Authorization of Emergency Use of Oral Formulations of Doxycycline; Availability, 47197-47210 [2011-19622]

Download as PDF 47197 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices information, for information on the child, information describing the type of trafficking and circumstances surrounding the situation, and the strengths and needs of the child. The form also asks the requestor to verify the information contained in the form because the information could be the basis for a determination of an alien child’s eligibility for federally funded benefits. Finally, the form takes into consideration the need to compile information regarding a child’s circumstances and experiences in a nondirective, child-friendly way, and assists the potential requestor in assessing whether the child may have been subjected to trafficking in persons. The information provided through the completion of a Request for Assistance for Child Victims of Human Trafficking form will enable HHS to make prompt determinations regarding the eligibility of an alien child for interim assistance, inform HHS’ determination regarding the child’s eligibility for assistance as a victim of a severe form of trafficking in persons, facilitate the required consultation process, and enable HHS to assess and address potential child protection issues. Respondents: Representatives of governmental and nongovernmental entities providing social, legal, or protective services to alien persons under the age of 18 (children) in the United States who may have been subjected to severe forms of trafficking in persons. ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Request for Assistance for Child Victims of Human Trafficking ..................... 200 1 1 200 Estimated Total Annual Burden Hours: 200. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285, E-mail: OIRA_SUBMISSION@OMB.eop.gov, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2011–19715 Filed 8–3–11; 8:45 am] sroberts on DSK5SPTVN1PROD with NOTICES BILLING CODE 4184–01–P VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0543] Authorization of Emergency Use of Oral Formulations of Doxycycline; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for oral formulations of doxycycline for the post-exposure prophylaxis of inhalational anthrax during a public health emergency involving aerosolized Bacillus anthracis (B. anthracis). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized doxycycline products. The Authorization follows the determination by the Secretary of the Department of Homeland Security (DHS) that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents—in this case, B. anthracis. On the basis of such determination, the Secretary of the Department of Health and Human Services (HHS) declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets, accompanied by emergency use information, and later SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 renewed that declaration. The Secretary of HHS then renewed and amended that declaration so that it applies to all doxycycline products covered by this authorization. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. The Authorization is effective as of July 21, 2011. ADDRESSES: Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4121, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization. DATES: FOR FURTHER INFORMATION CONTACT: Luciana Borio, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4280, Silver Spring, MD 20993, 301– 796–8510. SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb-3), as amended by the Project BioShield Act of 2004 (Pub. L. 108–276), allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a public health emergency that affects, E:\FR\FM\04AUN1.SGM 04AUN1 sroberts on DSK5SPTVN1PROD with NOTICES 47198 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices or has a significant potential to affect, national security, and that involves biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents. With this EUA authority, FDA can help assure that medical countermeasures may be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives. Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary must declare an emergency justifying the authorization based on one of the following grounds: ‘‘(A) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents; (B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or (C) a determination by the Secretary of a public health emergency under section 319 of the Public Health Service Act (PHS Act) that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.’’ Once the Secretary has declared an emergency justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish, in the Federal Register, a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use in a declared emergency. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), and 515 of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after consultation with the National Institutes of Health and CDC (to the extent feasible and appropriate given the circumstances of the emergency), FDA 1 concludes: (1) That an agent specified in a declaration of emergency can cause a serious or lifethreatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing—(1) Such disease or condition; or (2) a serious or lifethreatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and (4) that such other criteria as the Secretary may by regulation prescribe are satisfied. No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, FDA does not require regulations or guidance to implement the EUA authority. However, in the Federal Register of July 26, 2007 (72 FR 41083), FDA announced the availability of a guidance entitled ‘‘Emergency Use Authorization of Medical Products.’’ The guidance provides more information for stakeholders and the public about the EUA authority and the Agency’s process for the consideration of EUA requests. II. EUA Request for Oral Formulations of Doxycycline Products In 2004, the Secretary of DHS issued a material threat determination indicating that B. anthracis, the biological agent that causes anthrax disease, presents a material threat against the population of the United States sufficient to affect national security. On September 23, 2008, under section 564(b)(1)(A) of the FD&C Act, the Secretary of DHS determined that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents—in this case, B. anthracis. On October 1, 2008, under section 564(b) of the FD&C Act, and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued under section 564(a) of the FD&C Act, and on October 1, 2009, and on October 1, 2010, renewed that declaration. On July 20, 2011, the Secretary of HHS renewed and amended that declaration so that it applies to all doxycycline products covered by this authorization. Notice of the determination and the declaration of the Secretary were published in the Federal Register on July 27, 2011 (76 FR 44926). On May 5, 2011, CDC requested and, on July 21, 2011, FDA issued an EUA for oral formulations of doxycycline products for the postexposure prophylaxis of inhalational anthrax during a public health emergency involving aerosolized B. anthracis, subject to the terms and conditions of this authorization. III. Electronic Access An electronic version of this document and the full text of the Authorization are available on the Internet at https://www.regulations.gov. IV. The Authorization Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of oral formulations of doxycycline products for the post-exposure prophylaxis of inhalational anthrax during a public health emergency involving aerosolized B. anthracis subject to the terms and conditions of the authorization. The Authorization for doxycycline products follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act: BILLING CODE 4160–01–P 1 The Secretary has delegated her authority to issue an EUA under section 564 of the FD&C Act to the Commissioner of Food and Drugs. VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\04AUN1.SGM 04AUN1 VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 47199 EN04AU11.021</GPH> sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 EN04AU11.022</GPH> sroberts on DSK5SPTVN1PROD with NOTICES 47200 VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 47201 EN04AU11.023</GPH> sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 EN04AU11.024</GPH> sroberts on DSK5SPTVN1PROD with NOTICES 47202 VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 47203 EN04AU11.025</GPH> sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 EN04AU11.026</GPH> sroberts on DSK5SPTVN1PROD with NOTICES 47204 VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 47205 EN04AU11.027</GPH> sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 EN04AU11.028</GPH> sroberts on DSK5SPTVN1PROD with NOTICES 47206 VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 47207 EN04AU11.029</GPH> sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 EN04AU11.030</GPH> sroberts on DSK5SPTVN1PROD with NOTICES 47208 EN04AU11.032</GPH> 47209 VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 EN04AU11.031</GPH> sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices 47210 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices Dated: July 28, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–19622 Filed 8–3–11; 8:45 am] BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0518] Notices of Filing of Petitions for Food Additives and Color Additives; Relocation in the Federal Register AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is notifying the public that notices of filing of petitions for food additives and color additives that are published in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) will now be published in the ‘‘Proposed Rules’’ section of the Federal Register. Notices of filing have historically been published in the ‘‘Notices’’ section of the Federal Register. The Office of the Federal Register (OFR) recently informed FDA that, under OFR rules, these documents actually fall into the ‘‘Proposed Rules’’ category and requested that FDA reclassify these notices of filing documents as proposed rules. This change is effective immediately. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Regulations Editorial Section, Office of Policy, Planning and Budget, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 32, Rm. 3208, Silver Spring, MD 20993–0002, 301–796–9148, joyce.strong@fda.hhs.gov. SUMMARY: SUPPLEMENTARY INFORMATION: sroberts on DSK5SPTVN1PROD with NOTICES I. Background Section 409 of the FD&C Act (21 U.S.C. 348) establishes the food additive petition approval process for food additives for use in human and animal food. Section 409(b)(5) requires that the Secretary of Health and Human Services publish notice in general terms of the receipt of a petition within 30 days of its filing. Similarly, section 721 of the FD&C Act (21 U.S.C. 379e) establishes a petition approval process for color additives used in food, drugs, cosmetics, and devices, and requires that the Secretary publish notice in general terms of the receipt of a color additive petition within 30 days of its filing. These responsibilities of the Secretary VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 have been delegated to the Commissioner of Food and Drugs and redelegated to certain other FDA officials. These notices of filing are published in the Federal Register. Under the Federal Register Act (44 U.S.C. chapter 15), the Administrative Committee of the Federal Register issues regulations regarding publishing documents in the Federal Register (1 CFR chapter I). Based on these governing regulations, the OFR classifies Agency documents published in the Federal Register in one of three categories: rules and regulations, proposed rules, and notices. The regulation establishing document types is 1 CFR 5.9. FDA’s section 409 and section 721 notices of filing have historically been published in the ‘‘Notices’’ section of the Federal Register. OFR recently informed FDA that, in their view, these documents actually fall into the ‘‘Proposed Rules’’ category and requested that FDA classify future such notices of filing documents as proposed rules (Ref. 1). Accordingly, FDA documents providing notice under section 409(b)(5) or section 721(d)(1) of the FD&C Act will appear in the proposed rule section of the Federal Register. This change is effective immediately. II. Reference The following reference has been placed on display in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Memo from Amy P. Bunk, Office of the Federal Register, to Joyce Strong, Food and Drug Administration, May 9, 2011. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2011–M–0323, FDA– 2011–M–0256, FDA–2011–M–0257, FDA– 2011–M–0241, FDA–2011–M–0284, FDA– 2011–M–0295, FDA–2011–M–0300, FDA– 2011–M–0296, FDA–2011–M–0342, FDA– 2011–M–0338, FDA–2011–M–0343, FDA– 2011–M–0348, FDA–2011–M–0349, FDA– 2011–M–0430, FDA–2011–M–0431, FDA– 2011–M–0445, FDA–2011–M–0470, FDA– 2011–M–0472, FDA–2011–M–0502, and FDA–2011–M–0503] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency’s Division of Dockets Management. SUMMARY: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. ADDRESSES: FOR FURTHER INFORMATION CONTACT: [FR Doc. 2011–19765 Filed 8–3–11; 8:45 am] Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301–796–6570. SUPPLEMENTARY INFORMATION: BILLING CODE 4160–01–P I. Background Dated: July 29, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. PO 00000 In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the Agency now posts this information on the Internet on FDA’s home page at https://www.fda.gov. In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47197-47210]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0543]


Authorization of Emergency Use of Oral Formulations of 
Doxycycline; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of an Emergency Use Authorization (EUA) (the Authorization) 
for oral formulations of doxycycline for the post-exposure prophylaxis 
of inhalational anthrax during a public health emergency involving 
aerosolized Bacillus anthracis (B. anthracis). FDA is issuing this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as requested by the Centers for Disease Control and Prevention 
(CDC). The Authorization contains, among other things, conditions on 
the emergency use of the authorized doxycycline products. The 
Authorization follows the determination by the Secretary of the 
Department of Homeland Security (DHS) that there is a significant 
potential for a domestic emergency involving a heightened risk of 
attack with a specified biological, chemical, radiological, or nuclear 
agent or agents--in this case, B. anthracis. On the basis of such 
determination, the Secretary of the Department of Health and Human 
Services (HHS) declared an emergency justifying the authorization of 
the emergency use of doxycycline hyclate tablets, accompanied by 
emergency use information, and later renewed that declaration. The 
Secretary of HHS then renewed and amended that declaration so that it 
applies to all doxycycline products covered by this authorization. The 
Authorization, which includes an explanation of the reasons for 
issuance, is reprinted in this document.

DATES: The Authorization is effective as of July 21, 2011.

ADDRESSES: Submit written requests for single copies of the EUA to the 
Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4121, Silver 
Spring, MD 20993. Send one self-addressed adhesive label to assist that 
office in processing your request or include a fax number to which the 
Authorization may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Luciana Borio, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, rm. 4280, Silver Spring, MD 20993, 
301-796-8510.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3), as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276), allows FDA to 
strengthen the public health protections against biological, chemical, 
nuclear, and radiological agents. Among other things, section 564 of 
the FD&C Act allows FDA to authorize the use of an unapproved medical 
product or an unapproved use of an approved medical product during a 
public health emergency that affects,

[[Page 47198]]

or has a significant potential to affect, national security, and that 
involves biological, chemical, radiological, or nuclear agent or 
agents, or a specified disease or condition that may be attributable to 
such agent or agents. With this EUA authority, FDA can help assure that 
medical countermeasures may be used in an emergency to diagnose, treat, 
or prevent serious or life-threatening diseases or conditions caused by 
such agents, when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary must declare an emergency justifying the 
authorization based on one of the following grounds: ``(A) A 
determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a specified 
biological, chemical, radiological, or nuclear agent or agents; (B) a 
determination by the Secretary of Defense that there is a military 
emergency, or a significant potential for a military emergency, 
involving a heightened risk to United States military forces of attack 
with a specified biological, chemical, radiological, or nuclear agent 
or agents; or (C) a determination by the Secretary of a public health 
emergency under section 319 of the Public Health Service Act (PHS Act) 
that affects, or has a significant potential to affect, national 
security, and that involves a specified biological, chemical, 
radiological, or nuclear agent or agents, or a specified disease or 
condition that may be attributable to such agent or agents.''
    Once the Secretary has declared an emergency justifying an 
authorization under section 564 of the FD&C Act, FDA may authorize the 
emergency use of a drug, device, or biological product if the Agency 
concludes that the statutory criteria are satisfied. Under section 
564(h)(1) of the FD&C Act, FDA is required to publish, in the Federal 
Register, a notice of each authorization, and each termination or 
revocation of an authorization, and an explanation of the reasons for 
the action. Section 564 of the FD&C Act permits FDA to authorize the 
introduction into interstate commerce of a drug, device, or biological 
product intended for use in a declared emergency. Products appropriate 
for emergency use may include products and uses that are not approved, 
cleared, or licensed under sections 505, 510(k), and 515 of the FD&C 
Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42 
U.S.C. 262). FDA may issue an EUA only if, after consultation with the 
National Institutes of Health and CDC (to the extent feasible and 
appropriate given the circumstances of the emergency), FDA \1\ 
concludes: (1) That an agent specified in a declaration of emergency 
can cause a serious or life-threatening disease or condition; (2) that, 
based on the totality of scientific evidence available to FDA, 
including data from adequate and well-controlled clinical trials, if 
available, it is reasonable to believe that: (A) the product may be 
effective in diagnosing, treating, or preventing--(1) Such disease or 
condition; or (2) a serious or life-threatening disease or condition 
caused by a product authorized under section 564, approved or cleared 
under the FD&C Act, or licensed under section 351 of the PHS Act, for 
diagnosing, treating, or preventing such a disease or condition caused 
by such an agent; and (B) the known and potential benefits of the 
product, when used to diagnose, prevent, or treat such disease or 
condition, outweigh the known and potential risks of the product; (3) 
that there is no adequate, approved, and available alternative to the 
product for diagnosing, preventing, or treating such disease or 
condition; and (4) that such other criteria as the Secretary may by 
regulation prescribe are satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary has delegated her authority to issue an EUA 
under section 564 of the FD&C Act to the Commissioner of Food and 
Drugs.
---------------------------------------------------------------------------

    No other criteria of issuance have been prescribed by regulation 
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, FDA does not require regulations or guidance to implement 
the EUA authority. However, in the Federal Register of July 26, 2007 
(72 FR 41083), FDA announced the availability of a guidance entitled 
``Emergency Use Authorization of Medical Products.'' The guidance 
provides more information for stakeholders and the public about the EUA 
authority and the Agency's process for the consideration of EUA 
requests.

II. EUA Request for Oral Formulations of Doxycycline Products

    In 2004, the Secretary of DHS issued a material threat 
determination indicating that B. anthracis, the biological agent that 
causes anthrax disease, presents a material threat against the 
population of the United States sufficient to affect national security. 
On September 23, 2008, under section 564(b)(1)(A) of the FD&C Act, the 
Secretary of DHS determined that there is a significant potential for a 
domestic emergency involving a heightened risk of attack with a 
specified biological, chemical, radiological, or nuclear agent or 
agents--in this case, B. anthracis. On October 1, 2008, under section 
564(b) of the FD&C Act, and on the basis of such determination, the 
Secretary of HHS then declared an emergency justifying the 
authorization of the emergency use of doxycycline hyclate tablets 
accompanied by emergency use information subject to the terms of any 
authorization issued under section 564(a) of the FD&C Act, and on 
October 1, 2009, and on October 1, 2010, renewed that declaration. On 
July 20, 2011, the Secretary of HHS renewed and amended that 
declaration so that it applies to all doxycycline products covered by 
this authorization. Notice of the determination and the declaration of 
the Secretary were published in the Federal Register on July 27, 2011 
(76 FR 44926). On May 5, 2011, CDC requested and, on July 21, 2011, FDA 
issued an EUA for oral formulations of doxycycline products for the 
post-exposure prophylaxis of inhalational anthrax during a public 
health emergency involving aerosolized B. anthracis, subject to the 
terms and conditions of this authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorization are available on the Internet at https://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of oral formulations of doxycycline 
products for the post-exposure prophylaxis of inhalational anthrax 
during a public health emergency involving aerosolized B. anthracis 
subject to the terms and conditions of the authorization.
    The Authorization for doxycycline products follows and provides an 
explanation of the reasons for its issuance, as required by section 
564(h)(1) of the FD&C Act:
BILLING CODE 4160-01-P

[[Page 47199]]

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    Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19622 Filed 8-3-11; 8:45 am]
BILLING CODE 4160-01-C
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