Agency Forms Undergoing Paperwork Reduction Act Review, 76672-76673 [E6-21809]

Download as PDF 76672 Federal Register / Vol. 71, No. 245 / Thursday, December 21, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Centers for Disease Control and Prevention ACTION: Agency Forms Undergoing Paperwork Reduction Act Review Announcement of meeting. This notice announces the fifth meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92–463, 5 U.S.C., App.). SUMMARY: DATES: January 9, 2007, from 1 p.m. to 5 p.m. Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 4090. (You will need a photo ID to enter a Federal building.) ADDRESSES: FOR FURTHER INFORMATION CONTACT: https://www.hhs.gov/healthit/ahic/ quality_main.html. During the meeting, the Workgroup will continue their discussion on a core set of quality measures and on the specific charge to the Workgroup. The Workgroup members will continue discussion on their work to envision and describe a world in which quality measurement and reporting are automated and clinical decision support is used to improve performance on those quality measures. This shared vision will be used to inform potential recommendations to the AHIC addressing the broad and specific charges to the Workgroup. The meeting will be available via internet access. For additional information, go to https://www.hhs.gov/ healthit/ahic/quality_instruct.html. SUPPLEMENTARY INFORMATION: Dated: December 14, 2006. Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. 06–9809 Filed 12–20–06; 8:45 am] sroberts on PROD1PC70 with NOTICES BILLING CODE 4150–24–M VerDate Aug<31>2005 17:01 Dec 20, 2006 Jkt 211001 [30Day–07–0612] The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–6974. Written comments should be received within 30 days of this notice. Proposed Project Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System—EXTENSION—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The WISEWOMEN program, which focuses on reducing cardiovascular disease risk factors among at-risk women, was in response to the Secretary of Health and Human Services’ Continuous Improvement Initiative, asking for the development of programs that examine ways in which service delivery can be improved for select populations. Title XV of the Public Health Service Act, Section 1509 originally authorized the secretary of the Department of Health and Human Services to establish up to three demonstration projects. Through appropriations language, the CDC WISEWOMAN program is now allowed to fund up to 15 projects. Currently, WISEWOMAN funds 12 demonstration projects, which at full implementation are expected to screen approximately 30,000 women annually for cardiovascular disease risk factors. The program targets women already participating in the National Breast and PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Cervical Cancer Early Detection Program (NBCCEDP) and provides screening for select cardiovascular disease risk factors (including elevated cholesterol, hypertension and abnormal blood glucose levels), lifestyle interventions, and medical referrals as required in an effort to improve cardiovascular health among participants. The CDC proposes to collect and analyze baseline and follow-up date (12 months post enrollment) for all participants. These data called the minimum data elements (MDE’s), includes demographic and risk factor information about women served in each program and information concerning the number and type of intervention sessions attended. The MDE’s will be reported to CDC in April and October each year. The MDE allows or an assessment of how effective WISEWOMAN is at reducing the burden of cardiovascular disease risk factors among participants. The CDC also proposes to collect programmatic data for all WISEWOMAN programs. Programmatic data includes information related to grantee management, public education and outreach professional education service delivery, cost, and an assessment of how well each program is meeting their stated objectives. All required data will be submitted electronically to the contractor hired by CDC to conduct the WISEWOMAN evaluation. MDE and cost data will be submitted to RTI twice a year. All information collected as part of the WISEWOMAN evaluation will be used to assess the costs, effectiveness and cost-effectiveness of WISEWOMAN in reducing cardiovascular disease risk factors, for obtaining more complete health data among vulnerable populations, promoting public education of disease incidence and riskfactors, improving the availability of screening and diagnostic services for under-served women, ensuring the quality of services provided to women and developing strategies for improved interventions. Because certain demographic data are already collected as part of NBCCEDP, the additional burden on grantees will be modest. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 2,160. E:\FR\FM\21DEN1.SGM 21DEN1 76673 Federal Register / Vol. 71, No. 245 / Thursday, December 21, 2006 / Notices ESTIMATED ANNUALIZED BURDEN TABLE Number of respondents Report Screening MDE Report .............................................................................................................. Intervention MDE Report ........................................................................................................... Cost Report ................................................................................................................................ Quarterly Report ........................................................................................................................ Dated: December 15, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6–21809 Filed 12–20–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FOR FURTHER INFORMATION CONTACT: [Docket No. 2005D–0348] Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Availability AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Procedures for Handling Post-Approval Studies Imposed by PMA Order.’’ The guidance provides a standard format and content for submitting postapproval studies. The guidance is issued to help ensure that sponsors provide adequate information about the conduct of post-approval studies and that the Center for Devices and Radiological Health (CDRH) can properly track and evaluate post-approval studies. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Procedures for Handling PostApproval Studies Imposed by PMA Order’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240–276– 3151. See the SUPPLEMENTARY VerDate Aug<31>2005 17:01 Dec 20, 2006 INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. Jkt 211001 Steven H. Chasin, Center for Devices and Radiological Health (HFZ– 520), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3421. SUPPLEMENTARY INFORMATION: I. Background This guidance provides recommendations to sponsors and CDRH staff on expectations concerning format, content, and review of reports related to post-approval studies imposed by premarket approval application order to help ensure that the studies are conducted effectively and efficiently, and in a least burdensome manner. The guidance has been drafted in response to concerns by Congress, the Institute of Medicine, and FDA about the agency’s ability to monitor and track these studies and industry’s requests for more clarity about the agency’s expectations. FDA received a few comments on the draft document (announced at 70 FR 54561, September 15, 2005) and has made minor changes to the guidance. II. Significance of Guidance 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 post-approval studies. 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 statute and regulations. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 15 15 15 15 Responses per respondent Average burden per response (in hours) 2 2 2 4 16 8 16 16 III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Procedures for Handling Post-Approval Studies Imposed by PMA Order,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240–276–3151 to receive a hard copy. Please use the document number (1561) to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA’s regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 814 have been approved under OMB Control No. 0910–0231; the collections of information in 21 CFR part 822 have been approved under OMB Control No. 0910–0449. V. Comments Interested persons may submit to the Division of Dockets Management (See ADDRESSES), written or electronic E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 71, Number 245 (Thursday, December 21, 2006)]
[Notices]
[Pages 76672-76673]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21809]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-07-0612]

Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.

Proposed Project

Well-Integrated Screening and Evaluation for Women Across the
Nation (WISEWOMAN) Reporting System--EXTENSION--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).

Background and Brief Description

The WISEWOMEN program, which focuses on reducing cardiovascular
disease risk factors among at-risk women, was in response to the
Secretary of Health and Human Services' Continuous Improvement
Initiative, asking for the development of programs that examine ways in
which service delivery can be improved for select populations. Title XV
of the Public Health Service Act, Section 1509 originally authorized
the secretary of the Department of Health and Human Services to
establish up to three demonstration projects. Through appropriations
language, the CDC WISEWOMAN program is now allowed to fund up to 15
projects. Currently, WISEWOMAN funds 12 demonstration projects, which
at full implementation are expected to screen approximately 30,000
women annually for cardiovascular disease risk factors. The program
targets women already participating in the National Breast and Cervical
Cancer Early Detection Program (NBCCEDP) and provides screening for
select cardiovascular disease risk factors (including elevated
cholesterol, hypertension and abnormal blood glucose levels), lifestyle
interventions, and medical referrals as required in an effort to
improve cardiovascular health among participants.
The CDC proposes to collect and analyze baseline and follow-up date
(12 months post enrollment) for all participants. These data called the
minimum data elements (MDE's), includes demographic and risk factor
information about women served in each program and information
concerning the number and type of intervention sessions attended. The
MDE's will be reported to CDC in April and October each year. The MDE
allows or an assessment of how effective WISEWOMAN is at reducing the
burden of cardiovascular disease risk factors among participants. The
CDC also proposes to collect programmatic data for all WISEWOMAN
programs. Programmatic data includes information related to grantee
management, public education and outreach professional education
service delivery, cost, and an assessment of how well each program is
meeting their stated objectives.
All required data will be submitted electronically to the
contractor hired by CDC to conduct the WISEWOMAN evaluation. MDE and
cost data will be submitted to RTI twice a year. All information
collected as part of the WISEWOMAN evaluation will be used to assess
the costs, effectiveness and cost-effectiveness of WISEWOMAN in
reducing cardiovascular disease risk factors, for obtaining more
complete health data among vulnerable populations, promoting public
education of disease incidence and risk-factors, improving the
availability of screening and diagnostic services for under-served
women, ensuring the quality of services provided to women and
developing strategies for improved interventions. Because certain
demographic data are already collected as part of NBCCEDP, the
additional burden on grantees will be modest.
There are no costs to the respondents other than their time. The
total estimated annualized burden hours are 2,160.

[[Page 76673]]

Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average burden
Report Number of Responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Screening MDE Report........................................... 15 2 16
Intervention MDE Report........................................ 15 2 8
Cost Report.................................................... 15 2 16
Quarterly Report............................................... 15 4 16
----------------------------------------------------------------------------------------------------------------

Dated: December 15, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-21809 Filed 12-20-06; 8:45 am]
BILLING CODE 4163-18-P

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