Agency Information Collection Activities; Proposed Collection; Comment Request, 22888-22889 [2013-09026]
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22888
Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
requirements are penicillins. This
guidance explains that, due to the
potential health risks of crosscontamination, the Agency expects
separation for all classes of beta-lactam
drugs, including penicillins as well as
non-penicillin beta-lactams.
Specifically, FDA recommends that
manufacturers establish appropriate
separation and control systems designed
to prevent two types of contamination:
(1) The contamination of a nonpenicillin beta-lactam by any other nonpenicillin beta-lactam and (2) the
contamination of any other type of
product by a non-penicillin beta-lactam.
Accordingly, FDA recommends that the
area in which any class of sensitizing
beta-lactam is manufactured should be
separated from areas in which any other
products are manufactured, and should
have an independent air handling
system.
A draft version of this guidance was
published in March 2011 as ‘‘NonPenicillin Beta-Lactam Risk Assessment:
A CGMP Framework.’’ This final
version was revised in response to
docket comments to clarify that this
guidance does not provide a formal risk
assessment, but, rather, describes FDA’s
expectations and recommendations for
separation strategies to prevent crosscontamination.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on Non-Penicillin BetaLactam Drugs: A CGMP Framework for
Preventing Cross-Contamination. 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 either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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, and
will be posted to the docket at https://
www.regulations.gov.
VerDate Mar<15>2010
16:50 Apr 16, 2013
Jkt 229001
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: April 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–08913 Filed 4–16–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of Title
44, United States Code, as amended by
the Paperwork Reduction Act of 1995,
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
SUMMARY:
Information Collection Request Title:
Health Care and Other Facilities (OMB
No. 0915–0309)—Extension
Abstract: The Health Resources and
Services Administration’s Health Care
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
and Other Facilities (HCOF) program
provides congressionally-directed funds
to health-related facilities for
construction related activities and/or
capital equipment purchases. Awarded
facilities are required to provide a
periodic (quarterly for construction
related projects, annually for equipment
only projects) update of the status of the
funded project until it is completed. The
monitoring period averages about three
years, although some projects take up to
five years to complete. The information
collected from these updates is vital to
program management staff to determine
whether projects are progressing
according to the established timeframes,
meeting deadlines established in the
Notice of Award, and drawing down
funds appropriately. The data collected
from the updates is also shared with the
Division of Grants Management
Operations for their assistance in the
overall evaluation of each project’s
progress.
An electronic form is currently being
used for progress reporting for the
HCOF program. This form provides
awardees access to directly input the
required status update information in a
timely, consistent, and uniform manner.
The electronic form minimizes burden
to respondents and informs respondents
when there are missing data elements
prior to submission. We acknowledge a
change in the burden estimate due to
close out of old projects.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
E:\FR\FM\17APN1.SGM
17APN1
22889
Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Notices
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Construction Related ...........................................................
Equipment Only ...................................................................
200
317
4
1
800
317
.5
.5
400
158.5
Total ..............................................................................
517
........................
1,117
........................
558.5
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
Deadline: Comments on this
Information Collection Request must be
received within 60 days of this notice.
ADDRESSES:
Dated: April 10, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–09026 Filed 4–16–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of Title
44, United States Code, as amended by
the Paperwork Reduction Act of 1995,
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
SUMMARY:
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Information Collection Request Title:
Data Collection Tool for State Offices of
Rural Health Grant Program. (OMB No.
0915–0322)—Extension
Abstract: The mission of the Office of
Rural Health Policy (ORHP) is to sustain
and improve access to quality care
services for rural communities. In its
authorizing language (Section 711 of the
Social Security Act [42 U.S.C. 912]),
Congress charged ORHP with
administering grants, cooperative
agreements, and contracts to provide
technical assistance and other activities
as necessary to support activities related
to improving health care in rural areas.
In accordance with the Public Health
Service Act, Section 338J (42 U.S.C.
254r), the Health Resources and
Services Administration proposes to
revise the State Offices of Rural Health
Grant Program—Funding Opportunity
Announcement (FOA) and Forms for the
Application. The FOA is used annually
by 50 states in preparing applications
for Grants under the State Offices of
Number of
respondents
sroberts on DSK5SPTVN1PROD with NOTICES
Form name
Technical Assistance Report ...............................................
Total ..............................................................................
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
ADDRESSES:
VerDate Mar<15>2010
16:50 Apr 16, 2013
Jkt 229001
Number of
responses per
respondent
50
50
Frm 00048
Fmt 4703
Sfmt 4703
Total
responses
1
1
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
PO 00000
Rural Health Grant Program (SORH) of
the Public Health Service Act, and in
preparing the required report.
ORHP seeks to continue gathering
information from grantees on their
efforts to provide technical assistance to
clients within their state. SORH grantees
would be required to submit a Technical
Assistance Report that includes: (1) The
total number of technical assistance
encounters provided directly by the
grantee; and, (2) the total number of
unduplicated clients that received direct
technical assistance from the grantee.
Submission of the Technical Assistance
Report would be done via submission to
the HRSA Electronic Handbook no later
than 30 days after the end of each
twelve month budget period.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
50
50
Average
burden per
response
(in hours)
12.5
12.5
Total burden
hours
625
625
Deadline: Comments on this
Information Collection Request must be
received within 60 days of this notice.
E:\FR\FM\17APN1.SGM
17APN1
]]>Agencies
[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22888-22889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09026]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1984.
HRSA especially requests comments on: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions, (2) the accuracy of the estimated burden, (3)
ways to enhance the quality, utility, and clarity of the information to
be collected, and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
Information Collection Request Title: Health Care and Other Facilities
(OMB No. 0915-0309)--Extension
Abstract: The Health Resources and Services Administration's Health
Care and Other Facilities (HCOF) program provides congressionally-
directed funds to health-related facilities for construction related
activities and/or capital equipment purchases. Awarded facilities are
required to provide a periodic (quarterly for construction related
projects, annually for equipment only projects) update of the status of
the funded project until it is completed. The monitoring period
averages about three years, although some projects take up to five
years to complete. The information collected from these updates is
vital to program management staff to determine whether projects are
progressing according to the established timeframes, meeting deadlines
established in the Notice of Award, and drawing down funds
appropriately. The data collected from the updates is also shared with
the Division of Grants Management Operations for their assistance in
the overall evaluation of each project's progress.
An electronic form is currently being used for progress reporting
for the HCOF program. This form provides awardees access to directly
input the required status update information in a timely, consistent,
and uniform manner. The electronic form minimizes burden to respondents
and informs respondents when there are missing data elements prior to
submission. We acknowledge a change in the burden estimate due to close
out of old projects.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions, to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information, to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information, and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
The annual estimate of burden is as follows:
[[Page 22889]]
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Construction Related............ 200 4 800 .5 400
Equipment Only.................. 317 1 317 .5 158.5
-------------------------------------------------------------------------------
Total....................... 517 .............. 1,117 .............. 558.5
----------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857.
Deadline: Comments on this Information Collection Request must be
received within 60 days of this notice.
Dated: April 10, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-09026 Filed 4-16-13; 8:45 am]
BILLING CODE 4165-15-P
