Proposed Information Collection Activity; Comment Request, 50482-50483 [2011-20646]
Download as PDF
50482
Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–20614 Filed 8–12–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Objective Work Plan (OSP),
Objective Progress Report (OPR) and
Project Abstract.
OMB No. 0980–0204.
Description: Content changes are
being made to the OPR and OWP only.
The information in the OPR is being
collected on a quarterly basis to monitor
the performance of grantees and better
gauge grantee progress. The OWP is
utilized by applications when they
submit their proposals and then by
grantees to monitor their projects once
awarded. ANA has reworded and
renumbered the OPR questions to allow
for better flow and clarity. The majority
of content being requested from the
grantees is the same and has not
changed.
OPR: Following are content changes
being made:
Objective Work Plan Update: Content
is the same. Questions 1 and 2 were
originally questions 3 and 4 on the
previous OPR. ANA has also reduced
the number of objectives under this
section to 3. ANA is also separating out
the current status of expected results
and the current status of expected
Project Sustainability: Content is the
same. Questions 12 and 13 were
originally questions 18 and 17 on the
previous OPR.
Financial: The content requested in
this section is similar to the previous
OPR with some additional information
being requested. Questions 14 and 16a
were originally questions 9, 10, and 7 on
the previous OPR. Question 17 is a new
question. This question will not require
the grantee to conduct additional work
as they will be able to respond to this
question utilizing the required OPR and
425 forms. Question 18 was originally
question 8 on the previous OPR.
Four additional questions have been
added that are specific to a special
initiative ANA is funding this year.
These questions are only to be filled out
by the Asset for Independence Grantees.
OWP: ANA has reformatted the OWP
(content is same). ANA has added a
field for applicants to include problem
statement identified in grant
application; has separated the results
and benefits expected to align with
ANA’s funding opportunity
announcement. ANA is no longer
requesting data on non-personnel hours.
On the previous OWP ANA requested
applicants to provide the position
responsible for each activity. This title
has changed to ‘position performing the
activity’ and applicants will be asked to
identify the lead person in one cell and
other support in a second cell.
Project Abstract: ANA is no longer
managing this form. Grants.gov has
taken control of this form and will
submit any additional requests for this
submission.
Respondents: Tribal Government,
Native non-profit organizations, Tribal
Colleges & Universities.
benefits. This will match ANA’s revised
OWP.
Partnerships and Leveraged
Resources: Content is the same.
Questions 3 and 4 were originally part
of questions 11–13. The leveraged
resources table under question 4 has
been reformatted to allow for easier data
collection.
Impact indicator: The content
requested in this section is similar to the
previous OPR with some additional
information being requested. Question 5
was originally captured under question
11 of the previous OPR. ANA has added
additional fields to this section:
Tracking mechanism, pre-grant status,
and three-year target to align with
ANA’s funding opportunity
announcement. Questions 5a and 5b are
new and ask the grantee for the status
of the impact indicator at the end of
each budget period. This information
was captured quantitatively in the
previous OPR.
Native American Youth and Elder
Opportunities: Content is the same.
Questions 6 and 6a were originally
questions 14 and 14a on the previous
OPR.
Staffing: Content is the same.
Questions 7 and 7a were originally
question 16 on the previous OPR.
Question 7b was originally question 15
on the previous OPR. ANA has added
one field to this table: Type of position.
Challenges: Content is the same.
Questions 8 and 9 were originally
questions 1 and 5 on the previous OPR.
For question 9 ANA has added a table
to capture information that was
previously provided in a narrative
format. Questions 10 and 11 were
originally questions 2 and 6 on the
previous OPR.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
OWP ................................................................................................
OPR .................................................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Instrument
500
275
1
4
3
1
1,500
1,100
Estimated Total Annual Burden
Hours: 2,600.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
VerDate Mar<15>2010
16:05 Aug 12, 2011
Jkt 223001
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. E-mail address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
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Frm 00032
Fmt 4703
Sfmt 4703
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
E:\FR\FM\15AUN1.SGM
15AUN1
Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–20646 Filed 8–12–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Application Requirements for
the Low Income Home Energy
Assistance Program (LIHEAP)
Residential Energy Assistance Challenge
Program (REACH) Model Plan.
OMB No.: 0970–0348.
Description: States, including the
District of Columbia, Tribes, Tribal
organizations and Territories applying
for LIHEAP REACH funds must Submit
an annual application prior to receiving
Federal funds. The Human Services
Amendments of 1994 (Pub. L. 103–252)
amended the LIHEAP statute to add
Section 2607B, which established the
REACH program. REACH was funded
for the first time in FY 1996 and is
intended to: (1) Minimize health and
safety risks that result from high energy
burdens on low-income Americans; (2)
reduce home energy vulnerability and
prevent homelessness as a result of the
inability to pay energy bills; (3) increase
50483
the efficiency of energy usage by lowincome families, helping them achieve
energy self-sufficiency; and (4) target
energy assistance to individuals who are
most in need. The REACH Model Plan
clarifies the information being requested
and ensures the submission of all the
information required by statute. The
form facilitates our response to
numerous queries each year concerning
the information that should be included
in the REACH application. Submission
of a REACH application and use of the
REACH Model Plan is voluntary.
Grantees have the option to use another
format.
Respondents: State Governments,
Tribal governments, Insular Areas, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average burden
hours per response
Total burden
hours
Reach model plan ............................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Instrument
51
1
72
3,672
Estimated Total Annual Burden
Hours: 3,672.
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: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–20613 Filed 8–12–11; 8:45 am]
BILLING CODE 4184–01–P
VerDate Mar<15>2010
16:05 Aug 12, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0577]
Draft Guidance for Industry and Food
and Drug Administration Staff; Factors
to Consider When Making Benefit-Risk
Determinations in Medical Device
Premarket Review; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
document entitled ‘‘Factors to Consider
When Making Benefit-Risk
Determinations in Medical Device
Premarket Review.’’ The
recommendations in this guidance are
intended to provide greater clarity on
FDA’s decisionmaking process with
regard to benefit-risk determinations in
the premarket review of medical
devices. This draft guidance is not final
nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
electronic or written comments on the
draft guidance by November 14, 2011.
SUMMARY:
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Frm 00033
Fmt 4703
Sfmt 4703
Submit written requests for
single copies of the draft guidance
document entitled ‘‘Factors to Consider
When Making Benefit-Risk
Determinations in Medical Device
Premarket Review’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your request, or
fax your request to 301–847–8149. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: For
Devices Regulated by CDRH: Rachel
Turow, Center for Devices and
ADDRESSES:
E:\FR\FM\15AUN1.SGM
15AUN1
Agencies
[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Notices]
[Pages 50482-50483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20646]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Objective Work Plan (OSP), Objective Progress Report (OPR)
and Project Abstract.
OMB No. 0980-0204.
Description: Content changes are being made to the OPR and OWP
only. The information in the OPR is being collected on a quarterly
basis to monitor the performance of grantees and better gauge grantee
progress. The OWP is utilized by applications when they submit their
proposals and then by grantees to monitor their projects once awarded.
ANA has reworded and renumbered the OPR questions to allow for better
flow and clarity. The majority of content being requested from the
grantees is the same and has not changed.
OPR: Following are content changes being made:
Objective Work Plan Update: Content is the same. Questions 1 and 2
were originally questions 3 and 4 on the previous OPR. ANA has also
reduced the number of objectives under this section to 3. ANA is also
separating out the current status of expected results and the current
status of expected benefits. This will match ANA's revised OWP.
Partnerships and Leveraged Resources: Content is the same.
Questions 3 and 4 were originally part of questions 11-13. The
leveraged resources table under question 4 has been reformatted to
allow for easier data collection.
Impact indicator: The content requested in this section is similar
to the previous OPR with some additional information being requested.
Question 5 was originally captured under question 11 of the previous
OPR. ANA has added additional fields to this section: Tracking
mechanism, pre-grant status, and three-year target to align with ANA's
funding opportunity announcement. Questions 5a and 5b are new and ask
the grantee for the status of the impact indicator at the end of each
budget period. This information was captured quantitatively in the
previous OPR.
Native American Youth and Elder Opportunities: Content is the same.
Questions 6 and 6a were originally questions 14 and 14a on the previous
OPR.
Staffing: Content is the same. Questions 7 and 7a were originally
question 16 on the previous OPR. Question 7b was originally question 15
on the previous OPR. ANA has added one field to this table: Type of
position.
Challenges: Content is the same. Questions 8 and 9 were originally
questions 1 and 5 on the previous OPR. For question 9 ANA has added a
table to capture information that was previously provided in a
narrative format. Questions 10 and 11 were originally questions 2 and 6
on the previous OPR.
Project Sustainability: Content is the same. Questions 12 and 13
were originally questions 18 and 17 on the previous OPR.
Financial: The content requested in this section is similar to the
previous OPR with some additional information being requested.
Questions 14 and 16a were originally questions 9, 10, and 7 on the
previous OPR. Question 17 is a new question. This question will not
require the grantee to conduct additional work as they will be able to
respond to this question utilizing the required OPR and 425 forms.
Question 18 was originally question 8 on the previous OPR.
Four additional questions have been added that are specific to a
special initiative ANA is funding this year. These questions are only
to be filled out by the Asset for Independence Grantees.
OWP: ANA has reformatted the OWP (content is same). ANA has added a
field for applicants to include problem statement identified in grant
application; has separated the results and benefits expected to align
with ANA's funding opportunity announcement. ANA is no longer
requesting data on non-personnel hours. On the previous OWP ANA
requested applicants to provide the position responsible for each
activity. This title has changed to `position performing the activity'
and applicants will be asked to identify the lead person in one cell
and other support in a second cell.
Project Abstract: ANA is no longer managing this form. Grants.gov
has taken control of this form and will submit any additional requests
for this submission.
Respondents: Tribal Government, Native non-profit organizations,
Tribal Colleges & Universities.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
OWP................................. 500 1 3 1,500
OPR................................. 275 4 1 1,100
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,600.
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
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. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or
[[Page 50483]]
other forms of information technology. Consideration will be given to
comments and suggestions submitted within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-20646 Filed 8-12-11; 8:45 am]
BILLING CODE 4184-01-P