Agency Information Collection Request; 30-Day Public Comment Request, 70354 [E8-27628]

Download as PDF 70354 Federal Register / Vol. 73, No. 225 / Thursday, November 20, 2008 / Notices William Blumenthal, General Counsel. [FR Doc. E8–27534 Filed 11–19–08: 8:45 am] BILLING CODE 6750–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–0263] Agency Information Collection Request; 30-Day Public Comment Request Office of the Secretary. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed information collection request 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 functions; (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 AGENCY: use of automated collection techniques or other forms of information technology to minimize the information collection burden. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to Sherette.funncoleman@hhs.gov, or call the Reports Clearance Office on (202) 690–5683. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 30 days. Proposed Project: Protection of Human Subjects: Assurance Identification/IRB Certification/ Declaration of Exemption Form Extension—OMB No. 0990–0263— Office for Human Research Protections. Abstract: The Federal Policy for the Protection of Human Subjects, known as the Common Rule, requires that before engaging in non-exempt human subjects research that is conducted or supported by a Common Rule department or agency, each institution must: (1) Hold an applicable assurance of compliance [Section 103(a)]; and (2) certify to the awarding department or agency that the application or proposal for research has been reviewed and approved by an IRB designated in the assurance [Sections 103(b) and (f)]. The Office for Human Research Protections is requesting a three-year extension of the Protection of Human Subjects: Assurance Identification/IRB Certification/ Declaration of Exemption Form. That form is designed to promote uniformity among departments and agencies, and to help ensure common means of ascertaining institutional review board certifications and other reporting requirements relating to the protection of human subjects in research. Respondents are institutions engaged in research involving human subjects where the research is supported by HHS. Institutional use of the form is also relied upon by other federal departments and agencies that have codified or follow the Federal Policy for the Protection of Human Subjects (Common Rule). There are an estimated total of 70,000 health or human research studies supported each year, meaning an average of 7 certifications per institution annually, requiring an estimated one-half hour per certification for a total burden of 35,000 hours. Data is collected as needed. ESTIMATED ANNUALIZED BURDEN IN HOURS FOR IRB CERTIFICATION BURDEN Number of respondents Form name Number of responses per respondent Average burden per response (in hours) 10,000 7 0.5 Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption ................................................................................................................ John Teeter, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E8–27628 Filed 11–19–08; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Proposed Project Centers for Disease Control and Prevention [30Day–08–0010] rwilkins on PROD1PC63 with NOTICES 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. VerDate Aug<31>2005 18:26 Nov 19, 2008 Jkt 217001 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. The National Birth Defects Prevention Study (NBDPS)—Revision—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description Address the following criteria provided in 5 CFR 1320.5(a): CDC has been monitoring the occurrence of serious birth defects and genetic PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Total burden hours 35,000 diseases in Atlanta since 1967 through the Metropolitan Atlanta Congenital Defects Program (MACDP). The MACDP is a population-based surveillance system for birth defects in the 5 counties of Metropolitan Atlanta, which is being requested for OMB clearance for three additional years. Its primary purpose is to describe the spatial and temporal patterns of birth defects occurrence and serves as an early warning system for new Teratogens. In 1997, the Birth Defects Risk Factor Surveillance (BDRFS) study, a case-control study of risk factors for selected birth defects, became the National Birth Defects Prevention Study (NBDPS). The major components of the study did not change. The NBDPS is a case-control study of major birth defects that includes cases identified from existing birth defect surveillance registries in nine states, E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 73, Number 225 (Thursday, November 20, 2008)]
[Notices]
[Page 70354]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0263]


Agency Information Collection Request; 30-Day Public Comment 
Request

AGENCY: Office of the Secretary.
    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Office of the Secretary (OS), 
Department of Health and Human Services, is publishing the following 
summary of a proposed information collection request 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 functions; (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.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, e-mail your 
request, including your address, phone number, OMB number, and OS 
document identifier, to Sherette.funncoleman@hhs.gov, or call the 
Reports Clearance Office on (202) 690-5683.
    Written comments and recommendations for the proposed information 
collections must be directed to the OS Paperwork Clearance Officer at 
the above e-mail address within 30 days.
    Proposed Project: Protection of Human Subjects: Assurance 
Identification/IRB Certification/Declaration of Exemption Form 
Extension--OMB No. 0990-0263--Office for Human Research Protections.
    Abstract: The Federal Policy for the Protection of Human Subjects, 
known as the Common Rule, requires that before engaging in non-exempt 
human subjects research that is conducted or supported by a Common Rule 
department or agency, each institution must: (1) Hold an applicable 
assurance of compliance [Section 103(a)]; and (2) certify to the 
awarding department or agency that the application or proposal for 
research has been reviewed and approved by an IRB designated in the 
assurance [Sections 103(b) and (f)]. The Office for Human Research 
Protections is requesting a three-year extension of the Protection of 
Human Subjects: Assurance Identification/IRB Certification/Declaration 
of Exemption Form. That form is designed to promote uniformity among 
departments and agencies, and to help ensure common means of 
ascertaining institutional review board certifications and other 
reporting requirements relating to the protection of human subjects in 
research. Respondents are institutions engaged in research involving 
human subjects where the research is supported by HHS. Institutional 
use of the form is also relied upon by other federal departments and 
agencies that have codified or follow the Federal Policy for the 
Protection of Human Subjects (Common Rule). There are an estimated 
total of 70,000 health or human research studies supported each year, 
meaning an average of 7 certifications per institution annually, 
requiring an estimated one-half hour per certification for a total 
burden of 35,000 hours. Data is collected as needed.

                        Estimated Annualized Burden in Hours for IRB Certification Burden
----------------------------------------------------------------------------------------------------------------
                                                                            Number of     Average
                                                               Number of    responses    burden per     Total
                          Form name                           respondents      per        response      burden
                                                                            respondent   (in hours)     hours
----------------------------------------------------------------------------------------------------------------
Protection of Human Subjects: Assurance Identification/IRB         10,000            7          0.5       35,000
 Certification/Declaration of Exemption.....................
----------------------------------------------------------------------------------------------------------------


John Teeter,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. E8-27628 Filed 11-19-08; 8:45 am]
BILLING CODE 4150-36-P