Federal RegisterVol 74_ No 241Thursday_ December 17_ 2009

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					                                                     66988                     Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Notices

                                                        Dated: December 11, 2009.                              Date: January 27–28, 2010.                             Date and Time: The public workshop
                                                                                                               Time: 8 a.m. to 5 p.m.                              will be held on Wednesday, March 3,
                                                     Jennifer Spaeth,
                                                                                                               Agenda: To review and evaluate grant                2010, from 8 a.m. to 5 p.m., and
                                                     Director, Office of Federal Advisory                    applications.
                                                     Committee Policy.                                         Place: National Institutes of Health, 6701
                                                                                                                                                                   Thursday, March 4, 2010, from 8 a.m. to
                                                     [FR Doc. E9–30022 Filed 12–16–09; 8:45 am]              Rockledge Drive, Bethesda, MD 20892.                  4:35 p.m.
                                                     BILLING CODE 4140–01–P                                  (Virtual Meeting.)                                       Location: The public workshop will
                                                                                                               Contact Person: Maqsood A. Wani, DVM,               be held at The Wyndham Orlando
                                                                                                             PhD, Scientific Review Officer, Center for            Resort, 8001 International Dr., Orlando,
                                                     DEPARTMENT OF HEALTH AND                                Scientific Review, National Institutes of             FL 32819, 407–351–2420.
                                                                                                             Health, 6701 Rockledge Drive, Room 2114,
                                                     HUMAN SERVICES                                          MSC 7814, Bethesda, MD 20892. 301–435–                   Attendees are responsible for their
                                                                                                             2270, wanimaqs@csr.nih.gov.                           own accommodations. To make
                                                     National Institutes of Health                                                                                 reservations at the Wyndham Orlando
                                                                                                             (Catalogue of Federal Domestic Assistance
                                                                                                             Program Nos. 93.306, Comparative Medicine;            Resort, at the discounted rate of $149
                                                     Center for Scientific Review; Notice of
                                                                                                             93.333, Clinical Research; 93.306, 93.333,            per night (plus applicable taxes), contact
                                                     Closed Meetings
                                                                                                             93.337, 93.393–93.396, 93.837–93.844,                 the hotel before February 10, 2010,
                                                       Pursuant to section 10(d) of the                      93.846–93.878, 93.892, 93.893, National               citing ‘‘SoCRA’’. The hotel’s Web site is:
                                                     Federal Advisory Committee Act, as                      Institutes of Health, HHS)                            http://www.wyndham.com/hotels/
                                                     amended (5 U.S.C. App.), notice is                        Dated: December 10, 2009.                           MCOWD/main.wnt. (FDA has verified
                                                     hereby given of the following meetings.                 Jennifer Spaeth,                                      the Web site address, but is not
                                                       The meetings will be closed to the                    Director, Office of Federal Advisory                  responsible for subsequent changes to
                                                     public in accordance with the                           Committee Policy.                                     the Web site after this document
                                                     provisions set forth in sections                        [FR Doc. E9–30021 Filed 12–16–09; 8:45 am]            publishes in the Federal Register.)
                                                     552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              BILLING CODE 4140–01–P                                   Contacts:
                                                     as amended. The grant applications and                                                                           For FDA: C. Stewart Watson, Food
                                                     the discussions could disclose                                                                                and Drug Administration, 555
                                                     confidential trade secrets or commercial                DEPARTMENT OF HEALTH AND                              Winderley Pl., suite 200, Maitland, FL
                                                     property such as patentable material,                   HUMAN SERVICES                                        32751, 407–475–4756, FAX: 407–475–
                                                     and personal information concerning                                                                           4768, e-mail:
                                                     individuals associated with the grant                   Food and Drug Administration                          charles.watson@fda.hhs.gov.
                                                     applications, the disclosure of which                   [Docket No. FDA–2009–N–0664]                             For SoCRA: SoCRA Administrative
                                                     would constitute a clearly unwarranted                                                                        Office, 530 West Butler Ave., suite 109,
                                                     invasion of personal privacy.                           Food and Drug Administration Clinical                 Chalfont, PA 18914, 1–800–762–7292 or
                                                       Name of Committee: Center for Scientific              Trial Requirements, Regulations,                      215–822–8644, FAX: 215–822–8633, e-
                                                     Review Special Emphasis Panel, Member                   Compliance and Good Clinical                          mail: SoCRAmail@aol.com.
                                                     Conflict: Auditory Neuroscience.                        Practices; Public Workshop                               Registration: You are encouraged to
                                                       Date: January 19–20, 2010.
                                                       Time: 8 a.m. to 5 p.m.                                AGENCY:    Food and Drug Administration,              register by February 26, 2010. Seats are
                                                       Agenda: To review and evaluate grant                  HHS.                                                  limited; please submit your registration
                                                     applications.                                           ACTION:   Notice of public workshop.                  as soon as possible. Workshop space
                                                       Place: National Institutes of Health, 6701                                                                  will be filled in order of receipt of
                                                     Rockledge Drive, Bethesda, MD 20892.                    SUMMARY: The Food and Drug                            registration. Registration will close
                                                     (Virtual Meeting.)                                      Administration (FDA) Florida District,                when the workshop is filled. Those
                                                       Contact Person: John Bishop, PhD,                     in cosponsorship with The Society of                  accepted into the workshop will receive
                                                     Scientific Review Officer, Center for                   Clinical Research Associates, Inc.                    confirmation. Registration at the site is
                                                     Scientific Review, National Institutes of
                                                     Health, 6701 Rockledge Drive, Room 5182,
                                                                                                             (SoCRA), is announcing a public                       not guaranteed but may be possible on
                                                     MSC 7844, Bethesda, MD 20892, (301) 408–                workshop entitled ‘‘FDA Clinical Trial                a space available basis on the day of the
                                                     9664, bishopj@csr.nih.gov.                              Requirements, Regulations, Compliance                 public workshop beginning at 8 a.m.
                                                       Name of Committee: Center for Scientific              and GCP.’’ This 2-day public workshop                 The SoCRA registration fees cover the
                                                     Review Special Emphasis Panel, PAR–07–                  is intended to provide information                    cost of the workshop facilities,
                                                     420: Lymphatic Biology in Health and                    about FDA clinical trial requirements to              materials, breaks, and lunches. The cost
                                                     Disease.                                                the regulated industry.                               of registration is as follows:

                                                                                                                       COST OF REGISTRATION
                                                                                              Affiliation                                                                        Fee

                                                     FDA Employee                                                                                                                                  Fee waived

                                                     Federal Government (SoCRA Member)                                                                                                                $450.00
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                                                     Federal Government (Non-SoCRA Member)                                                                                                            $525.00

                                                     Non-Federal Government (SoCRA Member)                                                                                                            $575.00

                                                     Non-Federal Government (Non-SoCRA Member)                                                                                                        $650.00



                                                       If you need special accommodations                    Stewart Watson at least 7 days in                       Registration instructions: To register,
                                                     due to a disability, please contact C.                  advance of the meeting.                               please submit your name, affiliation,



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                                                                               Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Notices                                              66989

                                                     mailing address, phone/fax number, and                    Dated: December 10, 2009.                           year term of approval for this
                                                     e-mail, along with a check or money                     David Horowitz,                                       information collection activity.
                                                     order payable to SoCRA. Please mail                     Assistant Commissioner for Policy.                      Comments are invited on: (1) The
                                                     your payment to: SoCRA Administrative                   [FR Doc. E9–30017 Filed 12–16–09; 8:45 am]            need for the collection of information
                                                     Office, 530 West Butler Ave., suite 109,                BILLING CODE 4160–01–S                                for the performance of the functions of
                                                     Chalfont, PA 18914. Registration may be
                                                                                                                                                                   the agency; (2) the accuracy of the
                                                     downloaded on the SoCRA Web site at
                                                                                                                                                                   agency’s burden estimates; (3) ways to
                                                     http://www.socra.org. (FDA has verified                 DEPARTMENT OF THE INTERIOR
                                                     the Web site address, but is not                                                                              enhance the quality, utility and clarity
                                                     responsible for subsequent changes to                                                                         of the information collection; and (4)
                                                                                                             Office of Surface Mining Reclamation                  ways to minimize the information
                                                     the Web site after this document                        and Enforcement
                                                     publishes in the Federal Register.)                                                                           collection burden on respondents, such
                                                                                                             Notice of Proposed Information                        as use of automated means of collection
                                                       Other payment forms accepted are
                                                                                                             Collection for 1029–0089                              of the information. A summary of the
                                                     major credit cards (VISA, MasterCard, or
                                                                                                                                                                   public comments will accompany
                                                     American Express only). For more                        AGENCY: Office of Surface Mining
                                                     information on the meeting, or for                                                                            OSM’s submission of the information
                                                                                                             Reclamation and Enforcement.                          collection request to OMB.
                                                     questions on registration, contact the                  ACTION: Notice and request for
                                                     SoCRA Administrative Office (see                                                                                Before including your address, phone
                                                                                                             comments.
                                                     Contact).                                                                                                     number, e-mail address, or other
                                                                                                             SUMMARY: In compliance with the                       personal identifying information in your
                                                     SUPPLEMENTARY INFORMATION:      The                     Paperwork Reduction Act of 1995, the                  comment, you should be aware that
                                                     public workshop helps fulfill the                       Office of Surface Mining Reclamation                  your entire comment—including your
                                                     Department of Health and Human                          and Enforcement (OSM) is announcing                   personal identifying information—may
                                                     Services’ and FDA’s important mission                   its intention to request renewed                      be made publicly available at any time.
                                                     to protect the public health. The public                authority for the following collection of             While you can ask us in your comment
                                                     workshop will provide those engaged in                  information: 30 CFR Part 702 regarding
                                                     FDA-regulated (human) clinical trials                                                                         to withhold your personal identifying
                                                                                                             the exemption of coal extraction                      information from public review, we
                                                     with information on a number of topics                  incidental to the extraction of other
                                                     concerning FDA requirements related to                                                                        cannot guarantee that we will be able to
                                                                                                             minerals. This information collection                 do so.
                                                     informed consent, clinical investigation                activity was previously approved by the
                                                     requirements, institutional review board                Office of Management and Budget                         Title: 30 CFR Part 702 Exemption for
                                                     investigations, electronic record                       (OMB), and assigned clearance number                  Coal Extraction Incidental to the
                                                     requirements, and investigator initiated                1029–0089.                                            Extraction of Other Minerals.
                                                     research. Topics for discussion include                                                                         OMB Control Number: 1029–0089.
                                                                                                             DATES: Comments on the proposed
                                                     the following: (1) What FDA Expects in
                                                     a Pharmaceutical Clinical Trial, (2)                    information collection must be received                 Summary: This part implements the
                                                     Adverse Event Reporting, (3) Part 11                    by February 16, 2010, to be assured of                requirement in Section 701(28) of the
                                                     Compliance—electronic signatures, (4)                   consideration.                                        Surface Mining Control and
                                                     Informed Consent Regulations, (5) IRB                   ADDRESSES: Comments may be mailed to                  Reclamation Act of 1977 (SMCRA),
                                                     Regulations and FDA Inspections, (6)                    John Trelease, Office of Surface Mining               which grants an exemption from the
                                                     Keeping Informed and Working                            Reclamation and Enforcement, 1951                     requirements of SMCRA to operators
                                                     Together, (7) FDA Conduct of Clinical                   Constitution Ave., NW., Room 202–SIB,                 extracting not more than 162⁄3
                                                     Investigator Inspections, (8) Meetings                  Washington, DC 20240. Comments may                    percentage tonnage of coal incidental to
                                                     with the FDA, (9) Investigator Initiated                also be submitted electronically to                   the extraction of other minerals. This
                                                     Research, (10) Medical Device Aspects                   jtrelease@osmre.gov.                                  information will be used by the
                                                     of Clinical Research, (11) Working with                 FOR FURTHER INFORMATION CONTACT: To                   regulatory authorities to make that
                                                     FDA’s Center for Biologics Evaluation                   request a copy of the information                     determination.
                                                     and Research, (12) Ethical Issues in                    collection request and explanatory                      Bureau Form Number: None.
                                                     Subject Enrollment, (13) The Inspection                 information contact John Trelease, at
                                                     is Over—What Happens Next? Possible                     (202) 208–2783 or e-mail at the address                 Frequency of Collection: Once and
                                                     FDA Compliance Actions.                                 provided above.                                       annually thereafter.
                                                        FDA has made education of the drug                   SUPPLEMENTARY INFORMATION: OMB                          Description of Respondents:
                                                     and device manufacturing community a                    regulations at 5 CFR 1320, which                      Producers of coal and other minerals
                                                     high priority to help ensure the quality                implement provisions of the Paperwork                 and State regulatory authorities.
                                                     of FDA-regulated drugs and devices.                     Reduction Act of 1995 (Pub. L. 104–13),                 Total Annual Responses: 120.
                                                     The public workshop helps to achieve                    require that interested members of the
                                                     objectives set forth in section 406 of the              public and affected agencies have an                    Total Annual Burden Hours: 535.
                                                     FDA Modernization Act of 1997 (21                       opportunity to comment on information                   Total Non-wage Costs: $200.
                                                     U.S.C. 393) which includes working                      collection and recordkeeping activities
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                                                                                                                                                                     Dated: December 11, 2009.
                                                     closely with stakeholders and                           [see 5 CFR 1320.8 (d)]. This notice
                                                                                                                                                                   Dennis G. Rice,
                                                     maximizing the availability and clarity                 identifies an information collection that
                                                     of information to stakeholders and the                  OSM will be submitting to OMB for                     Acting Chief, Division of Regulatory Support.
                                                     public. The public workshop also is                     approval. This collection is contained in             [FR Doc. E9–29933 Filed 12–16–09; 8:45 am]
                                                     consistent with the Small Business                      30 CFR part 702—Exemption for Coal                    BILLING CODE 4310–05–M
                                                     Regulatory Enforcement Fairness Act of                  Extraction Incidental to the Extraction
                                                     1996 (Public Law 104–121), as outreach                  of Other Minerals. The information
                                                     activities by Government agencies to                    submitted by respondents is required to
                                                     small businesses.                                       obtain a benefit. OSM will request a 3-


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