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50932 Federal Register / Vol. 71, No.

166 / Monday, August 28, 2006 / Notices

DEPARTMENT OF HEALTH AND Scientific Review, National Institutes of DATES: Only written comments and/or
HUMAN SERVICES Health, 6701 Rockledge Drive, Room 3206, application for a license, which are
MSC 7808, Bethesda, MD 20814–9692, (301) received by the NIH Office of
National Institutes of Health 435–1149, elzaataf@csr.nih.gov. Technology Transfer on or before
Name of Committee: Center for Scientific
October 27, 2006 will be considered.
Center for Scientific Review; Notice of Review Special Emphasis Panel; Program
Project Review: Cryo-Electon Microscopy. ADDRESSES: Requests for a copy of the
Closed Meetings
Date: September 25, 2006. patent application, inquiries, comments
Pursuant to section 10(d) of the Time: 1 p.m. to 5 p.m. and other materials relating to the
Federal Advisory Committee Act, as Agenda: To review and evaluate grant contemplated license should be directed
amended (5 U.S.C. Appendix 2), notice applications. to: Chekesha Clingman, Ph.D., Office of
is hereby given of the following Place: National Institutes of Health, 6701 Technology Transfer, National Institutes
Rockledge Drive, Bethesda, MD 20892, of Health, 6011 Executive Boulevard,
meetings.
(Telephone Conference Call).
The meetings will be closed to the Suite 325, Rockville, MD 20852–3804; e-
Contact Person: Sally Ann Amero, PhD,
public in accordance with the Scientific Review Administrator, Center for mail: clingmac@mail.nih.gov; telephone:
provisions set forth in sections Scientific Review, National Institutes of (301) 435–5018; facsimile: (301) 402–
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Health, 6701 Rockledge Drive, Room 4190, 0220.
as amended. The grant applications and MSC 7849, Bethesda, MD 20892, 301–435– SUPPLEMENTARY INFORMATION: The
the discussions could disclose 1159, ameros@csr.nih.gov. present invention relates to systems and
confidential trade secrets or commercial (Catalogue of Federal Domestic Assistance methods for sensitive detection and
property such as patentable material, Program Nos. 93.306, Comparative Medicine; characterization of macromolecular
and personal information concerning 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–83.844,
interactions in homogenous or
individuals associated with the grant heterogeneous solutions of
applications, the disclosure of which 93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS) macromolecules, such as proteins, DNA,
would constitute a clearly unwarranted RNA, biopolymers, organic and
invasion of personal privacy. Dated: August 21, 2006.
inorganic polymers, macromolecular
Name of Committee: Center for Scientific Anna Snouffer, pharmaceutical compounds and others.
Review Special Emphasis Panel; Diabetic Acting Director, Office of Federal Advisory The methods employed by this system
Neuropathy. Committee Policy. do not require the need for labeling or
Date: August 29, 2006. [FR Doc. 06–7175 Filed 8–25–06; 8:45 am] chemical modification of any test
Time: 5:30 p.m. to 6:30 p.m.
Agenda: To review and evaluate grant
BILLING CODE 4140–01–M substance, and it is more rapid than any
applications. conventional methods. The system
Place: National Institutes of Health, 6701 includes a dispenser to dispense a
Rockledge Drive, Bethesda, MD 20892, DEPARTMENT OF HEALTH AND solution containing the macromolecule,
(Telephone Conference Call). HUMAN SERVICES and one or more detectors to measure a
Contact Person: William C. Benzing, PhD, light scattering and concentration
Scientific Review Administrator, Center for National Institutes of Health
associated with the macromolecule in
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5206, Prospective Grant of Exclusive solution. For instance, the first detector
MSC 7846, Bethesda, MD 20892, (301) 435– License: System and Methods for can be a light scattering detector (such
1254, benzingw@csr.nih.gov. Detecting and Characterizing as a static light-scattering detector). The
This notice is being published less than 15 Macromolecular Interactions in second detector (such as a UV–Vis
days prior to the meeting due to the timing Solution detector) can be added in to measure
limitations imposed by the review and light absorbance and hence
funding cycle. concentration. The detectors can be
AGENCY: National Institutes of Health,
Name of Committee: Center for Scientific arranged in parallel, to receive identical
Review Special Emphasis Panel; Confocal
Public Health Service, HHS.
flow of solution from the dispenser, so
Microscopy Shared Instrumentation Panel. ACTION: Notice.
Date: September 18–19, 2006. that at any given time point, both
Time: 8:30 a.m. to 4 p.m. detectors collect data on flow of
SUMMARY: This is notice, in accordance identical concentrations.
Agenda: To review and evaluate grant
applications. with 35 U.S.C. 209(c)(1) and 37 CFR The prospective exclusive license will
Place: Beacon Hotel and Corporate 404.7(a)(1)(i), that the National be royalty bearing and will comply with
Quarters, 1615 Rhode Island Avenue, NW., Institutes of Health (NIH), Department the terms and conditions of 35 U.S.C.
Washington, DC 20036. of Health and Human Services, is 209 and 37 CFR 404.7. The prospective
Contact Person: Laura M. Roman, PhD, contemplating the grant of an exclusive exclusive license may be granted unless,
Scientific Review Administrator, Center for license to practice the inventions
Scientific Review, National Institutes of within 60 days from the date of this
Health, 6701 Rockledge Drive, Room 2138,
embodied in PCT (application number published Notice, NIH receives written
MSC 7720, Bethesda, MD 20892, 301–435– pending) filed July 28, 2006 from U.S. evidence and argument that establishes
0715, romanl@csr.nih.gov. provisional application 60/703,814 (E– that the grant of the license would not
Name of Committee: Center for Scientific 167–2005/0–US–01), entitled ‘‘System be consistent with the requirements of
Review Special Emphasis Panel; Bacterial and Methods for Detecting and 35 U.S.C. 209 and 37 CFR 404.7.
Pathogenesis. Characterizing Macromolecular The field of use may be limited to the
Date: September 20, 2006. Interactions in Solution’’ (Inventors: development of a system and method
Time: 1 p.m. to 3 p.m. Drs. Allen Minton and Arun Attri) to for detecting and characterizing
mstockstill on PROD1PC61 with NOTICES

Agenda: To review and evaluate grant Wyatt Technology Corporation macromolecular interactions in
applications.
Place: National Institutes of Health, 6701
(hereafter Wyatt), having a place of solution.
Rockledge Drive, Bethesda, MD 20892, business in Goleta, California. The Properly filed competing applications
(Telephone Conference Call). patent rights in these inventions have for a license filed in response to this
Contact Person: Fouad A. El-Zaatari, PhD, been assigned to the United States of notice will be treated as objections to
Scientific Review Administrator, Center for America. the contemplated license. Comments

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Federal Register / Vol. 71, No. 166 / Monday, August 28, 2006 / Notices 50933

and objections submitted in response to Proposed Project: Opioid Drugs in care situation in which the physician
this notice will not be made available Maintenance and Detoxification must make a treatment decision that
for public inspection, and, to the extent Treatment of Opioid Dependence—42 differs from the treatment regimen
permitted by law, will not be released CFR part 8 (OMB No. 0930–0206)— required by the regulation. Form SMA–
under the Freedom of Information Act, Revision 162 is used as the initial application to
5 U.S.C. 552. This regulation establishes a request certification of an OTP, to
certification program managed by request renewal of certification and to
Dated: August 21, 2006.
SAMHSA’s Center for Substance Abuse change existing information regarding
Steven M. Ferguson, the program’s location, sponsor and
Treatment (CSAT). The regulation
Director, Division of Technology Development requires that Opioid Treatment medical director. This form collects
and Transfer, Office of Technology Transfer, Programs (OTPs) be certified. information such as address, program
National Institutes of Health.
‘‘Certification’’ is the process by which name, contact information, sponsor
[FR Doc. E6–14190 Filed 8–25–06; 8:45 am] SAMHSA determines that an OTP is name and address and medical director
BILLING CODE 4140–01–P qualified to provide opioid treatment name and address. Attachments are
under the Federal opioid treatment required to complete this form regarding
standards established by the Secretary the OTPs accrediting status,
DEPARTMENT OF HEALTH AND of Health and Human Services. To organizational structure, and operating
HUMAN SERVICES become certified, an OTP must be procedures. Form SMA–163 is used as
accredited by a SAMHSA-approved an application to become a SAMHSA
Substance Abuse and Mental Health accreditation body. The regulation also approved accrediting body. This form
Services Administration provides standards for such services as collects accrediting body name, address
individualized treatment planning, and contact information. Attachments
Agency Information Collection increased medical supervision, and are required to complete this form
Activities: Submission for OMB assessment of patient outcomes. This regarding the accrediting body’s
Review; Comment Request submission seeks continued approval of operating procedures and standards and
the information collection requirements their staff’s education and experience.
Periodically, the Substance Abuse and in the regulation and of the forms used
Mental Health Services Administration Form SMA–168 is a simplified,
in implementing the regulation.
(SAMHSA) will publish a summary of SAMHSA currently has approval for standardized form to facilitate the
information collection requests under the Application for Certification to Use documentation, request, and approval
OMB review, in compliance with the Opioid Drugs in a Treatment Program process for exceptions. This form
Under 42 CFR 8.11 (Form SMA–162); collects patient admission date, dosage
Paperwork Reduction Act (44 U.S.C.
the Application for Approval as amount, patient status, attendance
Chapter 35). To request a copy of these
Accreditation Body Under 42 CFR 8.3(b) schedule per week, dates of exception
documents, call the SAMHSA Reports
(Form SMA–163); and the Exception and justification.
Clearance Officer on (240) 276–1243.
Request and Record of Justification The tables that follow summarize the
Under 42 CFR 8.12 (Form SMA–168), annual reporting burden associated with
which may be used on a voluntary basis the regulation, including burden
by physicians when there is a patient associated with the forms.

ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES


Number of Responses/
42 CFR citation Purpose Hours/response Total hours
respondents respondent

8.3(b)(1–11) .................................... Initial approval (SMA–163) ............. 1 1 6.0 6


8.3(c) ............................................... Renewal of approval (SMA–163) ... 2 1 1.0 2
8.3(e) ............................................... Relinquishment notification ............ 1 1 0.5 0.5
8.3(f)(2) ........................................... Non-renewal notification to accred- 1 90 0.1 9
ited OTPs.
8.4(b)(1)(ii) ...................................... Notification to SAMHSA for seri- 2 2 1.0 4
ously noncompliant OTPs.
8.4(b)(1)(iii) ..................................... Notification to OTP for serious non- 2 10 1.0 20
compliance.
8.4(d)(1) .......................................... General documents and informa- 6 5 0.5 15
tion to SAMHSA upon request.
8.4(d)(2) .......................................... Accreditation survey to SAMHSA 6 75 0.02 9
upon request.
8.4(d)(3) .......................................... List of surveys, surveyors to 6 6 0.2 7.2
SAMHSA upon request.
8.4(d)(4) .......................................... Report of less than full accredita- 6 5 0.5 15
tion to SAMHSA.
8.4(d)(5) .......................................... Summaries of Inspections .............. 6 50 0.5 150
8.4(e) ............................................... Notifications of Complaints ............. 6 6 0.5 18
8.6(a)(2) and (b)(3) ......................... Revocation notification to Accred- 1 185 0.3 55.5
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ited OTPs.
8.6(b) ............................................... Submission of 90-day corrective 1 1 10 10.0
plan to SAMHSA.
8.6(b)(1) .......................................... Notification to accredited OTPs of 1 185 0.3 55.0
Probationary Status.

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