Agency Information Collection Activities: Submission for OMB Review; Comment Request, 794-796 [E6-22576]
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794
Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Felix Frueh,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 4512,
Silver Spring, MD 20993–0002,
301–796–1530; or
Raj K. Puri, Center for Biologics
Evaluation and Research (HFM–
735), Food and Drug
Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD
20852–1448, 301–827–0471.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
jlentini on PROD1PC65 with NOTICES
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission,
the European Federation of
Pharmaceutical Industries Associations,
the Japanese Ministry of Health, Labour,
and Welfare, the Japanese
Pharmaceutical Manufacturers
Association, the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA, and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
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The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In October 2006, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘E15 Terminology in
Pharmacogenomics’’ should be made
available for public comment. The draft
guidance is the product of the E15
Pharmacogenomics Expert Working
Group of the ICH. Comments about this
draft will be considered by FDA and the
E15 Pharmacogenomics Expert Working
Group.
The draft guidance represents an
international effort to harmonize
pharmacogenomics definitions and
sample coding. Inconsistent definitions
make it difficult to achieve agreement
on parameters for implementation of
pharmacogenomics in global
pharmaceutical development, and might
lead to inconsistent assessments by
regulators. The draft guidance contains
definitions of key terms in the
discipline of pharmacogenomics and
pharmacogenetics, namely genomic
biomarkers, pharmacogenomics,
pharmacogenetics, and genomic data
and sample coding categories. Timely
harmonisation of terminology and
definitions will create a common
foundation for future guidance on
pharmacogenomics.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Submit
a single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
Dated: December 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–5 Filed 1–5–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Proposed Project: GPRA Client
Outcomes for the Substance Abuse and
Mental Health Services Administration
(SAMHSA)—(OMB No. 0930–0208)—
Revision.
The mission of the Substance Abuse
and Mental Health Services
Administration (SAMHSA) is to
improve the effectiveness and efficiency
of substance abuse and mental health
treatment and prevention services
across the United States. All of
SAMHSA’s activities are designed to
ultimately reduce the gap in the
availability of substance abuse and
mental health services and to improve
their effectiveness and efficiency.
Data are collected from all SAMHSA
discretionary services grants and
contracts where client/participant
outcomes are to be assessed at three
points (for the Center for Substance
Abuse Treatment (CSAT): Intake,
discharge, and post-intake and for the
Center for Substance Abuse Prevention
(CSAP): pre-intervention, postintervention, and follow-up). SAMHSAfunded projects are required to submit
these data as a contingency of their
award. The analysis of the data also will
help determine whether the goal of
reducing health and social costs of drug
use to the public is being achieved.
The primary purpose of this data
collection activity is to meet the
reporting requirements of the
Government Performance and Results
Act (GPRA) by allowing SAMHSA to
quantify the effects and
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08JAN1
795
Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices
accomplishments of SAMHSA
programs.
The burden for the Center for Mental
Health Services (CMHS) will be
transferred from this data collection to
its own separate Office of Management
and Budget (OMB) clearance. The 60day Federal Register Notice for National
Outcome Measures (NOMS) for
Consumers Receiving Mental Health
Services was published on Friday, June
9, 2006 (71 FR 33476).
The burden for the CSAP gradually
reduces due to the fact that this
clearance request only pertains to a
continuation of data collection for those
grantees initially funded prior to
FY2006. The new grantees (FY2006 and
beyond) are approved under the NOMS
for CSAP (OMB No. 0930–0230).
CSAT has no revisions to the
instrument and the data collection time
will remain the same but there is an
increase in the number of respondents
due to identifying the seven Screening,
Brief Intervention, and Referral to
Treatment program grantees that
provide data uploads. The estimated
annual response burden for this effort is
provided in the table below:
ESTIMATES OF ANNUALIZED HOUR BURDEN 1
Center/form/respondent
type
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total hour
burden
Added burden
proportion 2
Total annual
burden hours
CSAP GPRA Participant Outcome Measures for Discretionary Programs
Participants:
FY2007 .....................
FY2008 .....................
7,000
3,000
3
3
21,000
9,000
.33
.33
6,930
2,970
.72
.72
4,990
2,138
CSAP Subtotal
10,000
3
30,000
.33
9,900
.72
7,128
CSAP Annualized
Subtotal .............
5,000
15,000
3,564
CSAT GPRA Client Outcome Measures for Discretionary Programs
Clients ..........................
Adults ...........................
Adolescents ..................
Screening, Brief Intervention and Referral
to Treatment
(SBIRT): 3
Screening Only .........
Brief Intervention ......
Brief Tx & Referral to
Tx ..........................
28,000
3,900
3
4
84,000
15,600
.33
.33
27,720
5,148
.33
.33
9,148
1,699
150,618
27,679
1
3
150,618
83,037
.10
.16
15,062
13,286
0
0
0
0
9,200
3
27,600
.33
9,108
.33
3,006
SBIRT Client
Subtotal ......
187,497
261,255
Client Subtotal ......
219,397
360,855
Data Extract by
Grants: 4
Adult Records ...........
Adolescent Records
Screening, Brief Intervention and Referral
to Tx (SBIRT)
Records:
Screening Only .........
Brief Intervention ......
Brief Tx & Referral to
Tx ..........................
37,456
3,006
13,853
400 grants
73 grants
70 × 3
53 × 4
210
212
.16
.16
34
34
34
34
7 grants
7 grants
21,517 × 1
3,954 × 3
21,517
11,862
.05
.08
1,076
949
1,076
949
7 grants
1,314 × 3
3,942
.16
631
631
480
37,743
Upload 5 ........................
5 grants
171,639
Upload Subtotal ....
5 grants
171,639
29
CSAT Subtotal ......
jlentini on PROD1PC65 with NOTICES
Data Extract Subtotal ....................
219,896
570,237
16,606
TOTAL ...........
224,896
585,237
20,170
2,724
1 hr. per 6,000
records
29
29
NOTES:
1. This table represents the maximum additional burden if adult respondents provide three sets of responses/data and if CSAT adolescent respondents provide four sets of responses/data.
2. Added burden proportion is an adjustment reflecting customary and usual business practices programs engage in (e.g., they already collect
the data items).
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Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices
3. Screening, Brief Intervention, Treatment and Referral (SBIRT) grant program:
• 150,618 Screening Only (SO) respondents complete section A of the GPRA instrument, all of these items are asked during a customary and
usual intake process resulting in zero burden; and
• 27,679 Brief Intervention (BI) respondents complete sections A & B of the GPRA instrument, all of these items are asked during a customary
and usual intake process resulting in zero burden; and
• 9,200 Brief Treatment (BT) & Referral to Treatment (RT) respondents complete all sections of the GPRA instrument.
4. Data Extract by Grants: Grant burden for capturing customary and usual data.
5. Upload: 5 of the 7 SBIRT grants upload data; the other 2 grants conduct direct data entry.
6. Estimate based on $5.15 for program staff and $15 for IT staff.
Written comments and
recommendations concerning the
proposed information collection should
be sent by February 5, 2007 to:
SAMHSA Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
6974.
Dated: December 22, 2006.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E6–22576 Filed 1–5–07; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
DEPARTMENT OF TRANSPORTATION
[USCG–2006–24685]
Long Range Aids to Navigation
(LORAN) Program; Office of Navigation
and Spectrum Management
Coast Guard, DHS, Office of the
Secretary, DOT.
ACTION: Notice; request for public
comments.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: The Department of
Transportation in coordination with the
Department of Homeland Security is
considering the need to continue to
operate or invest in the North American
LORAN–C Radionavigation System
beyond fiscal year 2007. Future
investment decisions might include:
Decommissioning the LORAN–C
system, maintaining the LORAN–C
system as currently configured, or
developing a fully deployed Enhanced
LORAN (eLORAN) system. Contributing
factors to these decisions are (1)
whether the Global Positioning System
(GPS) and other available back-up
systems are adequate for the public’s
navigation and timing needs, thus
making the LORAN–C system
redundant, and (2) whether the
eLORAN investments made to date
VerDate Aug<31>2005
17:57 Jan 05, 2007
Jkt 211001
provide enhancements that now merit
consideration as a complementary
capability to GPS, and not merely as a
GPS back-up. The Department of
Transportation and the Department of
Homeland Security seek public input on
the various decisions currently under
consideration. For more information on
LORAN, you may visit https://
www.navcen.uscg.gov.
DATES: Comments and related material
must reach the Docket Management
Facility on or before February 7, 2007.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number USCG–2006–24685 to the
Docket Management Facility at the U.S.
Department of Transportation. To avoid
duplication, please use only one of the
following methods:
(1) Web Site: https://dms.dot.gov.
(2) Mail: Docket Management Facility,
U.S. Department of Transportation, 400
Seventh Street, SW., Washington, DC
20590–0001.
(3) Fax: 202–493–2251.
(4) Delivery: Room PL–401 on the
Plaza level of the Nassif Building, 400
Seventh Street, SW., Washington, DC,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The telephone number is 202–366–
9329.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
Mr. Greg Wheeler, Department of
Transportation, Office of Navigation and
Spectrum Policy, 202–366–4894, e-mail
Greg.Wheeler@dot.gov or LT Michael
Herring, Project Officer, Office of
Navigation Systems, Coast Guard,
telephone 202–372–1561, e-mail
Michael.L.Herring@uscg.mil. If you have
questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–493–0402.
You may obtain a copy of this notice
by calling the U.S. Coast Guard Infoline
at 1–800–368–5647 or read it on the
Internet on the Coast Guard Navigation
Center Web site at https://
www.navcen.uscg.gov or at https://
dms.dot.gov.
SUPPLEMENTARY INFORMATION:
Request for Comments
All comments received will be posted,
without change, to https://dms.dot.gov
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
and will include any personal
information you have provided. Please
see DOT’s ‘‘Privacy Act’’ paragraph
below.
Submitting comments: If you submit a
comment, please include your name and
address, identify the docket number for
this notice (USCG–2006–24685) and
give the reason for each comment. You
may submit your comments by
electronic means, mail, fax, or delivery
to the Docket Management Facility at
the address under ADDRESSES; but
please submit your comments by only
one means. If you submit them by mail
or delivery, submit them in an unbound
format, no larger than 81⁄2 by 11 inches,
suitable for copying and electronic
filing. If you submit them by mail and
would like to know that they reached
the Facility, please enclose a stamped,
self-addressed postcard or envelope. We
will consider all comments received
during the comment period.
Viewing comments and documents:
To view comments, go to https://
dms.dot.gov at any time, click on
‘‘Simple Search,’’ enter the last five
digits of the docket number for this
notice, and click on ‘‘Search.’’ You may
also visit the Docket Management
Facility in room PL–401 on the Plaza
level of the Nassif Building, 400
Seventh Street, SW., Washington, DC,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
Privacy Act: Anyone can search the
electronic form of all comments
received into any of our dockets by the
name of the individual submitting the
comment (or signing the comment, if
submitted on behalf of an association,
business, labor union, etc.). You may
review the Department of
Transportation’s Privacy Act Statement
in the Federal Register published on
April 11, 2000 (65 FR 19477), or you
may visit https://dms.dot.gov.
Background and Purpose
The North American LORAN–C
system is a low frequency hyperbolic
radionavigation system. It is approved
for use in the U.S. Coastal Confluence
Zone (CCZ) and as a supplemental air
navigation aid. More information about
LORAN–C is available at: https://
www.navcen.uscg.gov/loran/
default.htm.
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[Federal Register Volume 72, Number 4 (Monday, January 8, 2007)]
[Notices]
[Pages 794-796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22576]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Proposed Project: GPRA Client Outcomes for the Substance Abuse and
Mental Health Services Administration (SAMHSA)--(OMB No. 0930-0208)--
Revision.
The mission of the Substance Abuse and Mental Health Services
Administration (SAMHSA) is to improve the effectiveness and efficiency
of substance abuse and mental health treatment and prevention services
across the United States. All of SAMHSA's activities are designed to
ultimately reduce the gap in the availability of substance abuse and
mental health services and to improve their effectiveness and
efficiency.
Data are collected from all SAMHSA discretionary services grants
and contracts where client/participant outcomes are to be assessed at
three points (for the Center for Substance Abuse Treatment (CSAT):
Intake, discharge, and post-intake and for the Center for Substance
Abuse Prevention (CSAP): pre-intervention, post-intervention, and
follow-up). SAMHSA-funded projects are required to submit these data as
a contingency of their award. The analysis of the data also will help
determine whether the goal of reducing health and social costs of drug
use to the public is being achieved.
The primary purpose of this data collection activity is to meet the
reporting requirements of the Government Performance and Results Act
(GPRA) by allowing SAMHSA to quantify the effects and
[[Page 795]]
accomplishments of SAMHSA programs.
The burden for the Center for Mental Health Services (CMHS) will be
transferred from this data collection to its own separate Office of
Management and Budget (OMB) clearance. The 60-day Federal Register
Notice for National Outcome Measures (NOMS) for Consumers Receiving
Mental Health Services was published on Friday, June 9, 2006 (71 FR
33476).
The burden for the CSAP gradually reduces due to the fact that this
clearance request only pertains to a continuation of data collection
for those grantees initially funded prior to FY2006. The new grantees
(FY2006 and beyond) are approved under the NOMS for CSAP (OMB No. 0930-
0230).
CSAT has no revisions to the instrument and the data collection
time will remain the same but there is an increase in the number of
respondents due to identifying the seven Screening, Brief Intervention,
and Referral to Treatment program grantees that provide data uploads.
The estimated annual response burden for this effort is provided in the
table below:
Estimates of Annualized Hour Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total hour Added burden Total annual
Center/form/respondent type respondents respondent responses response burden proportion \2\ burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CSAP GPRA Participant Outcome Measures for Discretionary Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Participants:
FY2007................................ 7,000 3 21,000 .33 6,930 .72 4,990
FY2008................................ 3,000 3 9,000 .33 2,970 .72 2,138
---------------------------------------------------------------------------------------------------------------
CSAP Subtotal................... 10,000 3 30,000 .33 9,900 .72 7,128
---------------------------------------------------------------------------------------------------------------
CSAP Annualized Subtotal............ 5,000 .............. 15,000 .............. .............. .............. 3,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
CSAT GPRA Client Outcome Measures for Discretionary Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clients................................. .............. .............. .............. .............. .............. .............. ..............
Adults.................................. 28,000 3 84,000 .33 27,720 .33 9,148
Adolescents............................. 3,900 4 15,600 .33 5,148 .33 1,699
Screening, Brief Intervention and
Referral to Treatment (SBIRT): \3\
Screening Only........................ 150,618 1 150,618 .10 15,062 0 0
Brief Intervention.................... 27,679 3 83,037 .16 13,286 0 0
Brief Tx & Referral to Tx............. 9,200 3 27,600 .33 9,108 .33 3,006
---------------------------------------------------------------------------------------------------------------
SBIRT Client Subtotal........... 187,497 .............. 261,255 .............. 37,456 .............. 3,006
---------------------------------------------------------------------------------------------------------------
Client Subtotal..................... 219,397 .............. 360,855 .............. .............. .............. 13,853
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Extract by Grants: \4\
Adult Records......................... 400 grants 70 x 3 210 .16 34 .............. 34
Adolescent Records.................... 73 grants 53 x 4 212 .16 34 .............. 34
Screening, Brief Intervention and
Referral to Tx (SBIRT) Records:
Screening Only........................ 7 grants 21,517 x 1 21,517 .05 1,076 .............. 1,076
Brief Intervention.................... 7 grants 3,954 x 3 11,862 .08 949 .............. 949
Brief Tx & Referral to Tx............. 7 grants 1,314 x 3 3,942 .16 631 .............. 631
---------------------------------------------------------------------------------------------------------------
Data Extract Subtotal............... 480 .............. 37,743 .............. .............. .............. 2,724
--------------------------------------------------------------------------------------------------------------------------------------------------------
Upload \5\.............................. 5 grants .............. 171,639 1 hr. per 29 .............. 29
6,000 records
---------------------------------------------------------------------------------------------------------------
Upload Subtotal..................... 5 grants .............. 171,639 .............. .............. .............. 29
---------------------------------------------------------------------------------------------------------------
CSAT Subtotal....................... 219,896 .............. 570,237 .............. .............. .............. 16,606
---------------------------------------------------------------------------------------------------------------
TOTAL........................... 224,896 .............. 585,237 .............. .............. .............. 20,170
--------------------------------------------------------------------------------------------------------------------------------------------------------
NOTES:
1. This table represents the maximum additional burden if adult respondents provide three sets of responses/data and if CSAT adolescent respondents
provide four sets of responses/data.
2. Added burden proportion is an adjustment reflecting customary and usual business practices programs engage in (e.g., they already collect the data
items).
[[Page 796]]
3. Screening, Brief Intervention, Treatment and Referral (SBIRT) grant program:
150,618 Screening Only (SO) respondents complete section A of the GPRA instrument, all of these items are asked during a customary and usual
intake process resulting in zero burden; and
27,679 Brief Intervention (BI) respondents complete sections A & B of the GPRA instrument, all of these items are asked during a customary and
usual intake process resulting in zero burden; and
9,200 Brief Treatment (BT) & Referral to Treatment (RT) respondents complete all sections of the GPRA instrument.
4. Data Extract by Grants: Grant burden for capturing customary and usual data.
5. Upload: 5 of the 7 SBIRT grants upload data; the other 2 grants conduct direct data entry.
6. Estimate based on $5.15 for program staff and $15 for IT staff.
Written comments and recommendations concerning the proposed
information collection should be sent by February 5, 2007 to: SAMHSA
Desk Officer, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, DC
20503; due to potential delays in OMB's receipt and processing of mail
sent through the U.S. Postal Service, respondents are encouraged to
submit comments by fax to: 202-395-6974.
Dated: December 22, 2006.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E6-22576 Filed 1-5-07; 8:45 am]
BILLING CODE 4162-20-P
