Proposed Collection; 30-Day Comment Request; Evaluation of a Kidney Disease Education and Awareness Program in the Hispanic Community, 59706-59707 [2013-23673]
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59706
Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices
comparability review or a validation
review inspection is not acceptable, as
described under § 493.573 and
§ 493.575, or if the State of Washington
fails to pay the required fee every 2
years as required under § 493.646.
Laboratory Data
In accordance with our regulations at
§ 493.557(b)(8), the approval of this
exemption for laboratories located in
and licensed by the State of Washington
is conditioned on the State of
Washington’s continued compliance
with the assertions made in its
application, especially the provision of
information to us about changes to a
laboratory’s specialties or subspecialties
based on the state’s survey, and changes
to a laboratory’s certification status,
such as a change from a CLIA certificate
of compliance to a CLIA certificate of
waiver.
pmangrum on DSK3VPTVN1PROD with NOTICES
Required Administrative Actions
CLIA is a user-fee funded program.
The registration fee paid by laboratories
is intended to cover the cost of the
development and administration of the
program. However, when a state’s
application for exemption is approved,
we do not charge a fee to laboratories in
the state. The state’s share of the costs
associated with CLIA must be collected
from the state, as specified in § 493.645.
The State of Washington must pay for
the following:
• Costs of federal inspections of
laboratories in the state to verify that
Washington State’s laboratory licensure
program requirements are equivalent to
or more stringent than those in the CLIA
program, and that they are enforced in
an appropriate manner. The average
federal hourly rate is multiplied by the
total hours required to perform federal
validation surveys within the state.
• Costs incurred for federal surveys,
including investigations of complaints
that are substantiated. We will bill the
State of Washington on a semiannual
basis.
• The State of Washington’s
proportionate share of the costs
associated with establishing,
maintaining, and improving the CLIA
computer system, based on the portion
of those services from which the State
of Washington received direct benefit or
which contributed to the CLIA program
in the state. Thus, the State of
Washington is being charged for a
portion of our direct and indirect costs
of administering the CLIA program.
Such costs will be incurred by CMS, the
Centers for Disease Control and
Prevention (CDC), the Food and Drug
Administration (FDA) and contractors
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14:21 Sep 26, 2013
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working on behalf of these respective
agencies.
To estimate the State of Washington’s
proportionate share of the general
overhead costs to develop and
implement CLIA, we determined the
ratio of laboratories in the state to the
total number of laboratories nationally.
Approximately 1.5 percent of the
registered laboratories are in the State of
Washington. We determined that a
corresponding percentage of the
applicable CMS, CDC, FDA, and their
respective contractor costs should be
borne by the State of Washington.
The State of Washington has agreed to
pay the state’s pro rata share of the
anticipated overhead costs and costs of
actual validation (including complaint
investigation surveys). A final
reconciliation for all laboratories and all
expenses will be made. We will
reimburse the state for any overpayment
or bill it for any balance.
II. Approval
In light of the foregoing, we grant
approval of the State of Washington’s
laboratory licensure program under
subpart E. All laboratories located in
and licensed by the State of Washington
under the Medical Test Site law,
Chapter 70.42 of the Revised Code of
Washington, are CLIA-exempt for all
specialties and subspecialties until
September 27, 2019.
FOR FURTHER INFORMATION CONTACT:
Katharine Neckers, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Building 51, Rm. 4259,
301–796–3339, email:
Katharine.Neckers@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR
Doc. 2013–20215, appearing on page
51192 in the Federal Register of August
20, 2013, the following correction is
made:
On page 51194, in the second column,
under ‘‘IV. Process for Applying to
Participate in the Pilot,’’ in the third full
paragraph, the sentence that reads ‘‘For
communications other than the
submission of the SSCPP application
(Form FDA 3676), please contact the
CDER SSCPP mailbox at
SSCPPMailbox@fda.hhs.gov’’ is
corrected to read ‘‘For communications
other than the submission of the SSCPP
application (Form FDA 3676), please
contact the CDER SSCPP mailbox at
CDERSSCPP@fda.hhs.gov.’’
Dated: September 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23563 Filed 9–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: Section 353(p) of the Public
Health Service Act (42 U.S.C. 263a).
National Institutes of Health
Dated: August 8, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Proposed Collection; 30-Day Comment
Request; Evaluation of a Kidney
Disease Education and Awareness
Program in the Hispanic Community
[FR Doc. 2013–23659 Filed 9–26–13; 8:45 am]
SUMMARY:
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0656]
Secure Supply Chain Pilot Program;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
document that appeared in the Federal
Register of August 20, 2013 (78 FR
51192). The document announced the
start of the Secure Supply Chain Pilot
Program (SSCPP). The document was
published with an incorrect email
address for the SSCPP mailbox. This
document corrects that error.
SUMMARY:
PO 00000
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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 for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on July 19, 2013,
Volume 78, pages 43214–43215, and
allowed 60-days for public comment.
One public comment was received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Kidney Disease Education
Program, the National Institute of
Diabetes and Digestive and Kidney
Diseases, the National Institutes of
Health (NIH), 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.
E:\FR\FM\27SEN1.SGM
27SEN1
59707
Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices
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
Management and Budget, Office of
Regulatory Affairs, OIRA_submission @
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer. To obtain
a copy of the data collection plans and
instruments, submit comments in
writing, or request more information on
the proposed project, contact: Eileen
Newman, Associate Director, National
Kidney Disease Education Program,
OCPL, NIDDK, NIH, Building 31, Room
9A06, 9000 Rockville Pike, Bethesda,
MD 20892, or call non-toll-free number
(301) 435–8116 or Email your request,
including your address to:
Eileen.newman@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
training, and areas for program
improvement; (b) effectiveness of the
program on the clients (the community
members being educated); and (c)
effectiveness of materials and training,
including promotores’ ability to deliver
education to the client and administer
the client pre-test/post-test surveys. The
pilot study will deliver strategic and
actionable guidance for refining the
educational and training materials for
national dissemination. Based on
outcomes from the pilot study, a
national evaluation is planned that will
use the client pre-test/post-test surveys
to assess: (a) Knowledge gains about
kidney disease, (b) awareness of NKDEP
resources and importance of kidney
health, (c) reported behavior change
outcomes and (d) reported health status.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
101 (see table below).
best assured of having their full effect if
received within 30 days of the date of
this publication.
Proposed Collection: Evaluation of a
Kidney Disease Education Program with
Promotores in the Hispanic Community,
0925—NEW, National Kidney Disease
Education Program, National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), National Institutes of
Health (NIH).
Need and Use of Information
Collection: NKDEP is developing a
kidney disease education program to
raise awareness among the Hispanic
community at risk for kidney disease.
Since diabetes is the most common
cause of kidney disease, the program is
being developed for inclusion in
existing diabetes programs being
conducted by ‘‘promotores de salud’’
(Spanish/English-speaking community
health workers). A pilot evaluation will
assess: (a) Overall quality of the program
from the client and promotor/a
perspective, including strengths and
weaknesses of the program and the
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Pilot study collection:
Promotores ....................
Promotores ....................
Client Group ..................
Client Group (partial) .....
Promotores training pre-test, post-test, and qualitative in-depth interview post client session
(Attachment 1 and 2).
Administer client pre-test, post-test, and second
post-tests for experimental and control groups
(Attachment 3).
Client pre-test, post-test, second post-test for
experimental and control groups (Attachment
3).
Client qualitative in-depth interview post-client
session (Attachment 4).
Total ........................
[FR Doc. 2013–23673 Filed 9–26–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
14:21 Sep 26, 2013
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5/60
1
20
17
15/60
85
85
1
10/60
14
4
1
10/60
1
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HIV Vaccine Research and
Design.
Date: October 21–22, 2013.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Frm 00061
Fmt 4703
Sfmt 4703
Total
burden
hours
1
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
Response
burden
(hours)
12
121
Dated: September 23, 2013.
Camille M. Hoover,
Executive Officer, NIDDK, NIH.
VerDate Mar<15>2010
No. of
responses per
respondent
Number of
respondents
Form name
101
Place: Hilton Washington/Rockville,
Regency Ballroom, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Kelly Y. Poe, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 6700–B
Rockledge Drive, MDS–7616, Bethesda, MD
20892, 301–451–2639, poeky@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Peer Review Meeting.
Date: October 21–23, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Residence Inn Bethesda,
Montgomery I & II, 7335 Wisconsin Avenue,
Bethesda, MD 20814.
Contact Person: Maja Maric, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
DHHS/NIH/NIAID, 6700B Rockledge Drive,
E:\FR\FM\27SEN1.SGM
27SEN1
]]>Agencies
[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59706-59707]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23673]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 30-Day Comment Request; Evaluation of a
Kidney Disease Education and Awareness Program in the Hispanic
Community
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 for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on July 19, 2013, Volume 78, pages 43214-43215, and allowed
60-days for public comment. One public comment was received. The
purpose of this notice is to allow an additional 30 days for public
comment. The National Kidney Disease Education Program, the National
Institute of Diabetes and Digestive and Kidney Diseases, the National
Institutes of Health (NIH), 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.
[[Page 59707]]
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 Management and Budget, Office of Regulatory
Affairs, OIRA--submission @omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer. To obtain a copy of the data collection
plans and instruments, submit comments in writing, or request more
information on the proposed project, contact: Eileen Newman, Associate
Director, National Kidney Disease Education Program, OCPL, NIDDK, NIH,
Building 31, Room 9A06, 9000 Rockville Pike, Bethesda, MD 20892, or
call non-toll-free number (301) 435-8116 or Email your request,
including your address to: Eileen.newman@nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
Comment 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.
Proposed Collection: Evaluation of a Kidney Disease Education
Program with Promotores in the Hispanic Community, 0925--NEW, National
Kidney Disease Education Program, National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), National Institutes of Health
(NIH).
Need and Use of Information Collection: NKDEP is developing a
kidney disease education program to raise awareness among the Hispanic
community at risk for kidney disease. Since diabetes is the most common
cause of kidney disease, the program is being developed for inclusion
in existing diabetes programs being conducted by ``promotores de
salud'' (Spanish/English-speaking community health workers). A pilot
evaluation will assess: (a) Overall quality of the program from the
client and promotor/a perspective, including strengths and weaknesses
of the program and the training, and areas for program improvement; (b)
effectiveness of the program on the clients (the community members
being educated); and (c) effectiveness of materials and training,
including promotores' ability to deliver education to the client and
administer the client pre-test/post-test surveys. The pilot study will
deliver strategic and actionable guidance for refining the educational
and training materials for national dissemination. Based on outcomes
from the pilot study, a national evaluation is planned that will use
the client pre-test/post-test surveys to assess: (a) Knowledge gains
about kidney disease, (b) awareness of NKDEP resources and importance
of kidney health, (c) reported behavior change outcomes and (d)
reported health status.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 101 (see table below).
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of
Type of respondent Form name Number of responses per Response Total burden
respondents respondent burden (hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot study collection:
Promotores..................................... Promotores training pre-test, post- 12 1 5/60 1
test, and qualitative in-depth
interview post client session
(Attachment 1 and 2).
Promotores..................................... Administer client pre-test, post-test, 20 17 15/60 85
and second post-tests for experimental
and control groups (Attachment 3).
Client Group................................... Client pre-test, post-test, second post- 85 1 10/60 14
test for experimental and control
groups (Attachment 3).
Client Group (partial)......................... Client qualitative in-depth interview 4 1 10/60 1
post-client session (Attachment 4).
---------------------------------------------------------------
Total...................................... 121 101
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: September 23, 2013.
Camille M. Hoover,
Executive Officer, NIDDK, NIH.
[FR Doc. 2013-23673 Filed 9-26-13; 8:45 am]
BILLING CODE 4140-01-P
