 Notification of denial or revocation of passport.
(a)The Department will notify in writing any person whose application for issuance of a passport has been denied, or whose passport has been revoked. The notification will set forth the specific reasons for the denial or revocation, and, if applicable, the procedures for review available under 22 CFR 51.70 through 51.74.
(b)An application for a passport will be denied or treated as abandoned if an applicant fails to meet his or her burden of proof under 22 CFR 51.23(a) and 51.40 or otherwise does not provide documentation sufficient to establish entitlement to passport issuance within ninety days of notification by the Department that additional information from the applicant is required. Thereafter, if an applicant wishes to pursue a claim of entitlement to passport issuance, he or she must submit a new application and supporting documents, photographs, and statements in support of the application, along with applicable application and execution fees. § 51.66 Surrender of passport. The bearer of a passport that is revoked must surrender it to the Department or its authorized representative upon demand. Subpart F—Procedures for Review of Certain Denials and Revocations § 51.70 Request for hearing to review certain denials and revocations.
(a)A person whose passport has been denied or revoked under 22 CFR 51.60(b)(1) through (10), 51.60(c), 51.60(d), 51.61(b), 51.62(a)(1) where the basis for the adverse action would entitle the applicant to a hearing under this section, or § 51.62(a)(2) may request a hearing to the Department to review the basis for the denial or revocation within 60 days of receipt of the notice of the denial or revocation.
(b)The provisions of §§ 51.70 through 51.74 do not apply to any action of the Department taken on an individual basis in denying, restricting, revoking, or invalidating a passport or in any other way adversely affecting the ability of a person to receive or use a passport for reasons excluded from § 51.70(a) including:
(1)Non-nationality;
(2)Refusal under the provisions of 51.60(a);
(3)Refusal to grant a discretionary exception under emergency or humanitarian relief provisions of § 51.61(c);
(4)Refusal to grant a discretionary exception from geographical limitations of general applicability.
(c)If a timely request for a hearing is made, the Department will hold it within 60 days of the date the Department receives the request, unless the person requesting the hearing asks for a later date and the Department and the hearing officer agree.
(d)The Department will give the person requesting the hearing not less than 10 business days' written notice of the date and place of the hearing. § 51.71 The hearing.
(a)The Department will name a hearing officer, who will make findings of fact and submit recommendations based on the record of the hearing as defined in § 51.72 to the Deputy Assistant Secretary for Passport Services in the Bureau of Consular Affairs.
(b)The person requesting the hearing may appear in person, or with or by his designated attorney. The attorney must be admitted to practice in any state of the United States, the District of Columbia, any territory or possession of the United States, or be admitted to practice before the courts of the country in which the hearing is to be held.
(c)The person requesting the hearing may testify, offer evidence in his or her own behalf, present witnesses, and make arguments at the hearing. The person requesting the hearing is responsible for all costs associated with the presentation of his or her case. The Department may present witnesses, offer evidence, and make arguments in its behalf. The Department is responsible for all costs associated with the presentation of its case.
(d)Formal rules of evidence will not apply, but the hearing officer may impose reasonable restrictions on relevancy, materiality, and competency of evidence presented. Testimony will be under oath or by affirmation under penalty of perjury. The hearing officer may not consider any information that is not also made available to the person requesting the hearing and made a part of the record of the proceeding.
(e)If any witness is unable to appear in person, the hearing officer may, in his or her discretion, accept an affidavit from or order a deposition of the witness, the cost for which will be the responsibility of the requesting party. § 51.72 Transcript and record of the hearing. A qualified reporter will make a complete verbatim transcript of the hearing. The person requesting the hearing and/or his or her attorney may review and purchase a copy of the transcript. The hearing transcript and the documents received by the hearing officer will constitute the record of the hearing. § 51.73 Privacy of hearing. Only the person requesting the hearing, his or her attorney, the hearing officer, official reporters, and employees of the Department directly concerned with the presentation of the case for the Department may be present at the hearing. Witnesses may be present only while actually giving testimony or as otherwise directed by the hearing officer. § 51.74 Final decision. After reviewing the record of the hearing and the findings of fact and recommendations of the hearing officer, the Deputy Assistant Secretary for Passport Services will decide whether to uphold the denial or revocation of the passport. The Department will promptly notify the person requesting the hearing in writing of the decision. If the decision is to uphold the denial or revocation, the notice will contain the reason(s) for the decision. The decision is final and is not subject to further administrative review. Dated: November 8, 2007. Janice L. Jacobs, Principal Deputy Assistant Secretary, Consular Affairs, Department of State. [FR Doc. E7-22461 Filed 11-16-07; 8:45 am] BILLING CODE 4710-06-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 31 [TD 9367] RIN 1545—BH00 Payments Made by Reason of a Salary Reduction Agreement AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Final regulation. SUMMARY: This document promulgates a final regulation that defines the term *salary reduction agreement* for purposes of section 3121(a)(5)(D) of the Internal Revenue Code (Code). The final regulation provides guidance to employers (public educational institutions and section 501(c)(3) organizations) purchasing annuity contracts described in section 403(b) on behalf of their employees. DATES: *Effective Date:* This regulation is effective November 15, 2007. *Applicability Date:* This regulation applies to contributions to section 403(b) plans made on or after November 15, 2007. FOR FURTHER INFORMATION CONTACT: Neil D. Shepherd,
(202)622-6040 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background 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). Summary of Comments and Explanation of Provisions 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. Salary Reduction Agreement 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: The bill also provides that any amounts paid by an employer to a tax-sheltered annuity by reason of a salary reduction agreement between the employer and the employee would be includible in the employee's social security wage base. The committee intended that the provision would merely codify the holding of Revenue Ruling 65-208, 1965-2 Cum. Bull. 383, without any implication with respect to the issue of whether a particular amount paid by an employer to a tax-sheltered annuity is, in fact, made by reason of a “salary reduction agreement.” S. Rep. No. 98-23, at 40-41, 98th Cong., 1st Sess. (1983). 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: The bill conforms the statutory language to the legislative history by providing that contributions to a tax-sheltered annuity are not considered elective deferrals if the contributions are made pursuant to a one-time irrevocable election made by the employee at the time of initial eligibility to participate in the annuity or are made pursuant to a similar arrangement specified in regulations. The bill does not change the definition of salary reduction agreement for purpose of section 3121(a)(5)(D). Sen. Rep. 100-445, 100th Cong., 2d Sess.
(1988)151. 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. Applicability Date 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. Special Analyses 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. Drafting Information 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. List of Subjects in 26 CFR Part 31 Employment taxes, Income taxes, Penalties, Pensions, Railroad retirement, Reporting and recordkeeping requirements, Social security, Unemployment compensation. Adoption of Amendments to the Regulations Accordingly, 26 CFR part 31 is amended as follows: PART 31—EMPLOYMENT TAXES **Paragraph 1.** The authority citation for part 31 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 31.3121(a)(5)-2 is added to read as follows: § 31.3121(a)(5)-2 Payments under or to an annuity contract described in section 403(b).
(a)*Salary reduction agreement defined.* For purposes of section 3121(a)(5)(D), the term *salary reduction agreement* means a plan or arrangement (whether evidenced by a written instrument or otherwise) whereby payment will be made by an employer, on behalf of an employee or his or her beneficiary, under or to an annuity contract described in section 403(b)—
(1)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 this chapter;
(2)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); or
(3)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 his or her compensation.
(b)*Effective/applicability date.* This section is applicable on November 15, 2007. § 31.3121(a)(5)-2T [Removed] **Par. 3.** Section 31.3121(a)(5)-2T is removed. Approved: November 13, 2007. Linda E. Stiff, Deputy Commissioner for Services and Enforcement. Eric Solomon, Assistant Secretary of the Treasury (Tax Policy). [FR Doc. 07-5730 Filed 11-14-07; 1:17 pm]
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U.S. Code
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  • 11 CFR 111
  • 11 CFR 111.16-111
  • 11 CFR 111.11-111
  • 21 CFR 1306
  • 423 U.S. 122
  • 5 USC 601-612
  • 22 CFR 51
  • 5 USC 301-612
  • Pub. L. 104-121
  • Pub. L. 104-4
  • 109 Stat. 48
  • Pub. L. 106-113
  • 113 Stat. 1536
  • 26 USC 6039E
  • Pub. L. 103-317
  • 108 Stat. 1760
  • Pub. L. 109-210
  • 120 Stat. 319
  • Pub. L. 109-167
  • 119 Stat. 3578
  • Pub. L. 109-472
  • 120 Stat. 3554
  • Pub. L. 108-447
  • 118 Stat. 2896
  • 8 USC 1165
  • 26 CFR 31
  • T.D. 9367
  • Pub. L. 98-21
  • Pub. L. 104-188
  • 110 Stat. 1755
  • 769 F.2d 126
  • 799 F.2d 18
  • 153 F.3d 1160
Citation graph
cites case law
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Rule of Agency Procedure
U.S.C.§ 437g
C.F.R.§ 111.16
C.F.R.§ 111.23
U.S.C.§ 553
U.S.C.§ 605
C.F.R.§ 111.3
C.F.R.§ 111.4
C.F.R.§ 111.5
C.F.R.§ 111.6
SCOTUS423 U.S. 122
F. App'x769 F.2d 126
F. App'x799 F.2d 18
Cites 96 · showing 12Cited by 0 across 0 sources
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