Agency Information Collection Activities: Submission for OMB Review; Comment Request, 60127-60128 [2012-24249]

Download as PDF Federal Register / Vol. 77, No. 191 / Tuesday, October 2, 2012 / Notices INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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. FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993–0002, 301– 796–1300. SUPPLEMENTARY INFORMATION: wreier-aviles on DSK5TPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Acute Bacterial Otitis Media: Developing Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in the overall clinical development of drugs to support an indication for the treatment of ABOM, defined in the guidance as ‘‘the recent or acute onset of inflammation of the middle ear caused by a bacterial pathogen.’’ This guidance finalizes the revised draft guidance issued on January 18, 2008, which in turn revised the draft guidance for industry entitled ‘‘Acute Otitis Media— Developing Antimicrobial Drugs for Treatment’’ issued in 1998. Changes from the revised draft guidance are incorporated in the appropriate sections of the guidance and are based on comments received to the docket for the draft guidance. In addition, developments in scientific and medical information and technology in the treatment of ABOM are included in this guidance. This guidance fulfills the statutory requirement described in the Food and Drug Administration Amendments Act of 2007 that directed FDA to update the guidance within 5 years.1 This guidance also responds to the requirement set forth in the Food and Drug Administration Safety and Innovation Act of 2012 that FDA review guidances for the conduct of clinical trials with respect to antibacterial and antifungal drugs and revise such guidances as appropriate.2 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 developing drugs 1 See Title IX, section 911, of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110–85). 2 See Title VIII, section 804(a)(1), of the Food and Drug Administration Safety and Innovation Act of 2012 (Pub. L. 112–144). VerDate Mar<15>2010 15:04 Oct 01, 2012 Jkt 229001 for the treatment of ABOM. 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. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 312 and 314 have been approved under 0910– 0014 and 0910–0001, respectively. The collections of information referred to in the guidance for clinical trial sponsors entitled ‘‘Establishment and Operation of Clinical Trial Data Monitoring Committees’’ have been approved under 0910–0581. III. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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. IV. 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: September 26, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–24211 Filed 10–1–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request The Health Resources and Services Administration (HRSA) periodically PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 60127 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 at (301) 443–1984. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Healthy Weight Collaborative Evaluation (OMB No. 0915–xxxx)—[NEW] Background: Supported by the Prevention and Public Health Fund created by Section 4002 of the Affordable Care Act, HRSA awarded $5 million to the National Initiative for Children’s Healthcare Quality (NICHQ) to create the Collaborative for Healthy Weight, a national initiative to bring together primary care providers, public health professionals, and leaders of community-based organizations to use quality improvement methods to address the obesity epidemic in communities across the country. A key part of that initiative was creation of the Healthy Weight Collaborative (HWC), a quality improvement project working with 50 community teams to identify, test, and evaluate a national ‘‘change package’’ of evidence-based program and policy interventions to address childhood obesity. The HWC is being implemented in two consecutive phases, each with a series of learning sessions and action periods. The first phase (July 2011 to July 2012) includes 10 community teams; the second phase (March 2012 to March 2013) includes 40 additional teams. Purpose: The purpose of this evaluation is to assess the quality and effectiveness of the HWC. This one-year information collection will supplement the analysis of existing quantitative HWC administrative and team data by collecting primary data using individual and group interviews with two groups of stakeholders: (a) NICHQ project leadership, staff, and faculty; and (b) community team members at 11 selected sites (four Phase 1 teams and seven Phase 2 teams). Data from these interviews will be used to evaluate the quality and effectiveness of the HWC. NICHQ leadership, staff, and faculty interview topics include: the design and implementation of the HWC project; the content and quality of the HWC learning sessions, coaching assistance, and other action period activities; the community teams’ experiences implementing the E:\FR\FM\02OCN1.SGM 02OCN1 60128 Federal Register / Vol. 77, No. 191 / Tuesday, October 2, 2012 / Notices HWC change package and quality improvement indicators; and stakeholders’ perceptions of the quality and effectiveness of the HWC in accelerating community efforts to address childhood obesity. Community team interviews will be conducted with the team coordinator, the quality improvement data manager, and other team members, including primary care providers, public health officials, school administrators, and other community volunteers. Separate interview protocols will be developed for the Phase 1 and Phase 2 community teams. Phase 1 protocols will examine community team strategies, activities, and approaches that have been sustained and spread after the end of Phase 1. Phase 2 protocols will examine: (1) Team goals, Number of respondents Instrument Responses per respondent objectives, and program elements; (2) team implementation of the HWC change package; (3) team engagement in HWC activities; and (4) team linkages and organizational and policy changes resulting from the team’s participation in the HWC. The annual estimate of burden is as follows: Total responses Hours per response Total burden hours NICHQ Leaders Interview .................................................... NICHQ Staff Interview ......................................................... NICHQ Faculty Group Interview .......................................... Phase 1 Team Group Interview ........................................... Phase 1 Team Coordinator Interview .................................. Phase 1 Team Data Manager Interview .............................. Phase 2 Team Group Interview ........................................... Phase 2 Team Coordinator Interview .................................. Phase 2 Team Data Manager Interview .............................. 4 5 *6 ** 24 4 4 *** 42 7 7 1 1 1 1 1 1 1 1 1 4 5 6 24 4 4 42 7 7 1.0 1.0 1.0 1.5 1.5 .5 1.5 1.5 .5 4.0 5.0 6.0 36.0 6.0 2.0 63.0 10.5 3.5 Total .............................................................................. 103 ........................ 103 ........................ 136.0 * One group interview: 6 people per group. ** Four group interviews: 6 people per group. *** Seven group interviews: 6 people per group. 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 202–395–5806. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Dated: September 26, 2012. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2012–24249 Filed 10–1–12; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Noncompetitive Supplements to Nursing Assistant and Home Health Aide Program Grantees wreier-aviles on DSK5TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Grantees of record are: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice of Noncompetitive Program Expansion Supplements to Develop, Implement, and Evaluate Educational Curricula in Medication Administration and Management; Care Coordination and Follow Up; and Behavioral Health and Social Support for Home Health Aides. AGENCY: The Health Resources and Services Administration (HRSA) will SUMMARY: VerDate Mar<15>2010 17:27 Oct 01, 2012 Jkt 229001 offer noncompetitive program expansion supplements of $100,000 to 10 Nursing Assistant and Home Health Aide (NAHHA) Program grantees to develop, implement, and evaluate enhanced training programs to build competency in medication administration and management, care coordination and follow up, and behavioral health and social support for home health aides. Approximately $1,000,000 is available in fiscal year (FY) 2012. The NAHHA grantees have the capability, expertise, experience and infrastructure to expeditiously and effectively implement this enhanced training program. Their existing curricular efforts have built-in opportunities to offer continuing/ expanded training, and these skills represent ones that have been identified by program participants and employers as highly desirable areas for training. American Red Cross, Greater Cleveland Chapter, 3747 Euclid Avenue, Cleveland, OH 44115–2501, T51HP20694 American Red Cross of Sonoma, Mendocino & Lake Counties, 5297 Aero Drive, Santa Rosa, CA 95403, T51HP20693 College of Menominee Nation, PO Box 1179, Keshena, WI 54135, T51HP20696 Erie 1 BOCES (Board of Cooperative Educational Services), 355 Harlem Road, West Seneca, NY 14224, T51HP20701 Hazard Community and Technical College, One Community Drive, Hazard, KY 41701, T51HP20697 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Jewish Vocational Service and Employment Center, 216 W. Jackson Boulevard, Suite 700, Chicago, IL 60606–6921, T51HP20695 Penn Asian Senior Services, 420 York Road, Jenkintown, PA 19046, T51HP20699 Sears Methodist Retirement System, Inc., Texas Tech University Health Sciences Center (TTUHSC) School of Nursing, 302 Pine Street, Abilene, TX 79601, T51HP20702 Southwestern Oregon Community College, 1988 Newmark Avenue, Coos Bay, OR 97420, T51HP20698 St. Joseph Medical Center, P.O. Box 316, Reading, PA 19603–0316, T51HP20700 Intended Recipients of the Award: 10 Existing NAHHA awardees. Intended Amount of Each Award: $100,000. CFDA Number: 93.503 Project Period: September 30, 2012, through September 29, 2013. Authority: Public Health Service Act, Title VIII, Section 831, 42 U.S.C. 296p, as amended by the Affordable Care Act (Pub. L. 111–148). Justification: These program expansion supplements allow the Bureau of Health Professions to consolidate resources and provide enhanced curricular offerings and technical assistance, grant monitoring and oversight to the NAHHA initiative within currently existing grants. Moreover, providing additional funding to existing grantees offers the opportunity to expand upon the program evaluation imbedded in the existing NAHHA program, increasing the knowledge yield for HRSA and the E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Notices]
[Pages 60127-60128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24249]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    The Health Resources and Services Administration (HRSA) 
periodically 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 at (301) 443-1984.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Healthy Weight Collaborative Evaluation (OMB No. 
0915-xxxx)--[NEW]

    Background: Supported by the Prevention and Public Health Fund 
created by Section 4002 of the Affordable Care Act, HRSA awarded $5 
million to the National Initiative for Children's Healthcare Quality 
(NICHQ) to create the Collaborative for Healthy Weight, a national 
initiative to bring together primary care providers, public health 
professionals, and leaders of community-based organizations to use 
quality improvement methods to address the obesity epidemic in 
communities across the country. A key part of that initiative was 
creation of the Healthy Weight Collaborative (HWC), a quality 
improvement project working with 50 community teams to identify, test, 
and evaluate a national ``change package'' of evidence-based program 
and policy interventions to address childhood obesity. The HWC is being 
implemented in two consecutive phases, each with a series of learning 
sessions and action periods. The first phase (July 2011 to July 2012) 
includes 10 community teams; the second phase (March 2012 to March 
2013) includes 40 additional teams.
    Purpose: The purpose of this evaluation is to assess the quality 
and effectiveness of the HWC. This one-year information collection will 
supplement the analysis of existing quantitative HWC administrative and 
team data by collecting primary data using individual and group 
interviews with two groups of stakeholders: (a) NICHQ project 
leadership, staff, and faculty; and (b) community team members at 11 
selected sites (four Phase 1 teams and seven Phase 2 teams). Data from 
these interviews will be used to evaluate the quality and effectiveness 
of the HWC. NICHQ leadership, staff, and faculty interview topics 
include: the design and implementation of the HWC project; the content 
and quality of the HWC learning sessions, coaching assistance, and 
other action period activities; the community teams' experiences 
implementing the

[[Page 60128]]

HWC change package and quality improvement indicators; and 
stakeholders' perceptions of the quality and effectiveness of the HWC 
in accelerating community efforts to address childhood obesity. 
Community team interviews will be conducted with the team coordinator, 
the quality improvement data manager, and other team members, including 
primary care providers, public health officials, school administrators, 
and other community volunteers. Separate interview protocols will be 
developed for the Phase 1 and Phase 2 community teams. Phase 1 
protocols will examine community team strategies, activities, and 
approaches that have been sustained and spread after the end of Phase 
1. Phase 2 protocols will examine: (1) Team goals, objectives, and 
program elements; (2) team implementation of the HWC change package; 
(3) team engagement in HWC activities; and (4) team linkages and 
organizational and policy changes resulting from the team's 
participation in the HWC.
    The annual estimate of burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
           Instrument               respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
NICHQ Leaders Interview.........               4               1               4             1.0             4.0
NICHQ Staff Interview...........               5               1               5             1.0             5.0
NICHQ Faculty Group Interview...             * 6               1               6             1.0             6.0
Phase 1 Team Group Interview....           ** 24               1              24             1.5            36.0
Phase 1 Team Coordinator                       4               1               4             1.5             6.0
 Interview......................
Phase 1 Team Data Manager                      4               1               4              .5             2.0
 Interview......................
Phase 2 Team Group Interview....          *** 42               1              42             1.5            63.0
Phase 2 Team Coordinator                       7               1               7             1.5            10.5
 Interview......................
Phase 2 Team Data Manager                      7               1               7              .5             3.5
 Interview......................
                                 -------------------------------------------------------------------------------
    Total.......................             103  ..............             103  ..............           136.0
----------------------------------------------------------------------------------------------------------------
* One group interview: 6 people per group.
** Four group interviews: 6 people per group.
*** Seven group interviews: 6 people per group.

    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 202-395-5806. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: September 26, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-24249 Filed 10-1-12; 8:45 am]
BILLING CODE 4165-15-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.