Submission for OMB Review; Comment Request, 72806-72807 [E8-28249]
Download as PDF
<![CDATA[
72806
Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Hours per
response
Total burden
hours
POC Questionnaire ..........................................................................................
Focus Groups ..................................................................................................
3
4
2,100
8
2/60
1
210
32
Total ..........................................................................................................
7
na
na
242
Average hourly wage rate*
($)
Total cost burden ($)
Exhibit 2 shows the annualized cost
burden for the respondent’s time to
participate in this project. The total cost
burden is estimated to be $21,775.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of respondents
Form name
Total burden
hours
POC Questionnaire ..........................................................................................
Focus Groups ..................................................................................................
3
4
210
32
92.03
76.53
19,326
2,449
Total ..........................................................................................................
7
242
na
21,775
* Based upon the weighted average of the ‘‘registered nurse’’ mean and the ‘‘surgeon’’ mean of the average wages, May 2007 National Occupational Employment and Wage Estimates, United States, U.S. Department of Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/
oes_nat.htm#b29–0000 (accessed Nov. 1, 2008). The ‘‘surgeon’’ mean salary was used for the 3 ED respondents and the ‘‘registered nurse’’
mean salary was used for the 1 Call Center.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost of this two-year project
to the federal government. The total cost
is $34,730 and includes $7,500 for
project development, $8,400 for data
collection activities, $6,580 for data
processing and analysis, $1,000 for the
publication of results and $11,250 for
project management.
EXHIBIT 3—ESTIMATED COST
Cost component
Total cost ($)
Annualized
cost ($)
Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................
7,500
8,400
6,580
1,000
11,250
0
3,750
4,200
3,290
500
5,625
0
Total ..................................................................................................................................................................
34,730
17,365
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, quality
improvement and 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
VerDate Aug<31>2005
16:47 Nov 28, 2008
Jkt 217001
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 14, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–28033 Filed 11–28–08; 8:45 am]
BILLING CODE 4160–90–M
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: State Council on Developmental
Disabilities Program Performance
Report.
OMB No.: 0980–0172.
Description: A Developmental
Disabilities Council Program
Performance Report is required by
federal statute. Each State
Developmental Disabilities Council
must submit an annual report for the
preceding fiscal year of activities and
accomplishments. Information provided
E:\FR\FM\01DEN1.SGM
01DEN1
72807
Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 / Notices
in the Program Performance Report will
be used (1) in the preparation of the
biennial Report to the President, the
Congress, and the National Council on
Disabilities and (2) to provide a national
perspective on program
accomplishments and continuing
challenges. This information will also
be used to comply with requirements in
the Government Performance and
Results Act of 1993.
Respondents: State Governments.
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
State Council on Developmental Disabilities Program Performance Report ..
55
1
138
7,590
Estimated Total Annual Burden Hours: ....................................................
........................
........................
........................
7,590
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: November 24, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–28249 Filed 11–28–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
availability of a guidance entitled ‘‘Data
Retention When Subjects Withdraw
from FDA-Regulated Clinical Trials.’’
This guidance clarifies FDA’s position
that it is critical that data be retained
from trial participants who decide to
discontinue participation in a clinical
study of an investigational product, who
are withdrawn by their legally
authorized representative, as applicable,
or who were discontinued from
participation by the clinical
investigator. The guidance will be of
interest especially to sponsors, clinical
investigators, and members of
investigational review boards (IRBs).
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written comments
on the guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
ADDRESSES:
Sara
F. Goldkind, Office of Science and
Health Coordination/Good Clinical
Practice Program (HF–34), Food and
Drug Administration, 5600 Fishers
Lane, Rockville MD 20857, 301–827–
3340.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
I. Background
[Docket No. FDA–2008–D–0576]
FDA is announcing the availability of
a guidance for sponsors, clinical
investigators, and IRBs entitled ‘‘Data
Retention When Subjects Withdraw
from FDA-Regulated Clinical Trials.’’
This guidance clarifies FDA’s longstanding position that it is critical that
data be retained from individuals who
decide to discontinue participation in a
clinical study of an investigational
product, or who were discontinued from
participation by the clinical
investigator.
rwilkins on PROD1PC63 with NOTICES
Guidance for Sponsors, Clinical
Investigators, and IRBs; Data
Retention When Subjects Withdraw
From FDA-Regulated Clinical Trials;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
VerDate Aug<31>2005
16:47 Nov 28, 2008
Jkt 217001
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
FDA developed this guidance in
response to questions from sponsors,
clinical investigators, and members of
IRBs about previously collected data
from subjects who withdraw or are
withdrawn from clinical investigations.
This guidance describes the regulatory
and statutory basis for FDA’s position,
as well as the supporting ethical and
quality standards, and outlines key
points regarding the withdrawal of
subjects from a clinical investigation.
Because data resulting from these
clinical investigations is used to support
research applications and new product
approvals, it is critical that FDA have a
complete and accurate data set. If data
were to be removed from the study
database, the scientific validity of the
data and thus FDA’s analysis of it could
be jeopardized potentially
compromising the agency’s ability to
safeguard the public health.
This Level 1 guidance is being issued
for immediate implementation to
prevent the potential loss of important
clinical trial data. This approach is
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). If
comments are received on this Level 1
guidance, FDA will review the
comments and revise the guidance if
appropriate. This guidance represents
the agency’s long-standing policy and
current thinking on the retention of data
when subjects withdraw from FDAregulated clinical trials. 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.
Interested persons may submit written
comments on the guidance to the
Division of Dockets Management (see
ADDRESSES).
Elsewhere in this issue of the Federal
Register, the Office of Human Research
Protections (OHRP) is announcing the
availability of a draft guidance
document entitled ‘‘Guidance on
Important Considerations for When
E:\FR\FM\01DEN1.SGM
01DEN1
]]>Agencies
[Federal Register Volume 73, Number 231 (Monday, December 1, 2008)]
[Notices]
[Pages 72806-72807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28249]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: State Council on Developmental Disabilities Program
Performance Report.
OMB No.: 0980-0172.
Description: A Developmental Disabilities Council Program
Performance Report is required by federal statute. Each State
Developmental Disabilities Council must submit an annual report for the
preceding fiscal year of activities and accomplishments. Information
provided
[[Page 72807]]
in the Program Performance Report will be used (1) in the preparation
of the biennial Report to the President, the Congress, and the National
Council on Disabilities and (2) to provide a national perspective on
program accomplishments and continuing challenges. This information
will also be used to comply with requirements in the Government
Performance and Results Act of 1993.
Respondents: State Governments.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
State Council on Developmental Disabilities 55 1 138 7,590
Program Performance Report.....................
---------------------------------------------------------------
Estimated Total Annual Burden Hours:........ .............. .............. .............. 7,590
----------------------------------------------------------------------------------------------------------------
Additional Information:
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Administration,
Office of Information Services, 370 L'Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests
should be identified by the title of the information collection. E-mail
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
6974, Attn: Desk Officer for the Administration for Children and
Families.
Dated: November 24, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8-28249 Filed 11-28-08; 8:45 am]
BILLING CODE 4184-01-P
