Agency Information Collection Activities: Proposed Collection; Comment Request, 67732-67733 [07-5886]
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67732
Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices
In Section VIII, strike the sentence
‘‘This Declaration has not previously
been amended.’’ and replace it with:
‘‘This is the first amendment to this
Declaration. The Original Declaration
was published in the Federal Register at
72 FR 4710.’’
All other provisions of the Original
declaration remain in full force.
This amendment to the Declaration
will be published in the Federal
Register pursuant to section 319F–
3(b)(4) of the Act.
DATES: This notice and the attached
declaration are effective November 30,
2007.
FOR FURTHER INFORMATION CONTACT:
RADM W. Craig Vanderwage, MD,
Assistant Secretary for Preparedness
and Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue,
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll-free
number).
Dated: November 21, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 07–5884 Filed 11–29–07; 8:45 am]
BILLING CODE 4150–37–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, Department of Health and
Human Services.
ACTION: Notice.
rwilkins on PROD1PC63 with NOTICES
AGENCY:
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) allow the renewal of the
generic information collection project:
‘‘AHRQ Grants Reporting System
(GRS).’’ In accordance with the
Paperwork Reduction Act of 1995,
Public Law 104–13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public
to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by December 31, 2007.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540
Gaither Road, Room #5036, Rockville,
VerDate Aug<31>2005
16:27 Nov 29, 2007
Jkt 214001
MD 20850, or by e-mail at
doris.lefkowitz@ahrq.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from AHRQ’s Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427–1477.
SUPPLEMENTARY INFORMATION:
Proposed Project
‘‘AHRQ Grants Reporting System
(GRS)’’
AHRQ has identified the need to
establish a systematic method for its
grantees to report project progress and
important preliminary findings for
grants funded by the Agency. The
proposed system will address the
shortfalls in the current reporting
process and establish a consistent and
comprehensive grants reporting solution
for AHRQ. Currently, AHRQ receives
grants continuation applications on an
annual basis from all grantees. The
progress report, which represents a
portion of the annual continuation
application, is inadequate because it is
too infrequent and does not necessarily
capture the information that AHRQ
requires to respond to internal and
external inquiries. The reporting system
will also provide a centralized
repository of grants research
information that can be used to support
initiatives within the Agency’s research
plans for the future and to support
activities such as performance
monitoring, budgeting, knowledge
transfer as well as strategic planning.
AHRQ currently conducts quarterly
conference calls with some grantees.
The content, frequency, and focus of
these calls vary. In some grant programs,
the number of participants on these
calls may be so large as to prohibit
quarterly updates from all participants
in order to avoid creating an extremely
lengthy conference call and to allow the
Agency to address other important
issues during these calls. The GRS will
support the timely collection of
important information related to the life
cycle of a grant. This information
includes: Significant changes in project
goals, methods, study design, sample or
subjects, interventions, evaluation,
dissemination, training, key personnel,
key preliminary findings; significant
problems and resolutions; publications
and presentations; tools and products;
and new collaborations/partnerships
with AHRQ grantees or others
conducting related research. Collecting
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
this information in a systematic manner
will:
• Promote the transfer of critical
information more frequently and
efficiently which will enhance the
Agency’s ability to support research
designed to improve the outcomes and
quality of health care, reduce its costs,
and broaden access to effective services.
• Increase the efficiency of the
Agency in responding to ad-hoc
information requests, Freedom of
Information Act requests, and producing
responses related to federally mandated
programs and regulations.
• Establish a consistent approach
throughout the Agency for information
collection about grant progress and a
systematic basis for oversight and for
facilitating potential collaboration with
or among grantees.
• Decrease the inconvenience and
burden on grantees of unanticipated
adhoc requests for information by the
Agency in response to particular (onetime) internal and external requests for
information.
This proposed information collection
was previously published in the Federal
Register on September 17th, 2007 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. This
project was previously approved by
OMB on November 10th, 2004. The
OMB control number is 0935–0122 and
will expire on November 30th, 2007.
Data Confidentiality Provisions
Confidential commercial information
will be protected in accordance with 18
U.S.C. 1905. Information about
Principal Investigators will be
maintained in accordance with the
Privacy Act, 5 U.S.C. 552a. Also,
individuals and organizations will be
assured of the confidentiality of their
data under section 934(c) of the
Healthcare Research and Quality Act of
1999. The submitted reports will be
printed and included in the official file
for each grant. All of these files will be
retained according to existing agency
policies and procedures and archived as
required. The data will be collected
using a Web based reporting interface
developed specifically for the purpose
of collecting information quarterly. To
reduce burden and to the extent
possible, these forms will be
prepopulated with reoccurring
information needed to specifically
identify the institution, project,
principal investigator, and other similar
information.
E:\FR\FM\30NON1.SGM
30NON1
67733
Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices
EXHIBIT 1.—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Data entry into GRS ........................................................................................
.
500
3
10/60
250
Total ..........................................................................................................
500
na
na
250
EXHIBIT 2.—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total burden
hours
Average
hourly
wage rate*
Total cost
burden
Data entry into GRS ........................................................................................
.
500
250
$30.00
$7,500
Total ..........................................................................................................
500
250
na
7,500
*Based upon the average wages, ‘‘National Compensation Survey: Occupational Wages in the United States, May 2006,’’ U.S. Department of
Labor, Bureau of Labor Statistics.
This information collection will not
impose a cost burden on the
respondents beyond that associated
with their time to provide the required
data. There will be no additional costs
for capital equipment, software,
computer services, etc.
Dated: November 26, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–5886 Filed 11–29–07; 8:45 am]
Estimated Annual Costs to the Federal
Government
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The annual cost to the government is
$100,000 for licensing, support and
maintenance.
Food and Drug Administration
rwilkins on PROD1PC63 with NOTICES
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
VerDate Aug<31>2005
16:27 Nov 29, 2007
Jkt 214001
BILLING CODE 4160–90–M
[Docket No. 2007N–0323]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
Food and Drug Administration,
HHS.
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 December
31, 2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0045. Also
include the FDA docket number found
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4816.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Comment Request; Registration of
Producers of Drugs and Listing of Drugs
in Commercial Distribution—(OMB
Control Number 0910–0045—Extension)
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (the act),
(21 U.S.C. 360), FDA is authorized to
establish a system for registration of
producers of drugs and for listing of
drugs in commercial distribution. To
implement section 510 of the act, FDA
issued part 207 (21 CFR part 207).
Under current1 21 CFR 207.20,
1 This notice requests comments on the
information collection in current part 207. In the
Federal Register of August 29, 2006 (71 FR 51276),
FDA proposed to revise part 207. The proposed
revisions would reorganize, consolidate, clarify,
and modify current regulations concerning who
must register establishments and list, and describes
when and how to register and list and what
information must be submitted for registration and
listing. In addition, the proposal would make
certain changes to the National Drug Code (NDC)
system and would require the appropriate NDC
number to appear on the labels for drugs subject to
the listing requirements. The proposed regulations
generally also require the electronic submission of
all registration and most listing information. The
August 29, 2006, proposed rule requested
comments on the information collection for revised
part 207. When the proposal is finalized, the
E:\FR\FM\30NON1.SGM
Continued
30NON1
]]>Agencies
[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67732-67733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5886]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) allow the renewal of the generic
information collection project: ``AHRQ Grants Reporting System (GRS).''
In accordance with the Paperwork Reduction Act of 1995, Public Law 104-
13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on
this proposed information collection.
DATES: Comments on this notice must be received by December 31, 2007.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 5036,
Rockville, MD 20850, or by e-mail at doris.lefkowitz@ahrq.hhs.gov.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from AHRQ's Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427-1477.
SUPPLEMENTARY INFORMATION:
Proposed Project
``AHRQ Grants Reporting System (GRS)''
AHRQ has identified the need to establish a systematic method for
its grantees to report project progress and important preliminary
findings for grants funded by the Agency. The proposed system will
address the shortfalls in the current reporting process and establish a
consistent and comprehensive grants reporting solution for AHRQ.
Currently, AHRQ receives grants continuation applications on an annual
basis from all grantees. The progress report, which represents a
portion of the annual continuation application, is inadequate because
it is too infrequent and does not necessarily capture the information
that AHRQ requires to respond to internal and external inquiries. The
reporting system will also provide a centralized repository of grants
research information that can be used to support initiatives within the
Agency's research plans for the future and to support activities such
as performance monitoring, budgeting, knowledge transfer as well as
strategic planning. AHRQ currently conducts quarterly conference calls
with some grantees. The content, frequency, and focus of these calls
vary. In some grant programs, the number of participants on these calls
may be so large as to prohibit quarterly updates from all participants
in order to avoid creating an extremely lengthy conference call and to
allow the Agency to address other important issues during these calls.
The GRS will support the timely collection of important information
related to the life cycle of a grant. This information includes:
Significant changes in project goals, methods, study design, sample or
subjects, interventions, evaluation, dissemination, training, key
personnel, key preliminary findings; significant problems and
resolutions; publications and presentations; tools and products; and
new collaborations/partnerships with AHRQ grantees or others conducting
related research. Collecting this information in a systematic manner
will:
Promote the transfer of critical information more
frequently and efficiently which will enhance the Agency's ability to
support research designed to improve the outcomes and quality of health
care, reduce its costs, and broaden access to effective services.
Increase the efficiency of the Agency in responding to ad-
hoc information requests, Freedom of Information Act requests, and
producing responses related to federally mandated programs and
regulations.
Establish a consistent approach throughout the Agency for
information collection about grant progress and a systematic basis for
oversight and for facilitating potential collaboration with or among
grantees.
Decrease the inconvenience and burden on grantees of
unanticipated adhoc requests for information by the Agency in response
to particular (one-time) internal and external requests for
information.
This proposed information collection was previously published in
the Federal Register on September 17th, 2007 and allowed 60 days for
public comment. No comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. This project was
previously approved by OMB on November 10th, 2004. The OMB control
number is 0935-0122 and will expire on November 30th, 2007.
Data Confidentiality Provisions
Confidential commercial information will be protected in accordance
with 18 U.S.C. 1905. Information about Principal Investigators will be
maintained in accordance with the Privacy Act, 5 U.S.C. 552a. Also,
individuals and organizations will be assured of the confidentiality of
their data under section 934(c) of the Healthcare Research and Quality
Act of 1999. The submitted reports will be printed and included in the
official file for each grant. All of these files will be retained
according to existing agency policies and procedures and archived as
required. The data will be collected using a Web based reporting
interface developed specifically for the purpose of collecting
information quarterly. To reduce burden and to the extent possible,
these forms will be prepopulated with reoccurring information needed to
specifically identify the institution, project, principal investigator,
and other similar information.
[[Page 67733]]
Exhibit 1.--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Data entry into GRS............................. 500 3 10/60 250
�������������������������������������������������
Total....................................... 500 na na 250
----------------------------------------------------------------------------------------------------------------
Exhibit 2.--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Form name Number of Total burden hourly wage Total cost
respondents hours rate* burden
----------------------------------------------------------------------------------------------------------------
Data entry into GRS............................. 500 250 $30.00 $7,500
�������������������������������������������������
Total....................................... 500 250 na 7,500
----------------------------------------------------------------------------------------------------------------
*Based upon the average wages, ``National Compensation Survey: Occupational Wages in the United States, May
2006,'' U.S. Department of Labor, Bureau of Labor Statistics.
This information collection will not impose a cost burden on the
respondents beyond that associated with their time to provide the
required data. There will be no additional costs for capital equipment,
software, computer services, etc.
Estimated Annual Costs to the Federal Government
The annual cost to the government is $100,000 for licensing,
support and maintenance.
Request for Comments
In accordance with the above-cited Paperwork Reduction Act
legislation, comments on AHRQ's information collection are requested
with regard to any of the following: (a) Whether the proposed
collection of information is necessary for the proper performance of
AHRQ health care research and health care information dissemination
functions, including whether the information will have practical
utility; (b) the accuracy of AHRQ's estimate of burden (including hours
and costs) of the proposed collection(s) of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information upon the respondents, including the use of automated
collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: November 26, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07-5886 Filed 11-29-07; 8:45 am]
BILLING CODE 4160-90-M
