Submission for OMB Review; Comment Request: National Institutes of Health Construction Grants, 66723-66724 [2011-27850]
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Federal Register / Vol. 76, No. 208 / Thursday, October 27, 2011 / Notices
FOR FURTHER INFORMATION CONTACT:
Karen Shields, Grants Policy Specialist,
Department of Health and Human
Services, Administration for Children
and Families, OA/Division of Grants
Policy, 370 L’Enfant Promenade, SW.,
Aerospace Building, 6th Floor East,
Washington, DC 20447. Email:
karen.shields@acf.hhs.gov. Fax: (202)
205–6400.
Dated: October 21, 2011.
Jason Donaldson,
Deputy Assistant Secretary for
Administration, Administration for Children
and Families.
[FR Doc. 2011–27878 Filed 10–26–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0528]
Food Safety Modernization Act
Domestic and Foreign Facility
Reinspections, Recall, and Importer
Reinspection User Fee Rates for Fiscal
Year 2012; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA) is extending the
comment period to November 30, 2011,
for the notice entitled, ‘‘Food Safety
Modernization Act Domestic and
Foreign Facility Reinspections, Recall,
and Importer Reinspection User Fee
Rates for Fiscal Year 2012’’ that
appeared in the Federal Register of
August 1, 2011 (76 FR 45820). In that
document, FDA announced the
establishment of a docket to obtain
comments that would be considered in
establishing the fee rates for fiscal year
(FY) 2013. In particular, the Agency
provided the current FY 2012 fees and
requested public comments to the
document and intends to consider such
comments, as well as experience and
additional data gained in implementing
these fees in FY 2012, in establishing
the fee rates for FY 2013. The Agency
is taking this action in response to
requests for an extension to allow
interested persons additional time to
submit comments.
DATES: Submit either electronic or
written comments by November 30,
2011.
ADDRESSES: Submit electronic
comments to https://
wreier-aviles on DSK7SPTVN1PROD with NOTICES
SUMMARY:
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14:47 Oct 26, 2011
Jkt 226001
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.
66723
Dated: October 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–27845 Filed 10–26–11; 8:45 am]
BILLING CODE 4160–01–P
FOR FURTHER INFORMATION CONTACT:
Amy Waltrip, 12420 Parklawn Dr., rm.
2012, Rockville, MD 20857, (301) 796–
8811, email: Amy.Waltrip@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
National Institutes of Health
I. Background
Submission for OMB Review;
Comment Request: National Institutes
of Health Construction Grants
In the Federal Register of August 1,
2011 (76 FR 45820), FDA published a
notice with a 90-day comment period to
request comments on the establishment
of domestic and foreign facility
reinspections, non-compliance with
recall order, and importer reinspection
FY 2012 user fees. The FDA Food Safety
Modernization Act provides the Agency
with authority under section 743 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j–31) to assess and collect
fees, including those for costs associated
with certain domestic and foreign
facility reinspections, failure to comply
with a recall order, and importer
reinspections. The Agency is seeking
public comment on the established FY
2012 user fees. In particular, the Agency
is seeking public comments intending to
consider such comments, as well as
experience and additional data gained
in implementing these user fees in FY
2012, in establishing the fee rates for FY
2013. The Agency has received a request
for an extension of the comment period.
The request conveyed concern that the
current 90-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the notice.
FDA has considered the request and
is extending the comment period for the
notice for 30 days until November 30,
2011. The Agency believes that this
extension allows adequate time for
interested persons to submit comments.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments on this document. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments 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.
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Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on August 17, 2011, pages
51042–51043, and allowed 60 days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The NIH may not
conduct or sponsor, and the respondent
is not required to respond to,
information that has been extended,
revised or implemented on or after
October 1, 2008, unless it displays a
currently valid OMB control number.
Proposed Collection: Title: National
Institutes of Health Construction
GrantsB42 CFR part 52b (Final Rule).
Type of Information Collection Request:
Extension of No. 0925–0424, expiration
date 8/31/2008. Need and Use of the
Information Collection: This request is
for OMB review and approval of an
extension for the information collection
and recordkeeping requirements
contained in the regulation codified at
42 CFR part 52b. The purpose of the
regulation is to govern the awarding and
administration of grants awarded by
NIH and its components for
construction of new buildings and the
alteration, renovation, remodeling,
improvement, expansion, and repair of
existing buildings, including the
provision of equipment necessary to
make the buildings (or applicable part of
the buildings) suitable for the purpose
for which it was constructed. In terms
of reporting requirements: Section
52b.9(b) of the regulation requires the
transferor of a facility which is sold or
transferred, or owner of a facility, the
use of which has changed, to provide
written notice of the sale, transfer or
change within 30 days. Section 52b.10(f)
requires a grantee to submit an
approved copy of the construction
E:\FR\FM\27OCN1.SGM
27OCN1
66724
Federal Register / Vol. 76, No. 208 / Thursday, October 27, 2011 / Notices
schedule prior to the start of
construction. Section 52b.10(g) requires
a grantee to provide daily construction
logs and monthly status reports upon
request at the job site. Section 52b.11(b)
requires applicants for a project
involving the acquisition of existing
facilities to provide the estimated cost of
the project, cost of the acquisition of
existing facilities, and cost of
remodeling, renovating, or altering
facilities to serve the purposes for which
they are acquired. In terms of
recordkeeping requirements: Section
52b.10(g) requires grantees to maintain
daily construction logs and monthly
status reports at the job site. Frequency
of Response: On occasion. Affected
Public: Non-profit organizations and
Federal agencies. Type of respondents:
Grantees. The estimated respondent
burden is as follows:
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Number of
respondents
Frequency of
response
Average time per
response
Annual hour
burden
60
720
100
1
60
60
100
1
1
12
1
.50
1.0
1.0
1.0
60
260
1.0
Totals .............................................................................
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Reporting:
Section 52b.9(b) ...................................................................
Section 2b.10(f) ....................................................................
Section 2b.10(g) ...................................................................
Section 2b.11(b) ...................................................................
Recordkeeping.
Section 2b.10(g) ...................................................................
281
............................
The annualized cost to the public,
based on an average of 60 active grants
in the construction phase, is estimated
at: $576,818. There are no Capital Costs
to report. There are no operating or
Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information and
recordkeeping are necessary for the
proper performance of the function of
the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency=s estimate of the burden of the
proposed collection of information and
recordkeeping, including the
methodology and assumptions used; (3)
Enhance the quality, utility, and clarity
of the information to be collected and
the recordkeeping information to be
maintained; and (4) Minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection and
recordkeeping techniques of other forms
of information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to (202) 395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Jerry
VerDate Mar<15>2010
14:47 Oct 26, 2011
Jkt 226001
Moore, NIH Regulations Officer, Office
of Management Assessment, Division of
Management Support, National
Institutes of Health, 6011 Executive
Boulevard, Room 601, MSC 7669,
Rockville Maryland 20852; call (301)
496–4607 (this is not a toll free number)
or email your request to jm40z@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: October 20, 2011.
Jerry Moore,
NIH Regulations Officer, National Institutes
of Health.
[FR Doc. 2011–27850 Filed 10–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request: New Proposed
Collection, Neuropsychosocial
Measures Formative Research
Methodology Studies for the National
Children’s Study
Summary: Under the provisions of
Section (3507(a)(1)(D)) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on May 2, 2011, pages 24497–
24498, and allowed 60 days for public
comment. Two written comments and
PO 00000
Frm 00043
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..............................
.50
15,600
16,480.5
two verbal comments were received.
The verbal comments expressed support
for the broad scope of the study. The
written comments were identical and
questioned the cost and utility of the
study. The purpose of this notice is to
allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: Neurodevelopmental and Psycho-Social
Measures Formative Research Studies
for the National Children’s Study (NCS).
Type of Information Request: New.
Need and Use of Information Collection:
The Children’s Health Act of 2000 (Pub.
L. 106–310) states:
(a) Purpose.—It is the purpose of this
section to authorize the National
Institute of Child Health and Human
Development* to conduct a national
longitudinal study of environmental
influences (including physical,
chemical, biological, and psychosocial)
on children’s health and development.
(b) In General.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including
the Centers for Disease Control and
Prevention, the Environmental
Protection Agency) to—
(1) Plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of
both chronic and intermittent exposures
on child health and human
development; and
E:\FR\FM\27OCN1.SGM
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[Federal Register Volume 76, Number 208 (Thursday, October 27, 2011)]
[Notices]
[Pages 66723-66724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27850]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request: National Institutes
of Health Construction Grants
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Institutes of Health
(NIH) has submitted to the Office of Management and Budget (OMB) a
request to review and approve the information collection listed below.
This proposed information collection was previously published in the
Federal Register on August 17, 2011, pages 51042-51043, and allowed 60
days for public comment. No public comments were received. The purpose
of this notice is to allow an additional 30 days for public comment.
The NIH may not conduct or sponsor, and the respondent is not required
to respond to, information that has been extended, revised or
implemented on or after October 1, 2008, unless it displays a currently
valid OMB control number.
Proposed Collection: Title: National Institutes of Health
Construction GrantsB42 CFR part 52b (Final Rule). Type of Information
Collection Request: Extension of No. 0925-0424, expiration date 8/31/
2008. Need and Use of the Information Collection: This request is for
OMB review and approval of an extension for the information collection
and recordkeeping requirements contained in the regulation codified at
42 CFR part 52b. The purpose of the regulation is to govern the
awarding and administration of grants awarded by NIH and its components
for construction of new buildings and the alteration, renovation,
remodeling, improvement, expansion, and repair of existing buildings,
including the provision of equipment necessary to make the buildings
(or applicable part of the buildings) suitable for the purpose for
which it was constructed. In terms of reporting requirements: Section
52b.9(b) of the regulation requires the transferor of a facility which
is sold or transferred, or owner of a facility, the use of which has
changed, to provide written notice of the sale, transfer or change
within 30 days. Section 52b.10(f) requires a grantee to submit an
approved copy of the construction
[[Page 66724]]
schedule prior to the start of construction. Section 52b.10(g) requires
a grantee to provide daily construction logs and monthly status reports
upon request at the job site. Section 52b.11(b) requires applicants for
a project involving the acquisition of existing facilities to provide
the estimated cost of the project, cost of the acquisition of existing
facilities, and cost of remodeling, renovating, or altering facilities
to serve the purposes for which they are acquired. In terms of
recordkeeping requirements: Section 52b.10(g) requires grantees to
maintain daily construction logs and monthly status reports at the job
site. Frequency of Response: On occasion. Affected Public: Non-profit
organizations and Federal agencies. Type of respondents: Grantees. The
estimated respondent burden is as follows:
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time per Annual hour
respondents response response burden
----------------------------------------------------------------------------------------------------------------
Reporting:
Section 52b.9(b).................. 1 1 .50 .50
Section 2b.10(f).................. 60 1 1.0 60
Section 2b.10(g).................. 60 12 1.0 720
Section 2b.11(b).................. 100 1 1.0 100
Recordkeeping.....................
Section 2b.10(g).................. 60 260 1.0 15,600
-------------------------------------------------------------------------
Totals........................ 281 ................ ................. 16,480.5
----------------------------------------------------------------------------------------------------------------
The annualized cost to the public, based on an average of 60 active
grants in the construction phase, is estimated at: $576,818. There are
no Capital Costs to report. There are no operating or Maintenance Costs
to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information and recordkeeping are necessary for the proper performance
of the function of the agency, including whether the information will
have practical utility; (2) Evaluate the accuracy of the agency=s
estimate of the burden of the proposed collection of information and
recordkeeping, including the methodology and assumptions used; (3)
Enhance the quality, utility, and clarity of the information to be
collected and the recordkeeping information to be maintained; and (4)
Minimize the burden of the collection of information on those who are
to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection and recordkeeping
techniques of other forms of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to (202) 395-6974, Attention: Desk
Officer for NIH. To request more information on the proposed project or
to obtain a copy of the data collection plans and instruments, contact
Jerry Moore, NIH Regulations Officer, Office of Management Assessment,
Division of Management Support, National Institutes of Health, 6011
Executive Boulevard, Room 601, MSC 7669, Rockville Maryland 20852; call
(301) 496-4607 (this is not a toll free number) or email your request
to jm40z@nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: October 20, 2011.
Jerry Moore,
NIH Regulations Officer, National Institutes of Health.
[FR Doc. 2011-27850 Filed 10-26-11; 8:45 am]
BILLING CODE 4140-01-P
