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Code · REGISTER · 2005-12-22 · Food and Drug Administration, HHS · Proposed Rules

Proposed Rules. Notice of proposed rule

23,817 words·~108 min read·/register/2005/12/22/05-23938

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 7535-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 310, 341, and 357 [Docket Nos. 1976N-0052N (formerly 1976N-052N) and 1981N-0022 (formerly 81N-0022)] RIN 0910-AF34, 0910-AF45 Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs AGENCY: Food and Drug Administration, HHS. ACTION: Notice of proposed rule. SUMMARY: The Food and Drug Administration
(FDA)is issuing a notice of proposed rulemaking (notice) for over-the-counter
(OTC)nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products. DATES: Submit written and electronic comments and new data by March 22, 2006. Written and electronic comments on the agency's economic impact determination by March 22, 2006. Please see section X of this document for the effective date of any final rule that may be published based on this proposal. ADDRESSES: You may submit comments, identified by Docket Nos. 1976N-0052N and 1981N-0022 and/RIN number 0910-AF34 and 0910-AF45, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number
(RIN)(if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow or Robert L. Sherman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5426, Silver Spring, MD 20993, 301-796-2090. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of September 9, 1976 (41 FR 38312), FDA published an advance notice of proposed rulemaking
(ANPR)under 21 CFR 330.10(a)(6) to establish a monograph for OTC cold, cough, allergy, bronchodilator, and antiasthmatic drug products together with the recommendations of the Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (Cough-Cold Panel). This Panel was the advisory review panel responsible for evaluating data on the active ingredients in these drug classes. This Panel recommended monograph (Category I) status for phenylpropanolamine preparations (phenylpropanolamine bitartrate, phenylpropanolamine hydrochloride, and phenylpropanolamine maleate) as an oral nasal decongestant. In the **Federal Register** of February 26, 1982 (47 FR 8466), FDA published an ANPR to establish a monograph for OTC weight control drug products, together with the recommendations of the Advisory Review Panel on OTC Miscellaneous Internal Drug Products (Miscellaneous Internal Panel). This Panel was the advisory review panel responsible for evaluating data on the active ingredients in this drug class. This Panel recommended monograph status for phenylpropanolamine hydrochloride for weight control use. However, after the Panel submitted its report, FDA became aware of and discussed studies indicating that certain dosages of phenylpropanolamine cause blood pressure elevation (47 FR 8466). Therefore, in the preamble to the Panel's report, FDA specifically requested data and information on the extent to which phenylpropanolamine induces or aggravates hypertension (47 FR 8466 at 8468). In the **Federal Register** of January 15, 1985 (50 FR 2220), FDA published a proposed regulation for OTC nasal decongestant drug products in the form of a tentative final monograph. Because the issues concerning the safety of phenylpropanolamine for nasal decongestant and weight control use were closely related, FDA stated in that document that it was deferring phenylpropanolamine and would consider the issues concurrently in a future **Federal Register** publication (50 FR 2220 at 2221). Phenylpropanolamine was not included in the October 30, 1990 (55 FR 45788), proposed rule or the August 8, 1991 (56 FR 37792), final rule for OTC weight control drug products, in which 111 weight control active ingredients were determined to be nonmonograph. Benzocaine and phenylpropanolamine hydrochloride, the two ingredients the Miscellaneous Internal Panel classified as Category I, were deferred to a future publication. The current document addresses phenylpropanolamine. FDA will discuss benzocaine for weight control use in a future issue of the **Federal Register** . In a letter to the Nonprescription Drug Manufacturers Association dated March 9, 1993 (Ref. 1), FDA stated that, based on a relatively small number of spontaneous reports of intracranial bleeding associated with weight control drug products containing phenylpropanolamine, FDA's principal safety concern was the possibility that phenylpropanolamine might increase the risk of stroke. FDA further stated that although the available data could not support a conclusion that phenylpropanolamine increased the rate of strokes, these data could not rule out the possibility of an increased stroke risk associated with OTC phenylpropanolamine use. Phenylpropanolamine preparations also were not included in the final rule for OTC nasal decongestant drug products that published in the **Federal Register** of August 23, 1994 (59 FR 43386). FDA stated that because of still unresolved safety issues concerning phenylpropanolamine preparations, it was deferring action on this drug (59 FR 43386). In the **Federal Register** of February 14, 1996 (61 FR 5912), FDA published a proposed regulation requiring new warning labeling for all OTC phenylpropanolamine preparations. In that document, FDA stated that dose-response studies submitted by drug manufacturers to investigate phenylpropanolamine's effects on blood pressure were inadequate to alleviate FDA's concern that phenylpropanolamine used in OTC drug products might increase the risk of hemorrhagic stroke. Spontaneous case reports and published case series accumulated from 1969 to 1991 suggested a possible association between phenylpropanolamine use and an increased risk of hemorrhagic stroke. Thus, the status of phenylpropanolamine had been deferred pending further study. In an effort to resolve these issues, representatives of the manufacturers of products containing phenylpropanolamine and FDA staff met in 1991 to plan a study that could further examine whether there was an association between phenylpropanolamine use and risk of hemorrhagic stroke. An epidemiologic case-control study was determined to be the most feasible study design to evaluate the possible association between exposure to phenylpropanolamine and a rare outcome such as hemorrhagic stroke. The industry sponsors of the study selected investigators at Yale University School of Medicine to conduct the study. The Yale investigators submitted protocols to FDA for review. The results of the study are discussed in section II of this document. In this proposed rule, FDA proposes to categorize all phenylpropanolamine preparations as nonmonograph (Category II) for OTC use in both nasal decongestant and weight control drug products. This action is based on reports published in the medical literature, FDA's initial review of adverse drug event reports associated with OTC phenylpropanolamine drug products between 1969 and 1991, continuing adverse drug event reports since 1991, and the results of the Yale Hemorrhagic Stroke Project (Ref. 2). Because safety concerns are the basis for this proposed nonmonograph status, FDA does not address the effectiveness of phenylpropanolamine preparations in this document. II. Data on the Safety of Phenylpropanolamine from the Yale Hemorrhagic Stroke Project A. Introduction and Rationale The following discussion was developed from the study report (Ref. 2) submitted to FDA. The Yale Hemorrhagic Stroke Project (Ref. 2) was a case-control study. Because several case reports had involved strokes in young women who took phenylpropanolamine as an appetite suppressant, often after a first dose, the study examined three questions:
(1)Whether all users of phenylpropanolamine, compared to nonusers, had an increased risk of hemorrhagic stroke,
(2)the possible association between phenylpropanolamine and hemorrhagic stroke by type of exposure (appetite suppressant or cough-cold product), and
(3)among women age 18 to 49 years, the possible association between first use of phenylpropanolamine and hemorrhagic stroke and the possible association between use of phenylpropanolamine-containing appetite suppressants and hemorrhagic stroke. The study was performed between December 1994 and July 1999 and involved men and women 18 to 49 years old who were hospitalized with a primary subarachnoid hemorrhage
(SAH)or a primary intracerebral hemorrhage
(ICH)(unrelated to ischemic infarction, trauma, cerebral thrombosis, or thrombolytic therapy). The subjects were recruited from 44 hospitals in 4 geographic regions of the United States. Both SAH and ICH were determined by clinical symptoms and specific diagnostic information from computed tomography. Magnetic resonance imaging was accepted for the diagnosis of SAH or ICH only if other procedures were not diagnostic. Because misclassification of exposure status by surrogate responders could increase or reduce the observed odds ratio and the true level of risk (Ref. 2), subjects were ineligible for enrollment if they died (n=389) or were not able to communicate (n=194) within 30 days after their event. Subjects were also ineligible if they had a previously diagnosed brain lesion predisposing to hemorrhage risk (e.g., arteriovenous malformation, vascular aneurysm, or tumor) (n=48), a prior stroke (n=120), or first experienced stroke symptoms after being in the hospital for 72 hours (e.g., for an unrelated matter) (n=33). For each case subject, random digit dialing (matched to the first three digits of the case subject's telephone number) was used to identify two control subjects who were matched on :
(1)Gender,
(2)race (African-American versus non-African-American),
(3)age (within 3 years for case subjects less than 30 years and within 5 years for subjects 30 years or over),
(4)educational level, and
(5)telephone exchange (as a surrogate for socioeconomic status). Case subjects and control subjects were interviewed to ascertain medical history, medication use, and habits affecting health, such as use of tobacco and alcohol. Interviews of control subjects were completed within 30 days of the case subject's stroke event to minimize seasonal differences in the likelihood of exposure to cough-cold drug products. Eligibility criteria for control subjects were the same as for case subjects except for the stroke event. During the consent procedure, all subjects (cases and controls) were told that the study was designed to examine causes of hemorrhagic stroke in young persons without specific mention of phenylpropanolamine or other potential risk factors. Case and control subjects were interviewed by a trained interviewer using a structured questionnaire developed for this study. Reported phenylpropanolamine exposures were verified by the study investigators, who documented the actual product(s) used and their ingredients. A focal time (the calendar day and the time of onset of symptoms plausibly related to hemorrhagic stroke that caused a subject to seek medical help) was identified for each case subject. The focal time used for each control subject was matched to the day of the week and the time of day that corresponded to the case subject's focal time. Control subjects were interviewed within 7 days of their focal time to minimize recall bias. The exposure window referred to the interval before the focal time (onset of symptoms) when the status of a subject's exposure to phenylpropanolamine was defined. For analyses other than those involving first use of phenylpropanolamine, the exposure window was defined as 4 days preceding the focal time. For first use of phenylpropanolamine, the exposure window was within 24 hours before the focal time, provided that the subject had not used any other phenylpropanolamine products during the preceding 2 weeks. To maintain a consistent reference group, nonexposure for all analyses was defined as no use of phenylpropanolamine within 2 weeks before the focal time. Exposure windows for control subjects were matched to those for the corresponding case subjects. B. Statistical Analysis Case and control subjects were compared on a variety of clinical and demographic features, including those used in matching, to determine the comparability of the two groups. Statistical comparisons were made using chi-square tests and the Fisher's exact test (where appropriate) for categorical variables, and the Student t-test for continuous variables. For the analyses of the primary endpoints, conditional logistic models for matched sets (with a variable number of controls per case) were used to estimate odds ratios, lower limits of the one-sided 95 percent confidence intervals, and p-values for the risk factors under investigation. One-tailed statistical results were reported because the focus of the study was whether phenylpropanolamine use increased the risk of stroke and this was the pre-specified analysis. Each logistic model was estimated with two mutually exclusive binary exposure terms:
(1)The subject's primary exposure status as defined by the specific aim (e.g., phenylpropanolamine use in the 3-day window; yes/no), and
(2)phenylpropanolamine users who were not exposed within the 3-day window (but with some exposure within 2 weeks of the focal time). In multivariate conditional logistic models (using asymptotic methods), adjustments were made for race (African-American compared with non-African-American), history of hypertension (yes/no), and current cigarette smoking (current compared with never or ex-smoker) because these are the major risk factors for stroke. Other underlying diseases and/or conditions (i.e. diabetes, polycystic kidney disease, congestive heart failure, sickle cell anemia, and clotting disorders) were also examined to determine if any of them, when added to this basic adjusted model, altered the matched odds ratio by at least 10 percent. C. Study Results There were 702 case subjects, including 425 subjects (60 percent) with an SAH and 277 (40 percent) with an ICH, and 1,376 control subjects. Hemorrhage was associated with an aneurysm in 307 subjects (44 percent), an arteriovenous malformation in 50 subjects (7 percent), and a tumor in one subject (0.1 percent). Two control subjects were located for each of 674 case subjects (96 percent) and one control subject for each of 28 case subjects (4 percent). All control subjects were matched to their case subjects on gender and telephone exchange. Age matching was successful for 1,367 controls (99 percent) and race matching was achieved for 1,321 controls (96 percent). Twenty-seven case subjects and 33 control subjects reported phenylpropanolamine use within the 3-day exposure window. Compared to control subjects, case subjects were significantly more likely to be African-American (21 percent compared with 17 percent). Case subjects were also more likely to report lower educational achievement (20 percent did not graduate from high school compared with 9 percent of control subjects), current cigarette smoking (51 percent compared with 30 percent), a history of hypertension (39 percent compared with 20 percent), family history of hemorrhagic stroke (9 percent compared with 5 percent), heavy alcohol use (14 percent compared with 7 percent), and recent cocaine use (2 percent compared with less than 1 percent). For all other clinical variables examined, case and control subjects were not dissimilar. Case subjects were significantly (0.05) less likely to report use of nonsteroidal anti-inflammatory drugs and significantly more likely to report use of caffeine and nicotine in the 3 days before their event. Of the factors examined, only education changed the adjusted odds ratio for the association between phenylpropanolamine and hemorrhagic stroke by more than 10 percent, and this demographic factor was included in all subsequent models. Analyses of the study results demonstrated an association between hemorrhagic stroke and use of phenylpropanolamine (in both nasal decongestant and weight control drug products) in the 3 days prior to the event. Such use of phenylpropanolamine, compared to no use in the prior 2 weeks, was associated with a relative risk for hemorrhagic stroke of 1.67 (unadjusted odds ratio) (p=0.040). The corresponding adjusted odds ratio was 1.49 (lower limit of the one-sided 95 percent confidence interval (LCL)=0.93, p=0.084). The relative risks of hemorrhagic stroke observed with use of the two types of phenylpropanolamine-containing products (in the 3-day exposure window, compared to no use in the prior 2 weeks) were as follows. For cough-cold products, the unadjusted odds ratio was 1.38 (p=0.163) and the adjusted odds ratio
(AOR)was 1.23 (LCL=0.75, p=0.245). For weight control products, the unadjusted odds ratio was 11.98 (p=0.007) and the AOR was 15.92 (LCL=2.04, p=0.013). To analyze the relation between recency of phenylpropanolamine exposure and risk for hemorrhagic stroke, odds ratios were also calculated according to the timing of the most recent phenylpropanolamine use. The pre-specified definition for current use was use of any phenylpropanolamine-containing product on the day of the event (before focal time) or the preceding calendar day. Prior use was defined as use 2 or 3 calendar days before the focal time. The odds ratio was slightly higher for current use (AOR=1.61, LCL=0.93, p=0.078) than for prior use (AOR=l.16, LCL=0.47, p=0.393). Within current use, odds ratios were then calculated according to first use or non-first use. First use was defined as current use with no other use within the prior 2 weeks. Non-first use included other uses within the 2-week interval. The odds ratio was higher for first use (AOR=3.14, LCL=l.16, p=0.029) than for non-first use (AOR=1.20, LCL=0.61, p=0.329). All first uses of phenylpropanolamine (n=13) reported in these data were in cough-cold products. In women using phenylpropanolamine in weight control drug products (3-day exposure window, versus no use in the prior 2 weeks), the unadjusted odds ratio for hemorrhagic stroke was 12.19 (p=0.006) and the AOR was 16.58 (LCL=2.22, p=0.0l1). All hemorrhagic stroke events that occurred within the 3-day exposure window were in women. In the analyses of the association between hemorrhagic stroke and first-day use of phenylpropanolamine, 11 of the 13 first-day use events were in women (7 cases compared with 4 controls). The unadjusted odds ratio was 3.50 (p=0.039) and the AOR was 3.13 (LCL=1.05, p=0.042). Based on the findings that risk for hemorrhagic stroke seemed to be concentrated among current users, the association between current phenylpropanolamine dose and risk for hemorrhagic stroke was examined. Among 21 exposed control subjects, the median current dose of phenylpropanolamine (i.e., total amount taken on the index day or preceding day) was 75 milligrams (mg). Analysis according to dose shows that the odds ratio was higher for current doses above the median (greater than 75 mg) (AOR=2.31, LCL=l.10, p=0.031) than for lower doses (AOR=l.0l, LCL=0.43, p=0.490). Among first-dose users, four of eight cases and two of five controls were exposed to greater than 75 mg of phenylpropanolamine. To examine the potential effect of ambiguity in the correct focal time, the odds ratios were recalculated after excluding all 154 case subjects who were classified as having a definite (n=76) or uncertain (n=78) sentinel symptom preceding the stroke event. The magnitude of the AORs did not change substantially. D. Study Conclusions According to the investigators, several features of the study supported the validity of the study findings regarding a demonstrated association between phenylpropanolamine use and risk of hemorrhagic stroke in subjects between 18 and 49 years of age. First, in addition to the finding of elevated odds ratios that reached statistical significance, the magnitude of the odds ratios for phenylpropanolamine use as an appetite suppressant (15.92) and as a first-dose use (3.14) remained large even after adjustment for important clinical features. Second, the data demonstrate an association between both types of phenylpropanolamine drug products (nasal decongestant and weight control) and hemorrhagic stroke. Because so few men were exposed to phenylpropanolamine in this study (n=19), it was not possible to determine whether their risk for hemorrhagic stroke (when using phenylpropanolamine) is different from that of women. E. FDA's Evaluation of the Study Observational studies, particularly case-control studies, are potentially subject to a number of biases, and this case-control study is no exception. The hallmark of a good case-control study is that biases are anticipated and measures are instituted in the design and analysis stages to minimize biases to the greatest extent possible. Strict diagnostic criteria, as described previously, were developed to ensure accurate identification of hemorrhagic stroke cases in the target population. A number of steps were taken to minimize misclassification bias. One of the investigators confirmed the stroke by reviewing the medical records of suspected cases, without knowledge of the exposure status. Inclusion and exclusion criteria were clearly defined for both cases and controls. Exposure was clearly defined, an exposure window was identified, and exposure was ascertained by trained interviewers. Interviewers were randomly assigned to cases or controls, and questions were asked about multiple medications, thus blinding subjects to the exact exposure under study. The interviews were highly structured and scripted to protect against interviewer bias. Because phenylpropanolamine use might be seasonal, controls were identified and interviewed within 30 days of the date of their matched case subject's stroke, to ensure that cases and controls had similar opportunities for exposure. Controls were also matched to cases for day of the week and time of day of the stroke. This matching strategy helped increase the probability that exposure to any seasonal medication or other covariates (e.g., alcohol drinking or cigarette smoking) was similar between cases and controls. The investigators attempted to identify two controls per case by using random digit dialing (with a match for the first three digits of the telephone number). Because controls were population-based, the results were generalizable to the source population from which the cases and controls were drawn. Matching on race and educational level was slightly unequal between cases and controls. The investigators further controlled for these inequalities by adjustment during analysis. The agency concludes that matching was largely successful. The investigators reduced the possibility of misclassification of phenylpropanolamine use by using a highly structured questionnaire. Each reported medication was verified by asking subjects to present the actual container or by picking out reported brand-name medications from a book containing photographs. Verification of medication use in the 3-day window prior to the focal time was 96 and 94 percent for cases and controls, respectively. The investigators conducted two additional steps to further ensure that the possibility of exposure misclassification error was reduced to an absolute minimum:
(1)Only “definite” and “possible” exposure responses were considered in the analyses, and
(2)the use of other OTC drugs between cases and controls were compared to ensure that the cases did not have greater recall of the use of any drugs as a reason for their stroke. Based on this analysis, FDA did not find any evidence of recall or misclassification bias. Several key elements of study design and conduct determine the success of a case-control study. Studies must have adequate sample size and/or power to detect a difference between treatment groups if a difference really exists, and detection of rare events can require substantial numbers of study subjects. FDA had concerns that the protocol might result in an underpowered study because the sample size calculation was based on an odds ratio of five for an association between first-day use of phenylpropanolamine and hemorrhagic stroke. This ratio was derived primarily from study conduct considerations, such as time and cost, rather than on predictive epidemiologic data that may have suggested that a greater number of subjects would be needed to show a difference between groups. Because case-control studies also demand adherence to strict matching criteria between case and control subjects, the duration of this study was longer than expected due to difficulties in recruiting well-matched controls. The resultant study was the largest prospective case-control study ever conducted on hemorrhagic stroke. FDA finds that, despite these limitations, this study was well-conducted and the statistical analyses demonstrate an association between phenylpropanolamine and hemorrhagic stroke, as explained as follows. FDA notes that the three most important risk factors (race, history of hypertension, and cigarette smoking) were included in the multivariate analysis (basic adjusted model). The confounding effect of the other covariates was examined if adding any of them to the basic model altered the odds ratio estimate by 10 percent. High school education was the only covariate determined to change the odds ratio by at least 10 percent. Because the study had a matched design, FDA considers the conditional logistic regression model appropriate to calculate both unadjusted and AORs. In addition, the number of exposures was small, particularly for analysis of appetite suppressant and first use, thus, the authors calculated the confidence interval of the unadjusted odds ratio based on an exact method. Hypertension is the single most important risk factor for a stroke. Misclassification of hypertension status could result in residual confounding. FDA examined the possible effects of this residual confounding on the results of the study. FDA found that the odds ratio for appetite suppressant use was 15.92, a substantial increase in risk. Its very magnitude makes it difficult to explain by confounding alone. Because product labeling advises hypertensive persons to avoid phenylpropanolamine use, the association of phenylpropanolamine use with hypertension should be negative. Such a negative association would result in biasing the result towards no association if the confounding factor is not controlled for. In addition to the steps taken by the investigators, FDA examined this further by additional analyses restricted to subjects without a past history of hypertension, and the results were not significantly different, thereby providing additional evidence that confounding by hypertension was not present in the study. FDA requested the Yale investigators to explore the possible impact of cigarette smoking and alcohol consumption in more detail. The investigators found that the odds ratios for phenylpropanolamine and stroke were essentially unchanged by inclusion of several qualitative and quantitative measures of smoking and alcohol consumption. The investigators examined the association between current phenylpropanolamine dose and risk for hemorrhagic stroke. Among 21 exposed control subjects, the median current dose of phenylpropanolamine (i.e., the total amount taken on the index day or preceding day) was 75 mg. The AOR was higher for current doses above 75 mg than for lower doses. Among first dose users, four of eight cases and two of five controls were exposed to greater than 75 mg of phenylpropanolamine. As 75 mg is a single dose of many OTC extended-release phenylpropanolamine cough-cold drug products with recommended adult dosing every 12 hours (150 mg a day), the agency further evaluated the association between risk of hemorrhagic stroke and a range of current phenylpropanolamine doses. Exploratory analyses suggest that there may be an increased risk of hemorrhagic stroke with labeled doses at or above 75 mg a day. Although not statistically significant, a trend toward a dose-ordering of odds ratios was seen. The odds ratio was higher (AOR=2.31, LCL=1.10, p=0.031) for current doses above 75 mg than for doses below 75 mg (AOR=1.01, LCL=0.43, p=0.490). FDA concludes that the Yale study (Ref. 2) was well-designed and demonstrated an association between use of phenylpropanolamine and an increased risk of hemorrhagic stroke. The increased risk was most striking in women and was associated with both use in appetite suppressants and first-dose use in cough-cold products. The case-control design was best suited for this study because the outcome under investigation was rare. The investigators took reasonable steps to minimize bias and confounding and built quality control measures into the study design. Analysis was appropriate for the type of study and was performed according to the protocol. The study had clear objectives and sound epidemiology practices were used in its design and execution. F. Additional Reports FDA reviewed its adverse events reporting system for spontaneous reports of hemorrhagic stroke from 1991 to 2000 and identified 22 cases, 16 in the 18 to 49 age group with 13 cases in women (Ref. 3). In all cases, the suspect drug was an extended-release product containing 75 mg of phenylpropanolamine per unit dose. Of 11 cases for which the indication for use was provided, 10 reported use for respiratory symptoms. FDA believes that the fact that there were no reports associated with immediate release drug products marketed under the OTC drug monograph system may be related to the lack of a requirement to submit any such reports to the agency. Therefore, the absence of such reports does not indicate these products are not associated with adverse events. G. Advisory Committee Recommendations On October 19, 2000, at a public meeting, FDA presented to its Nonprescription Drugs Advisory Committee
(NDAC)the regulatory history of OTC phenylpropanolamine (including FDA's concerns about case reports of hemorrhagic stroke associated with phenylpropanolamine prior to 1991), the data from the Yale Hemorrhagic Stroke Project, and additional case reports of stroke since 1991. The Yale investigators presented the study results and their conclusions. Industry representatives raised concerns about the design of the study that they believed made interpretation of the results difficult (Ref. 4). NDAC evaluated whether the Yale study showed an association between phenylpropanolamine use and an increased risk of stroke in different populations aged 18 to 49 (female, male, both) and for different uses (nasal decongestant, appetite suppressant, all) (Ref. 5). More importantly, NDAC was asked if the data support the conclusion that there is an association between phenylpropanolamine and an increased risk of hemorragic stroke, taking into account all currently available information, including:
(1)Phenylpropanolamine's effects on blood pressure,
(2)spontaneous reports of hemorrhagic stroke associated with phenylpropanolamine from 1969 to 1991,
(3)case reports in the medical literature,
(4)continuing adverse drug reports to FDA from 1991 to the present, and
(5)the results of the Yale Hemmorhagic Stroke Project. Thirteen of 14 NDAC members voted (with 1 voting “uncertain”) that there is such an association (Ref. 5). When asked whether phenylpropanolamine can be generally recognized as safe for use as a nasal decongestant, 12 of the 14 NDAC members voted (with 2 abstaining) that phenylpropanolamine could not be considered to be generally recognized as safe for OTC nasal decongestant use. In addition, when asked whether phenylpropanolamine can be generally recognized as safe for use as an appetite suppressant, 13 of the 14 NDAC members voted (with 1 abstaining) that phenylpropanolamine could not be considered to be generally recognized as safe for OTC weight control use. III. FDA's Tentative Conclusions on the Safety of Phenylpropanolamine FDA believes that the known scientific evidence supports the conclusion that nasal decongestant and weight control drug products containing phenylpropanolamine cannot be generally recognized as safe and should no longer be available for OTC use. This evidence includes the results of the Yale study suggesting an association between phenylpropanolamine and hemorrhagic stroke, previous and continuing adverse event reports, reports in the published medical literature, and the biological plausibility related to phenylpropanolamine's ability to cause increases in blood pressure. As stated in section II.E of this document, FDA concludes that the Yale study (Ref. 2) was well-designed and demonstrated an association between use of phenylpropanolamine and an increased risk of hemorrhagic stroke. The increased risk was most striking in women and was associated with both use in appetite suppressants and first-dose use in cough-cold products. The case-control design was best suited for this study because the outcome under investigation was rare. The investigators took reasonable steps to minimize bias and confounding and built quality control measures into the study design. Analysis was appropriate for the type of study and was performed according to the protocol. The study had clear objectives and sound epidemiology practices were used in its design and execution. Regardless of the analytic methods used, the findings were consistent. Although the Yale study focused on men and women 18 to 49 years of age, FDA has no data to show that the increased risk of hemorrhagic stroke is limited to a specific age range. While the Yale study was being conducted, FDA received spontaneous reports of hemorrhagic stroke in people 28 to 54 years of age with cough-cold products that contain OTC doses of phenylpropanolamine. Because the factors that may cause some individuals to be particularly sensitive to the effects of phenylpropanolamine are unknown, individuals at risk cannot be adequately warned through labeling. Although there is no other active ingredient that is generally recognized as safe and effective for OTC weight control use, OTC nasal decongestant drug products can be reformulated with other ingredients, such as pseudoephedrine and phenylephrine. Because hemorrhagic strokes often lead to catastrophic, irreversible outcomes, FDA concludes that the benefits of the intended uses of phenylpropanolamine do not outweigh the potential risk, and that phenylpropanolamine is not considered to be generally recognized as safe. IV. Analysis of Impacts FDA has examined the impacts of this proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 *et seq.* ). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule might have a significant economic impact on a substantial number of small entities, an agency must consider alternatives that would minimize any significant economic impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation) in any one year. FDA tentatively concludes that this proposed rule is consistent with the principles set out in Executive Order 12866 and in these two statutes. As shown as follows, FDA does not believe the proposed rule will be economically significant as defined by the Executive order. Based on its preliminary Regulatory Flexibility Analysis, FDA tentatively concludes that this proposed rule would not impose a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 does not require FDA to prepare a statement of costs and benefits for the proposed rule, because the proposed rule is not expected to result in an expenditure that would exceed $100 million adjusted for inflation in any one year. The current inflation-adjusted statutory threshold is about $110 million. The purpose of the proposed rule is to establish that phenylpropanolamine preparations are not generally recognized as safe for OTC use both as a nasal decongestant and for weight control. This proposed rule would assure the removal of OTC drug products containing phenylpropanolamine, if any are still marketed, and prohibit future marketing of such products. FDA believes that the benefits of this rule justify the costs. Our estimate of the benefits of complete elimination of phenylpropanolamine preparations suggests that they could be as high as $250 million to $625 million annually, if estimated using a willingness to pay approach. The vast majority of these benefits are not directly attributable to this rule, however, because industry previously took voluntary action to discontinue production and marketing of phenylpropanolamine preparations. Similarly, most costs of product withdrawal or reformulation have already been incurred because of the voluntary actions. However, a few affected products may still be available and products that have been withdrawn could still, in principle, be reintroduced in the absence of the rule. Any remaining products containing phenylpropanolamine will need to cease OTC marketing upon the effective date of any final rule, but can be reformulated with another ingredient, where applicable. Products that are reformulated will also need to be relabeled. A. Background for Analysis of Impact In November 2000, FDA issued a public health advisory on the safety of phenylpropanolamine and announced that it would take steps to remove phenylproanolamine from all drug products and had requested all drug companies to voluntarily discontinue marketing products containing phenylpropanolamine (Ref. 6). As a result of this announcement and the publication of the Yale Hemorrhagic Stroke Project, national chain drugstore and major and smaller manufacturers voluntarily removed phenylpropanolamine-containing OTC drug products from the market. Manufacturers of phenylpropanolamine-containing OTC drug products were aware of the potential health problem and some manufacturers of OTC nasal decongestant drug products containing phenylpropanolamine had already reformulated or were in the process of reformulating their products to remove phenylpropanolamine in advance of FDA's announcement. Nevertheless, a number of factors markedly accelerated this trend: • The recommendation of FDA's NDAC • The publication of the results of the Yale Hemorrhagic Stroke Project • FDA's subsequent announcement of its intent to reclassify phenylpropanolamine as a Category II ingredient, and FDA's request for a voluntary recall. These events led to the voluntary removal from the market of most remaining phenylpropanolamine-containing OTC drug products. Both market forces (i.e., avoidance of tort liability) and FDA's request for a voluntary recall contributed to the decision by retail establishments and manufacturers to discontinue sales. Because public awareness, market forces, and FDA's announcement and request to voluntarily withdraw occurred within a short span of time, it is not possible for FDA to disentangle the impact these various factors had on manufacturers' decisions to voluntarily recall phenylpropanolamine drug products. OMB guidelines on economic impact analyses direct agencies to estimate costs and benefits from an appropriate baseline. “This baseline should be the best assessment of the way the world would look absent the proposed regulation” (Ref. 7). We do not believe that the conditions prior to FDA's announcement of its intent to classify this ingredient as nonmonograph are the appropriate baseline because the publication of the Yale Hemorrhagic Stroke Project in a leading medical journal alone would have generated a market response. We acknowledge that the timing and wording of FDAs public announcement and request for voluntary recalls contributed to the magnitude of the incurred costs. However, because the costs attributable to the withdrawal of phenylpropanolamine-containing OTC drug products have already occurred, and may have occurred absent this proposed rule, albeit at a slower pace, FDA believes present conditions are the appropriate baseline from which to estimate the impact of this proposed rule. Even if all of these costs were attributed to this proposed rule, however, they would not rise to the $100 million per year threshold sufficient to categorize this rule as economically significant under section 3.f. of E.O. 12866. Nonetheless, we account for as much of the cost as possible using 2000 as the baseline year for the number of affected products B. Costs of Regulation a. *Costs of removing products from the market* . FDA finds that a number of affected firms incurred substantial costs from these voluntary product withdrawals. In addition, we are not aware of any phenylpropanolamine-containing OTC drug products currently marketed, so we believe the removal- related costs have already been incurred. The voluntary product withdrawals primarily affected two major OTC drug markets—weight control and cough-cold medications. The weight control drug products sector reported $48 million in annual sales for phenylpropanolamine-containing drug products in 2000. The much larger cough-cold products sector had total sales of about $1.2 billion (Ref. 8), but FDA does not have an estimate of the proportion of this figure that included only phenylpropanolamine-containing products. As a result, FDA cannot estimate the total sales of all OTC drug product lines that contained phenylpropanolamine. In 2000, FDAs drug listing system included approximately 400 drug products containing phenylpropanolamine, with approximately 100 manufacturers and 250 distributors and repackers. Many of the 400 products were marketed by distributors and hence do not represent unique formulations. FDA estimates that there may have been around 150 distinct products for both cough-cold and weight loss. Not all of these products, however, were reformulated. Some manufacturers had already added product lines containing a substitute active ingredient and had no plans to reformulate the older product. The sales volume of some products was too small to cover the cost of reformulation. Also, only one substitute active ingredient was available for weight control drug products. Hence, FDA estimates that only about 100 products were reformulated. The cost to reformulate a product varies greatly depending on the nature of the change in formulation, the product, the process, and the size of the firm. To reformulate, manufacturers also have to redo validation (product, process, new supplier), conduct stability tests, and change master production records. FDA estimates that the full cost of reformulation ranged from $100,000 to $500,000 per product. Assuming that 100 products were reformulated implies a total estimated one-time reformulation cost of from $10 million to $50 million. Manufacturers that reformulated would also have incurred costs to relabel their products. They would have had to revise the active (and for some the inactive) ingredient list and may have had to make other labeling changes if they removed the phenylpropanolamine from a combination product and did not replace it with another ingredient. FDA believes that relabeling costs of the type required by this proposed rule generally averaged about $3,000 to $4,000 per stockkeeping unit
(SKU)(individual products, packages, and sizes). Assuming 350 OTC SKUs in the marketplace were relabeled, the total one-time costs of relabeling would have ranged from $1.05 to $1.4 million. Using 2000 as the baseline year for affected products, the total estimated one-time costs for reformulation and labeling range from $11 million to $51 million. Annualized over 20 years yields annual costs of $0.7 - $3.4 million (at 3 percent) and $1.0 - $4.8 million (at 7 percent). b. *Distributional issues and impact on industry* . Other costs incurred by the industry include costs associated with the recall and destruction of inventory and the loss of product sales. FDA does not have reliable information to estimate either the incremental impacts of recalling and destroying product or to distinguish the market response to the results of the Yale study from FDAs announcement and request for voluntary withdrawal . Moreover, industry costs would be offset substantially by countervailing events including avoided lawsuits associated with continued marketing of products containing phenylpropanolamine and possibly reduced insurance costs. The value of lost profit due to lost product sales would generally be offset as firms gain sales by distributing substitute products. These gains and losses represent transfers within the industry and are not a social cost. Reports of withdrawal related expenses from trade press and some 10-K filings with the Securities and Exchange Commission include other costs not attributable to costs of this regulation, such as set-asides for potential litigation. Because of this, we cannot use these reports as a basis for estimating regulatory costs. These reports, however, provide anecdotal information about the magnitude of the impact of the voluntary actions on specific firms. One of the hardest hit large multinational firms explained that the Company immediately ceased global production and shipments of any products containing phenylpropanolamine and voluntarily withdrew any such products from customer warehouses and retail store shelves. As a result, the Company recorded a special charge of $80,000,000 to provide primarily for product returns and the write-off of inventory” (Ref. 9). Another heavily impacted large firm claimed that withdrawal would cost between $51 and $68 million (Ref. 10). Similarly, a large private-label manufacturer reportedly took a $24 million charge against earnings (Ref. 11). These last two figures likely included costs of product reformulation as well as lost inventory value and sales revenues. These accounts represent projections and are estimates for financial reporting requirements but do not accurately reflect actual costs used for regulatory impact analyses. FDA believes that the lost sales estimates may be overstated, as alternative cough-cold drug products were widely available. Most manufactures quickly offered alternative products and received offsetting increases in sales revenues. OMB guidelines for economic analysis state that, “[t]he preferred measure of cost is the ‘opportunity cost of the resources used or the benefits forgone as a result of the regulatory action” (Ref. 7). The costs of reformulation, recalls, and lost inventories are clearly “opportunity costs,” but the company sales revenues lost from recalled phenylpropanolamine-containing cough-cold drug products were likely matched by increased sales of other phenylpropanolamine-free products, frequently manufactured by the same or competing drug companies. These distributional effects are important to individual firms, but are not considered “opportunity costs.” c. *Summary of costs* . The regulatory costs of the proposed rule would include:
(1)The one-time costs to reformulate and relabel affected products,
(2)lost inventory, and
(3)the cost of recalls. We estimate one-time costs of $11 million to $51 million for reformulation and labeling. Annualized over 20 years yields annual costs of $0.7 - $3.4 million (at 3 percent) and $1.0 - $4.8 million (at 7 percent). We lack sufficient information to estimate the value of lost inventories or the costs of recall. The uncertainty associated with the costs presented in financial reports and the inability to adjust for transfers makes it impossible to use these data to estimate the potential incremental regulatory impact of this proposed rule. C. Benefits of Regulation The benefit of removing phenylpropanolamine-containing products from the market was the reduction in the number of hemorrhagic strokes that would otherwise occur each year. Because phenylpropanolamine-containing OTC drug products have already been removed from the market, most of the expected health benefits are attributable to these past voluntary product withdrawals, rather than to FDA's future regulatory action. FDA has estimated that phenylpropanolamine causes 200 to 500 hemorrhagic strokes per year in people 18 to 49 years old (Ref. 5). Assigning a monetary value to the prevention of strokes is problematic and there is no consensus on how it should be calculated. Taylor (Ref. 12) used a lifetime cost model to estimate the cost, by type of stroke. The model accounts for direct medical costs and indirect costs, such as earnings and premature mortality and morbidity. Updating this estimate to 2003 dollars (Ref. 13) and weighting it for the occurrence rate of subarachnoid and intracerebral hemorrhage (60 percent and 40 percent, respectively) (Ref. 14) results in an estimated figure of about $304,719 for the lifetime cost of stroke per person. With these values, the monetized benefit of preventing from 200 to 500 strokes per year by removing all phenylpropanolamine-containing OTC drug products from the market ranges from $60.9 million to $152.4 million per year. When groups less than 18 and over 49 years old (the ages of the subjects in the Yale Hemorrhagic Stroke Project) are included, the total yearly benefits will be higher. Another method of calculating benefits is to value the statistical-lives saved due to the removal of drug products containing phenylpropanolamine. Assuming a mortality rate from phenylpropanolamine-caused strokes of about 25 percent, an estimated 50 to 125 lives saved per year in people 18 to 49 years old would be attributed to the removal of products containing phenylpropanolamine. The value of a statistical-life has been estimated to range from $1.6 million to $8.5 million 1986-dollars (Ref. 15). Using a rough midpoint value of $5 million per statistical-life, the estimated benefit of averting these stroke-induced fatalities ranges from $250 million to $625 million per year. Again, FDA is not asserting that this proposed rule will generate such benefits, because the benefit-producing activities have already occurred. Nevertheless, to the extent that some phenylpropanolamine-containing OTC drug products might remain available or might return to the market, some fraction of these benefits would be attributable to the issuance of this proposed rule. D. Small Business Impacts A drug manufacturer is defined as small by the Small Business Administration if it employs fewer than 750 people. Approximately 70 percent of all OTC drug manufacturers meet the definition of a small entity, and FDA believes that the same rate applies to manufacturers of phenylpropanolamine-containing OTC drug products. Hence, 70 of the 100 manufacturers were classified as small. The cost to distributors and repackers was not significant because the manufacturers of the products bore the brunt of the recall costs, product destruction, and usually were responsible for designing new labels. As explained in this section, to the extent that there are still phenylpropanolamine-containing OTC drug products being marketed, the impact on a manufacturer can vary greatly depending on the number and type of phenylpropanolamine-containing products it produces, the availability of substitute ingredients, and the number of SKUs that will require reformulation and/or relabeling. For example, a small branded product manufacturer may have to reformulate three products and relabel nine SKUs for a total one-time reformulation and relabeling cost ranging from $327,000 (3 products x $100,000 reformulation + 9 SKUs x $3,000 label) to $1.536 million (3 products x $500,000 reformulation + 9 SKUs x $4,000 label). Because there is only one substitute available for OTC weight control drug products, the manufacturer would have to cease production of its existing product and the impact to the firm would be lost sales. The lost sales could be partially offset by sales of a substitute product, if marketed. The cost of the voluntary product recall would also vary by firm and again depend on the number and quantity of products that needed to be recalled and destroyed. Because these products must be manufactured in compliance with the pharmaceutical current good manufacturing practices (21 CFR parts 210 and 211), all firms would have the necessary skills and personnel to perform these tasks either in-house or by contractual arrangement. No additional professional skills are needed. In addition, there are no other Federal rules that duplicate, overlap, or conflict with the proposed rule. FDA considered but rejected alternatives such as leaving products containing this ingredient on the OTC market, or not publicly announcing our intent to reclassify phenylpropanolamine as a Category II ingredient. These alternatives were unacceptable because the health risk posed by products containing phenylpropanolmine was greater than the benefits the products provided, especially given the number of substitute OTC drug products available that did not pose such risks. To have further delayed the removal of OTC phenylpropanolamine drug products from the market would have left consumers exposed to an unacceptable level of risk. Because the cost of removal and reformulation of phenylpropanolamine containing OTC drug products has already been incurred when the products were voluntarily recalled, and FDA has chosen to use the present as a baseline for its analysis, FDA tentatively concludes that this proposed rule will not have a significant impact on a substantial number of small entities. V. Paperwork Reduction Act of 1995 FDA tentatively concludes that there are no paperwork requirements in this document under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). VI. Environmental Impact The agency has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VII. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement has not been prepared. VIII. Request for Comments Three copies of all written comments are to be submitted. Individuals submitting written comments or anyone submitting electronic comments may submit one copy. Comments are to be identified with the docket numbers found in brackets in the heading of this document and may be accompanied by a supporting memorandum or brief. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IX. Time for Submission of New Data The OTC drug review procedures (21 CFR 330.10(a)(7)(iii)) provide for a 12-month period after publication of a TFM for any interested person to file new data and information to support a condition excluded from the monograph in the TFM. As discussed in section I of this document, FDA has published proposed and final rules for OTC nasal decongestant and weight control drug products and deferred a decision on the status of phenylpropanolamine so new data on this ingredient could be included in the record before a TFM or notice of proposed rulemaking was published. Manufacturers have been aware of this deferral for a number of years and have waited for the results of the study described in section II of this document to resolve the monograph status of phenylpropanolamine. It has taken many years for the phenylpropanolamine study to be completed, and the results indicate a major safety concern about this ingredient. FDA does not believe that any additional significant new safety data and information will be presented in the next 12 months. Because of the need to address and finalize FDA action on the existing safety concerns, and because there has already been public consideration of the issues before an FDA advisory committee, the comment period and the time for submission of new data is 90 days. FDA considers it an important public health concern to complete its classification of phenylpropanolamine preparations in OTC drug products as quickly as possible. X. Proposed Effective Date FDA is proposing that any final rule that may issue based on this proposal become effective 30 days after its date of publication in the **Federal Register** . XI. References The following references are on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the **Federal Register** .) 1. Comment No. LET86, Docket No. 1981N-0022 (formerly Docket No. 81N-0022). 2. Horwitz et al., “Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of The Hemorrhagic Stroke Project,” May 10, 2000 in Comment No. C230, Docket No. 1976N-0052N (formerly Docket No. 76N-052N) and Comment No. RPT14, Docket No. 1981N-0022 (formerly Docket No. 81N-0022). 3. Phenylpropanolamine case reports from 1991 to 2000 on file in Docket Nos. 1976N-0052N (formerly 76N-052N) and 1981N-0022 (formerly 81N-0022). 4. Consumer Healthcare Products Association (CHPA), “Comments on the Hemmorhagic Stroke Project Report,” May 24, 2000, in Comment No. C231, Docket No. 1976N-0052N (formerly Docket No. 76N-052N) and Comment No. C113, Docket No. 1981N-0022 (formerly Docket No. 81N-0022). 5. Food and Drug Administration, Transcript of Nonprescription Drugs Advisory Committee meeting, October 19, 2000, in Docket Nos. 1976N-0052N, (formerly 76N-052N) and 1981N-0022 (formerly 81N-0022). 6. Food and Drug Administration, Public Health Advisory, “Safety of Phenylpropanolamine,” November 6, 2000, Comment No. M1 in Docket No. 1976N-0052N (formerly 76N-052N) and Comment No. M7 in Docket No. 1981N-0022 (formerly 81N-0022). 7. Office of Management and Budget, “Guidelines to Standardized Measures of Costs and Benefits and the Format of Accounting Statements,” M0008, March 22, 2000, downloaded from *http://www.whitehouse.gov/omb/memoranda/index.html* , accessed June, 13, 2001. 8. Jarvis, Lisa, “PPA Ban Is a Serious Threat to OTC Diet Aids,” Chemical Market Reporter, November 20, 2000. 9. U.S. Security and Exchange Commission, Form 10-K, Voluntary Market Withdrawals, fiscal year ended December 31, 2000, American Home Products Corp., in Docket Nos. 1976N-0052N (formerly Docket No. 1976N-052N) and 1981N-0022. 10. F-D-C Reports-“The Tan Sheet,” “Dexatrim Natural Fattens Chattem's First Quarter; Extensions Planned,” vol. 9, no. 14, April 2, 2001. 11. F-D-C Reports-“The Tan Sheet,” “AHP Dimetapp, Robitussin PPA Withdrawals Lead To $80 Mil. Charge In 2000,” vol. 9, no. 5, January 29, 2001. 12. Taylor, Thomas N., “The Medical Economics of Stroke,” Drugs, supp. 3:51-58, 1997. 13. U.S. Census Bureau, No. 768, Consumer Price Index by Major Group., downloaded from *http://www.census.gov/statab/freq/00s0768.txt* , accessed June 12, 2001. U.S. Bureau of Labor Statistics, accessed July 23, 2004. Updated 1999 data to 2003 (18.56 percent increase in medical care CPI). 14. Kernan, Walter N. et al., “Phenylpropanolamine and the Risk of Hemorrhagic Stroke,” *The New England Journal of Medicine* , 343: 1826-1832, 2000. 15. Fisher, A., L., G. Chestnut, and D. M. Violette, “The Value of Reducing Tisks of Death: a Note on New Evidence,” *Journal of Policy Analysis and Management* , 8: 88-100, 1989. List of Subjects 21 CFR Part 310 Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 341 Labeling, Over-the-counter drugs. 21 CFR Part 357 Labeling, Over-the-counter drugs, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 310, 341 (as proposed in the **Federal Register** of September 9, 1976 (41 FR 38312)), and 357 (as proposed in the **Federal Register** of February 26, 1982 (47 FR 8466)) be amended as follows: PART 310-NEW DRUGS 1. The authority citation for 21 CFR part 310 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b-263n. 2. Section 310.545 is amended by redesignating the text of paragraph (a)(20) as paragraph (a)(20)(i) and by adding paragraph (a)(20)(i) heading, by adding paragraphs (a)(6)(ii)(D), (a)(20)(ii), and (d)(35), and by revising paragraph (d)(2) to read as follows: § 310.545 Drug products containing certain active ingredients offered over-the-counter
(OTC)for certain uses.
(a)* * *
(6)* * *
(ii)* * *
(D)Approved as of January 23, 2006. Any phenylpropanolamine ingredient.
(a)* * *
(20)* * *
(i)Approved as of February 8, 1991. * * *
(ii)Approved as of January 23, 2006. Any phenylpropanolamine ingredient.
(d)* * *
(2)February 10, 1992, for products subject to paragraph (a)(20)(i) of this section.
(35)January 23, 2006, for products subject to paragraphs (a)(6)(ii)(D) and (a)(20)(ii) of this section. PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 3. The authority citation for 21 CFR part 341 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. § 341.20 [Amended] 4. Section 341.20 of the proposed rule published at 41 FR 38312 is amended by removing paragraph
(e)and redesignating paragraphs (f), (g), and
(h)as paragraphs (e), (f), and (g), respectively. PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 5. The authority citation for 21 CFR part 357 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. § 357.510 [Amended] 6. Section 357.510 of the proposed rule published at 47 FR 8466 is amended by removing and reserving paragraph (b). § 357.520 [Removed] 7. Section 357.520 of the proposed rule published at 47 FR 8466 is removed. § 357.550 [Amended] 8. Section 357.550 of the proposed rule published at 47 FR 8466 is amended by removing and reserving paragraphs (c)(2) and (d)(2). § 357.555 [Removed] 9. Section 357.555 of the proposed rule published at 47 FR 8466 is removed. Dated: December 5, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5-7646 Filed 12-21-05; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 54 [REG-138647-04] RIN 1545-BE30 Employer Comparable Contributions to Health Savings Accounts Under Section 4980G; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of public hearing on proposed rulemaking. SUMMARY: This document contains a notice of public hearing on proposed regulations providing guidance on employer comparable contributions to Health Savings Accounts
(HSAs)under section 4980G. DATES: The public hearing is being held on February 23, 2006, at 10 a.m. The IRS must receive outlines of the topics to be discussed at the hearing by February 2, 2006. ADDRESSES: The public hearing is being held in the IRS Auditorium, Internal Revenue Service Building, 1111 Constitution Avenue, NW., Washington, DC. Send submissions to: CC:PA:LPD:PR (REG-138647-04), Room 5203, Internal Revenue Service, POB 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-138647-04), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Alternatively, taxpayers may submit electronic outlines of oral comments directly to the IRS Internet site *http://www.irs.gov/regs.* FOR FURTHER INFORMATION CONTACT: Concerning submission of comments, the hearing, and/or to be placed on the building access to attend the hearing, Kelly Banks at
(202)622-7180 (not a toll-free number). SUPPLEMENTARY INFORMATION: The subject of the public hearing is the notice of proposed rulemaking (REG-138647-04) that was published in the **Federal Register** on August 26, 2005 (70 FR 50233). The rules of 26 CFR 601.601(a)(3) apply to the hearing. A period of 10 minutes is allotted to each person for presenting oral comments. The IRS will prepare an agenda containing the schedule of speakers. Copies of the agenda will be made available, free of charge, at the hearing. Because of access restrictions, the IRS will not admit visitors beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the FOR FURTHER INFORMATION CONTACT section of this document. Guy R. Traynor, Acting Chief, Publications and Regulations Branch, Associate Chief Counsel, (Procedure and Administration). [FR Doc. E5-7650 Filed 12-21-05; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 153 [0790-AH73] Criminal Jurisdiction Over Civilians Employed by or Accompanying the Armed Forces Outside the United States, Service Members, and Former Service Members AGENCY: Department of Defense. ACTION: Proposed rule. SUMMARY: The Military Extraterritorial Jurisdiction Act of 2000
(MEJA)establishes Federal criminal jurisdiction over whoever engages in conduct outside the United States that would constitute an offense punishable by imprisonment for more than one year ( *i.e.* , a felony offense) while employed by or accompanying the Armed Forces outside the United States, certain members of the Armed Forces subject to the Uniform Code of Military Justice and former members of the Armed Forces. DATES: Comments must be received on or before February 21, 2006. ADDRESSES: Forward comments to the Deputy General Counsel (Personnel and Health Policy), 1600 Defense Pentagon, Washington, DC 20301-1600. FOR FURTHER INFORMATION CONTACT: Mr. Robert Reed, 703-695-1055. SUPPLEMENTARY INFORMATION: Executive Order 12866, “Regulatory Planning and Review” This proposed regulatory action is a significant regulatory action, as defined by Executive Order 12866 and has been reviewed by OMB and approved for publication. Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)) This regulatory action will not have a significant adverse impact on a substantial number of small entities. Unfunded Mandates Act of 1995 (Sec. 202, Pub. L. 104-4) This regulatory action does not contain a Federal mandate that will result in the expenditure by State, local, and tribal governments, in aggregate, or by the private sector of $100 million or more in any 1 year. This rule making will not significantly or uniquely affect small governments. Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) This regulatory action will not impose any additional reporting or recordkeeping requirements under the Paperwork Reduction Act. Federalism (Executive Order 13132) This regulatory action does not have Federalism implications, as set forth in Executive Order 13132. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. Chapter 6) It has been certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. This rule establishes procedures for coordinating criminal jurisdiction matters between the Department of Defense, Justice, and State that involve crimes committed by civilians employed by or accompanying the Armed Forces overseas. List of Subjects in 32 CFR Part 153 Courts, Intergovernmental relations, Military personnel. Accordingly, 32 CFR part 153 is proposed to be revised to read as follows: PART 153—CRIMINAL JURISDICTION OVER CIVILIANS EMPLOYED BY OR ACCOMPANYING THE ARMED FORCES OUTSIDE THE UNITED STATES, CERTAIN SERVICE MEMBERS, AND FORMER SERVICE MEMBERS Sec. 153.1 Purpose. 153.2 Applicability and scope. 153.3 Definitions. 153.4 Responsibilities. 153.5 Procedures. Appendix A to Part 153—Guidelines Appendix B to Part 153—Acknowledgement of Limited Legal Representative (Sample) Authority: 18 U.S.C. Chapter 212. § 153.1 Purpose. This part:
(a)Implements policies and procedures, and assigns responsibilities under the Military Extraterritorial Jurisdiction Act of 2000, as amended by section 1088 of the “Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005,” (hereinafter the Act) for exercising extraterritorial criminal jurisdiction over certain military personnel, former service members of the United States Armed Forces, and over civilians employed by or accompanying the Armed Forces outside the United States (U.S.).
(b)Implements section 3266 of the Act. § 153.2 Applicability and scope.
(a)This part applies to the Office of the Secretary of Defense, the Military Departments (including the Coast Guard by agreement with the Department of Homeland Security when it is not operating as a Service of the Department of the Navy), the Chairman of the Joint Chiefs of Staff, the Combatant Commands, the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the Department of Defense (hereafter referred to collectively as “the DoD Components”). The term “Military Services,” as used herein, refers to the Army, the Navy, the Air Force, and the Marine Corps.
(b)*Coast Guard.* The Coast Guard ordinarily operates as a separate branch of the Armed Forces in the Department of Homeland Security (DHS). However, upon Presidential Directive, the Coast Guard operates as a Service within the Department of the Navy and becomes part of the Department of Defense. By agreement with the Secretary of the Department of Homeland Security, when the Coast Guard is operating as a separate Service within the DHS, this part shall apply to the Coast Guard to the extent permitted by the Act. Whether a provision of this Instruction applies to a Coast Guard case is determined by whether the Coast Guard is operating as a Service in the DHS or as a Service within the Department of the Navy.
(c)While some Federal criminal statutes are expressly or implicitly extraterritorial, many acts described therein are criminal only if they are committed within “the special maritime and territorial jurisdiction of the United States” or if they affect interstate or foreign commerce. Therefore, in most instances, Federal criminal jurisdiction ends at the nation's borders. State criminal jurisdiction, likewise, normally ends at the boundaries of each State. Because of these limitations, acts committed by military personnel, former service members, and civilians employed by or accompanying the Armed Forces in foreign countries, which would be crimes if committed in the U.S., often do not violate either Federal or State criminal law. Similarly, civilians are generally not subject to prosecution under the Uniform Code of Military Justice (UCMJ), unless Congress had declared a “time of war” when the acts were committed. As a result, these acts are crimes, and therefore criminally punishable, only under the law of the foreign country in which they occurred. See section 2 of Report Accompanying the Act. While the U.S. could impose administrative discipline for such actions, the Act and this Part are intended to address the jurisdictional gap with respect to criminal sanctions.
(d)Nothing in this part may be construed to deprive a court-martial, military commission, provost court, or other military tribunal of concurrent jurisdiction with respect to offenders or offenses that by statute or the law of war may be tried by court-martial, military commission, provost court, or other military tribunal (18 U.S.C. 3261(c)). In some cases, conduct that violates section 3261(a) of the Act may also violate the UCMJ, or the law of war generally. Therefore, for military personnel, military authorities would have concurrent jurisdiction with a U.S. District Court to try the offense. The Act was not intended to divest the military of jurisdiction and recognizes the predominant interest of the military in disciplining its service members, while still allowing for the prosecution of members of the Armed Forces with non-military co-defendants in a U.S. District Court under section 3261(d) of the Act.
(e)This part, including its enclosures, is intended exclusively for the guidance of military personnel and civilian employees of the Department of Defense, and of the United States Coast Guard by agreement with the Department of Homeland Security. Nothing contained herein creates or extends any right, privilege, or benefit to any person or entity. See *United States* v. *Caceres,* 440 U.S. 741 (1979). § 153.3 Definitions.
(a)*Accompanying the Armed Forces Outside the United States.* As defined in section 3267 of the Act, the dependent of:
(1)A member of the Armed Forces; or
(2)A civilian employee of the Department of Defense (including a non-appropriated fund instrumentality of the Department); or
(3)A DoD contractor (including a subcontractor at any tier); or
(4)An employee of a DoD contractor (including a subcontractor at any tier); and
(5)Residing with such member, civilian employee, contractor, or contractor employee outside the United States; and
(6)Not a national of or ordinarily resident in the host nation.
(b)*Active Duty.* Full-time duty in the active military service of the United States. It includes full-time training duty, annual training duty, and attendance, while in the active military service, at a school designated as a service school by law or by the Secretary of the Military Department concerned. See 10 U.S.C. 101(d)(1).
(c)*Armed Forces.* The Army, the Navy, the Air Force, the Marine Corps, and the Coast Guard. See 10 U.S.C. 101(a)(4).
(d)*Arrest.* To be taken into physical custody by law enforcement officials.
(e)*Charged.* As used in the Act and this part, this term is defined as an indictment or the filing of information against a person under the Federal Rules of Criminal Procedure. See the analysis to Section 3264 of the Report Accompanying the Act.
(f)*Civilian Component.* A person or persons employed by the Armed Forces outside the United States, as defined in this section and section 3267(a)(1), as amended, of the Act. A term used in Status of Forces Agreements.
(g)*Dependent.* A person for whom a member of the Armed Forces, civilian employee, contractor (or subcontractor at any tier) has legal responsibility while that person is residing outside the United States with or accompanying that member of the Armed Forces, civilian employee, contractor (or subcontractor at any tier), and while that responsible person is so assigned, employed or obligated to perform a contractual obligation to the Department of Defense. For purposes of this part, a person's “command sponsorship” status while outside the United States is not to be considered in determining whether the person is a dependent within the meaning of this part, except that there shall be a rebuttable presumption that a command-sponsored individual is a dependent.
(h)*Designated Commanding Officer (DCO).* A single military commander in each foreign country where U.S. Forces are stationed and as contemplated by DoD Directive 5525.1, 1 Status of Forces Policy and Information. 1 Copies may be obtained at *http://www.dtic.mil/whs/directives/* .
(i)*Detention.* To be taken into custody by law enforcement officials and placed under physical restraint.
(j)*District.* A District Court of the United States.
(k)*Employed by the Armed Forces Outside the United States.* Any person employed as:
(1)A civilian employee of the Department of Defense (including a non-appropriated fund instrumentality of the Department); or
(2)A civilian employee of any other Federal agency, or any provisional authority, to the extent such employment relates to supporting the mission of the Department of Defense overseas; or
(3)A contractor (including a subcontractor at any tier) of the Department of Defense (including a non-appropriated fund instrumentality of the Department of Defense); or
(4)A contractor (including a subcontractor at any tier) of any other Federal agency, or any provisional authority, to the extent such employment relates to supporting the mission of the Department of Defense overseas; or
(5)An employee of a contractor (including a subcontractor at any tier) of the Department of Defense (including a non-appropriated fund instrumentality of the Department of Defense); or
(6)An employee of a contractor (including a subcontractor at any tier) of any other Federal agency, or any provisional authority, to the extent such employment relates to supporting the mission of the Department of Defense overseas; and, when the person:
(i)Is present or resides outside the United States in connection with such employment; and
(ii)Is not a national of or ordinarily resident in the host nation.
(l)*Federal Magistrate Judge.* As used in the Act and this part, this term includes both Judges of the United States and U.S. Magistrate Judges, titles that, in general, should be given their respective meanings found in the Federal Rules of Criminal Procedure. (See footnote 32 of the Report to Accompany H. R. 3380, House of Representatives Report 106-778, July 20, 2000.) The term does not include Military Magistrates or Military Judges, as prescribed by the UCMJ, or regulations of the Military Departments or the Department of Defense.
(m)*Felony Offense.* Conduct that is an offense punishable by imprisonment for more than one year if the conduct had been engaged in the special maritime and territorial jurisdiction of the United States. See sections 3261 of the Act and 18 U.S.C. 7. Although the Act, uses the conditional phrase “if committed within the special maritime and territorial jurisdiction of the United States,” acts that would be a Federal crime regardless of where they are committed in the U.S., such as drug crimes contained in 21 U.S.C. chapter 13, also fall within the scope of section 3261(a) of the Act. See the analysis to section 3261 of the Report Accompanying the Act.
(n)*Host Country National.* A person who is not a citizen of the United States, but who is a citizen of the foreign country in which that person is located.
(o)*Inactive Duty Training.* Duty prescribed for Reservists by the Secretary of the Military Department concerned under 37 U.S.C. 206, or any other provision of law; and special additional duties authorized for Reservists by an authority designated by the Secretary of the Military Department concerned and performed by them on a voluntary basis in connection with the prescribed training or maintenance activities of the units to which they are assigned. Inactive Duty Training includes those duties performed by Reservists in their status as members of the National Guard while in Federal service. See 10 U.S.C. 101(d)(7).
(p)*Juvenile.* A person who has not attained his or her eighteenth birthday, as defined in 18 U.S.C. 5031.
(q)*Military Department.* The Department of the Army, the Department of the Navy, and the Department of the Air Force. See 10 U.S.C. 101(a)(8).
(r)*National of the United States.* As defined in 8 U.S.C. 1101(a)(22).
(s)*Outside the United States.* Those places that are not within the definition of “United States” below and, with the exception of subparagraph 7(9), those geographical areas and locations that are not within the special maritime and territorial jurisdiction of the United States, as defined in 18 U.S.C. 7. The locations defined in 18 U.S.C. 7(9) are to be considered “Outside the United States” for the purposes of this Part. See 18 U.S.C. 3261-3267.
(t)*Qualified Military Counsel.* Judge advocates assigned to or employed by the Military Services and designated by the respective Judge Advocate General, or a designee, to be professionally qualified and trained to perform defense counsel responsibilities under the Act.
(u)*Staff Judge Advocate.* A judge advocate so designated in the Army, the Air Force, the Marine Corps, or the Coast Guard; the principal legal advisor of a command in the Navy who is a judge advocate, regardless of job title. See Rule for Courts-Martial 103(17), Manual for Courts-Martial, United States (2002 Edition).
(v)*Third Country National.* A person whose citizenship is that of a country other than the U.S. and the foreign country in which the person is located.
(w)*United States.* As defined in 18 U.S.C. 5, this term, as used in a territorial sense, includes all places and waters, continental or insular, subject to the jurisdiction of the United States, except for the Panama Canal Zone. § 153.4 Responsibilities.
(a)The *General Counsel of the Department of Defense* shall provide initial coordination and liaison with the Departments of Justice and State, on behalf of the Military Departments, regarding a case for which investigation and/or Federal criminal prosecution under the Act is contemplated. This responsibility may be delegated entirely, or delegated for categories of cases, or delegated for individual cases. The General Counsel, or designee, shall advise the Domestic Security Section of the Criminal Division, Department of Justice (DSS/DOJ), as soon as practicable, when DoD officials intend to recommend that the DOJ consider the prosecution of a person subject to the Act for offenses committed outside the United States. The Assistant Attorney General, Criminal Division, Department of Justice, has designated the Domestic Security Section (DSS/DOJ) as the Section responsible for the Act.
(b)The *Inspector General of the Department of Defense* shall:
(1)Pursuant to section 4(d) of the Inspector General Act of 1978, as amended (5 U.S.C. App. 3), “report expeditiously to the Attorney General whenever the Inspector General has reasonable grounds to believe there has been a violation of Federal criminal law.” This statutory responsibility is generally satisfied once an official/special agent of the Office of the Inspector General of the Department of Defense notifies either the cognizant Department of Justice representative or the Assistant Attorney General (Criminal Division) of the “reasonable grounds.”
(2)Pursuant to section 8(c)(5) of the Inspector General Act of 1978, as amended 5 U.S.C. App. 3), and 10 U.S.C. 141(b), ensure the responsibilities described in DoD Directive 5525.7, 2 “Implementation of the Memorandum of Understanding Between the Department of Justice and the Department of Defense Relating to the Investigation and Prosecution of Certain Crimes,” January 22, 1985, 3 to implement the investigative policies, monitor compliance by DoD criminal investigative organizations, and provide specific guidance regarding investigative matters, as appropriate are satisfied relative to violations of the Military Extraterritorial Jurisdiction Act of 2000. 2 See footnote 1 to § 153.3(h). 3 See footnote 1 to § 153.3(h).
(c)The *Heads of Military Law Enforcement Organizations and Military Criminal Investigative Organizations, or Their Designees* shall:
(1)Advise the Commander and Staff Judge Advocate (or Legal Advisor) of the Combatant Command concerned, or designees, of an investigation of an alleged violation of the Act. Such notice shall be provided as soon as practicable. In turn, the General Counsel of the Department of Defense, or designee, shall be advised so as to ensure notification of and consultation with the Departments of Justice and State regarding information about the potential case, including the host nation's position regarding the case. At the discretion of the General Counsel of the Department of Defense, other agencies and organizations (such as the Legal Counsel to the Chairman of the Joint Chiefs of Staff and Secretary of the Military Department that sponsored the person into the foreign country) shall be informed, as appropriate. Effective investigations lead to successful prosecutions and, therefore, these cases warrant close coordination and cooperation between the Departments of Defense, Justice, and State.
(2)Provide briefings to, and coordinate with, appropriate local law enforcement authorities in advance or, if not possible, as soon thereafter as is practicable, of investigations or arrests in specific cases brought under the Act. If not previously provided to local law enforcement authorities, such briefings about the case shall, at a minimum, describe the Host Nation's position regarding the exercise of jurisdiction under the Act that followed from any briefings conducted pursuant to appendix A of this part.
(d)*The Domestic Security Section, Criminal Division, Department of Justice (DSS/DOJ)* has agreed to:
(1)Provide preliminary liaison with the Department of Defense, coordinate initial notifications with other entities of the Department of Justice and Federal law enforcement organizations; make preliminary decisions regarding proper venue; designate the appropriate U.S. Attorney's Office; and coordinate the further assignment of DOJ responsibilities.
(2)Coordinate with the designated U.S. Attorney's office arrangements for a Federal Magistrate Judge to preside over the initial proceedings required by the Act. Although the assignment of a particular Federal Magistrate Judge shall ordinarily be governed by the jurisdiction where a prosecution is likely to occur, such an assignment does not determine the ultimate venue of any prosecution that may be undertaken. Appropriate venue is determined in accordance with the requirements of 18 U.S.C. 3238.
(3)Coordinate the assistance to be provided the Department of Defense with the U.S. Attorney's office in the district where venue for the case shall presumptively lie.
(4)Continue to serve as the primary point of contact for DoD personnel regarding all investigations that may lead to criminal prosecutions and all associated pretrial matters, until such time as DSS/DOJ advises that the case has become the responsibility of a specific U.S. Attorney's Office.
(e)The *Commanders of the Combatant Commands* shall:
(1)Assist the DSS/DOJ on specific cases occurring within the Commander's area of responsibility. These responsibilities include providing available information and other support essential to an appropriate and successful prosecution under the Act with the assistance of the Commanders' respective Staff Judge Advocates (or Legal Advisors), or their designees, to the maximum extent allowed and practicable.
(2)Ensure command representatives are made available, as necessary, to participate in briefings of appropriate host nation authorities concerning the operation of this Act and the implementing provisions of this part.
(3)Determine when military necessity in the overseas theater requires a waiver of the limitations on removal in section 3264(a) of the Act and when the person arrested or charged with a violation of the Act shall be moved to the nearest U.S. military installation outside the United States that is adequate to detain the person and facilitate the initial proceedings prescribed in section 3265(a) of the Act and this part. Among the factors to be considered are the nature and scope of military operations in the area, the nature of any hostilities or presence of hostile forces, and the limitations of logistical support, available resources, appropriate personnel, or the communications infrastructure necessary to comply with the requirements of section 3265 of the Act governing initial proceedings.
(4)Annually report to the General Counsel of the Department of Defense, by the last day of February for the immediately preceding calendar year, all cases involving the arrest of persons for violations of the Act; persons placed in temporary detention for violations of the Act; the number of requests for Federal prosecution under the Act, and the decisions made regarding such requests.
(5)Determine the suitability of the locations and conditions for the temporary detention of juveniles who commit violations of the Act within the Commander's area of responsibility. The conditions of such detention must, at a minimum, meet the following requirements: Juveniles alleged to be delinquent shall not be detained or confined in any institution or facility in which the juvenile has regular contact with adult persons convicted of a crime or awaiting trial on criminal charges; insofar as possible, alleged juvenile delinquents shall be kept separate from adjudicated delinquents; and every juvenile in custody shall be provided adequate food, heat, light, sanitary facilities, bedding, clothing, recreation, and medical care, including necessary psychiatric, psychological, or other care and treatment.
(6)As appropriate, promulgate regulations consistent with and implementing this part. The Combatant Commander's duties and responsibilities pursuant to this part may be delegated.
(f)The *Secretaries of the Military Departments* shall:
(1)Consistent with the provisions of paragraph
(c)of this section, make provision for defense counsel representation at initial proceedings conducted outside the United States pursuant to the Act for those persons arrested or charged with violations of section 3261(a) of the Act.
(2)Issue regulations establishing procedures that, to the maximum extent practicable, provide notice to all persons covered by the Act who are not nationals of the United States but who are employed by or accompanying the Armed Forces outside the United States, with the exception of individuals who are nationals of or ordinarily resident in the host nation, that they are potentially subject to the criminal jurisdiction of the United States under the Act. At a minimum, such regulations shall require that employees and persons accompanying the Armed Forces outside the United States, who are not nationals of the United States, be informed of the jurisdiction of the Act at the time that they are hired for overseas employment, or upon sponsorship into the overseas command, whichever event is earlier applicable. Such notice shall also be provided during employee training and any initial briefings required for these persons when they first arrive in the foreign country. For employees and persons accompanying the Armed Forces outside the United States who are not nationals of the United States, but who have already been hired or are present in the overseas command at the time this part becomes effective, such notice shall be provided within 60 days of the effective date of this part.
(3)Ensure that orientation training, as described in paragraph (f)(2) of this section, is also provided for all U.S. nationals who are, or who are scheduled to be, employed by or accompanying the Armed Forces outside the United States, including their dependents, and include information that such persons are potentially subject to the criminal jurisdiction of the United States under the Act.
(i)For members of the Armed Forces, civilian employees of the Department of Defense and civilians accompanying the Armed Forces overseas, notice and briefings on the applicability of the Act shall, at a minimum, be provided to them and their dependents when travel orders are issued and, again, upon their arrival at command military installations or place of duty outside the United States.
(ii)For civilian employees, contractors (including subcontractors at any tier), and employees of contractors (including subcontractors at any tier) of any other Federal agency, or any provisional authority, permit such persons to attend the above-referenced briefings on a voluntary basis. In addition, to the maximum extent practicable, make available to representatives of such other Federal agencies or provisional authorities such notice and briefing materials as is provided to civilian employees, contractors, and contractor employees of the Department of Defense overseas.
(4)Failure to provide notice or orientation training pursuant to paragraphs (f)(2) and (f)(3) of this section shall not create any rights or privileges in the persons referenced and shall not operate to defeat the jurisdiction of a court of the United States or provide a defense or other remedy in any proceeding arising under the Act or this part.
(5)Provide training to personnel who are authorized under the Act and designated pursuant to this part to make arrests outside the United States of persons who allegedly committed a violation of section 3261(a) of the Act. The training, at a minimum, shall include the rights of individuals subject to arrest. § 153.5 Procedures.
(a)*Applicability.*
(1)*Offenses and Punishments.* Section 3261(a) of the Act establishes a separate Federal offense under 18 U.S.C. for an act committed outside the United States that would be a felony crime as if such act had been committed within the special maritime and territorial jurisdiction of the United States, as defined in 18 U.S.C. 7. Charged as a violation of section 3261(a) of the Act, the elements of the offense and maximum punishment are the same as the crime committed within the geographical limits of 18 U.S.C. 7, but without the requirement that the conduct be committed within such geographical limits. See section 1 of the Section-By-Section Analysis and Discussion to section 3261 in the “Report Accompanying the Act.”
(2)*Persons Subject to This Part.* This part applies to certain military personnel, former military service members, and persons employed by or accompanying the Armed Forces outside the United States, and their dependents, as those terms are defined in § 153.3 of this part, alleged to have committed an offense under the Act while outside the United States. For purposes of the Act and this part, persons employed by or accompanying the Armed Forces outside the U.S. are subject to the “military law” of the U.S., but only to the extent to which this term has been used and its meaning and scope have been understood within the context of a SOFA or any other similar form of international agreement.
(3)*Military Service Members.* Military service members subject to the Act's jurisdiction are:
(i)Only those active duty service members who, by Federal indictment or information, are charged with committing an offense with one or more defendants, at least one of whom is not subject to the UCMJ. See section 3261(d)(2) of the Act.
(ii)Members of a Reserve component with respect to an offense committed while the member was not on active duty or inactive duty for training (in the case of members of the Army National Guard of the United States or the Air National Guard of the United States, only when in Federal service), are not subject to UCMJ jurisdiction for that offense and, as such, are amenable to the Act's jurisdiction without regard to the limitation of section 3261(d)(2) of the Act.
(4)*Former Military Service Members.* Former military service members subject to the Act's jurisdiction are:
(i)Former service members who were subject to the UCMJ at the time the alleged offenses were committed, but are no longer subject to the UCMJ with respect to the offense due to their release or separation from active duty.
(ii)Former service members, having been released or separated from active duty, who thereafter allegedly commit an offense while in another qualifying status, such as while a civilian employed by or accompanying the Armed Forces outside the United States, or while the dependent of either or of a person subject to the UCMJ.
(5)*Civilians Employed by the Armed Forces.* Civilian employees employed by the U.S. Armed Forces outside the United States (as defined in § 153.3), who commit an offense under the Act while present or residing outside the U.S. in connection with such employment, are subject to the Act and the provisions of this part. Such civilian employees include:
(i)Persons employed by the Department of Defense (including a non-appropriated fund instrumentality of the Department of Defense).
(ii)Persons employed as a DoD contractor (including a subcontractor at any tier).
(iii)Employees of a DoD contractor (including a subcontractor at any tier).
(iv)Civilian employees, contractors (including subcontractors at any tier), and civilian employees of a contractor (or subcontractor at any tier) of any other Federal agency, or any provisional authority, to the extent such employment relates to supporting the mission of the Department of Defense overseas.
(6)*Civilians Accompanying the Armed Forces.* Subject to the requirements of paragraph (a)(6)(ii) of this section, the following persons are civilians accompanying the Armed Forces outside the United States who are covered by the Act and the provisions of this part:
(i)Dependents of:
(A)An active duty service member.
(B)A member of the reserve component while the member was on active duty or inactive duty for training, but in the case of members of the Army National Guard of the United States or the Air National Guard of the United States, only when in Federal service.
(C)A former service member who is employed by or is accompanying the Armed Forces outside the United States.
(D)A civilian employee of the Department of Defense (including non-appropriated fund instrumentalities of the Department of Defense).
(E)A contractor (including a subcontractor at any tier) of the Department of Defense.
(F)An employee of a contractor (including a subcontractor at any tier) of the Department of Defense.
(ii)In addition to the person being the dependent of a person who is listed in paragraph (a)(6)(i) of this section, jurisdiction under the Act requires that the dependent also:
(A)Reside with one of the persons listed in paragraph (a)(6)(i).
(B)Allegedly commit the offense while outside the United States; and
(C)Not be a national of, or ordinarily resident in, the host nation where the offense is committed.
(iii)Command sponsorship of the dependent is not required for the Act and this part to apply.
(iv)If the dependent is a juvenile, as defined in § 153.3, who engaged in conduct that is subject to prosecution under section 3261(a) of the Act, then the provisions of 18 U.S.C. chapter 403 would apply to U.S. District Court prosecutions.
(7)*Persons Not Subject to the Act or the Procedures of This Part.*
(i)Persons who are the nationals of, or ordinarily resident in, the host nation where the offense is committed, regardless of their employment or dependent status.
(ii)Persons, including citizens of the United States, whose presence outside the United States at the time the offense is committed, is not then as a member of the Armed Forces, a civilian employed by the Armed Forces outside the United States, or accompanying the Armed Forces outside the United States.
(A)Persons (including members of a Reserve component) whose presence outside the United States at the time the offense is committed, is solely that of a tourist, a student, or a civilian employee or civilian accompanying any other non-federal agency, organization, business, or entity (and thereby can not be said to be employed by or accompanying the Armed Forces within the definitions of those terms as established by the Act, as modified) are not subject to the Act. Civilian employees of an agency, organization, business, or entity accompanying the Armed Forces outside the U.S. may, by virtue of the agency, organization, business, or entity relationship with the Armed Forces, be subject to the Act and this part.
(B)Persons who are subject to the Act and this part remain so while present, on official business or otherwise (e.g., performing temporary duty or while in leave status), in a foreign country other than the foreign country to which the person is regularly assigned, employed, or accompanying the Armed Forces outside the United States.
(iii)Persons who have recognized dual citizenship with the United States and who are the nationals of, or ordinarily resident in, the host nation where the alleged conduct took place are not persons “accompanying the Armed Forces outside the United States” within the meaning of the Act and this part.
(iv)Juveniles whose ages are below the minimum ages authorized for the prosecution of juveniles in U.S. District Court under the provisions of 18 U.S.C. chapter 403.
(v)Persons subject to the UCMJ (See 10 U.S.C. 802 and 803) are not subject to prosecution under the Act unless, pursuant to section 3261(d) of the Act, the member ceases to be subject to the UCMJ or an indictment or information charges that the member committed the offense with one or more other defendants, at least one of whom is not subject to the UCMJ. A member of a Reserve component who is subject to the UCMJ at the time the UCMJ offense was committed is not relieved from amenability to UCMJ jurisdiction for that offense. Such reserve component members are not subject to the Act unless section 3261(d)(2) of the Act applies. Retired members of a regular component who are entitled to pay remain subject to the UCMJ after retiring from active duty. Such retired members are not subject to prosecution under the Act unless section 3261(d)(2) of the Act applies.
(vi)Whether Coast Guard members and civilians employed by or accompanying the Coast Guard outside the United States, and their dependents, are subject to the Act and this part depends on whether at the time of the offense the Coast Guard was operating as a separate Service in the Department of Homeland Security or as a Service in the Department of the Navy.
(8)*Persons Having a Tenuous Nexus to the United States.* Third Country Nationals who are not ordinarily resident in the host nation, and who meet the definition of “a person accompanying the Armed Forces outside the United States,” may have a nexus to the United States that is so tenuous that it places into question whether the Act's jurisdiction should be applied and whether such persons should be subject to arrest, detention, and prosecution by U.S. authorities. Depending on the facts and circumstances involved, and the relationship or connection of the foreign national with the U.S. Armed Forces, it may be advisable to consult first with the DSS/DOJ before taking action with a view toward prosecution. In addition, to facilitate consultation with the government of the nation of which the Third Country National is a citizen, the State Department should be notified of any potential investigation or arrest of a Third Country National.
(b)*Investigation, Arrest, Detention, and Delivery of Persons to Host Nation Authorities.*
(1)*Investigation.*
(i)Investigations of conduct reasonably believed to constitute a violation of the Act committed outside the United States must respect the sovereignty of the foreign nation in which the investigation is conducted. Such investigations shall be conducted in accordance with recognized practices with host nation authorities and applicable international law, SOFA and other international agreements. After general coordination with appropriate host nation authorities, as referenced in Appendix A of this part, specific investigations shall, to the extent practicable, be coordinated with appropriate local law enforcement authorities, unless not required by agreement with host nation authorities.
(ii)When a Military Criminal Investigative Organization is the lead investigative organization, the criminal investigator, in order to assist DSS/DOJ and the designated U.S. Attorney representative in making a preliminary determination of whether the case warrants prosecution under the Act, shall provide a copy of the Investigative Report, or a summary thereof, to the Office of the Staff Judge Advocate of the Designated Commanding Officer
(DCO)at the location where the offense was committed for review and transmittal, through the Combatant Commander, to the DSS/DOJ and the designated U.S. Attorney representative. The Office of the Staff Judge Advocate shall also furnish the DSS/DOJ and the designated U.S. Attorney representative an affidavit or declaration from the criminal investigator or other appropriate law enforcement official that sets forth the probable cause basis for believing that a violation of the Act has occurred and that the person identified in the affidavit or declaration has committed the violation.
(iii)When the Defense Criminal Investigative Service
(DCIS)is the lead investigative organization, the criminal investigator, in order to assist the DSS/DOJ and the designated U.S. Attorney representative in making a preliminary determination of whether the case warrants prosecution under the Act, shall provide a copy of the Investigative Report, or a summary thereof, to the DSS/DOJ and the designated U.S. Attorney representative. The criminal investigator shall also furnish the DSS/DOJ and the designated U.S. Attorney representative, an affidavit or declaration that sets forth the probable cause basis for believing that a violation of the Act has occurred and that the person identified in the affidavit or declaration has committed the violation. Within the parameters of 5 U.S.C. App 3, the Inspector General may also notify the General Counsel of the Department of Defense and the DCO's Office of the Staff Judge Advocate at the location where the offense was committed, as appropriate.
(2)*Residence Information.* To the extent that it can be determined from an individual's personnel records, travel orders into the overseas theater, passport, or other records, or by questioning upon arrest or detention, as part of the routine “booking” information obtained, an individual's last known residence in the United States shall be determined and forwarded promptly to the DSS/DOJ and the designated U.S. Attorney representative. See *Pennsylvania* v. *Muniz,* 496 U.S. 582, at 601
(1990)and *United States* v. *D'Anjou,* 16 F.3d 604 (4th Cir. 1993). The information is necessary to assist in determining what law enforcement authorities and providers of pretrial services, including those who issue probation reports, shall ultimately have responsibility for any case that may develop. Determination of the individual's “last known address” in the United States is also important in determining what Federal district would be responsible for any possible future criminal proceedings.
(i)Due to the venue provisions of 10 U.S.C. 3238, the DSS/DOJ and the designated U.S. Attorney representative shall be consulted prior to removal of persons arrested or charged with a violation of the Act by U.S. law enforcement officials. The venue for Federal criminal jurisdiction over offenses committed on the high seas or elsewhere beyond the jurisdiction of a particular State or District (as would be required under the Act), is in the Federal district in which the offender is arrested or first brought. However, if the individual is not so arrested in or brought into any Federal district in the United States (i.e., is to be indicted, or an information obtained, prior to the individual's return to the United States), then an indictment or information may be sought in the district of the person's last known residence. If no such residence is known, the indictment or information may be filed in the District of Columbia.
(ii)“First brought” connotes the location within the U.S. to which the person is returned in a custodial status.
(iii)“Last known residence” refers to that U.S. location where the person lived or resided. It is not necessarily the same as the person's legal domicile or home of record.
(iv)Prompt transmittal of venue information to the DSS/DOJ and the designated U.S. Attorney representative in the United States may prove helpful in determining whether a particular case may be prosecuted, and may ultimately be a pivotal factor in determining whether the host nation or the U.S. shall exercise its jurisdiction over the matter.
(v)The Investigative Report, and any affidavit or declaration, as well as all other documents associated with a case shall be transmitted promptly by the command Staff Judge Advocate to the DSS/DOJ and the designated U.S. Attorney representative. This may be accomplished through the use of facsimile or other means of electronic communication.
(3)*Notice of Complaint or Indictment.* Upon receipt of information from command authorities or Defense Criminal Investigation Organizations (the Defense Criminal Investigation Service, the Army's Criminal Investigation Command, the Naval Criminal Investigative Service, and the Air Force Office of Special Investigations) that a person subject to jurisdiction under this Act has violated section 3261(a), the U.S. Attorney for the District in which there would be venue for a prosecution may, if satisfied that probable cause exists to believe that a crime has been committed and that the person identified has committed this crime, file a complaint under Federal Rule of Criminal Procedure 3. As an alternative, the U.S. Attorney may seek the indictment of the person identified. In either case, a copy of the complaint or indictment shall be provided to the Office of the Staff Judge Advocate of the overseas command that reported the offense. The DSS/DOJ and the designated U.S. Attorney representative will ordinarily be the source from which the command's Staff Judge Advocate is able to obtain a copy of any complaint or indictment against a person outside the United States who is subject to the jurisdiction under the Act. This may be accomplished through the use of facsimile or other means of electronic communication.
(4)*Arrest.*
(i)Federal Rule of Criminal Procedure 4 takes the jurisdiction of the Act into consideration in stating where arrest warrants may be executed: “Location. A warrant may be executed, or a summons served, within the jurisdiction of the United States or anywhere else a federal statute authorizes an arrest.” The Advisory Committee Note explains that the new language reflects the enactment of the Military Extraterritorial Jurisdiction Act permitting arrests of certain military and Department of Defense personnel overseas.
(ii)The Act specifically authorizes persons in DoD law enforcement positions, as designated by the Secretary of Defense, to make arrests outside the United States, upon probable cause and in accordance with recognized practices with host nation authorities and applicable international agreements, those persons subject to the Act who violate section 3261(a) of the Act. Section 3262(a) of the Act constitutes authorization by law to conduct such functions pursuant to 10 U.S.C. 801-946 and therefore avoids possible restrictions of the Posse Comitatus Act regarding military personnel supporting civilian law enforcement agencies.
(iii)When the host nation has interposed no objections after becoming aware of the Act, arrests in specific cases shall, to the extent practicable, be first coordinated with appropriate local law enforcement authorities, unless not required by agreement with host nation authorities.
(iv)Military and civilian special agents assigned to the Defense Criminal Investigative Organizations are hereby authorized by the Secretary of Defense to make an arrest, outside the United States, of a person who has committed an offense under section 3261(a) of the Act. Civilian special agents assigned to Defense Criminal Investigative Organizations while performing duties outside the U.S. shall make arrests consistent with the standardized guidelines established for such agents, as approved in accordance with 10 U.S.C. 1585a, 4027, 7480, and 9027.
(v)Military personnel and DoD civilian employees (including local nationals, either direct hire or indirect hire) assigned to security forces, military police, shore patrol, or provost offices at military installations and other facilities located outside the United States are also authorized to make an arrest, outside the United States, of a person who has committed an offense under section 3261(a) of the Act. This authority includes similarly-assigned members of the Coast Guard law enforcement community, but only when the Coast Guard is operating at such locations as a Service of the Department of the Navy.
(vi)Law enforcement personnel thus designated and authorized by the Secretary of Defense in this part may arrest a person, outside the United States, who is suspected of committing a felony offense in violation of section 3261(a) of the Act, when the arrest is based on probable cause to believe that such person violated section 3261(a) of the Act, and when made in accordance with applicable international agreements. Because the location of the offense and offender is outside the United States, it is not normally expected that the arrest would be based on a previously-issued Federal arrest warrant. Law enforcement personnel authorized to make arrests shall follow the Secretaries of the Military Departments' guidelines for making arrests without a warrant, as prescribed by 10 U.S.C. 1585a, 4027, 7480, and 9027. Authorizations issued by military magistrates under the UCMJ may not be used as a substitute for Federal arrest warrant requirements.
(vii)The foregoing authorization to DoD law enforcement personnel to arrest persons subject to 18 U.S.C. chapter 212, for violations of the Act is not intended as a limitation upon the authority of other Federal law enforcement officers to effect arrests when authorized to do so. (e.g., see 18 U.S.C. 3052 authorizing agents of the Federal Bureau of Investigation to make arrests “for any felony cognizable under the laws of the United States, 21 U.S.C. 878(a)(3) for the same authority for Drug Enforcement Administration agents, and 18 U.S.C. 3053 for the same authority for U.S. Marshals and their deputies.)
(5)*Temporary Detention.*
(i)The Commander of a Combatant Command, or designee, may order the temporary detention of a person, within the Commander's area of responsibility outside the United States, who is arrested or charged with a violation of the Act. The Commander of the Combatant Command, or designee, may determine that a person arrested need not be held in custody pending the commencement of the initial proceedings required by section 3265 of the Act and paragraph
(d)of this section. The Commander of the Combatant Command may designate those component commanders or DCO commanders who are also authorized to order the temporary detention of a person, within the commanding officer's area of responsibility outside the United States, who is arrested or charged with a violation of the Act.
(ii)A person arrested may be temporarily detained in military detention facilities for a reasonable period, in accordance with regulations of the Military Departments and subject to the following:
(A)Temporary detention should be ordered only when a serious risk is believed to exist that the person shall flee and not appear, as required, for any pretrial investigation, pretrial hearing or trial proceedings, or the person may engage in serious criminal misconduct (e.g., the intimidation of witnesses or other obstructions of justice, causing injury to others, or committing other offenses that pose a threat to the safety of the community or to the national security of the United States). The decision as to whether temporary detention is appropriate shall be made on a case-by-case basis. 18 U.S.C. 3142 provides additional guidance regarding conditions on release and factors to be considered.
(B)A person arrested or charged with a violation of the Act who is to be detained temporarily shall, to the extent practicable, be detained in areas that separate them from sentenced military prisoners and members of the Armed Forces who are in pretrial confinement pending trial by courts-martial.
(C)Separate temporary detention areas shall be used for male and female detainees.
(D)Generally, juveniles should not be ordered into temporary detention. However, should circumstances warrant temporary detention, the conditions of such temporary detention must, at a minimum, meet the following requirements: Juveniles alleged to be delinquent shall not be detained or confined in any institution or facility in which the juvenile has regular contact with adult persons convicted of a crime or awaiting trial on criminal charges; insofar as possible, alleged juvenile delinquents shall be kept separate from adjudicated delinquents; and every juvenile in custody shall be provided with adequate food, heat, light, sanitary facilities, bedding, clothing, recreation, and medical care, including necessary psychiatric, psychological, or other care and treatment. Appointment of a guardian ad litem may be required under 18 U.S.C. 5034 to represent the interests of the juvenile when the juvenile's parents are not present or when the parents' interests may be adverse to that of the juvenile.
(iii)Persons arrested or charged with a violation of the Act, upon being ordered into temporary detention and processed into the detention facility, shall, as part of the processing procedures, be required to provide the location address of their last U.S. residence as part of the routine booking questions securing “biographical data necessary to complete booking or pretrial services.” See *United States* v. *D'Anjou,* 16 F.3d 604 (4th Cir.1993). This information shall be recorded in the detention documents and made available to the DCO's Office of the Staff Judge Advocate. This information shall be forwarded with other case file information, including affidavits in support of probable cause supporting the arrest and detention, to the DSS/DOJ. The information is provided so that the DSS/DOJ may make appropriate preliminary decisions about venue. See paragraph (b)(2) of this section.
(A)Notice of the temporary detention of any person for a violation of the Act shall be forwarded through command channels, without unnecessary delay, to the Combatant Commander, who shall advise the General Counsel of the Department of Defense, as the representative of the Secretary of Defense, of all such detentions. At the discretion of the General Counsel of the Department of Defense, other agencies and organizations (such as the Legal Counsel to the Chairman of the Joint Chiefs of Staff and Secretary of the Military Department that sponsored the person into the foreign country) shall be informed, as appropriate.
(B)Such notice shall include a summary of the charges, facts and circumstances surrounding the offenses, information regarding any applicable SOFA or other international agreements affecting jurisdiction in the case, and the reasons warranting temporary detention.
(iv)If military command authorities at the military installation outside the United States intend to request a person's detention by order of the Federal Magistrate Judge, the military representative assigned to the case shall gather the necessary information setting forth the reasons in support of a motion to be brought by the attorney representing the government at the initial proceeding conducted pursuant to section 3265 of the Act.
(v)This part is not intended to eliminate or reduce existing obligations or authorities to detain persons in foreign countries as required or permitted by agreements with host countries. See generally, *United States* v. *Murphy,* 18 M.J. 220 (CMA 1984).
(6)*Custody and Transport of Persons While in Temporary Detention.*
(i)The Department of Defense may only take custody of and transport the person as specifically set forth in the Act. This is limited to delivery as soon as practicable to the custody of U.S. civilian law enforcement authorities for removal to the United States for judicial proceedings; delivery to appropriate authorities of the foreign country in which the person is alleged to have committed the violation of section 3261(a) of the Act in accordance with section 3263; or, upon a determination by the Secretary of Defense, or the Secretary's designee, that military necessity requires it, removal to the nearest U.S. military installation outside the United States adequate to detain the person and to facilitate the initial appearance described in 3265(a) of the Act.
(ii)Responsibility for a detained person's local transportation, escort, and custody requirements remains with the command that placed the person in temporary detention for a violation of section 3261(a) of the Act. This responsibility includes:
(A)Attendance at official proceedings and other required health and welfare appointments (e.g., appointments with counsel, medical and dental appointments, etc.).
(B)Delivery to host nation officials under section 3263 of the Act.
(C)Attendance at Initial Proceedings conducted under section 3265 of the Act.
(D)Delivery under the Act to the custody of U.S. civilian law enforcement authorities for removal to the United States.
(iii)A person who requires the continued exercise of custody and transportation to appointments and locations away from the detention facility, including delivery of the person to host nation officials under section 3263 of the Act, may be transferred under the custody of command authorities or those law enforcement officers authorized to make arrests in paragraphs (b)(4)(iv) and (b)(4)(v) of this section. Transportation of a detainee outside an installation shall be coordinated with the host nation's local law enforcement, as appropriate and in accordance with recognized practices.
(iv)Military authorities retain responsibility for the custody and transportation of a person arrested or charged with a violation of the Act who is to be removed from one military installation outside the United States to another military installation outside the United States, including when the person is transferred under the provisions of section 3264(b)(5) of the Act. Unless otherwise agreed to between the sending and receiving commands, it shall be the responsibility of the sending command to make arrangements for the person's transportation and custody during the transport or transfer to the receiving command.
(v)In coordination with appropriate host nation authorities, U.S. civilian law enforcement authorities shall be responsible for taking custody of a person arrested or charged with a violation of the Act and for the removal of that person to the United States for any pretrial or trial proceedings. DoD officials shall consult with the DSS/DOJ to determine which civilian law enforcement authority (i.e., U.S. Marshals Service, Federal Bureau of Investigation, Drug Enforcement Agency, or other Federal agency) shall dispatch an officer to the overseas' detention facility to assume custody of the person for removal to the United States. Until custody of the person is delivered to such U.S. civilian law enforcement authorities, military authorities retain responsibility for the custody and transportation of the person arrested or charged with a violation of the Act, to include transportation within the host nation to help facilitate the removal of the person to the United States under the Act.
(7)*Release From Temporary Detention.* When a person subject to the Act has been placed in temporary detention, in the absence of a Criminal Complaint or Indictment pursuant to the Federal Rules of Criminal Procedure, only the Commander who initially ordered detention, or a superior Commander, or a Federal Magistrate Judge, may order the release of the detained person. If a Criminal Complaint or Indictment exists, or if a Federal Magistrate Judge orders the person detained, only a Federal Magistrate Judge may order the release of the person detained. If a Federal Magistrate Judge orders the person temporarily detained to be released from detention, the Commander who ordered detention, or a superior Commander, shall cause the person to be released. When a person is released from detention under this provision, the Commander shall implement, to the extent practicable within the commander's authority, any conditions on liberty directed in the Federal Magistrate Judge's order. When the commander who independently ordered the person's temporary detention without reliance on a Federal Magistrate Judge's order, or a superior commander, orders a person's release before a Federal Magistrate Judge is assigned to review the matter, the commander may, within the commander's authority, place reasonable conditions upon the person's release from detention.
(i)A person's failure to obey the conditions placed on his or her release from detention, in addition to subjecting that person to the commander's, or Federal Magistrate Judge's order to be returned to detention, may consistent with the commander's authority and applicable policy, laws, and regulations, subject the person to potential criminal sanctions, or to administrative procedures leading to a loss of command sponsorship to the foreign country, as well as the possibility of additional disciplinary or adverse action.
(ii)A copy of all orders issued by a Federal Magistrate Judge concerning initial proceedings, detention, conditions on liberty, and removal to the United States shall promptly be provided to the Commander of the Combatant Command concerned and the Commander of the detention facility at which the person is being held in temporary detention.
(8)*Delivery of Persons to Host Nation Authorities.*
(i)Persons arrested may be delivered to the appropriate authorities of the foreign country in which the person is alleged to have violated section 3261(a) of the Act, when:
(A)Authorities of a foreign country request that the person be delivered for trial because the conduct is also a violation of that foreign country's laws, and
(B)Delivery of the person is authorized or required by treaty or another international agreement to which the United States is a party.
(ii)Coast Guard personnel authorized to make arrests pursuant to paragraph (b)(4)(v) of this section are also authorized to deliver persons to foreign country authorities, as provided in section 3263 of the Act.
(iii)Section 3263(b) of the Act calls upon the Secretary of Defense, in consultation with the Secretary of State, to determine which officials of a foreign country constitute appropriate authorities to which persons subject to the Act may be delivered. For purposes of the Act, those authorities are the same foreign country law enforcement authorities as are customarily involved in matters involving foreign criminal jurisdiction under an applicable SOFA or other international agreement or arrangement between the United States and the foreign country.
(iv)No action may be taken under this part with a view toward the prosecution of a person for a violation of the Act if a foreign government, in accordance with jurisdiction recognized by the United States, has prosecuted or is prosecuting such person for the conduct constituting such offense(s), except upon the approval of the Attorney General or the Deputy Attorney General (or a person acting in either such capacity). See section 3261(b) of the Act. Requests for an exception shall be written and forwarded to the Combatant Commander. The Combatant Commander shall forward the request to the General Counsel of the Department of Defense, as representative for the Secretary of Defense, for review and transmittal to the Attorney General of the United States. At the discretion of the General Counsel of the Department of Defense, other agencies and organizations (such as the Legal Counsel to the Chairman of the Joint Chiefs of Staff and the Secretary of the Military Department that sponsored the person into the foreign country) shall be informed, as appropriate.
(v)Except for persons to be delivered to a foreign country, and subject to the limitations of section 3264 of the Act and paragraph (e)(5) of this section, persons arrested for conduct in violation of the Act shall, upon the issuance of a removal order by a Federal Magistrate Judge under section 3264(b) of the Act, be delivered, as soon as practicable, to the custody of U.S. civilian law enforcement authorities. See paragraph (b)(6)(iv) of this section.
(c)*Representation.*
(1)*Civilian Defense Counsel.*
(i)Civilian defense counsel representation shall not be at the expense of the Department of Defense or the Military Departments.
(ii)The Act contemplates that a person arrested or charged with a violation of the Act shall be represented by a civilian attorney licensed to practice law in the United States. However, it is also recognized that in several host nations where there has been a long-standing military presence, qualified civilian attorneys (including lawyers who are U.S. citizens) have established law practices in these host nations to assist assigned U.S. personnel and to represent service members in courts-martial, or before host nation courts. With the consent of the person arrested or charged with a violation of the Act who wishes to remain in the foreign country, these lawyers can provide adequate representation for the limited purpose of any initial proceedings required by the Act. When the person entitled to an attorney or requests counsel, staff judge advocates at such locations should assemble a list of local civilian attorneys for the person's consideration. The list shall contain a disclaimer stating that no endorsement by the United States government or the command is expressed or implied by the presence of an attorney's name on the list.
(A)To the extent practicable, military authorities shall establish procedures by which persons arrested or charged with a violation of the Act may seek the assistance of civilian defense counsel by telephone. Consultation with such civilian counsel shall be in private and protected by the attorney-client privilege.
(B)Civilian defense counsel, at no expense to the Department of Defense, shall be afforded the opportunity to participate personally in any initial proceedings required by the Act that are conducted outside the United States. When civilian defense counsel cannot reasonably arrange to be personally present for such representation, alternative arrangements shall be made for counsel's participation by telephone or by such other means that enables voice communication among the participants.
(C)When at least one participant cannot arrange to meet at the location outside the United States where initial proceedings required by the Act are to be conducted, whenever possible arrangements should be made to conduct the proceedings by video teleconference or similar means. Command video teleconference communication systems should be used for this purpose, if resources permit, and if such systems are not otherwise unavailable due to military mission requirements. When these capabilities are not reasonably available, the proceedings shall be conducted by telephone or such other means that enables voice communication among the participants. See section 3265 of the Act.
(D)The above provisions regarding the use of teleconference communication systems apply to any detention proceedings that are conducted outside the United States under section 3265(b) of the Act.
(E)Civilian defense counsel practicing in host nations do not gain Department of Defense sponsorship, nor any diplomatic status, as a result of their role as defense counsel. To the extent practicable, notice to this effect shall be provided to the civilian defense counsel when the civilian defense counsel's identity is made known to appropriate military authorities.
(2)*Qualified Military Counsel.*
(i)Counsel representation also includes qualified military counsel that the Judge Advocate General of the Military Department concerned determines is reasonably available for the purpose of providing limited representation at initial proceedings required by the Act and conducted outside the United States. By agreement with the Department of Homeland Security, Coast Guard commands and activities located outside the United States shall seek to establish local agreements with military commands for qualified military counsel from the Military Departments to provide similar limited representation in cases arising within the Coast Guard. The Secretaries of the Military Departments shall establish regulations governing representation by qualified military counsel. These regulations, at a minimum, shall require that the command's Staff Judge Advocate:
(ii)Prepare, update as necessary, and make available to a Federal Magistrate Judge upon request, a list of qualified military counsel who are determined to be available for the purpose of providing limited representation at initial proceedings.
(iii)Ensure that the person arrested or charged under the Act is informed that any qualified military counsel shall be made available only for the limited purpose of representing that person in any initial proceedings that are to be conducted outside the United States, and that such representation does not extend to further legal proceedings that may occur either in a foreign country or the United States. The person arrested or charged shall also be required, in writing, to acknowledge the limited scope of qualified military counsel's representation and therein waive that military counsel's further representation in any subsequent legal proceedings conducted within a foreign country or the United States. The “Acknowledgement of Limited Representation,” at appendix A of this part, may be used for this purpose. A copy of the “Acknowledgement of Limited Representation” shall be provided to the person arrested or charged under the Act, as well as to the qualified military counsel. The original acknowledgement shall be kept on file in the DCO's Office of the Staff Judge Advocate.
(iv)Provide available information that would assist the Federal Magistrate Judge make a determination that qualified civilian counsel are unavailable, and that the person arrested or charged under the Act is unable financially to retain civilian defense counsel, before a qualified military counsel who has been made available is assigned to provide limited representation. See Analysis and Discussion of Section 3265(c), Report Accompanying the Act.
(3)*Union Representation.* Agency law enforcement officials shall comply with applicable Federal civilian employee rights and entitlements, if any, regarding collective bargaining unit representation under 5 U.S.C. chapter 71, during pretrial questioning and temporary detention procedures under this part.
(4)*Military Representative.*
(i)To assist law enforcement officers and the U.S. Attorney's representative assigned to a case, a judge advocate, legal officer, or civilian attorney-advisor may be appointed as a military representative to represent the interests of the United States. As appropriate, the military representative may be appointed as a Special Assistant U.S. Attorney. The military representative shall be responsible for assisting the command, law enforcement, and U.S. Attorney representatives during pretrial matters, initial proceedings, and other procedures required by the Act and this part. These responsibilities include assisting the U.S. Attorney representative determine whether continued detention is warranted, and to provide information to the presiding Federal Magistrate Judge considering the following:
(ii)If there is probable cause to believe that a violation of the Act has been committed and that the person arrested or charged has committed it,
(iii)If the person being temporarily detained should be kept in detention or released from detention, and, if released, whether any conditions practicable and reasonable under the circumstances, should be imposed.
(d)*Initial Proceedings* .
(1)A person arrested for or charged with a violation of the Act may be entitled to an initial appearance before a judge and/or a detention hearing (collectively, the “initial proceedings”). The initial proceedings are intended to meet the requirements of the Federal Rules of Criminal Procedure. The initial proceedings are not required when the person under investigation for violating the Act has not been arrested or temporarily detained by U.S. military authorities, or the person's arrest or temporary detention by U.S. law enforcement authorities occurs after the person ceases to accompany or be employed by the Armed Forces outside the United States, or the arrest or detention takes place within the United States.
(2)The initial proceedings to be conducted pursuant to the Act and this part shall not be initiated for a person delivered to foreign country authorities and against whom the foreign country is prosecuting or has prosecuted the person for the conduct constituting such offense, except when the Attorney General or Deputy Attorney General (or a person acting in either such capacity) has approved an exception that would allow for prosecution in the United States may initial proceedings under the Act be conducted, under these circumstances. Requests for approval of such an exception shall be forwarded through the Commander of the Combatant Command to the General Counsel of the Department of Defense, in accordance with paragraph (b)(8)(iv) of this section.
(3)Initial proceedings required by the Act and this part shall be conducted, without unnecessary delay. In accordance with the U.S. Supreme Court decision in *County of Riverside* v. *McLaughlin* , 500 U.S. 44 (1991), the initial appearance shall be conducted within 48 hours of the arrest. The initial proceedings required by the Act shall be conducted when:
(i)The person arrested has not been delivered to foreign country authorities under the provisions of section 3263 of the Act; or
(ii)The foreign country authorities having custody of the person delivers the person to U.S. military authorities without first prosecuting the person for such conduct as an offense under the laws of that foreign country.
(4)A Federal Magistrate Judge shall preside over the initial proceedings that are required by the Act and this part. The proceedings should be conducted from the United States using video teleconference methods, if practicable, and with all parties to the proceedings participating. In the event that there is no video teleconference capability, or the video teleconference capability is unavailable due to military requirements or operations, the parties to the proceeding shall, at a minimum, be placed in contact by telephone.
(5)Initial proceedings conducted pursuant to the Act and this part shall include the requirement for the person's initial appearance under the Federal Rules of Criminal Procedure. The Federal Magistrate Judge shall determine whether probable cause exists to believe that an offense under section 3261(a) of the Act has been committed and that the identified person committed it. This determination is intended to meet the due process requirements to which the person is entitled, as determined by the U.S. Supreme Court in *Gerstein* v. *Pugh* , 420 U.S. 103 (1975).
(6)Initial proceedings shall also include a detention hearing where required under 18 U.S.C. 3142 and the Federal Rules of Criminal Procedure. A detention hearing may be required when:
(i)The person arrested or charged with a violation of the Act has been placed in temporary detention and the intent is to request continued detention; or
(ii)The United States seeks to detain a person arrested or charged with a violation of the Act who has not previously been detained.
(7)A detention hearing shall be conducted by a Federal Magistrate Judge. When the person arrested or charged requests, the detention hearing be conducted while the person remains outside the United States, detention hearing shall be conducted by the same Federal Magistrate Judge presiding over the initial proceeding and shall be conducted by telephone or other means that allow for voice communication among the participants, including the person's defense counsel. If the person does not so request, or if the Federal Magistrate Judge so orders, the detention hearing shall be held in the United States after the removal of the person to the United States.
(8)In the event that the Federal Magistrate Judge orders the person's release prior to trial, and further directs the person's presence in the district in which the trial is to take place, the U.S. Attorney Office's representative responsible for prosecuting the case shall inform the military representative and the DCO's Office of the Staff Judge Advocate.
(9)Under circumstances where the person suspected of committing an offense in violation of the Act has never been detained or an initial proceeding conducted, the presumption is that a trial date shall be established at which the defendant would be ordered to appear. Such an order would constitute an order under section 3264(b)(4) of the Act that “otherwise orders the person to be removed.” The person's failure to appear as ordered shall be addressed by the Court as with any other failure to comply with a valid court order.
(10)The DCO's Office of the Staff Judge Advocate shall assist in arranging for the conduct of initial proceedings required by the Act and this part, and shall provide a military representative to assist the U.S. Attorney's Office representative in presenting the information for the Federal Magistrate Judge's review. The military representative shall also provide any administrative assistance the Federal Magistrate Judge requires at the location outside the United States where the proceedings shall be conducted.
(e)*Removal of Persons to the United States or Other Countries* .
(1)In accordance with the limitation established by section 3264 of the Act, military authorities shall not remove, to the United States or any other foreign country, a person suspected of violating section 3261(a) of the Act, except when:
(i)The person's removal is to another foreign country in which the person is believed to have committed a violation of section 3261(a) of the Act; or
(ii)The person is to be delivered, upon request, to authorities of a foreign country under section 3263 of the Act and paragraph (b)(8) of this section; or
(iii)The person is arrested or charged with a violation of the Act and the person is entitled to, and does not waive, a preliminary examination under Federal Rule of Criminal Procedure 5.1, in which case the person shall be removed to the U.S. for such examination; or
(iv)The person's removal is ordered by a Federal Magistrate Judge. See paragraph (e)(2) of this section; or
(v)The Secretary of Defense, or the Secretary's designee, directs the person be removed, as provided in section 3264(b)(5) of the Act and paragraph (e)(3) of this section.
(2)*Removal By Order of a Federal Magistrate Judge* . Military authorities may remove a person suspected of violating section 3261(a) of the Act to the United States, when:
(i)A Federal Magistrate Judge orders that the person be removed to the United States to be present at a detention hearing; or
(ii)A Federal Magistrate Judge orders the detention of the person prior to trial (See 18 U.S.C. 3142(e), in which case the person shall be promptly removed to the United States for such detention; or
(iii)A Federal Magistrate Judge otherwise orders the person be removed to the United States.
(3)*Removal By Direction of the Secretary of Defense or Designee* . The Secretary of Defense, or designee, may order a person's removal from a foreign country within the Combatant Command's geographic area of responsibility when, in his sole discretion, such removal is required by military necessity. See section 3264(b)(5) of the Act. Removal based on military necessity may be authorized in order to take into account any limiting factors that may result from military operations, as well as the capabilities and conditions associated with a specific location.
(i)When the Secretary of Defense, or designee, determines that a person arrested or charged with a violation of the Act should be removed from a foreign country, the person shall be removed to the nearest U.S. military installation outside the United States where the limiting conditions requiring such a removal no longer apply, and where there are available facilities and adequate resources to temporarily detain the person and conduct the initial proceedings required by the Act and this part.
(ii)The relocation of a person under this paragraph does not authorize the further removal of the person to the United States, unless that further removal is authorized by an order issued by a Federal Magistrate Judge under paragraph (e)(2) of this section.
(iii)*Delegation* . The Commander of a Combatant Command, and the Commander's principal assistant, are delegated authority to make the determination, based on the criteria stated in paragraph (e)(3) of this section, that a person arrested or charged with a violation of the Act shall be removed from a foreign country under section 3264(b)(5) of the Act and this part. Further delegation is authorized, but the delegation of authority is limited to a subordinate commander within the command who is designated as a general court-martial convening authority under the UCMJ.
(4)A person who is removed to the United States under the provisions of the Act and this part and who is thereafter released from detention, and otherwise at liberty to return to the location outside the United States from which he or she was were removed, shall be subject to any requirements imposed by a Federal District Court of competent jurisdiction.
(5)Where a person has been removed to the United States for a detention hearing or other judicial proceeding and a Federal Magistrate Judge orders the person's release and permits the person to return to the overseas location, the Department of Defense (including the Military Department originally sponsoring the person to be employed or to accompany the Armed Forces outside the United States) shall not be responsible for the expenses associated with the return of the person to the overseas location, or the person's subsequent return travel to the United States for further court proceedings that may be required. Appendix A To Part 153—Guidelines
(a)Civilians employed by the Armed Forces outside the United States who commit felony offenses while outside the U.S. are subject to U.S. criminal jurisdiction under the Act, and shall be held accountable for their actions, as appropriate.
(b)Civilians accompanying the Armed Forces outside the United States who commit felony offenses while outside the U.S. are subject to U.S. criminal jurisdiction under the Act, and shall be held accountable for their actions, as appropriate.
(c)Former members of the Armed Forces who commit felony offenses while serving as a member of the Armed Forces outside the U.S., but who ceased to be subject to UCMJ court-martial jurisdiction without having been tried by court-martial for such offenses are subject to U.S. criminal jurisdiction under the Act and shall be held accountable for their actions, as appropriate.
(d)The procedures of this part and DoD actions to implement the Act shall comply with applicable Status of Forces Agreements, and other international agreements affecting relationships and activities between the respective host nation countries and the U.S. Armed Forces. These procedures may be employed outside the United States only if the foreign country concerned has been briefed or is otherwise aware of the Act and has not interposed an objection to the application of these procedures. Such awareness may come in various forms, including but not limited to Status of Forces Agreements containing relevant language, Diplomatic Notes or other acknowledgements of briefings, or case-by-case arrangements, agreements, or understandings with appropriate host nation officials.
(e)Consistent with the long-standing policy of maximizing U.S. jurisdiction over its citizens, the Act and this part provide a mechanism for furthering this objective by closing a jurisdictional gap in U.S. law and thereby permitting the criminal prosecution of covered persons for offenses committed outside the United States. In so doing, the Act and this part provide, in appropriate cases, an alternative to a host nation's exercise of its criminal jurisdiction should the conduct that violates U.S. law also violate the law of the host nation, as well as a means of prosecuting covered persons for crimes committed in areas in which there is no effective host nation criminal justice system.
(f)In addition to the limitations imposed upon prosecutions by section 3261(b) of the Act, the Act and these procedures should be reserved generally for serious misconduct for which administrative or disciplinary remedies are determined to be inadequate or inappropriate. Because of the practical constraints and limitations on the resources available to bring these cases to successful prosecution in the United States, initiation of action under this part would not generally be warranted unless serious misconduct were involved.
(g)The procedures set out in the Act and this part do not apply to cases in which the return of fugitive offenders is sought through extradition and similar proceedings, nor are extradition procedures applicable to cases under the Act. Appendix B to Part 153—Acknowledgment of Limited Legal Representation (Sample) 1. I, __________, have been named as a suspect or defendant in a matter to which I have been advised is subject to the jurisdiction of the Military Extraterritorial Jurisdiction Act of 2000 (18 U.S.C. 3261, et. seq.); hereinafter referred to as “the Act”. I have also been informed that certain initial proceedings under 18 U.S.C. 3265 may be required under this Act, for which I am entitled to be represented by legal counsel. 2. I acknowledge and understand that the appointment of military counsel for the limited purpose of legal representation in proceedings conducted pursuant to the Act is dependent upon my being unable to retain civilian defense counsel representation for such proceedings, due to my indigent status, and that qualified military defense counsel has been made available. 3. Pursuant to the Act, __________, a Federal Magistrate Judge, has issued the attached Order and has directed that that military counsel be made available: __ For the limited purpose of representing me at an initial proceeding to be conducted outside the United States pursuant to 18 U.S.C. 3265, __ For the limited purpose of representing me in an initial detention hearing to be conducted outside the United States pursuant to 18 U.S.C. 3265(b), 4. _________, military counsel, has been made available in accordance with Department of Defense Instruction 5525.bb, and as directed by the attached Order of a Federal Magistrate Judge. 5. I
(do)(do not) wish to be represented by __________, military counsel ___ (Initials). 6. I understand that the legal representation of __________, military counsel, is limited to: a. Representation at the initial proceedings conducted outside the United States pursuant to 18 U.S.C. 3265. ___ (Initials) b. The initial detention hearing to be conducted outside the United States pursuant to the Military Extraterritorial Jurisdiction Act of 2000 (18 U.S.C. 3261, et. seq.). _____ (Initials) c. Other proceedings (Specify): __________. ___ (Initials) __________ Signature of Person To Be Represented By Military Counsel __________ Signature of Witness * Attachment: Federal Magistrate Judge Order (* **Note:** The witness must be a person other than the defense counsel to be made available for this limited legal representation.) Dated: December 2, 2005. L.M. Bynum, Alternate OSD Federal Register Liaison Officer, Department of Defense. [FR Doc. 05-23938 Filed 12-21-05; 8:45 am]
Connectionstraces to 28
Traces to 28 documents
U.S. Code
16 references not yet in our index
  • 5 USC 601-612
  • 21 CFR 310
  • 21 CFR 341
  • 21 CFR 357
  • 26 CFR 54
  • 32 CFR 153
  • Pub. L. 104-4
  • Pub. L. 96-354
  • 440 U.S. 741
  • 18 USC 3261-3267
  • 496 U.S. 582
  • 16 F.3d 604
  • 10 USC 3238
  • 10 USC 801-946
  • 500 U.S. 44
  • 420 U.S. 103
Citation graph
cites case law
Proposed Rules
Notice of proposed rule
C.F.R.§ 330.10
Fed. Reg.Notices
U.S.C.§ 1501
U.S.C.§ 3501
C.F.R.§ 25.31
Fed. Reg.Proposed Rules
U.S.C.§ 321
U.S.C.§ 216
C.F.R.§ 601.601
SCOTUS440 U.S. 741
SCOTUS496 U.S. 582
F. App'x16 F.3d 604
Cites 44 · showing 12Cited by 0 across 0 sources
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