Agency Information Collection Activities: Submission for OMB Review; Comment Request, 77839-77840 [2011-32014]

Download as PDF 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 mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 15:14 Dec 13, 2011 Jkt 226001 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] BILLING CODE 4160–01–P PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 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 E:\FR\FM\14DEN1.SGM 14DEN1 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 VerDate Mar<15>2010 15:14 Dec 13, 2011 Jkt 226001 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 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 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. E:\FR\FM\14DEN1.SGM 14DEN1

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]


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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

[[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