Submission for OMB Review; Comment Request, 447-448 [E8-31306]

Download as PDF Federal Register / Vol. 74, No. 3 / Tuesday, January 6, 2009 / Notices 3. The acquisition is not a commercial item acquisition. 4. The acquisition offers more than minimal subcontracting opportunities. B. Annual Reporting Burden Respondents: 1,020. Responses per Respondent: 1. Hours Per Response: 12. Total Burden Hours: 12,240. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501–4755. Please cite OMB Control No. 3090–0252, Preparation, Submission, and Negotiation of Subcontracting Plans, in all correspondence. Dated: December 2, 2008. Al Matera, Director, Office of Acquisition Policy. [FR Doc. E8–31456 Filed 1–5–09; 8:45 am] BILLING CODE 6820–61–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of the Release of the U.S. Department of Health and Human Services’ Action Plan To Prevent Healthcare-Associated Infections AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science. ACTION: Notice. Authority: 42 U.S.C 200u. The Office of Public Health and Science (OPHS), U.S. Department of Health and Human Services (HHS), announces the release of the HHS Action Plan To Prevent HealthcareAssociated Infections (HHS Action Plan). The effort represents a culmination of several months of deliberation by subject matter experts across HHS to identify key actions in the prevention of healthcare-associated infections (HAIs). The document establishes national goals for enhancing and coordinating HHS-supported efforts, including the development of (1) National benchmarks; (2) prioritized recommended clinical practices to facilitate implementation of and adherence to existing recommended practices in hospitals; (3) a coordinated research agenda to strengthen the science for infection control prevention in hospitals; (4) a plan to progress towards the standardized measures and data definitional alignment needed to more accurately measure HAIs and mstockstill on PROD1PC66 with NOTICES SUMMARY: VerDate Nov<24>2008 16:52 Jan 05, 2009 Jkt 217001 make the varied HHS data systems interoperable; (5) opportunities for evaluating compliance with infection control practices in hospitals through certification processes and potential options for the use of payment policies and financial incentives to motivate organizations to provide better, more efficient care; and (6) a national messaging plan to build partnerships with various stakeholder groups across the country. Background: Healthcare-associated infections exact a significant toll on human life. They are among the top ten leading causes of death in the United States, accounting for an estimated 1.7 million infections and 99,000 associated deaths. In hospitals, they are a significant cause of morbidity and mortality. In addition to the substantial human suffering exacted by HAIs, the financial burden attributable to these infections is staggering. It is estimated that HAIs incur nearly $20 billion in excess healthcare costs each year. For these reasons, the reduction of HAIs is a top priority for HHS. The HHS Steering Committee to Prevent Healthcare-Associated Infections (Committee) was established in July 2008. The Committee was charged with developing a strategy to reduce HAIs and issuing a plan which establishes national goals for HAI prevention and outlines key actions for achieving identified short- and longterm objectives. The plan is also intended to enhance collaboration with external stakeholders to maximize coordination and impact of national efforts. Thus, the development process of the HHS Action Plan is inclusive. The goal is to effectively collaborate with multiple stakeholders to maximize reach and impact in order to effectively prevent HAIs. The process strives to maximize transparency, public input, and stakeholder dialogue to ensure that the HHS Action Plan is relevant to multiple audiences and diverse public health needs and seizes opportunities to achieve its goals. Drawing on the expertise of the HHS Steering Committee To Prevent HealthcareAssociated Infections, other experts across the Federal Government, various stakeholders, and the public, the HHS Action Plan will establish a national strategy for the reduction and prevention of HAIs. The public is invited to comment through the Web site on the content of the document. The plan is intended to be updated periodically in response to public input and new recommendations for infection prevention. PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 447 ADDRESSES: The Action Plan To Prevent Healthcare-Associated Infections and instructions for submitting comments can be viewed at http://www.hhs.gov/ ophs. FOR FURTHER INFORMATION CONTACT: Send questions to the Office of Public Health and Science, U.S. Department of Health and Human Services, Ms. Julie Moreno at Julie.Moreno@hhs.gov (e-mail), (202) 401–9581 (phone), or (202) 690–6960 (fax) or Ms. Rani Jeeva at Rani.Jeeva@hhs.gov (e-mail), (240) 276–9824 (phone), or (240) 276–9860 (fax). Dated: December 22, 2008. Donald Wright, Principal Deputy Assistant Secretary for Health. [FR Doc. E8–31195 Filed 1–5–09; 10:58 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Proposed Project: Title: Feasibility Test for Design Phase of National Study of Child Care Supply and Demand. OMB No.: New Collection. Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), intends to request approval from the Office of Management and Budget to collect information as part of the Design Phase of the National Study of Child Care Supply and Demand. This effort will gather information that will be useful for evaluating the feasibility and improving the design of a national study of child care supply and demand. The proposed collection will consist of: A random-digit dial survey of households with children under age 13 for participation in a questionnaire about the demand for child care; a random-digit dial survey of households with individuals providing care to children under age 13 in a residential setting; a telephone screening of afterschool programs for eligibility in a survey of child care providers; a telephone survey of providers of care to children under age 13; an in-person survey of providers of care to children under age 13; and, an in-person survey of parents of children under age 13 who are in non-parental care arrangements. These data collection efforts will be used to examine the functioning of draft E:\FR\FM\06JAN1.SGM 06JAN1 448 Federal Register / Vol. 74, No. 3 / Tuesday, January 6, 2009 / Notices survey instruments. The feasibility test procedures will help inform several decisions about proposed design of the national study including sampling methods, costs and advantages associated with alternative interviewing protocols and reactions to the proposed methods. Respondents: General population households, home-based and centerbased child care providers, and public schools serving children under age 13. ANNUAL BURDEN ESTIMATES Annual number of respondents Instrument Eligibility calls to Before/After School Programs ......................................... Household screening calls ........................................................................... Telephone calls with households with children under age .......................... Telephone calls with providers of home-based care ................................... Telephone calls with center-based providers of before/after school care .. In-person interviews with parents of children in non-parental care ............ In-person interviews with child-care provider staff ...................................... Estimated Total Annual Burden Hours: 365.2. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: OPREinfocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. Dated: December 29, 2008. Steven M. Hanmer, OPRE Reports Clearance Officer. [FR Doc. E8–31306 Filed 1–5–09; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on PROD1PC66 with NOTICES National Institutes of Health Submission for OMB Review; Comment Request Information Program on Clinical Trials: Maintaining a Registry and Results Databank SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), the National VerDate Nov<24>2008 16:52 Jan 05, 2009 Jkt 217001 Number of responses per respondent Average burden hours per response 1 1 1 1 1 1 1 .2 15 5 .3 .5 .4 4 150 1000 160 104 68 50 50 Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 8, 2008 (Vol. 73, No. 196, p. 58973) 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 Institutes of Health 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. Proposed Collection: Title: Information Program on Clinical Trials: Maintaining a Registry and Results Databank; Type of Information Collection Request: Revision of currently approved collection [OMB No. 0925–0586, expiration date 01/31/2009], Form Number: N/A; Need and Use of Information Collection: The National Institutes of Health is modifying the clinical trial registry databank established under previous law [FDAMA, Section 113] to comply with provisions of Title VIII of Public Law 110–85 (Food and Drug Administration Amendments Act of 2007). The databank collects specified registration and results information on certain clinical trials identified in the law, with the objective of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical trials, to the benefit of public health. The databank is widely used by patients, physicians, and medical researchers; in particular, those involved in clinical research studies. Public Law 110–85 expands the scope of clinical trials that must be registered in ClinicalTrials.gov, increases the clinical trial information that must be submitted PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 Estimated annual burden hours 30 150 80 31.2 34 20 20 as part of each registration, and requires the submission of basic results information for registered trials of approved drugs, biologics and devices. Frequency of Response: Responsible parties must submit the required registration information not later than 21 days after enrolling the first subject. Results information is to be reported not later than 12 months after the completion date (as defined in the law), but the responsible party may request an extension of the deadline or delay submission by certifying that the drug or device under study has not yet been approved. Updates to submitted information are required at least once a year, unless there are no changes to report. Changes in recruitment status and completion of a trial must be reported not later than 30 days after such events. Description of Respondents: Respondents are referred to in the law as ‘‘responsible parties,’’ and are defined as: (1) The sponsor of the clinical trial (as defined in 21 CFR 50.3) or (2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, provided that ‘‘the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements’’ for submitting information under the law. Estimate of Burden: The burden associated with this information collection consists of two parts: the burden associated with registration of clinical trials; and the burden associated with the reporting of results information. In both cases, the burden includes the time necessary to extract information from the study protocol or results record, reformat and review it, enter it into the databank, and provide necessary updating over the course of the study. It is estimated that E:\FR\FM\06JAN1.SGM 06JAN1

Agencies

[Federal Register Volume 74, Number 3 (Tuesday, January 6, 2009)]
[Notices]
[Pages 447-448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31306]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Proposed Project:
    Title: Feasibility Test for Design Phase of National Study of Child 
Care Supply and Demand.
    OMB No.: New Collection.
    Description: The Administration for Children and Families (ACF), 
U.S. Department of Health and Human Services (HHS), intends to request 
approval from the Office of Management and Budget to collect 
information as part of the Design Phase of the National Study of Child 
Care Supply and Demand. This effort will gather information that will 
be useful for evaluating the feasibility and improving the design of a 
national study of child care supply and demand.
    The proposed collection will consist of: A random-digit dial survey 
of households with children under age 13 for participation in a 
questionnaire about the demand for child care; a random-digit dial 
survey of households with individuals providing care to children under 
age 13 in a residential setting; a telephone screening of after-school 
programs for eligibility in a survey of child care providers; a 
telephone survey of providers of care to children under age 13; an in-
person survey of providers of care to children under age 13; and, an 
in-person survey of parents of children under age 13 who are in non-
parental care arrangements.
    These data collection efforts will be used to examine the 
functioning of draft

[[Page 448]]

survey instruments. The feasibility test procedures will help inform 
several decisions about proposed design of the national study including 
sampling methods, costs and advantages associated with alternative 
interviewing protocols and reactions to the proposed methods.
    Respondents: General population households, home-based and center-
based child care providers, and public schools serving children under 
age 13.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                   Number of     Average burden     Estimated
                  Instrument                     Annual number   responses per     hours per      annual burden
                                                of respondents    respondent        response          hours
----------------------------------------------------------------------------------------------------------------
Eligibility calls to Before/After School                   150               1               .2             30
 Programs.....................................
Household screening calls.....................            1000               1             15              150
Telephone calls with households with children              160               1              5               80
 under age....................................
Telephone calls with providers of home-based               104               1               .3             31.2
 care.........................................
Telephone calls with center-based providers of              68               1               .5             34
 before/after school care.....................
In-person interviews with parents of children               50               1               .4             20
 in non-parental care.........................
In-person interviews with child-care provider               50               1              4               20
 staff........................................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 365.2.
    Additional Information: Copies of the proposed collection may be 
obtained by writing to the Administration for Children and Families, 
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade, 
SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All 
requests should be identified by the title of the information 
collection. E-mail address: OPREinfocollection@acf.hhs.gov.
    OMB Comment: OMB is required to make a decision concerning the 
collection of information between 30 and 60 days after publication of 
this document in the Federal Register. Therefore, a comment is best 
assured of having its full effect if OMB receives it within 30 days of 
publication. Written comments and recommendations for the proposed 
information collection should be sent directly to the following: Office 
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
6974, Attn: Desk Officer for the Administration for Children and 
Families.

    Dated: December 29, 2008.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
 [FR Doc. E8-31306 Filed 1-5-09; 8:45 am]
BILLING CODE 4184-01-M