Proposed Data Collections Submitted for Public Comment and Recommendations, 71537-71538 [E5-6671]

Download as PDF 71537 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices difference between the type of original researcher (e.g., academic or non-profit) on maintenance and fidelity; (f) identification of perceived and actual benefits as well as instrumental and conceptual utility of REP-packaged interventions that can be used in marketing the intervention packages to other HIV prevention providers. Researchers administering the in-person surveys will also assess fidelity to intervention protocols by observing facilitators delivering the intervention to (a) identification of factors associated with maintenance and termination of REP-packaged interventions; (b) determination of why and how agencies adapted the packaged interventions; (c) examination of the impact of elapsed time on maintenance of the intervention and fidelity to intervention protocols; (d) identification of any differences between the type of agency (e.g., community-based organization or health department) on maintenance and fidelity; (e) identification of any and by recording their observations on a checklist designed for the particular intervention being observed. Survey questionnaire data will be collected once from each respondent (i.e., agency administrator, intervention supervisor, intervention facilitator). CDC is requesting OMB approval to collect this data for one year. There are no costs to the respondents other than their time. Total burden hours for this data collection are 105 hours. ESTIMATED ANNUALIZED BURDEN HOURS Agency Administrators (content review) .................................................................... Agency Administrators (questionnaire) ...................................................................... Intervention Supervisors ............................................................................................ Intervention Facilitators .............................................................................................. Dated: November 18, 2005. Betsey Dunaway, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E5–6670 Filed 11–28–05; 8:45 am] BILLING CODE 4163–18–P 16 16 15 30 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 Health Communication Planning, Implementation, and Evaluation for People with Disabilities—New— National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–06–05AO] Proposed Data Collections Submitted for Public Comment and Recommendations 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) 639–4766 or send an e- Number of responses per respondent Number of respondents Respondents Background and Brief Description The National Center on Birth Defects and Developmental Disabilities (NCBDDD) at CDC promotes the health of babies, children, and adults with disabilities. As part of these efforts the Center is actively involved in improving the health and wellness of people with disabilities. Of particular interest is how health information is communicated to people with disabilities. This project involves the conduct of an e-mail survey Average burden per response (in hours) 1 1 1 1 20/60 1.5 1.5 1.75 for an initiative evaluating the effectiveness of health communication materials and strategies developed for people with disabilities by North Carolina, New Mexico, and New York with the support of health promotion grants from CDC. The survey data will be analyzed to evaluate awareness of the state-developed materials among health care providers, human services providers and consumer advocates using these materials, their impressions of and satisfaction with the materials, the impact of the materials, and suggestions for improvement. Data will be collected using an on-line selfreporting survey distributed via e-mail and administered by linking to a webbased questionnaire. The results will be used to develop a training handbook to assist state agencies and public health officials in planning, developing, and implementing health communication materials for people with disabilities. There are no costs to respondents except their time to participate in the survey. The total estimated annualized burden hours are 45. ESTIMATE OF ANNUALIZED BURDEN HOURS No. of respondents Type of respondents Health Care Providers ............................................................................................... Human Services Providers ........................................................................................ Consumer Advocates ................................................................................................ VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 No. of responses per respondent 50 50 50 E:\FR\FM\29NON1.SGM 1 1 1 29NON1 Average burden per response (in hours) 18/60 18/60 18/60 71538 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices Dated: November 18, 2005. Betsey Dunaway, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E5–6671 Filed 11–28–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control. [FR Doc. 05–23425 Filed 11–28–05; 8:45 am] Centers for Disease Control and Prevention BILLING CODE 4163–18–P Breast and Cervical Cancer Early Detection and Control Advisory Committee In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following committee meeting: Name: Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC). Times and Dates: 8:30 a.m.–5 p.m., December 6, 2005. 8:30 a.m.–1 p.m., December 7, 2005. Place: Embassy Suites Hotel, Centennial Olympic Park, 267 Marietta Street, Atlanta, Georgia 30313. Phone: 1–404–223–2300. Status: Open to the public, limited only by the space available. Purpose: The committee is charged with advising the Secretary, Department of Health and Human Services, and the Director, CDC, regarding the early detection and control of breast and cervical cancer. The committee makes recommendations regarding national program goals and objectives; implementation strategies; and program priorities including surveillance, epidemiologic investigations, education and training, information dissemination, professional interactions and collaborations, and policy. Matters to be Discussed: The agenda will include discussion and review of the vision for National Cancer Prevention and Control Program; strategies for Performance-Based Funding; Case Management; update of expert panel meetings; HPV Testing and the Breast and Cervical Program; and HPV Vaccine update. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Debra Younginer, Executive Secretary, BCCEDCAC, Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway, Mailstop K–57, Chamblee, Georgia 30316, Telephone: 770–488– 1074. VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0374] Nonprescription Drugs Advisory Committee and Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting and Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committees: Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee. General Function of the Committees: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on January 24, 2006, from 8 a.m. to 5 p.m. Interested persons and organizations may submit written or electronic comments until January 6, 2006, to the Division of Dockets Management (see Addresses). Addresses: Electronic comments should be submitted to https:// www.fda.gov/dockets/ecomments. Select ‘‘2005N–0374 Use of OzoneDepleting Substance: Essential-Use Determination of Over-the-Counter (OTC) Epinephrine Metered Dose Inhalers’’ and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Location: Holiday Inn Select Bethesda, The Ballrooms, 8120 Wisconsin Ave., Bethesda, MD. The hotel telephone number is 301–652– 2000. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 Contact Person: Darrell Lyons, Center for Drug Evaluation and Research (HFD 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, (301–827–7001, FAX: 301– 827–6776, e-mail: lyonsd@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area) codes 3014512541 or 3014512545. Please call the Information Line for up to date information on this meeting. Agenda: The committee will discuss the continued need for the designation of OTC epinephrine-metered dose inhalers for the treatment of asthma as an essential use of ozone-depleting substances (ODSs) under § 2.125 (21 CFR 2.125). ODSs are substances that deplete the stratospheric ozone, which include chlorofluorocarbons (CFCs). Once released, CFCs rise to the stratosphere. In the stratosphere, CFCs are gradually broken down by strong ultraviolet light, and they release chlorine atoms that then deplete stratospheric ozone. Depletion of stratospheric ozone by CFCs and other ODSs leads to higher ultraviolet B radiation levels, which in turn increase skin cancers and cataracts, as well as cause other significant environmental damage. FDA is soliciting comments and data to support or refute an essential-use designation for OTC epinephrine metered-dose inhaler (MDI) drug products. These products include the only OTC drug available in an MDI dosage form for the treatment of asthma. The OTC epinephrine MDIs use CFCs as propellants. The OTC indication is ‘‘for temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma.’’ In some instances, use of this product early during an asthma attack could avert a serious or life-threatening worsening of the attack. There are currently a limited number of marketed OTC drug products containing epinephrine in a MDI dosage form. According to § 2.125(f)(1), the following are criteria for continued ODS essential-use designation: (1) Substantial technical barriers exist to formulating the product without ODSs; (2) The product will provide an otherwise unavailable important public health benefit; and (3) Use of the product does not release cumulative significant amounts of ODSs into the atmosphere or the release is warranted in view of the high E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 70, Number 228 (Tuesday, November 29, 2005)]
[Notices]
[Pages 71537-71538]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-6671]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-06-05AO]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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) 639-4766 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

    Health Communication Planning, Implementation, and Evaluation for 
People with Disabilities--New--National Center on Birth Defects and 
Developmental Disabilities (NCBDDD), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The National Center on Birth Defects and Developmental Disabilities 
(NCBDDD) at CDC promotes the health of babies, children, and adults 
with disabilities. As part of these efforts the Center is actively 
involved in improving the health and wellness of people with 
disabilities. Of particular interest is how health information is 
communicated to people with disabilities. This project involves the 
conduct of an e-mail survey for an initiative evaluating the 
effectiveness of health communication materials and strategies 
developed for people with disabilities by North Carolina, New Mexico, 
and New York with the support of health promotion grants from CDC. The 
survey data will be analyzed to evaluate awareness of the state-
developed materials among health care providers, human services 
providers and consumer advocates using these materials, their 
impressions of and satisfaction with the materials, the impact of the 
materials, and suggestions for improvement. Data will be collected 
using an on-line self-reporting survey distributed via e-mail and 
administered by linking to a web-based questionnaire. The results will 
be used to develop a training handbook to assist state agencies and 
public health officials in planning, developing, and implementing 
health communication materials for people with disabilities. There are 
no costs to respondents except their time to participate in the survey. 
The total estimated annualized burden hours are 45.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                 Average burden
                  Type of respondents                          No. of        No. of responses  per response  (in
                                                            respondents       per respondent         hours)
----------------------------------------------------------------------------------------------------------------
Health Care Providers..................................                 50                  1              18/60
Human Services Providers...............................                 50                  1              18/60
Consumer Advocates.....................................                 50                  1              18/60
----------------------------------------------------------------------------------------------------------------



[[Page 71538]]

    Dated: November 18, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E5-6671 Filed 11-28-05; 8:45 am]
BILLING CODE 4163-18-P
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