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,
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, firstname.lastname@example.org. 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
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 email@example.com.
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, firstname.lastname@example.org. 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
FDA Employee Fee waived
Federal Government (SoCRA Member) $450.00
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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
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 email@example.com. 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
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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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