Agency Information Collection Activities: Submission for OMB Review; Comment Request, 77839-77840 [2011-32014]
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77839
Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices
the FD&C Act, a person that intends to
use such a claim must submit a
notification of its intention to use the
claim 120 days before it begins
marketing the product bearing the
claim. In the Federal Register of June 11,
1998 (63 FR 32102), FDA announced the
availability of a guidance entitled
‘‘Guidance for Industry: Notification of
a Health Claim or Nutrient Content
Claim Based on an Authoritative
Statement of a Scientific Body.’’ The
guidance provides the Agency’s
interpretation of terms central to the
submission of a notification and the
Agency’s views on the information that
should be included in the notification.
The Agency believes that the guidance
will enable persons to meet the criteria
for notifications that are established in
section 403(r)(2)(G) and (r)(3)(C) of the
FD&C Act. In addition to the
information specifically required by the
FD&C Act to be in such notifications,
the guidance states that the notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. FDA intends
to review the notifications the Agency
receives to ensure that they comply with
the criteria established by the FD&C Act.
In the Federal Register of August 3,
2011 (76 FR 46819), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses
per
respondent
Number of
respondents
Section of the FD&C Act
Average
burden per
response
Total annual
responses
Total hours
403(r)(2)(G) (nutrient content claims) ..................................
403(r)(2)(C) (health claims) .................................................
Guidance for notifications ....................................................
1
1
2
1
1
1
1
1
2
250
450
1
250
450
2
Total ..............................................................................
........................
........................
........................
........................
702
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
experience with health claims, nutrient
content claims, and other similar
notification procedures that fall under
our jurisdiction. To avoid estimating the
number of respondents as zero, the
Agency estimates that there will be one
or fewer respondents annually for
nutrient content claim and health claim
notifications. FDA estimates that it will
receive one nutrient content claim
notification and one health claim
notification per year over the next 3
years.
Section 403(r)(2)(G) and (r)(3)(C) of
the FD&C Act requires that the
notification include the exact words of
the claim, a copy of the authoritative
statement, a concise description of the
basis upon which such person relied for
determining that this is an authoritative
statement as outlined in the FD&C Act,
and a balanced representation of the
scientific literature relating to the
relationship between a nutrient and a
disease or health-related condition to
which a health claim refers or to the
nutrient level to which the nutrient
content claim refers. This balanced
representation of the scientific literature
is expected to include a bibliography of
the scientific literature on the topic of
the claim and a brief, balanced account
or analysis of how this literature either
supports or fails to support the
authoritative statement.
Since the claims are based on
authoritative statements of a scientific
body of the U.S. Government or NAS,
FDA believes that the information that
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is required by the FD&C Act to be
submitted with a notification will be
readily available to a respondent.
However, the respondent will have to
collect and assemble that information.
Based on communications with firms
that have submitted notifications, FDA
estimates that 1 respondent will take
250 hours to collect and assemble the
information required by the statute for
a nutrient content claim notification.
Further, FDA estimates that 1
respondent will take 450 hours to
collect and assemble the information
required by the statute for a health claim
notification.
Under the guidance, notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. The
guidance applies to both nutrient
content claim and health claim
notifications. FDA has determined that
this information should be readily
available to a respondent and, thus, the
Agency estimates that it will take a
respondent 1 hour to incorporate the
information into each notification. The
Agency expects there will be 2
respondents for a total of 2 hours.
Dated: December 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–32025 Filed 12–13–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Cultural and
Linguistic Competency and Health
Literacy Data Collection Checklist (OMB
No. 0915–xxxx)—[New].
The Health Resources and Services
Administration’s (HRSA) vision is
‘‘Healthy Communities, Healthy
People.’’ In addition, the HRSA mission
statement is ‘‘To improve health and
achieve health equity through access to
quality services, a skilled health
workforce and innovative programs.’’
This framework supports a health care
system that assures access to
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77840
Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices
comprehensive, culturally competent,
quality care.
Performance measures have been
useful in helping HRSA to assess the
progress of each grantee. The measure
used will be informed by the degree to
which HRSA-funded programs have
incorporated cultural and linguistic
competence and health literacy
elements into their policies, guidelines,
contracts and training. HRSA bureaus
and offices will be encouraged to
incorporate this performance measure
(or a modified version of this measure)
into their funding opportunity
announcements, as either a stand-alone
or integrated measure.
Using a scale of 0–3, the grantee may
use the Cultural and Linguistic
Competency and Health Literacy Data
Collection Checklist to assess if
specified cultural/linguistic competence
and health literacy elements have been
incorporated into their policies,
guidelines, contracts and training. Each
HRSA program may add data sources
and year of data used for scoring to
provide a rationale for determining a
score, and/or applicability of elements
to a specific program.
Number of
respondents
Instrument
Responses
per
respondent
The goal of this checklist is to
increase the number of HRSA-funded
programs that have integrated cultural
and linguistic competence and health
literacy into their policies, guidelines,
contracts and training. In addition,
variations of the proposed tool have
proven useful for grantees’ selfassessment. This proposed tool can also
offer insights into technical assistance
challenges and opportunities.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Data Collection Checklist .....................................................
900
1
900
1
900
Total ..............................................................................
900
1
900
1
900
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: December 8, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–32014 Filed 12–13–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 76 FR 64953–64954
dated October 19, 2011).
This notice reflects organizational
changes to the Health Resources and
Services Administration. Specifically,
this notice updates the functional
statement for the Office of Federal
Assistance Management (RJ). The
update to the functional statement will
better align functional responsibility
with improved management and
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administrative efficiencies and
improved alignment of current liaison
functions and grant policy processes
within the Office of Federal Assistance
Management.
Chapter RJ—Office of Federal
Assistance Management
Section RJ–10, Organization
Delete in its entirety and replace with
the following:
The Office of Federal Assistance
Management (RJ) is headed by the
Associate Administrator, who reports
directly to the Administrator, Health
Resources Services Administration. The
Office of Federal Assistance
Management includes the following
components:
(1) Office of the Associate
Administrator (RJ);
(2) Division of Financial Integrity
(RJ1);
(3) Division of Grants Policy (RJ2);
(4) Division of Grants Management
Operations (RJ3); and
(5) Division of Independent Review
(RJ4).
Section RJ–20, Functions
(1) Delete the functional statement for
the Office of Federal Assistance
Management (RJ) and replace in its
entirety.
Office of Associate Administrator (RJ)
Provides national leadership in the
administration and assurance of the
financial integrity of HRSA’s programs
and provides oversight over all HRSA
activities to ensure that HRSA’s
resources are being properly used and
protected. Provides leadership,
direction and coordination to all phases
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of grants policy, administration, and
independent review of competitive
grant applications. Specifically: (1)
Serves as the Administrator’s principal
source for grants policy and financial
integrity of HRSA programs; (2)
exercises oversight over the Agency’s
business processes related to assistance
programs; (3) facilitates, plans, directs
and coordinates the administration of
HRSA grant policies and operations; (4)
plans, directs and carries out the grants
officer functions for all of HRSA’s grant
programs as well as awarding official
functions for various scholarship, loan
and loan repayment assistance
programs; and (5) directs and carries out
the independent review of grant
applications for all of HRSA’s programs.
Division of Financial Integrity (RJ1)
(1) Coordinates agency-wide efforts
addressing HHS’s Program Integrity
Initiative; (2) serves as the Agency’s
focal point for coordinating financial
audits of grantees; (3) coordinates the
external financial assessment of HRSA
grantees and the resolution of any audit
findings; (4) conducts the pre-award and
post-award review of grant applicants’
and grantees’ accounting systems; (5)
conducts ad hoc studies and reviews
related to the financial integrity of the
HRSA business processes related to
assistance programs; (6) serves as the
Agency’s liaison with the Office of
Inspector General (OIG) for issues
related to grants; (7) coordinates the
Agency’s response to HHS OIG Hotline
complaints reporting fraudulent fiscal
activities pertaining to HRSA grant
funds; and (8) establishes an assessment
model for grantee oversight.
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]]>Agencies
[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77839-77840]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32014]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To request
a copy of the clearance requests submitted to OMB for review, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: Cultural and Linguistic Competency and Health
Literacy Data Collection Checklist (OMB No. 0915-xxxx)--[New].
The Health Resources and Services Administration's (HRSA) vision is
``Healthy Communities, Healthy People.'' In addition, the HRSA mission
statement is ``To improve health and achieve health equity through
access to quality services, a skilled health workforce and innovative
programs.'' This framework supports a health care system that assures
access to
[[Page 77840]]
comprehensive, culturally competent, quality care.
Performance measures have been useful in helping HRSA to assess the
progress of each grantee. The measure used will be informed by the
degree to which HRSA-funded programs have incorporated cultural and
linguistic competence and health literacy elements into their policies,
guidelines, contracts and training. HRSA bureaus and offices will be
encouraged to incorporate this performance measure (or a modified
version of this measure) into their funding opportunity announcements,
as either a stand-alone or integrated measure.
Using a scale of 0-3, the grantee may use the Cultural and
Linguistic Competency and Health Literacy Data Collection Checklist to
assess if specified cultural/linguistic competence and health literacy
elements have been incorporated into their policies, guidelines,
contracts and training. Each HRSA program may add data sources and year
of data used for scoring to provide a rationale for determining a
score, and/or applicability of elements to a specific program.
The goal of this checklist is to increase the number of HRSA-funded
programs that have integrated cultural and linguistic competence and
health literacy into their policies, guidelines, contracts and
training. In addition, variations of the proposed tool have proven
useful for grantees' self-assessment. This proposed tool can also offer
insights into technical assistance challenges and opportunities.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Data Collection Checklist....... 900 1 900 1 900
-------------------------------------------------------------------------------
Total....................... 900 1 900 1 900
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: December 8, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-32014 Filed 12-13-11; 8:45 am]
BILLING CODE 4165-15-P
