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DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: HUMAN SERVICES HUMAN SERVICES I. Background Administration for Children and Food and Drug Administration Section 564 of the act (21 U.S.C. Families [Docket No. 2005N–0040] 360bbb–3), as amended by the Project BioShield Act of 2004 (Public Law 108– Delegation of Authority Authorization of Emergency Use of 276), allows FDA to strengthen the Anthrax Vaccine Adsorbed for public health protections against Notice is hereby given that, under the Prevention of Inhalation Anthrax by biological, chemical, nuclear, and authority vested in me by the Secretary, Individuals at Heightened Risk of radiological agents. Among other things, Department of Health and Human Exposure Due to Attack With Anthrax; section 564 of the act allows FDA to Services, I have redelegated to the Availability authorize the use of an unapproved Commissioner, Administration on medical product or an unapproved use Children, Youth and Families, with the AGENCY: Food and Drug Administration, of an approved medical product during authority to further redelegate to the HHS. a declared emergency involving a Director, Family Youth Services Bureau, ACTION: Notice. heightened risk of attack on the public the authority to approve/disapprove or U.S. military forces. With this EUA SUMMARY: The Food and Drug authority, FDA can help assure that cooperative research or demonstration Administration (FDA) is announcing the medical countermeasures may be used projects under Section 1110 of the issuance of an Emergency Use in an emergency to diagnose, treat, or Social Security Act, and as amended Authorization (EUA) (the Authorization) prevent serious or life-threatening hereafter, when such projects pertain to for Anthrax Vaccine Adsorbed (AVA) diseases or conditions caused by such the abstinence education activities for prevention of inhalation anthrax for agents, when there are no adequate, referenced in Public Law 108–447 at individuals between 18 and 65 years of approved, and available alternatives to Title II, Division F. age who are deemed by the Department protect the American people and the of Defense (DoD) to be at heightened This delegation excludes the authority U.S. military. to submit reports to Congress. Further, risk of exposure due to attack with anthrax. FDA is issuing this Section 564(b)(1) of the act provides this delegation shall be exercised under that, before an EUA may be issued, the the Department’s existing delegation Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as Secretary must declare an emergency and policy on regulations and under based on one of the following grounds: financial and administrative requested by DoD. The Authorization contains, among other things, (1) a determination by the Secretary of requirements applicable to all Homeland Security that there is a domestic Administration for Children and conditions on the emergency use of emergency, or a significant potential for a AVA. The Authorization follows the Families authorities. In addition, where domestic emergency, involving a heightened determination by DoD that there is a all or part of any research or risk of attack with a specified biological, significant potential for a military chemical, radiological, or nuclear agent or demonstration project is wholly emergency involving a heightened risk agents; financed with Federal funds made to U.S. military forces of attack with (2) a determination by the Secretary of available under section 1110 of the anthrax. On the basis of such Defense that there is a military emergency, or Social Security Act, without any State, determination, Secretary of Health and a significant potential for a military local, or other non-Federal financial Human Services Tommy G. Thompson emergency, involving a heightened risk to United States military forces of attack with a participation, that project must be (the Secretary) declared an emergency approved by the Secretary of Health and specified biological, chemical, radiological, justifying the authorization of the or nuclear agent or agents; or Human Services. emergency use of AVA. The (3) a determination by the Secretary of a I have ratified any actions taken by Authorization, which includes an public health emergency under section 319 of the Commissioner, Administration on explanation of the reasons for its the Public Health Service Act (PHS Act) that Children, Youth and Families, or any issuance, is reprinted in this Notice. affects, or has a significant potential to affect, national security, and that involves a DATES: The Authorization is effective as other Administration on Children, specified biological, chemical, radiological, Youth and Families officials, which, in of January 27, 2005. or nuclear agent or agents, or a specified effect, involved the exercise of this ADDRESSES: Submit written requests for disease or condition that may be attributable authority prior to the effective date of single copies of the Emergency Use to such agent or agents. this delegation. This delegation was Authorization to the Office of Once the Secretary has declared an effective on the date of signature. Counterterrorism Policy and Planning emergency justifying an authorization (HF–29), Food and Drug Dated: January 21, 2005. under section 564 of the act, FDA may Administration, 5600 Fishers Lane, authorize the emergency use of a drug, Wade F. Horn, Rockville, MD 20857. Send one self- device, or biological product if the Assistant Secretary for Children and Families. addressed adhesive label to assist that agency concludes, based on the [FR Doc. 05–1896 Filed 2–1–05; 8:45 am] office in processing your request or information and data available to the BILLING CODE 4184–01–M include a fax number to which the agency, that the statutory criteria of Authorization may be sent. See the section 564(c) of the act are satisfied. SUPPLEMENTARY INFORMATION section for Under section 564(h)(1) of the act FDA electronic access to the Authorization. is required to publish in the Federal FOR FURTHER INFORMATION CONTACT: Register notice of each authorization, Margaret O’K. Glavin, Office of and each termination or revocation of an Counterterrorism Policy and Planning authorization, and an explanation of the (HF–29), Food and Drug reasons for the action. The explanation Administration, 5600 Fishers Lane, may include a summary of data Rockville, MD 20857, 301–827–4067. submitted to FDA in an application

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under section 505(i) or 520(g) of the act Thompson declared an emergency www.fda.gov/ohrms/dockets/ (21 U.S.C. 355(i) or 21 U.S.C. 360j(g)). justifying the authorization of the default.htm. Section 564 of the act permits FDA to emergency use of AVA. Notice of the authorize, during the effective period of determination of the Deputy Secretary V. The Authorization the declaration, the introduction into of Defense and the declaration of the Having consulted with NIH and CDC, interstate commerce of a drug, device, or Secretary of Health and Human Services and having concluded that the criteria biological product intended for use in is published elsewhere in this issue of for issuance of this Authorization under an actual or potential emergency. the Federal Register. Products appropriate for emergency use section 564(c) of the act are met, FDA may include products and uses that are III. Significance of Notice has authorized the emergency use of AVA for prevention of inhalation not approved, cleared, or licensed under The issuance of this Authorization for anthrax for individuals between 18 and sections 505, 510(k), and 515 of the act the emergency use of AVA is the first (21 U.S.C. 355, 21 U.S.C. 360(k), 21 time that the EUA authority is being 65 years of age who are deemed by DoD U.S.C. 360e) or section 351 of the PHS used. FDA intends to explain clearly the to be at heightened risk of exposure due Act (42 U.S.C. 262). FDA may issue an reasons for each issuance, termination, to attack with anthrax. The EUA only if, after consultation with the or revocation of an EUA. The agency Authorization follows and provides an National Institutes of Health (NIH) and wishes to make its decision-making explanation of the reasons for its the Centers for Disease Control and understandable to help ensure that issuance, as required by section Prevention (CDC) (to the extent feasible members of the public, and particularly 564(h)(1) of the act: and appropriate given the circumstances those individuals who may be eligible to William Winkenwerder, Jr., M.D. of the emergency), FDA concludes: receive a medical product authorized for (1) That the agent specified in the Assistant Secretary of Defense for Health emergency use, are informed about the Affairs declaration of emergency can cause a basis of an EUA determination. The serious or life-threatening disease or The Pentagon amount of information that will be Washington, D.C. 20301–1200 condition; provided regarding each authorization (2) That, based on the totality of Re: Request for Emergency Use will depend on the circumstances of the scientific evidence available, including Authorization for the Armed Forces Pending emergency. We anticipate that in some data from adequate and well-controlled Re-determination on the Licensed Use of circumstances, an EUA will be issued Anthrax Vaccine Adsorbed for Protection clinical trials, if available, it is very quickly, and time may not permit Against Inhalational Anthrax reasonable to believe that the product the agency to prepare supplementary Dear Dr. Winkenwerder: may be effective in diagnosing, treating, documents beyond the letter of This is in response to your letter of or preventing—(a) the serious or life- authorization and the notice required by December 22, 2004, requesting that the Food threatening disease or condition referred section 564(h)(1) of the act. Other and Drug Administration (FDA) issue an to in paragraph (1); or (b) a serious or circumstances may afford greater Emergency Use Authorization (EUA) life-threatening disease or condition opportunity to produce materials in regarding the use of Anthrax Vaccine caused by a product authorized under addition to those prepared and Adsorbed (AVA) for the prevention of section 564, or approved, cleared, or disseminated as a condition of inhalational anthrax, pursuant to section 564 licensed under the act or PHS Act, for authorization under section 564(e) of of the Federal Food, Drug, and Cosmetic Act diagnosing, treating, or preventing the the act. Thus, the amount of additional (the Act). disease or condition referred to in information that we will provide will On December 10, 2004, pursuant to section paragraph (1) and caused by the agent necessarily vary on a case-by-case basis. 564(b)(1)(B) of the Act, 21 U.S.C. § 360bbb– specified in the declaration of The agency will publish notice of each 3(b)(1)(B), the Deputy Secretary of Defense emergency; EUA and intends also to make the determined that there is a significant (3) That the known and potential potential for a military emergency involving benefits of the product outweigh the notice and certain supplementary information available on its website and a heightened risk to U.S. military forces of known and potential risks of the attack with anthrax.1 On January 14, 2005, product when used to diagnose, in the Division of Dockets Management (HFA–305), Food and Drug pursuant to section 564(b) of the Act, and on prevent, or treat the serious or life- the basis of such determination, Secretary of threatening disease or condition that is Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, which is Health and Human Services, Tommy G. the subject of the declaration; and Thompson declared an emergency justifying (4) That there is no adequate, open to the public between 9 a.m. and 4 p.m., Monday through Friday. the authorization of the emergency use of approved, and available alternative to AVA. Having consulted with the National the product for diagnosing, preventing, Because the statute is self-executing, Institutes of Health (NIH) and the Centers for or treating such serious or life- FDA does not require regulations or Disease Control and Prevention (CDC), and threatening disease or condition. guidance to implement the EUA having concluded that the criteria for authority. However, we believe that it II. EUA Request for AVA issuance of this authorization under section would be helpful for stakeholders and 564(c) of the Act are met, I am authorizing On December 10, 2004, pursuant to the public to have more information the emergency use of AVA for prevention of section 564(b)(1)(B) of the act (21 U.S.C. about the EUA authority, and the inhalation anthrax,2 subject to the conditions 360bbb–3(b)(1)(B)), the Deputy process that the agency is proposing to established herein.3 Secretary of Defense determined that adopt for the consideration of EUA there is a significant potential for a requests. Accordingly the agency is 1 You state in your letter that the Deputy military emergency involving a planning to issue draft guidance on this Secretary of Defense has assigned authority from heightened risk to United States military topic in the near future. the Secretary of Defense to make the statutory forces of attack with anthrax. On determination under section 564(b)(1)(B) of the Act. IV. Electronic Access 2 January 14, 2005, pursuant to section The Secretary of Health and Human Services has delegated his authority to issue an EUA under 564(b) of the act, and on the basis of An electronic version of this notice section 564 to the FDA Commissioner. such determination, Secretary of Health and the full text of the Authorization are 3 The terms ‘‘inhalation anthrax’’ and and Human Services Tommy G. available on the Internet at http:// ‘‘inhalational anthrax’’ are used interchangeably.

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I. Background II. Criteria for Issuance of Authorization inhalation and cutaneous cases in those who AVA was first licensed by NIH in Having considered the December 10, 2004, were completely vaccinated, the calculated November 1970.4 Upon the delegation of determination by the Deputy Secretary of vaccine efficacy level against all reported cases of anthrax combined was 92.5 percent vaccine regulation to FDA in 1972, FDA Defense that there is a significant potential (lower 95 percent CI = 65 percent). The undertook a comprehensive review of the for a military emergency involving a heightened risk to U.S. military forces of efficacy analysis included all cases of anthrax safety, effectiveness, and labeling of all disease regardless of the route of exposure or 5 attack with anthrax, and the January 14, vaccines licensed prior to July 1, 1972. manifestation of disease. Under this review, independent advisory 2005, declaration of emergency by the • Secretary of Health and Human Services, and Epidemiological surveillance data on the panels evaluated the safety and effectiveness occurrence of anthrax disease in at-risk data of vaccines to assure that they met after consultation with NIH and CDC, I have concluded that the use of AVA to prevent industrial settings for the years 1962-1974 appropriate standards. The advisory panel provides further supportive evidence of the inhalation anthrax meets the criteria for that reviewed AVA concluded that it is safe, effectiveness of AVA. In that time period, issuance of an authorization under section effective, and not misbranded, and FDA individuals received either AVA, or an 564(c) of the Act, because I have concluded issued a proposal to adopt the panel’s earlier version of anthrax vaccine. Of the 24 that: recommendation (the Bacterial Vaccines and anthrax cases that occurred in mill (1) anthrax (Bacillus anthracis) can cause Toxoids Efficacy Review).6 employees during that period, no cases a serious or life-threatening disease or In March 2003, six plaintiffs, known as occurred in those who had received the full condition; vaccination series. John and Jane Doe 1 through 6, filed suit in (2) based on the totality of scientific the United States District Court for the • The safety of AVA was evaluated in a 5- evidence available to FDA, AVA is effective year (1967-1971) open-label safety study in District of Columbia (the Court) seeking the in preventing inhalation anthrax; therefore, it Court to enjoin the Anthrax Vaccine which 15,907 doses of AVA were is reasonable to believe that AVA may be administered to approximately 7,000 textile Immunization Program (AVIP) of the effective in preventing inhalation anthrax Department of Defense (DoD), and to declare employees, laboratory workers, and other at- pursuant to section 564(c)(2)(A) of the Act; risk individuals. Severe local reactions were AVA an investigational drug when used for and that the known and potential benefits of protection against inhalation anthrax. On reported in 0.15 percent of doses AVA, when used to prevent inhalation administered (24 reports). There were 150 December 22, 2003, the Court issued a anthrax, outweigh the known and potential reports (0.94 percent of doses administered) preliminary injunction barring inoculations risks of the product; and of moderate local reactions and 1,373 reports under the AVIP in the absence of informed (3) there is no adequate, approved, and (8.63 percent of doses administered) of mild consent or a Presidential waiver of the available alternative to AVA for preventing local reactions. In the same open label study, 9 informed consent requirement. inhalation anthrax. four cases of systemic reactions were In the Federal Register of January 5, 2004,7 Specifically, I have concluded, pursuant to reported during a 5-year reporting period FDA published a final rule and final order in section 564(c)(1) of the Act, that anthrax (<0.06 percent of doses administered). These response to the report and recommendations (Bacillus anthracis) can cause inhalation reactions, which were reported to have been of the independent advisory panel that anthrax, which is a serious or life-threatening transient, included fever, chills, nausea, and reviewed the safety and effectiveness data disease or condition. The fatality rate for general body aches. pertaining to AVA. Following FDA’s issuance inhalation anthrax in the United States is • Recently (1996-1999), an assessment of of the final rule and final order, the Court estimated to be approximately 45 percent to safety was conducted as part of a randomized lifted the preliminary injunction on January 90 percent. From 1900 to October 2001, there clinical study conducted by the U.S. Army 7, 2004, except as it applied to the six Doe were 18 identified cases of inhalation anthrax Medical Research Institute of Infectious plaintiffs. in the United States, the latest of which was Diseases. Four of the 28 volunteers reported On October 27, 2004, the Court issued a reported in 1976, with an 89 percent (16/18) seven acute adverse events within 30 memorandum opinion vacating and mortality rate. Most of these exposures minutes after the subcutaneous remanding the January 2004 final rule and occurred in industrial settings, i.e., textile administration of AVA. These adverse events final order to FDA for reconsideration, mills. From October 4, 2001, to December 5, included erythema (3), headache (2), fever 2001, a total of 11 cases of inhalation anthrax following an appropriate notice and (1), and elevated temperature (1). Of these linked to intentional dissemination of comment period. The Court also enjoined events, a single patient reported the Bacillus anthracis spores were identified in operation of the AVIP for inoculation using simultaneous occurrence of headache, fever, the United States. Five of these cases were ° AVA to prevent inhalation anthrax. On and elevated temperature (100.7 F). The most fatal. These fatalities occurred despite December 29, 2004, FDA published a common local reactions reported after the aggressive medical care, including proposed rule and proposed order reopening first dose in this study were tenderness (71 antibiotics. percent), erythema (43 percent), the comment period on the Bacterial Vaccine I have concluded that, based on the totality 8 subcutaneous nodule (36 percent), induration and Toxoids Efficacy Review for 90 days. As of scientific evidence available to FDA, a result of the Court’s order of October 27, (21 percent), warmth (11 percent), and local including data from at least one well- pruritus (7 percent). Local reactions were 2004, the use of AVA by DoD for the controlled field study, AVA is effective in prevention of inhalation anthrax under the found to occur more often in women. No preventing inhalation anthrax; therefore, it is abscess or necrosis was observed at the AVIP is deemed an unapproved use of an reasonable to believe that AVA may be approved product for purposes of section injection site. effective in preventing inhalation anthrax I have concluded, pursuant to section 564(a)(2) of the Act. But for the Court’s order, pursuant to section 564(c)(2)(A) of the Act. In 564(c)(3) of the Act, that there is no adequate, FDA would not consider the use of AVA for addition, pursuant to section 564(c)(2)(B) of approved, and available alternative to AVA inhalation anthrax to be an unapproved use. the Act, I have concluded that it is reasonable for preventing inhalation anthrax. No other to believe that the known and potential drugs are approved for the prevention (pre- 4 Biological products are licensed under section benefits of AVA outweigh the known and exposure) of anthrax infection. Antibiotics 351 of the Public Health Service Act (42 U.S.C. potential risks of the product. The available are effective against the germinated form of 262). scientific evidence that supports these Bacillus anthracis, but are not effective 5 See 21 C.F.R. § 601.25. conclusions includes the following: against the spore form of the organism. 6 Biological Products; Bacterial Vaccines and • A well-controlled efficacy field study Although antibiotics are available to treat Toxoids; Implementation of Efficacy Review, 50 using an earlier version of a protective anthrax infection, their effectiveness is Fed. Reg. 51002 (Dec. 13, 1985). antigen-based anthrax vaccine was 7 limited, in part due to delays from the time Biological Products; Bacterial Vaccines and conducted in mill workers from 1955-1959. Toxoids; Implementation of Efficacy Review, 69 of exposure to the initiation of treatment. Fed. Reg. 255 (Jan. 5, 2004). In a comparison of anthrax cases between the Delays in the treatment of exposed persons 8 Biological Products; Bacterial Vaccines and placebo and vaccine groups, including both are possible, considering the potential Toxoids; Implementation of Efficacy Review; scenarios of exposure, and the difficulties Proposed Rule and Proposed Order, 69 Fed. Reg. 9 No other criteria of issuance have been that exist in identifying anthrax as the 78281 (Dec. 29, 2004). prescribed by regulation under section 564(c)(4). etiology of illness.

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III. Scope of Authorization be at heightened risk of exposure due to action will be taken. You will not be Pursuant to section 564(d)(1) of the Act, attack with anthrax. processed for separation, and you will still be deployable. There will be no penalty or loss this authorization is limited to the use of IV. Conditions of Authorization AVA for the prevention of inhalation anthrax of entitlement for refusing anthrax for individuals between 18 and 65 years of Pursuant to section 564 of the Act, I am vaccination. age who are deemed by DoD to be at establishing the following conditions on this Other information, as outlined in your heightened risk of exposure due to attack authorization: request, is not a condition of this EUA, but with anthrax. Conditions Designed to Ensure that Health may be provided, including: That I have concluded, pursuant to section Care Providers or Authorized Dispensers unvaccinated people are more vulnerable to 564(d)(2) of the Act, that it is reasonable to Administering the Product Are Informed. lethal anthrax infection; morbidity or believe that the known and potential benefits DoD will conduct an educational and mortality due to anthrax could threaten the of AVA, when used to prevent inhalation information program under appropriate lives of others in the unit who depend on anthrax, outweigh the known and potential conditions designed to ensure that health each other; and anthrax infections could risks of the product for the population care providers or authorized dispensers jeopardize the success of the mission. described above. administering AVA under this authorization Individuals subject to the vaccination I have concluded, pursuant to section are informed: program may be informed that their military 564(d)(3) of the Act, based on the totality of (1) that FDA has authorized the emergency and civilian leaders strongly recommend scientific evidence available to FDA, that use of AVA for preventing inhalation anthrax vaccination, but such individuals AVA is effective in preventing inhalation anthrax; may not be forced to be vaccinated. In anthrax, and therefore, it is reasonable to (2) of the significant known and potential addition, the issue of mandatory vaccination believe that AVA may be effective in benefits and risks of the emergency use of will be reconsidered by DoD after FDA preventing inhalation anthrax pursuant to AVA, and the extent to which such benefits completes its administrative process, which 10 section 564(c)(2)(A) of the Act. FDA has and risks are unknown; and DoD expects to occur later this year. reviewed the scientific information available, (3) of the alternatives to AVA that are As a condition of this authorization, DoD including the studies described in Section II available, and of their benefits and risks. will provide to each potential AVA recipient, above, and concludes that AVA, when used With respect to condition (2), above, prior to vaccination, information that meets for preventing inhalation anthrax, meets the relating to provision of the significant known the requirements set forth above. FDA has standards set forth in section 564(c) of the and potential benefits and risks of the reviewed DoD’s trifold brochure, submitted Act. emergency use of AVA, DoD will assure that on January 19, 2005, and concludes that this FDA understands that DoD recognizes that the manufacturer’s package insert is available brochure meets such requirements. DoD will the current AVA license describes an to all health care providers or authorized obtain FDA’s prior approval of any revision immunization schedule consisting of six dispensers who administer AVA. DoD will to the trifold brochure. doses. Certain details of DoD’s EUA request also provide to all such health care providers Conditions for the Monitoring and are not specifically addressed in the package or authorized dispensers the same Reporting of Adverse Events Associated with insert, however. DoD notes that for some information provided to potential vaccine the Emergency Use of AVA. DoD will, as a personnel, the vaccination schedule was recipients described immediately below. condition of this authorization, actively unavoidably disrupted, and DoD intends for Conditions Designed to Ensure that encourage health care providers or such personnel to resume vaccinations at the Individuals to Whom the Product is authorized dispensers and vaccine recipients point in the dosing schedule where they left Administered Are Informed. DoD will to report adverse events to the Vaccine off, for individuals eligible under the EUA. conduct an educational and information Adverse Events Reporting System (VAERS). While this practice is not addressed in the program under appropriate conditions In addition, we understand that DoD will package insert, the practice is consistent with designed to ensure that individuals to whom conduct systematic monitoring of the health the general recommendations of the Advisory AVA is administered are informed: of recipients of AVA, e.g., cohort studies Committee on Immunization Practices. When (1) that FDA has authorized the emergency using the Defense Medical Surveillance it is impracticable to provide a dose on a use of AVA for preventing inhalation System databases of active-duty military specific date recommended by the schedule, anthrax; personnel; such monitoring is not a condition DoD intends to provide the vaccine dose as (2) of the significant known and potential of this authorization. soon as practicable thereafter. Based on the benefits and risks of the emergency use of Conditions Concerning Recordkeeping and totality of the scientific evidence available to AVA, and of the extent to which such Reporting, Including Records Access by FDA. FDA, it is reasonable to believe that such benefits and risks are unknown; and DoD will, as a condition of authorization, administration of AVA may be effective in (3) of the option to accept or refuse record in individual medical records, preventing inhalation anthrax. Furthermore, administration of AVA; of the consequences, including electronic immunization tracking the known and potential benefits of AVA, if any, of refusing administration of the systems, the names of individual recipients when used to prevent inhalation anthrax in product; and of the alternatives to AVA that of AVA and the dates of vaccination. DoD the manner described above, outweigh the are available, and of their benefits and risks. will provide FDA access to such records. known and potential risks of the product. With respect to condition (3), above, Advertising and Promotional Descriptive DoD also acknowledges that during the relating to the option to accept or refuse Printed Matter. FDA has the authority, under course of the EUA, the risk status of administration of AVA, the AVIP will be section 564(e)(4) of the Act to establish individuals initially eligible for vaccination revised to give personnel the option to refuse conditions on advertisements and other under the EUA may change (e.g., changes in vaccination. Individuals who refuse anthrax promotional descriptive printed matter that deployment or other circumstances). In such vaccination will not be punished. Refusal relate to the emergency use of AVA under cases, DoD must determine whether such may not be grounds for any disciplinary this authorization. As a condition of this individuals continue to be at heightened risk action under the Uniform Code of Military EUA, all advertising and promotional of exposure due to attack with anthrax, and Justice. Refusal may not be grounds for any descriptive printed matter relating to the use therefore, whether they continue to be adverse personnel action. Nor would either of AVA shall be consistent with the trifold eligible for vaccination with AVA under this military or civilian personnel be considered as well as the standards and requirements set EUA. non-deployable or processed for separation forth in this authorization. The use of AVA under this EUA must be based on refusal of anthrax vaccination. V. Duration of Authorization consistent with and not contrary to the There may be no penalty or loss of conditions of authorization set forth below. entitlement for refusing anthrax vaccination. This EUA will be effective for 6 months Subject to the foregoing limitations and This information shall read in the trifold from the date of issuance. However, this EUA under the circumstances set forth in the brochure provided to potential vaccine may be extended within the duration of the Deputy Secretary of Defense’s determination recipients as follows: declaration of emergency if the criteria under of military emergency, AVA may be You may refuse anthrax vaccination under section 564(c) of the Act for issuance of such administered for the prevention of inhalation the EUA, and you will not be punished. No anthrax to individuals determined by DoD to disciplinary action or adverse personnel 10 See Section I of this authorization.

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authorization are still met. Moreover, the Place: Sugarloaf Room, 1 Choke Cherry of the agency, including whether the EUA will cease to be effective when the Road, Rockville, MD 20857. information will have practical utility; declaration of emergency is terminated under Type: Open: February 16, 2005, 9 a.m.—5 (2) Evaluate the accuracy of the section 564(b) of the Act or the EUA is p.m.; February 17, 2005, 9:30 a.m.—1 p.m. agency’s estimate of the burden; revoked under section 564(g) of the Act. Closed: February 17, 2005, 9 a.m.—9:30 (3) Enhance the quality, utility, and Thank you in advance for your cooperation a.m. clarity of the information to be in implementing this EUA. Contact: Diane Abbate, MA, Acting Sincerely, Executive Secretary, 1 Choke Cherry Road, collected; and Lester M. Crawford, D.V.M., Ph.D. Room 6–1075, Rockville, Maryland 20857. (4) Minimize the burden of the Telephone: (240) 276–1830, and FAX (240) collection of information on those who Dated: January 28, 2005. 276–1850. E-mail: [email protected]. are to respond, including through the Jeffrey Shuren, use of appropriate automated, Dated: January 26, 2005. Assistant Commissioner for Policy. electronic, mechanical, or other Toian Vaughn, [FR Doc. 05–2028 Filed 1–31–05; 11:39 am] technological collection techniques or Committee Management Officer, Substance BILLING CODE 4160–01–S other forms of information technology Abuse and Mental Health Services where appropriate. Administration. 1652–0028, Flight Crew Self-Defense DEPARTMENT OF HEALTH AND [FR Doc. 05–1923 Filed 2–1–05; 8:45 am] Training—Registration and Evaluation. HUMAN SERVICES BILLING CODE 4162–20–P TSA is seeking to renew information collection request number 1652–0028 to Substance Abuse and Mental Health continue compliance with statutory Services Administration DEPARTMENT OF HOMELAND mandate. Section 603 of Vision 100— SECURITY Century of Aviation Reauthorization Center for Mental Health Services; Act, Public Law 108–176, requires TSA Notice of Meeting Transportation Security Administration to develop and provide a voluntary advanced self-defense training program Pursuant to Pub. L. 92–463, notice is Notice of Intent To Request Renewal for flight and cabin crew members of air hereby given of the meeting of the From the Office of Management and carriers providing scheduled passenger Center for Mental Health Services Budget (OMB) of One Current Public air transportation. TSA collects limited (CMHS) National Advisory Council in Collection of Information; Flight Crew biographical information from flight February 2005. Self-Defense Training—Registration crew members to confirm their A portion of the meeting will be open and Evaluation eligibility for training. TSA also asks and will include a roll call, general AGENCY: Transportation Security participants to complete an anonymous announcements, Director’s and and voluntary evaluation form after the Administrator’s Reports, as well as Administration (TSA), DHS. ACTION: Notice. training is completed to assess the presentations and discussions about quality of the training. TSA requests this Mental Health System Transformation. SUMMARY: TSA invites public comment renewal to continue confirming Attendance by the public will be on an existing information collection participants’ eligibility and attendance limited to space available. Public requirement, abstracted below, that will for the training program, as well as to comments are welcome. Please be submitted to OMB for renewal in continue to assess training quality. The communicate with the individual listed compliance with the Paperwork estimated number of annual below as contact to make arrangements Reduction Act. respondents is 3,000 and estimated to comment or to request special DATES: Send your comments by April 4, annual burden is 750 hours. There is no accommodations for persons with 2005. estimated annual cost burden to disabilities. respondents. ADDRESSES: Comments to be delivered The meeting also will include the The approval of this information to Katrina Wawer, Information review, discussion, and evaluation of collection expires on April 30, 2005. Collection Specialist, TSA grant applications. Therefore a portion Headquarters, East Tower, Floor 7, Issued in Arlington, Virginia, on January of the meeting will be closed to the TSA–9, 601 South 12th Street, 25, 2005. public as determined by the Arlington, VA 22202–4220; facsimile Lisa S. Dean, Administrator, SAMHSA, in accordance (571) 227–2594; email Privacy Officer. with Title 5 U.S.C. 552b(c)(6) and 5 [email protected]. [FR Doc. 05–1926 Filed 2–1–05; 8:45 am] U.S.C. App. 2 Section 10(d). BILLING CODE 4910–62–P Substantive program information, and FOR FURTHER INFORMATION CONTACT: a roster of Council members may be Katrina Wawer, Information Collection obtained by accessing the SAMHSA Specialist (571) 227–1995. DEPARTMENT OF HOMELAND Advisory Committee website (http:// SUPPLEMENTARY INFORMATION: In SECURITY www.samhsa.gov) or by communicating accordance with the Paperwork with the contact whose name and Reduction Act of 1995, (44 U.S.C. 3501 Transportation Security Administration telephone number are listed below. A et seq.), an agency may not conduct or summary of the meeting and the sponsor, and a person is not required to Notice of Intent To Request Renewal transcript for the open session will also respond to a collection of information, From the Office of Management and be available on the SAMHSA Advisory unless it displays a valid OMB control Budget (OMB) of a Current Public Committee Web site as soon as possible number. Therefore, in preparation for Collection of Information; Airport after the meeting. submission of the specified information Security Committee Name: Substance Abuse and collection for renewal, TSA solicits AGENCY: Transportation Security Mental Health Services Administration, comments in order to— Administration (TSA), Department of Center for Mental Health Services National (1) Evaluate whether the proposed Homeland Security (DHS). information requirement is necessary for Advisory Council. ACTION: Notice. Meeting Date: February 16–17, 2005. the proper performance of the functions

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