Advisory Committees; Filing of Closed Meeting Reports, 2864-2865 [2010-807]

Download as PDF jlentini on DSKJ8SOYB1PROD with NOTICES 2864 Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices data on positions in to-be-issued Treasury coupon securities, mainly the trading on a when-issued delivery basis. Current Actions: On November 2, 2009, the Federal Reserve published a notice in the Federal Register (74 FR 56633) requesting public comment for 60 days on the extension, with revision, of the FR 2004. The comment period for this notice expired on January 4, 2010. The Federal Reserve did not receive any comments. The revisions will be implemented as proposed. Final approval under OMB delegated authority of the implementation of the following survey: Report title: Central Bank Survey of Foreign Exchange and Derivatives Market Activity. Agency form number: FR 3036. OMB control number: 7100–0285. Frequency: One-time. Reporters: Financial institutions that serve as intermediaries in the wholesale foreign exchange and derivatives market and dealers. Estimated annual reporting hours: 2,165 hours. Estimated average hours per response: Turnover survey, 55 hours; outstandings survey, 60 hours. Number of respondents: Turnover survey, 35; outstandings survey, 4. General description of report: This information collection is voluntary (12 U.S.C. 225a and 263) and is given confidential treatment (5 U.S.C. 552(b)(4)). Abstract: The FR 3036 is the U.S. part of a global data collection that is conducted by central banks once every three years. More than 50 central banks plan to conduct the survey in 2010. The Bank for International Settlements compiles national data from each central bank to produce global market statistics. The Federal Reserve System and other government agencies use the survey to monitor activity in the foreign exchange and derivatives markets. Respondents use the published data to gauge their market share. Current Actions: On November 2, 2009, the Federal Reserve published a notice in the Federal Register (74 FR 56633) requesting public comment for 60 days on the implementation of the FR 3036. The comment period for this notice expired on January 4, 2010. The Federal Reserve did not receive any comments. The survey will be implemented as proposed. Board of Governors of the Federal Reserve System, January 12, 2010. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 2010–751 Filed 1–15–10; 8:45 am] BILLING CODE 6210–01–P VerDate Nov<24>2008 16:28 Jan 15, 2010 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Biodefense Science Board: Notification of Public Teleconference AGENCY: Department of Health and Human Services, Office of the Secretary. ACTION: Notice. SUMMARY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Biodefense Science Board (NBSB) will hold a teleconference meeting. The meeting is open to the public. Pre-registration is NOT required, however, individuals who wish to participate in the public comment session should e-mail NBSB@HHS.GOV to RSVP. DATES: The meeting will be held on February 10, 2010 from 2 p.m. to 4 p.m. ET. ADDRESSES: The meeting will occur by teleconference. To attend, call 1–866– 395–4129, pass-code ‘‘ASPR.’’ Please call 15 minutes prior to the beginning of the conference call to facilitate attendance. FOR FURTHER INFORMATION: E-mail: NBSB@HHS.GOV Pursuant to section 319M of the Public Health Service Act (42 U.S.C. 247d–7f) and section 222 of the Public Health Service Act (42 U.S.C. 217a), the Department of Health and Human Services established the National Biodefense Science Board. The Board shall provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to the Department of Health and Human Services regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. The Board may also provide advice and guidance to the Secretary on other matters related to public health emergency preparedness and response. The Board will discuss and consider recommendations from the National Biodefense Science Board’s Medical Countermeasure Markets and Sustainability Working Group report titled ‘‘Inventory of Issues Constraining or Enabling Industry Involvement in Medical Countermeasure Efforts.’’ Members of the public are invited to attend by teleconference via a toll-free call-in phone number. The teleconference will be operator assisted to allow the public the opportunity to provide comments to the Board. Public participation will be limited to time and space available. Public comments will SUPPLEMENTARY INFORMATION: PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 be limited to no more than 3 minutes per speaker. To be placed on the public comment list, notify the operator when you join the teleconference. Public comments received by close of business one week prior to each teleconference will be distributed to the NBSB in advance. Submit comments via e-mail to NBSB@HHS.GOV, with ‘‘NBSB Public Comment’’ as the subject line. A draft agenda and any additional materials/agendas will be posted on the NBSB Web site (https://www.hhs.gov/ aspr/omsph/nbsb/) prior to the meeting. Dated: January 11, 2010. Nicole Lurie, Assistant Secretary for Preparedness and Response. [FR Doc. 2010–778 Filed 1–15–10; 8:45 am] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2009. ADDRESSES: Copies are available from the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301–827– 6860. FOR FURTHER INFORMATION CONTACT: Teresa L. Hays, Committee Management Officer, Advisory Committee Oversight and Management Staff (HF–4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1220. SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app. 1) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2008, through September 30, 2009: Center for Biologics Evaluation and Research: Blood Products Advisory Committee, E:\FR\FM\19JAN1.SGM 19JAN1 Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices Vaccines and Related Biological Products Advisory Committee, Center for Drug Evaluation and Research: Anesthetic and Life Support Drugs Advisory Committee, Antiviral Drugs Advisory Committee, Endocrinologic and Metabolic Drugs Advisory Committee, Center for Devices and Radiological Health: Medical Devices Advisory Committee (consisting of report for Circulatory System Devices Panel). Annual reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday at the following locations: 1. The Library of Congress, Madison Bldg., Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE., rm. 133, Washington, DC; and 2. The Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Dated: January 13, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–807 Filed 1–15–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0488] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs; Adverse Event Reports on Forms FDA 1932, 1932a, and 2301 AGENCY: Food and Drug Administration, HHS. jlentini on DSKJ8SOYB1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 18, 2010. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of VerDate Nov<24>2008 16:28 Jan 15, 2010 Jkt 220001 2865 The electronic versions of Forms FDA 1932 and 1932a have been incorporated into the agency-wide information collection (MedWatchPlusPortal and Rational Questionnaire) that was announced for public comment in the Federal Register on October 23, 2008 (73 FR 63153). MedWatchPlus Portal and Rational Questionnaire is part of a new electronic system for collecting, FOR FURTHER INFORMATION CONTACT: submitting, and processing adverse Denver Presley, Jr. Office of Information event reports and other safety Management (HFA–710), Food and Drug information for all FDA-regulated Administration, 5600 Fishers Lane, products. In the Federal Register of May Rockville, MD 20857, 301–796–3793. 20, 2009 (74 FR 23721), FDA announced the submission for OMB review and SUPPLEMENTARY INFORMATION: In clearance of the electronic data compliance with 44 U.S.C. 3507, FDA collection using MedWatchPlus Portal has submitted the following proposed and Rational Questionnaire. collection of information to OMB for Burden hours for the electronic review and clearance. versions of these forms were included as Records and Reports Concerning part of the MedWatchPlus Portal and Experience With Approved New Rationale Questionnaire information Animal Drugs; Adverse Event Reports collection approved under OMB control on Forms FDA 1932, 1932a, and 2301 number 0910–0645. It is estimated that, (OMB Control Number 0910–0284)— during the first 3 years that the Extension MedWatchPlus Portal is in use, half of the reports will be submitted in paper Section 512(l) of the Federal Food, format and half will be submitted Drug, and Cosmetic Act (the act) (21 electronically. In order to avoid double U.S.C. 360b(l) and § 514.80 (21 CFR counting, an estimated 50 percent of 514.80) of FDA regulations require applicants of approved new animal drug total annual responses for FDA Form 1932 (404) and FDA Form 1932a (81.5) applications (NADAs) and abbreviated are counted here as part of OMB Control new animal drug applications No. 0910–0284 for the paper versions of (ANADAs) to report adverse drug experiences and product/manufacturing Forms FDA 1932 and 1932a, and an estimated 50 percent of the total annual defects (see § 514.80(b)). responses (404) and (81.5) for Form FDA This continuous monitoring of 1932 and FDA Form 1932a respectively, approved NADAs and ANADAs affords are counted as part of OMB Control No. the primary means by which FDA 0910–0645 for the electronic reporting obtains information regarding potential of these adverse reports using the problems with the safety and efficacy of MedWatchPlus Portal. marketed approved new animal drugs as In the Federal Register of October 15, well as potential product/manufacturing 2009 (74 FR 52967), FDA published a problems. Post-approval marketing 60-day notice requesting public surveillance is important because data comment on the proposed collection of previously submitted to FDA may not be information. No comments were adequate, as animal drug effects can received. change over time and less apparent In a separate 30-day notice, FDA effects may take years to manifest. requested public comment on data Under § 514.80(d), an applicant must elements associated with revisions to report adverse drug experiences and Forms FDA 1932 and 1932a (both paper product/manufacturing defects on Form and electronic) under revised OMB FDA 1932, ‘‘Veterinary Adverse Drug Control No. 0910–0645 (November 20, Reaction, Lack of Effectiveness, Product 2009, 74 FR 60265). The agency plans Defect Report.’’ Periodic drug experience to give companies time to accommodate reports and special drug experience the revisions since the proposed reports must be accompanied by a revisions may require changes to completed Form FDA 2301, validated databases. The agency plans to ‘‘Transmittal of Periodic Reports and provide a transition period for Promotional Material for New Animal respondents until September 30, 2010, Drugs’’ (see § 514.80(d)). Form FDA during which the current FDA Form 1932a, ‘‘Veterinary Adverse Drug 1932 (version dated 01/2007— approved Reaction, Lack of Effectiveness or under this OMB Control No. 0910–0284) Product Defect Report’’ allows for will be accepted as well as the revised voluntary reporting of adverse drug FDA Form 1932 approved under revised experiences or product/manufacturing OMB Control No. 0910–0645. After the defects. transition period, Form FDA 2301 will Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0284. Also include the FDA docket number found in brackets in the heading of this document PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2864-2865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Advisory Committees; Filing of Closed Meeting Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that, as 
required by the Federal Advisory Committee Act, the agency has filed 
with the Library of Congress the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2009.

ADDRESSES: Copies are available from the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, 301-827-6860.

FOR FURTHER INFORMATION CONTACT: Teresa L. Hays, Committee Management 
Officer, Advisory Committee Oversight and Management Staff (HF-4), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-1220.

SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory 
Committee Act (5 U.S.C. app. 1) and 21 CFR 14.60(d), FDA has filed with 
the Library of Congress the annual reports for the following FDA 
advisory committees that held closed meetings during the period October 
1, 2008, through September 30, 2009:
Center for Biologics Evaluation and Research:
    Blood Products Advisory Committee,

[[Page 2865]]

    Vaccines and Related Biological Products Advisory Committee,
Center for Drug Evaluation and Research:
    Anesthetic and Life Support Drugs Advisory Committee,
    Antiviral Drugs Advisory Committee,
    Endocrinologic and Metabolic Drugs Advisory Committee,
Center for Devices and Radiological Health:
    Medical Devices Advisory Committee (consisting of report for 
Circulatory System Devices Panel).
    Annual reports are available for public inspections between 9 a.m. 
and 4 p.m., Monday through Friday at the following locations:
    1. The Library of Congress, Madison Bldg., Newspaper and Current 
Periodical Reading Room, 101 Independence Ave. SE., rm. 133, 
Washington, DC; and
    2. The Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    Dated: January 13, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-807 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S

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