Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus, 25273-25274 [2013-10055]

Download as PDF Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Notices pmangrum on DSK3VPTVN1PROD with NOTICES compliance management system should ensure continuing compliance with applicable federal and state laws, rules and regulations, as well as internal policies and procedures. Banks should maintain adequate oversight of deposit advance programs and adequate quality control over those products and services to minimize exposure to potential significant financial loss, reputation damage, and supervisory action. Management should provide the appropriate oversight and allocate sufficient qualified staff to monitor deposit advance programs. Results of oversight activities should be reported periodically to the financial institution’s board of directors or designated committee, including identified weaknesses, which should be documented and promptly addressed. Third-Party Relationships: Because third-party relationships are important in assessing a bank’s overall risk profile, the FDIC’s primary supervisory concern in reviewing a bank’s relationships with third parties is whether the bank is assuming more risk than it can identify, monitor, and manage. Management should allocate sufficient qualified staff to monitor for significant third-party relationships, excessive usage by borrowers, and excessive risk taking by the bank. Therefore, examiners will review the risks associated with all material third-party relationships and activities together with other bank risks. In certain high risk situations, examiners may conduct on-site thirdparty reviews under specific authorities granted to the FDIC. Responsible Products To Meet SmallDollar Credit Needs The FDIC recognizes the need for responsible small-dollar credit products among consumers. A number of banks are currently offering reasonably priced small-dollar loans at reasonable terms to their customers. The FDIC’s 2007 Affordable Small-Dollar Loan Guidelines (Guidelines) encourage insured institutions to offer small-dollar loan products that have affordable, reasonable interest rates with no or low fees and payments that reduce the principal balance of the loan.23 The Guidelines indicate that if structured properly, small-dollar loans can provide a safe and affordable means for borrowers to transition away from reliance on high-cost debt products. The FDIC conducted a two-year case study from 2007 to 2009 that demonstrated that safe and affordable small-dollar 23 See FDIC Financial Institutions Letter FIL–50– 2007, ‘‘Affordable Small-Dollar Loan Guidelines,’’ (June 19, 2007). VerDate Mar<15>2010 13:22 Apr 29, 2013 Jkt 229001 lending is feasible for banks and resulted in a template of important elements for such lending.24 The FDIC encourages banks to continue to offer these products, consistent with safety and soundness and other supervisory considerations, and encourages other banks to consider offering such products as well. Properly managed small-dollar loan products offered with reasonable terms and at a reasonable cost do not pose the same level of supervisory risk as deposit advance products. Dated at Washington, DC, this 25th day of April, 2013. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. 25273 proposed co-trustee; to acquire voting shares of the First State Bank Southwest 2010 Amended and Restated KSOP Plan and Trust, and thereby indirectly acquire voting shares of First Rushmore Bancorporation, Inc., Worthington, Minnesota, and First State Bank Southwest, Pipestone, Minnesota. Board of Governors of the Federal Reserve System, April 25, 2013. Margaret McCloskey Shanks, Deputy Secretary of the Board. [FR Doc. 2013–10115 Filed 4–29–13; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2013–10101 Filed 4–29–13; 8:45 am] BILLING CODE 6714–01–P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than May 15, 2013. A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street NE., Atlanta, Georgia 30309: 1. Harvey Alan Sorkin, Palm Beach Gardens, Florida; to acquire at least 10 percent of the voting shares of Floridian Community Holdings, Inc., and thereby indirectly acquire voting shares of Floridian Community Bank, Inc., both of Davie, Florida. B. Federal Reserve Bank of Minneapolis (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480–0291: 1. Connie Jean Lonneman, Adrian, Minnesota, individually and as 24 FDIC, ‘‘FDIC Model Safe Accounts Pilot Final Report’’, (April 2012). PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: SUMMARY: The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb–3(b)(4). On April 19, 2013, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus. On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. § 360bbb–3(b)(1), subject to the terms of any authorization issued under that section. The Secretary also specified that this declaration is a declaration of an emergency with respect to in vitro diagnostics as defined under the Public Readiness and Emergency Preparedness (PREP) Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008.1 DATES: The determination and declaration are effective April 19, 2013. FOR FURTHER INFORMATION CONTACT: Nicole Lurie, M.D., MSPH, Assistant 1 73 E:\FR\FM\30APN1.SGM FR 78362 (Dec. 22, 2008). 30APN1 25274 Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Notices 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: I. Background Under Section 564 of the FD&C Act, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA): (1) Authorizing the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product. Before an EUA may be issued, the Secretary of HHS must declare an emergency justifying the authorization based on one of four determinations: (1) A determination of a domestic emergency, or a significant potential for a domestic emergency, by the Secretary of Homeland Security; (2) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F–2 of the Public Health Service (PHS) Act 2 sufficient to affect national security or the health and security of United States citizens living abroad; (3) a determination of a military emergency, or a significant potential for a military emergency, by the Secretary of Defense; or (4) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents (see 21 U.S.C. 360bbb–3(b)(1)).3 Based on any of these four determinations, the Secretary of HHS may then declare that circumstances exist that justify the EUA, at which point the FDA Commissioner may issue an EUA if the criteria for issuance of an 2 42 U.S.C. 247d–6b. amended by the Pandemic and All-Hazards Preparedness Reauthorization Act, Public Law 113– 5, the Secretary may make determination of a public health emergency, or a significant potential for a public health emergency, under section 564 of the FD&C Act. The Secretary is no longer required to make a determination of a public health emergency in accordance with section 319 of the PHS Act, 42 U.S.C. 247d to support a determination or declaration made under section 564 of the FD&C Act. pmangrum on DSK3VPTVN1PROD with NOTICES 3 As VerDate Mar<15>2010 13:22 Apr 29, 2013 Jkt 229001 authorization under section 564 of the FD&C Act are met. The Centers for Disease Control and Prevention (CDC), HHS, requested that the FDA, HHS, issue an EUA for in vitro diagnostics for detection of the avian influenza A (H7N9) virus to allow the Department to take preparedness measures based on information currently available about the avian influenza A (H7N9) virus detected in China. The determination of a significant potential for a public health emergency, and the declaration that circumstances exist justifying emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus by the Secretary of HHS, as described below, enable the FDA Commissioner to issue an EUA for certain in vitro diagnostics for emergency use under section 564(a) of the FD&C Act, 21 U.S.C. 360bbb–3(a). II. Determination by the Secretary of Health and Human Services On April 19, 2013, pursuant to section 564(b)(1)(C) of the FD&C Act, 21 U.S.C. 360bbb–3(b)(1)(C), I determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus. III. Declaration of the Secretary of Health and Human Services Also on April 19, 2013, on the basis of my determination of a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus, I declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus pursuant to section 564 of the FD&C Act, 21 U.S.C. 360bbb–3, subject to the terms of any authorization issued under that section. I also specified that this declaration is a declaration of an emergency with respect to in vitro diagnostics as defined under the PREP Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008. Notice of the EUAs issued by the FDA Commissioner pursuant to this determination and declaration will be provided promptly in the Federal PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 Register as required under 21 U.S.C. 360bbb–3(h). Dated: April 19, 2013. Kathleen Sebelius, Secretary. [FR Doc. 2013–10055 Filed 4–29–13; 8:45 am] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Matthew Poore, Advanced Liquid Logic Inc.: Based on the report of an inquiry conducted by Advanced Liquid Logic Inc. (Liquid Logic), the Respondent’s admission, and additional analysis conducted by ORI, ORI found that Mr. Matthew Poore, former Technician, Liquid Logic, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), contract HHSN272200900030C. ORI found that the Respondent engaged in research misconduct by falsifying data that were included in one (1) presentation and one (1) report to NIAID and in laboratory records at Liquid Logic. ORI finds that Respondent knowingly and intentionally falsified reverse transcription-polymerase chain reaction (RT–PCR) results by reporting the results from previous experiments as the actual results, when the experiments had not been performed. Specifically: • In Liquid Logic laboratory documents, the Respondent falsified the RT–PCR results of human immunodeficiency virus (HIV) viral loads in whole blood patient samples by falsely changing previous results for two (2) samples from negative to positive and one (1) sample from positive to negative. The latter falsified sample result, changed from HIV positive to negative, was included in an April 1– June 30, 2012, quarterly report and a July 12, 2012, presentation to NIAID. • In Liquid Logic laboratory documents, the Respondent falsified the RT–PCR whole blood lysis results of testing samples as 100 and 200 HIV viral copies per milliliter, when the experiments were not performed by the Respondent. These falsified results were E:\FR\FM\30APN1.SGM 30APN1

Agencies

[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Pages 25273-25274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10055]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Determination and Declaration Regarding Emergency Use of in Vitro 
Diagnostics for Detection of the Avian Influenza A (H7N9) Virus

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Secretary of Health and Human Services (HHS) is issuing 
this notice pursuant to section 564(b) of the Federal Food, Drug, and 
Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3(b)(4). On April 19, 2013, the 
Secretary determined that there is a significant potential for a public 
health emergency that has a significant potential to affect national 
security or the health and security of United States citizens living 
abroad and that involves the avian influenza A (H7N9) virus.
    On the basis of this determination, she also declared that 
circumstances exist justifying the authorization of emergency use of in 
vitro diagnostics for detection of the avian influenza A (H7N9) virus 
pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. Sec.  360bbb-
3(b)(1), subject to the terms of any authorization issued under that 
section. The Secretary also specified that this declaration is a 
declaration of an emergency with respect to in vitro diagnostics as 
defined under the Public Readiness and Emergency Preparedness (PREP) 
Act Declaration for Pandemic Influenza Diagnostics, Personal 
Respiratory Protection Devices, and Respiratory Support Devices signed 
by then Secretary Michael Leavitt on December 17, 2008.\1\
---------------------------------------------------------------------------

    \1\ 73 FR 78362 (Dec. 22, 2008).

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DATES: The determination and declaration are effective April 19, 2013.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, M.D., MSPH, Assistant

[[Page 25274]]

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: 

I. Background

    Under Section 564 of the FD&C Act, the Commissioner of the Food and 
Drug Administration (FDA), acting under delegated authority from the 
Secretary of HHS, may issue an Emergency Use Authorization (EUA): (1) 
Authorizing the emergency use of an unapproved drug, an unapproved or 
uncleared device, or an unlicensed biological product; or (2) an 
unapproved use of an approved drug, approved or cleared device, or 
licensed biological product. Before an EUA may be issued, the Secretary 
of HHS must declare an emergency justifying the authorization based on 
one of four determinations: (1) A determination of a domestic 
emergency, or a significant potential for a domestic emergency, by the 
Secretary of Homeland Security; (2) the identification of a material 
threat by the Secretary of Homeland Security pursuant to section 319F-2 
of the Public Health Service (PHS) Act \2\ sufficient to affect 
national security or the health and security of United States citizens 
living abroad; (3) a determination of a military emergency, or a 
significant potential for a military emergency, by the Secretary of 
Defense; or (4) a determination by the Secretary that there is a public 
health emergency, or a significant potential for a public health 
emergency, that affects, or has a significant potential to affect, 
national security or the health and security of United States citizens 
living abroad, and that involves a biological, chemical, radiological, 
or nuclear agent or agents, or a disease or condition that may be 
attributable to such agent or agents (see 21 U.S.C. 360bbb-3(b)(1)).\3\
---------------------------------------------------------------------------

    \2\ 42 U.S.C. 247d-6b.
    \3\ As amended by the Pandemic and All-Hazards Preparedness 
Reauthorization Act, Public Law 113-5, the Secretary may make 
determination of a public health emergency, or a significant 
potential for a public health emergency, under section 564 of the 
FD&C Act. The Secretary is no longer required to make a 
determination of a public health emergency in accordance with 
section 319 of the PHS Act, 42 U.S.C. 247d to support a 
determination or declaration made under section 564 of the FD&C Act.
---------------------------------------------------------------------------

    Based on any of these four determinations, the Secretary of HHS may 
then declare that circumstances exist that justify the EUA, at which 
point the FDA Commissioner may issue an EUA if the criteria for 
issuance of an authorization under section 564 of the FD&C Act are met.
    The Centers for Disease Control and Prevention (CDC), HHS, 
requested that the FDA, HHS, issue an EUA for in vitro diagnostics for 
detection of the avian influenza A (H7N9) virus to allow the Department 
to take preparedness measures based on information currently available 
about the avian influenza A (H7N9) virus detected in China. The 
determination of a significant potential for a public health emergency, 
and the declaration that circumstances exist justifying emergency use 
of in vitro diagnostics for detection of the avian influenza A (H7N9) 
virus by the Secretary of HHS, as described below, enable the FDA 
Commissioner to issue an EUA for certain in vitro diagnostics for 
emergency use under section 564(a) of the FD&C Act, 21 U.S.C. 360bbb-
3(a).

II. Determination by the Secretary of Health and Human Services

    On April 19, 2013, pursuant to section 564(b)(1)(C) of the FD&C 
Act, 21 U.S.C. 360bbb-3(b)(1)(C), I determined that there is a 
significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of United States citizens living abroad and that involves the 
avian influenza A (H7N9) virus.

III. Declaration of the Secretary of Health and Human Services

    Also on April 19, 2013, on the basis of my determination of a 
significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of United States citizens living abroad and that involves the 
avian influenza A (H7N9) virus, I declared that circumstances exist 
justifying the authorization of emergency use of in vitro diagnostics 
for detection of the avian influenza A (H7N9) virus pursuant to section 
564 of the FD&C Act, 21 U.S.C. 360bbb-3, subject to the terms of any 
authorization issued under that section.
    I also specified that this declaration is a declaration of an 
emergency with respect to in vitro diagnostics as defined under the 
PREP Act Declaration for Pandemic Influenza Diagnostics, Personal 
Respiratory Protection Devices, and Respiratory Support Devices signed 
by then Secretary Michael Leavitt on December 17, 2008.
    Notice of the EUAs issued by the FDA Commissioner pursuant to this 
determination and declaration will be provided promptly in the Federal 
Register as required under 21 U.S.C. 360bbb-3(h).

     Dated: April 19, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-10055 Filed 4-29-13; 8:45 am]
BILLING CODE 4150-37-P