Seeking To Evaluate Commercial Products, or Products in Development, for In Vitro Serological Diagnosis of Pertussis, 76031-76032 [E8-29580]

Download as PDF Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices Proposal To Approve Under OMB Delegated Authority the Discontinuance of the Following Reports: Report title: The Weekly Report of Assets and Liabilities for Large U.S. Branches and Agencies of Foreign Banks; the Weekly Report of Assets and Liabilities for Large Banks. Agency Form Numbers: FR 2069; FR 2416. OMB Control Number: 7100–0030; 7100–0075. Frequency: Weekly. Reporters: U.S. branches and agencies of foreign banks; Domestically chartered commercial banks. Annual Reporting Hours: 14,560 hours; 22,386 hours. Estimated Average Hours per Response: 4.00 hours; 8.61 hours. Number of Respondents: 70; 50. Current actions: If the proposal to revise the FR 2644 is approved, then the current FR 2416 and FR 2069 reporting forms would be discontinued. The current reporting panels for these reporting forms would be shifted to the proposed FR 2644 reporting panel and notified that either the FR 2416 or FR 2069 reporting form had been replaced with the proposed FR 2644 reporting form. 30618, May 28, 2008. No comments were received. This OMB clearance expires on January 31, 2009. Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected. Dated: December 9, 2008. Al Matera, Director, Office of Acquisition Policy. [FR Doc. E8–29629 Filed 12–12–08; 8:45 am] DATES: Submit comments on or before: January 14, 2009. Seeking To Evaluate Commercial Products, or Products in Development, for In Vitro Serological Diagnosis of Pertussis FOR FURTHER INFORMATION CONTACT: Ms. Jeritta Parnell, Procurement Analyst, Contract Policy Division, at telephone (202) 501–4082 or via e-mail to jeritta.parnell@gsa.gov. Board of Governors of the Federal Reserve System, December 10, 2008. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E8–29563 Filed 12–12–08; 8:45 am] Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Ms. Jasmeet Seehra, GSA Desk Officer, OMB, Room 10236, NEOB, Washington, DC 20503, and a copy to the Regulatory Secretariat (VPR), General Services Administration, Room 4041, 1800 F Street, NW., Washington, DC 20405. Please cite OMB Control No. 3090–0027, Contract Administration, Quality Assurance (GSAR Parts 542 and 546; GSA Form 1678, and GSA Form 308), in all correspondence. BILLING CODE 6210–01–P SUPPLEMENTARY INFORMATION: ADDRESSES: A. Purpose GENERAL SERVICES ADMINISTRATION Under certain contracts, because of reliance on contractor inspection in lieu of Government inspection, GSA’s Federal Acquisition Service (FAS) requires documentation from its contractors to effectively monitor contractor performance and ensure that it will be able to take timely action should that performance be deficient. [OMB Control No. 3090–0027] General Services Administration Acquisition Regulation; Information Collection; Contract Administration, Quality Assurance (GSAR Parts 542 and 546; GSA Form 1678, and GSA Form 308) Office of the Chief Acquisition Officer, GSA. ACTION: Notice of request for comments regarding a renewal to an existing OMB clearance. pwalker on PROD1PC71 with NOTICES AGENCY: SUMMARY: Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement regarding contract administration, and quality assurance. A request for public comments was published at 73 FR VerDate Aug<31>2005 20:00 Dec 12, 2008 Jkt 217001 76031 B. Annual Reporting Burden Respondents: 4,604. Total Responses: 116,869. Total Burden Hours: 7,830. 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. 3090–0027, Contract Administration, Quality Assurance (GSAR Parts 542 and 546; GSA Form 1678, and GSA Form 308), in all correspondence. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 BILLING CODE 6820–61–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention AGENCY: Centers for Disease Control and Prevention (CDC), Health and Human Services (HHS). ACTION: Notice. SUMMARY: The Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD), Division of Bacterial Diseases (DBD) through its component Branches have lead technical responsibility for research, development and evaluation of diagnostic tools for pertussis and application of these to epidemiologic studies of pertussis. CDC uses epidemiologic, laboratory, clinical, and biostatistical sciences to control and prevent vaccine preventable infectious diseases. CDC also conducts applied research in a variety of settings, and translates the findings of this research into public health practice. CDC is seeking to evaluate commercial products, or products in development, for in vitro serological diagnosis of pertussis. Specifically these should include tests to detect antipertussis toxin antibodies in infected and vaccinated individuals. The tests should be based on standardized reagents commonly used in the field (such as FDA Reference Serum Standard Lot #3 or equivalents). Products will be evaluated in CDC and collaborating laboratories and if appropriate, may be used in epidemiologic validation studies. Data obtained from this comparative analysis may be used by CDC in making recommendations and decisions for diagnosis of pertussis in the public health setting. Interested organizations that may have candidate products are invited to submit documentation for CDC to assess whether the offered product(s) are at a sufficient stage of development to be included in this comparative analysis. As a minimum, submitted information should be sufficient for CDC to E:\FR\FM\15DEN1.SGM 15DEN1 76032 Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices determine the following for each candidate product: a. Product package insert or detailed instructions for use b. Detailed information to determine if the product is calibrated to a recognized standard c. Preliminary data demonstrating suitability for validation studies Organizations that have products selected by CDC for this comparative analysis will be required to enter into an appropriate agreement prior to the transfer of any material to CDC. Sample agreements may be viewed at the following Web site: http://www.cdc.gov/ od/ads/techtran/forms.htm. All information submitted to CDC will be kept confidential as allowed by relevant federal law, including the Freedom of Information Act (5 U.S.C. 552) and the Trade Secrets Act (18 U.S.C. 1905). Only information submitted within thirty days of publication of this notice will be reviewed to determine if the offered product(s) will be acceptable for possible inclusion in this comparative analysis. Responses are preferred in electronic format and can be e-mailed to the attention of Jacqueline Goolsby jgoolsby@cdc.gov. Mailed responses can be sent to the following address: Jackie Goolsby, Branch Manager, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, 404–639–1319 (Phone), 404–639–3059 (Fax), 1600 Clifton Rd. NE., Mail Stop C–09, Atlanta, GA 30333. FOR FURTHER INFORMATION CONTACT: Technical Dr. M. Lucia Tondella, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road NE., Mail Stop D–11, Atlanta, GA 30333. Telephone (404) 639–1239, EMail at mtondella@cdc.gov. pwalker on PROD1PC71 with NOTICES Business Lisa Blake-DiSpigna, Technology Development Coordinator, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road NE., Mail Stop A–42, Atlanta, GA 30333. Telephone (404) 639–2620, E-Mail at LBlakeDiSpigna@cdc.gov. VerDate Aug<31>2005 20:00 Dec 12, 2008 Jkt 217001 Dated: December 3, 2008. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E8–29580 Filed 12–12–08; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10272, CMS–R– 254, CMS–29/30, CMS–372, CMS–10001, CMS–10009, CMS–10242 and CMS–R–52] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency’s function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Information Collection Request: New collection; Title of Information Collection: Hospital Leadership Quality Assessment Tool (HLQAT); Use: In 2006, the Hospital Leadership Collaborative (HLC) launched a public-private partnership to develop a CMS-endorsed selfassessment tool, ‘‘The Hospital Leadership and Quality Assessment Tool’’ (HLQAT) to assist hospitals in the improvement of quality through enhanced hospital governance, executive, physician, and clinical engagement. Hospitals leaders will take the HLQAT instrument via Web-based technology. This function will be carried out in conjunction with CMS and the Quality Improvement Organization (QIO) 9th Scope of Work (SOW), to convey the importance of this effort in relation to Medicare and other PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 public priorities. This administration of the HLQAT seeks responses from approximately a dozen leaders in each hospital, including physicians (e.g., CEO, CMO), board members, directorlevel, and mid-level clinical managers— these responses can provide a multilevel representation of hospital leadership showing its commitment to institutional change. Form Number: CMS–10272 (OMB# 0938–New); Frequency: Occasionally; Affected Public: Private Sector—Business or Other for-profits; Number of Respondents: 18,000; Total Annual Responses: 36,000; Total Annual Hours: 44,820. 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: National Medicare & You Education Program (NMEP) Survey of Medicare Beneficiaries Use: The Centers for Medicare and Medicaid Services is requesting a revision of this information collection request to continue to collect information from Medicare beneficiaries, caregivers, health care providers, and health information providers. It is critical for this agency to obtain feedback from the aforementioned groups so that the agency can accurately assess the needs of the Medicare audience. Using random digit dial and/or an administrative sample, members of the Medicare audience will be called and asked to complete the survey via telephone. The results of this survey will be compiled and studied so that communication may be amended to benefit Medicare’s audience. The survey has the following objectives: To assess satisfaction with and knowledge of the Medicare program; to gather information on health behaviors and quality of health care; to determine the most used source for Medicare information; and to gather information from health care provider and health information providers. Form Number: CMS–R–254 (OMB# 0938– 0738); Frequency: Once; Affected Public: Individuals and Households, Private Sector—Business or other forprofits; Number of Respondents: 7,000; Total Annual Responses: 7,000; Total Annual Hours: 1,750. 3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Request for Certification as Rural Health Clinic (RHC) and RHC Survey Report Form and Supporting Regulations in 42 CFR 491.1–491.11; Use: The CMS–29 is utilized as an application to be completed by suppliers of RHC services requesting participation in the E:\FR\FM\15DEN1.SGM 15DEN1

Agencies

[Federal Register Volume 73, Number 241 (Monday, December 15, 2008)]
[Notices]
[Pages 76031-76032]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29580]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Seeking To Evaluate Commercial Products, or Products in 
Development, for In Vitro Serological Diagnosis of Pertussis

AGENCY: Centers for Disease Control and Prevention (CDC), Health and 
Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), National 
Center for Immunization and Respiratory Diseases (NCIRD), Division of 
Bacterial Diseases (DBD) through its component Branches have lead 
technical responsibility for research, development and evaluation of 
diagnostic tools for pertussis and application of these to 
epidemiologic studies of pertussis. CDC uses epidemiologic, laboratory, 
clinical, and biostatistical sciences to control and prevent vaccine 
preventable infectious diseases. CDC also conducts applied research in 
a variety of settings, and translates the findings of this research 
into public health practice.
    CDC is seeking to evaluate commercial products, or products in 
development, for in vitro serological diagnosis of pertussis. 
Specifically these should include tests to detect anti-pertussis toxin 
antibodies in infected and vaccinated individuals. The tests should be 
based on standardized reagents commonly used in the field (such as FDA 
Reference Serum Standard Lot 3 or equivalents). Products will 
be evaluated in CDC and collaborating laboratories and if appropriate, 
may be used in epidemiologic validation studies. Data obtained from 
this comparative analysis may be used by CDC in making recommendations 
and decisions for diagnosis of pertussis in the public health setting.
    Interested organizations that may have candidate products are 
invited to submit documentation for CDC to assess whether the offered 
product(s) are at a sufficient stage of development to be included in 
this comparative analysis. As a minimum, submitted information should 
be sufficient for CDC to

[[Page 76032]]

determine the following for each candidate product:
    a. Product package insert or detailed instructions for use
    b. Detailed information to determine if the product is calibrated 
to a recognized standard
    c. Preliminary data demonstrating suitability for validation 
studies
    Organizations that have products selected by CDC for this 
comparative analysis will be required to enter into an appropriate 
agreement prior to the transfer of any material to CDC. Sample 
agreements may be viewed at the following Web site: http://www.cdc.gov/
od/ads/techtran/forms.htm.
    All information submitted to CDC will be kept confidential as 
allowed by relevant federal law, including the Freedom of Information 
Act (5 U.S.C. 552) and the Trade Secrets Act (18 U.S.C. 1905). Only 
information submitted within thirty days of publication of this notice 
will be reviewed to determine if the offered product(s) will be 
acceptable for possible inclusion in this comparative analysis.
    Responses are preferred in electronic format and can be e-mailed to 
the attention of Jacqueline Goolsby jgoolsby@cdc.gov. Mailed responses 
can be sent to the following address: Jackie Goolsby, Branch Manager, 
Centers for Disease Control and Prevention, National Center for 
Immunization and Respiratory Diseases, Division of Bacterial Diseases, 
404-639-1319 (Phone), 404-639-3059 (Fax), 1600 Clifton Rd. NE., Mail 
Stop C-09, Atlanta, GA 30333.

FOR FURTHER INFORMATION CONTACT:

Technical

    Dr. M. Lucia Tondella, Division of Bacterial Diseases, National 
Center for Immunization and Respiratory Diseases, Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road NE., Mail Stop D-11, 
Atlanta, GA 30333. Telephone (404) 639-1239, E-Mail at 
mtondella@cdc.gov.

Business

    Lisa Blake-DiSpigna, Technology Development Coordinator, National 
Center for Immunization and Respiratory Diseases, Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road NE., Mail Stop A-42, 
Atlanta, GA 30333. Telephone (404) 639-2620, E-Mail at LBlake-
DiSpigna@cdc.gov.

    Dated: December 3, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
 [FR Doc. E8-29580 Filed 12-12-08; 8:45 am]
BILLING CODE 4163-18-P