Renewal of Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information, 51279 [E9-24086]

Download as PDF Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices Dated: September 30, 2009. Jonathan Ishee, Office of Policy and Research, Office of the National Coordinator for Health Information Technology. [FR Doc. E9–24041 Filed 10–5–09; 8:45 am] BILLING CODE 4150–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Renewal of Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information AGENCY: Office of the Secretary (OS), HHS. jlentini on DSKJ8SOYB1PROD with NOTICES ACTION: Notice. SUMMARY: The Secretary of Homeland Security determined on September 23, 2008 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, Bacillus anthracis. On the basis of this determination, the Secretary of Health and Human Services is renewing the October 1, 2008 declaration by former Secretary Michael O. Leavitt of an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb–3(a). This notice is being issued in accordance with section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb–3(b)(4). DATES: This Notice and referenced HHS declaration are effective as of October 1, 2009. FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Telephone (202) 205–2882 (this is not a toll free number). SUPPLEMENTARY INFORMATION: On September 23, 2008, former Secretary of Homeland Security, Michael Chertoff, determined that there is a significant potential for a domestic emergency, VerDate Nov<24>2008 16:15 Oct 05, 2009 Jkt 220001 involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents—in this case, Bacillus anthracis, although there is no current domestic emergency involving anthrax, no current heightened risk of an anthrax attack, and no credible information indicating an imminent threat of an attack involving Bacillus anthracis. Pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb–3(b), and on the basis of such determination, on October 1, 2008, former Secretary of Health and Human Services, Michael O. Leavitt, 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 21 U.S.C. 360bbb–3(a).1 Pursuant to section 564(b)(2)(B) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb– 3(b), and on the basis of Secretary Chertoff’s September 23, 2008 determination, I hereby renew former Secretary Leavitt’s October 1, 2008 declaration of 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 21 U.S.C. 360bbb–3(a). I am issuing this notice in accordance with section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb–3(b)(4). Dated: October 1, 2009. Kathleen Sebelius, Secretary. [FR Doc. E9–24086 Filed 10–1–09; 4:15 pm] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on 1 Pursuant to section 564(b)(4) of the FFDCA, notice of the determination by the Secretary, DHS, and the declaration by the Secretary, HHS, was provided at 73 FR 58242 (October 6, 2008). PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 51279 proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Officer on (301) 443– 1129. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: National Health Service Corps Travel Request Worksheet—Extension Clinicians participating in the HRSA National Health Service Corps (NHSC) Scholarship Program use the online Travel Request Worksheet to receive travel funds from the Federal Government to perform pre-employment interviews at sites on the NHSC’s Opportunities List. The travel approval process is initiated when a scholar notifies the NHSC of an impending interview at one or more NHSC approved practice sites. The Travel Request Worksheet is also used to initiate the relocation process after a NHSC scholar has successfully been matched to an approved practice site. Upon receipt of the Travel Request Worksheet, the NHSC will review and approve or disapprove the request and promptly notify the scholar and the NHSC logistics contractor regarding travel arrangements and authorization of the funding for the site visit or relocation. The estimated annual burden is as follows: E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Page 51279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24086]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Renewal of Declaration Regarding Emergency Use of Doxycycline 
Hyclate Tablets Accompanied by Emergency Use Information

AGENCY: Office of the Secretary (OS), HHS.

ACTION: Notice.

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SUMMARY: The Secretary of Homeland Security determined on September 23, 
2008 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, 
Bacillus anthracis. On the basis of this determination, the Secretary 
of Health and Human Services is renewing the October 1, 2008 
declaration by former Secretary Michael O. Leavitt of an emergency 
justifying the authorization of emergency use of doxycycline hyclate 
tablets accompanied by emergency use information subject to the terms 
of any authorization issued by the Food and Drug Commissioner under 21 
U.S.C. 360bbb-3(a). This notice is being issued in accordance with 
section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 
U.S.C. 360bbb-3(b)(4).

DATES: This Notice and referenced HHS declaration are effective as of 
October 1, 2009.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD MSPH, Assistant 
Secretary for Preparedness and Response, Office of the Secretary, 
Department of Health and Human Services, 200 Independence Avenue, SW., 
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free 
number).

SUPPLEMENTARY INFORMATION: On September 23, 2008, former Secretary of 
Homeland Security, Michael Chertoff, 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, Bacillus anthracis, although 
there is no current domestic emergency involving anthrax, no current 
heightened risk of an anthrax attack, and no credible information 
indicating an imminent threat of an attack involving Bacillus 
anthracis. Pursuant to section 564(b) of the Federal Food, Drug and 
Cosmetic Act, 21 U.S.C. 360bbb-3(b), and on the basis of such 
determination, on October 1, 2008, former Secretary of Health and Human 
Services, Michael O. Leavitt, 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 21 U.S.C. 360bbb-3(a).\1\ Pursuant to 
section 564(b)(2)(B) of the Federal Food, Drug and Cosmetic Act, 21 
U.S.C. 360bbb-3(b), and on the basis of Secretary Chertoff's September 
23, 2008 determination, I hereby renew former Secretary Leavitt's 
October 1, 2008 declaration of 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 21 U.S.C. 360bbb-3(a). I am issuing this 
notice in accordance with section 564(b)(4) of the Federal Food, Drug, 
and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).
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    \1\ Pursuant to section 564(b)(4) of the FFDCA, notice of the 
determination by the Secretary, DHS, and the declaration by the 
Secretary, HHS, was provided at 73 FR 58242 (October 6, 2008).

    Dated: October 1, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-24086 Filed 10-1-09; 4:15 pm]
BILLING CODE 4150-37-P

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