Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment, 45402-45403 [2011-19064]

Download as PDF 45402 Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Rules and Regulations personnel to the presence of an inflatable restraint system. 8. It must be shown that the inflatable restraint will not impede rapid egress of the occupants 10 seconds after its deployment. 9. To comply with HIRF and lightning requirements, the inflatable restraint system is considered a critical system since its deployment could have a hazardous effect on the airplane. 10. It must be shown that the inflatable restraints will not release hazardous quantities of gas or particulate matter into the cabin. 11. The inflatable restraint system installation must be protected from the effects of fire such that no hazard to occupants will result. 12. There must be a means to verify the integrity of the inflatable restraint activation system before each flight or it must be demonstrated to reliably operate between inspection intervals. 13. A life limit must be established for appropriate system components. 14. Qualification testing of the internal firing mechanism must be performed at vibration levels appropriate for a general aviation airplane. Issued in Kansas City, Missouri, on July 21, 2011. Earl Lawrence, Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. 2011–19157 Filed 7–28–11; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No. FDA–2010–N–0002] Advisory Committee; Medical Imaging Drugs Advisory Committee; ReEstablishment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA) is announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA’s Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency’s list of standing advisory committees in FDA’s regulations. DATES: Effective date: This rule is effective August 5, 2011. Applicability date: Authority for the committee being established will end on May 18, 2013, unless the Commissioner of Food and Drugs (the Commissioner) formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation and Research, Food and Drug Administration, Division of Advisory Committee and Consultant Management, Bldg. 31, rm. 2417, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–9001, Fax: 301– 847–8533 or e-mail: MIDAC@fda.hhs.gov. SUMMARY: Under the Federal Advisory Committee Act of October 6, 1972 (Pub. L. 92–463 (5 U.S.C. app.2)); section 1004 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 394); and 21 CFR 14.40(b), FDA is announcing the establishment of the Medical Imaging Drugs Advisory Committee by the Commissioner. The Committee advises the Commissioner and designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology and makes SUPPLEMENTARY INFORMATION: DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection 19 CFR Part 102 Rules of Origin CFR Correction In Title 19 of the Code of Federal Regulations, Parts 0 to 140, revised as of April 1, 2011, on page 578, in § 102.20, in the table, the second entry for 8708.99 is removed. jlentini on DSK4TPTVN1PROD with RULES [FR Doc. 2011–19372 Filed 7–28–11; 8:45 am] BILLING CODE 1505–01–D VerDate Mar<15>2010 16:04 Jul 28, 2011 Jkt 223001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 appropriate recommendations to the Commissioner. The Medical Imaging Drugs Advisory Committee will be composed of a core of 12 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of nuclear medicine, radiology, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumeroriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Elsewhere in this issue of the Federal Register, FDA is publishing notices requesting nominations for membership of members as well as a consumer and industry representative on this committee. Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary and are not in the public interest as this final rule merely adds the name of the Medical Imaging Drugs Advisory Committee, already established by charter, to the list of standing advisory committees in 21 CFR 14.100. Therefore the Agency is amending 21 CFR 14.100(a) as set forth below. List of Subjects in 21 CFR Part 14 Administrative practice and procedure, Advisory committees, Color additives, Drugs, Radiation protection. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows: PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 1. The authority citation for 21 CFR part 14 continues to read as follows: ■ Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451–1461, 21 U.S.C. 41–50, 141–149, 321– 394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; Pub. L. 108–155. E:\FR\FM\29JYR1.SGM 29JYR1 Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Rules and Regulations 45403 2. Section 14.100 is amended by revising paragraph (c)(15) to read as follows: may call the Federal relay service tollfree at 1–800–877–8339 and ask to be connected to 202–326–4024.) DEPARTMENT OF THE TREASURY § 14.100 List of standing advisory committees. SUPPLEMENTARY INFORMATION: Section 4011 of ERISA requires certain underfunded plans to give an annual notice to participants of plan funding status and the limits on PBGC’s guarantee. PBGC’s implementing regulations are at 29 CFR part 4011. Section 501 of the Pension Protection Act of 2006, Public Law 109–280 (2006), repealed section 4011 of ERISA for plan years beginning after 2006 and replaced the disclosure requirement under that section with a disclosure requirement under Title I of ERISA (under the jurisdiction of the Department of Labor). On January 22, 2007 (at 72 FR 2615), PBGC amended its regulation part 4011 to reflect that statutory change. Executive Order 13563 on Improving Regulation and Regulatory Review, among other requirements, directs agencies to periodically review regulations to remove those that are obsolete. As a result of that review, PBGC is issuing this final rule to remove part 4011 from its regulations. Because this rule simply removes an obsolete regulation as a result of a statutory change, PBGC has determined that notice and public comment on this amendment are unnecessary. Further, for this same reason, PBGC finds good cause for making this final rule effective immediately. The PBGC has determined that this action is not a ‘‘significant regulatory action’’ under the criteria set forth in Executive Order 12866. Because no general notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2). 31 CFR Parts 1010 and 1022 ■ * * * * * (c) * * * (15) Medical Imaging Drugs Advisory Committee. (i) Date established: May 18, 2011. (ii) Function: Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology. * * * * * Dated: July 22, 2011. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2011–19064 Filed 7–28–11; 8:45 am] BILLING CODE 4160–01–P PENSION BENEFIT GUARANTY CORPORATION 29 CFR Part 4011 RIN 1212–AB12 Disclosure to Participants Pension Benefit Guaranty Corporation. ACTION: Final rule. AGENCY: This final rule removes PBGC’s regulation on Disclosure to Participants. The regulation is obsolete as a result of the Pension Protection Act of 2006. Prior to the effective date of the statutory change, section 4011 of ERISA required certain underfunded plans to notify participants of plan funding status and the limits on the Pension Benefit Guaranty Corporation’s guarantee. The Pension Protection Act of 2006 repealed section 4011 for plan years beginning after 2006 and replaced the disclosure requirement under that section with a disclosure requirement under Title I of ERISA. This rule is consistent with Executive Order 13563 on Improving Regulation and Regulatory Review. DATES: Effective Date: July 29, 2011. FOR FURTHER INFORMATION CONTACT: Catherine B. Klion (Klion.Catherine@pbgc.gov), Manager, Regulatory and Policy Division, Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202–326–4024. (TTY/TDD users jlentini on DSK4TPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 16:04 Jul 28, 2011 Jkt 223001 PART 4011—[REMOVED] For the reasons given above, and under the authority of 29 U.S.C. 1311, PBGC amends 29 CFR Chapter XL by removing part 4011. ■ Issued in Washington, DC, this 25th day of July 2011. Joshua Gotbaum, Director, Pension Benefit Guaranty Corporation. [FR Doc. 2011–19182 Filed 7–28–11; 8:45 am] BILLING CODE 7709–01–P PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 Financial Crimes Enforcement Network RIN 1506–AB07 Bank Secrecy Act Regulations— Definitions and Other Regulations Relating to Prepaid Access Financial Crimes Enforcement Network (‘‘FinCEN’’), Treasury. ACTION: Final rule. AGENCY: FinCEN is issuing this final rule to amend the Bank Secrecy Act (‘‘BSA’’) regulations applicable to Money Services Businesses (‘‘MSB’’) with regard to stored value. More specifically, this final rule amends the regulations by: renaming ‘‘stored value’’ as ‘‘prepaid access’’ and defining that term; deleting the terms ‘‘issuer’’ and ‘‘redeemer’’ of stored value; imposing suspicious activity reporting, customer information and transaction information recordkeeping requirements on both providers and sellers of prepaid access, and, additionally, a registration requirement on providers only; and exempting certain categories of prepaid access products and services posing lower risks of money laundering and terrorist financing from certain requirements. These changes address regulatory gaps that have resulted from the proliferation of prepaid innovations over the last twelve years and their increasing use as an accepted payment method. DATES: Effective Date: This rule is effective September 27, 2011. Compliance Date: The compliance date for 31 CFR 1022.380 is January 29, 2012. FOR FURTHER INFORMATION CONTACT: FinCEN, Regulatory Policy and Programs Division at (800) 949–2732 and select Option 1. SUPPLEMENTARY INFORMATION: SUMMARY: I. Statutory and Regulatory Background A. In General The BSA, Titles I and II of Public Law 91–508, as amended, codified at 12 U.S.C. 1829b and 1951–1959, and 31 U.S.C. 5311–5314 and 5316–5332, authorizes the Secretary of the Treasury (the ‘‘Secretary’’) to issue regulations requiring financial institutions to keep records and file reports that the Secretary determines ‘‘have a high degree of usefulness in criminal, tax, or regulatory investigations or proceedings, or in the conduct of intelligence or counterintelligence matters, including analysis to protect against international E:\FR\FM\29JYR1.SGM 29JYR1

Agencies

[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Rules and Regulations]
[Pages 45402-45403]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2010-N-0002]


Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-
Establishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the re-
establishment of the Medical Imaging Drugs Advisory Committee in FDA's 
Center for Drug Evaluation and Research. This rule amends the current 
language for the Medical Imaging Drugs Advisory Committee in the 
Agency's list of standing advisory committees in FDA's regulations.

DATES: Effective date: This rule is effective August 5, 2011. 
Applicability date: Authority for the committee being established will 
end on May 18, 2013, unless the Commissioner of Food and Drugs (the 
Commissioner) formally determines that renewal is in the public 
interest.

FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, Division of Advisory 
Committee and Consultant Management, Bldg. 31, rm. 2417, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-
847-8533 or e-mail: MIDAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the Federal Advisory Committee Act of 
October 6, 1972 (Pub. L. 92-463 (5 U.S.C. app.2)); section 1004 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 394); and 21 CFR 
14.40(b), FDA is announcing the establishment of the Medical Imaging 
Drugs Advisory Committee by the Commissioner. The Committee advises the 
Commissioner and designee in discharging responsibilities as they 
relate to helping to ensure safe and effective drugs for human use and, 
as required, any other product for which the Food and Drug 
Administration has regulatory responsibility. The Committee reviews and 
evaluates data concerning the safety and effectiveness of marketed and 
investigational human drug products for use in diagnostic and 
therapeutic procedures using radioactive pharmaceuticals and contrast 
media used in diagnostic radiology and makes appropriate 
recommendations to the Commissioner.
    The Medical Imaging Drugs Advisory Committee will be composed of a 
core of 12 voting members including the Chair. Members and the Chair 
are selected by the Commissioner or designee from among authorities 
knowledgeable in the fields of nuclear medicine, radiology, 
epidemiology or statistics, and related specialties. Members will be 
invited to serve for overlapping terms of up to 4 years. Almost all 
non-Federal members of this committee serve as Special Government 
Employees. The core of voting members may include one technically 
qualified member, selected by the Commissioner or designee, who is 
identified with consumer interests and is recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons. In addition to the voting members, the Committee may include 
one non-voting member who is identified with industry interests.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
notices requesting nominations for membership of members as well as a 
consumer and industry representative on this committee.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), 
the agency finds good cause to dispense with notice and public comment 
procedures and to proceed to an immediate effective date on this rule. 
Notice and public comment and a delayed effective date are unnecessary 
and are not in the public interest as this final rule merely adds the 
name of the Medical Imaging Drugs Advisory Committee, already 
established by charter, to the list of standing advisory committees in 
21 CFR 14.100.
    Therefore the Agency is amending 21 CFR 14.100(a) as set forth 
below.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority:  5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155.

[[Page 45403]]


0
2. Section 14.100 is amended by revising paragraph (c)(15) to read as 
follows:


Sec.  14.100  List of standing advisory committees.

* * * * *
    (c) * * *
    (15) Medical Imaging Drugs Advisory Committee.
    (i) Date established: May 18, 2011.
    (ii) Function: Reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in diagnostic and therapeutic procedures using radioactive 
pharmaceuticals and contrast media used in diagnostic radiology.
* * * * *

    Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19064 Filed 7-28-11; 8:45 am]
BILLING CODE 4160-01-P

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