Agency Forms Undergoing Paperwork Reduction Act Review, 76045-76046 [2012-31010]

Download as PDF 76045 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Notices reducing the burden of cardiovascular disease risk factors among women who utilize program services. CDC uses the information submitted through progress reports to assess each grantee’s progress toward meeting stated program objectives. Participation in the information collection is required under the terms of the WISEWOMAN cooperative agreement. OMB approval is requested for one year. The total estimated annualized burden hours are 1,680. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Form name WISEWOMAN Grantees ................................. Screening and Assessment MDE .................. Lifestyle Intervention MDE ............................. Progress Report ............................................. Dated: December 18, 2012. Ron A. Otten, Director, Office of Scientific Integrity (OSI), Office of the Associate Director for Science (OADS), Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2012–30929 Filed 12–21–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-13–0573] 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 (404) 639–7570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project tkelley on DSK3SPTVN1PROD with The National HIV Surveillance System (NHSS) (OMB No. 0920–0573, Expiration 01/31/2013)-RevisionNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). This title is being changed from the previously approved title Adult and Pediatric HIV/AIDS Confidential Case Reports for National HIV/AIDS Surveillance in 2009. Background and Brief Description The purpose of HIV surveillance is to monitor trends in HIV and describe the characteristics of infected persons (e.g., VerDate Mar<15>2010 06:31 Dec 22, 2012 Jkt 229001 demographics, modes of exposure to HIV, clinical and laboratory markers of HIV disease, manifestations of severe HIV disease, and deaths among persons with HIV). HIV surveillance data are widely used at all government levels to assess the impact of HIV infection on morbidity and mortality, to allocate medical care resources and services, and to guide prevention and disease control activities. CDC, in collaboration with health departments in the 50 states, the District of Columbia, and U.S. dependent areas, conduct national surveillance for cases of HIV infection. National surveillance includes tracking critical data across the spectrum of HIV disease from HIV diagnosis, to AIDS, the end-stage disease caused by infection with HIV, and death. In addition, this national system provides essential data to estimate HIV incidence and monitor patterns in viral resistance and HIV–1 subtypes, as well as provide information on perinatal exposures in the U.S. The CDC surveillance case definition has been modified periodically to accurately monitor disease in adults, adolescents and children and reflect use of new testing technologies and changes in HIV treatment. Information is then updated in the case report forms and reporting software as needed. In 2012, CDC convened an expert consultation to consider revisions of various aspects of the case definition including criteria for reporting a potential case, criteria for reporting a confirmed case, and case classification (disease staging system). Recommendations for revisions in the case definition were adopted by the Council of State and Territorial Epidemiologists in June 2012 and the final case definition revision is planned for implementation in 2013 after publication. The revisions requested include modifications to currently collected data elements and forms to align with anticipated changes in the case definitions for HIV surveillance to be PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 21 21 21 Number of responses per respondent 2 2 2 Average burden per response (in hr) 16 8 16 published in 2012 and continuation of HIV surveillance activities funded under the new funding opportunity announcement CDC–RFA–PS13–1302 National HIV Surveillance System (NHSS). These include minor modifications of testing categories to accommodate new testing algorithms and modifications to staging criteria and non-substantial editorial changes aimed at improving the format and usability of the forms such as improved wording of terms and changes in the format of some response options. In addition, the number of data elements from the former enhanced perinatal surveillance (EPS) was reduced and the form modified for continuation in 2013 as Perinatal HIV Exposure Reporting (PHER). Surveillance data collection on variant and atypical strains (formerly variant, atypical and resistant HIV surveillance (VARHS)) will be continued as Molecular HIV Surveillance (MHS) with a reduced number of data elements previously approved under VARHS. CDC provides funding for 59 jurisdictions to conduct adult and pediatric HIV case surveillance. Health department staffs compile information from laboratories, physicians, hospitals, clinics and other health care providers in order to complete the HIV and pediatric case reports. Updates to case reports are also entered into enhanced HIV/AIDS Reporting system (eHARS) by health departments, as additional information may be received from laboratories, vital statistics offices, or additional providers. Evaluations are also conducted by health departments on a subset of case reports (e.g. including re-abstraction/validation activities and routine interstate deduplication) in all jurisdictions. Supplemental surveillance data are collected in a subset of areas to provide additional information necessary to estimate HIV incidence, to better describe the extent of HIV viral E:\FR\FM\26DEN1.SGM 26DEN1 76046 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Notices resistance and quantify HIV subtypes among persons infected with HIV and to monitor and evaluate perinatal HIV prevention efforts. Health departments funded for these supplemental data collections obtain this information from laboratories, health care providers, and medical records. CDC estimates that 25 health departments will be reporting data elements containing HIV Incidence Surveillance (HIS) data, 53 health departments will report additional data elements on HIV nucleotide sequences as part of MHS, and 35 areas will be reporting data as part of PHER annually. The total estimated annual burden hours are 53,700. Estimated Annualized Burden Hours EXHIBIT 12.A ESTIMATES OF ANNUALIZED BURDEN HOURS Form name Health Departments ........................................ Health .............................................................. Departments .................................................... Health Departments ........................................ Health Departments ........................................ Health Departments ........................................ Health Departments ........................................ Health Departments ........................................ Kimberly S. Lane, Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2012–31010 Filed 12–21–12; 4:15 pm] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)—Health Disparities Subcommittee (HDS) 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 meeting of the aforementioned committee: tkelley on DSK3SPTVN1PROD with Number of responses per respondent 59 1,260 20/60 59 6 20/60 59 127 20/60 59 59 1,469 5,876 2/60 1/60 25 2,729 10/60 53 35 967 114 5/60 30/60 Adult ............................................................... HIV Case Report ............................................ Pediatric .......................................................... HIV Case Report ............................................ Case Report ................................................... Evaluations ..................................................... Case Report Updates ..................................... Laboratory ...................................................... Updates .......................................................... HIV .................................................................. Incidence Surveillance (HIS) .......................... Molecular HIV Surveillance (MHS) ................. Perinatal HIV Exposure Reporting (PHER) .... Health Departments ........................................ Time and Date: 3:00 p.m.—4:10 p.m., EDT, January 23, 2013. Place: Teleconference. Status: Open to the public, limited only by the availability of telephone ports. The public is welcome to participate during the public comment period. A public comment period is tentatively scheduled from 4:00 p.m. to 4:05 p.m. To participate in the teleconference, please dial (877) 953–5019 and enter code 5280655. Purpose: The subcommittee will provide advice to the CDC Director through the ACD on strategic and other broad issues facing CDC. Matters To Be Discussed: Agenda items will include the following: review of draft recommendations for health equity at CDC. VerDate Mar<15>2010 06:31 Dec 22, 2012 Jkt 229001 The agenda is subject to change as priorities dictate. Contact Person for More Information: Leandris Liburd, Ph.D., M.P.H., M.A., Designated Federal Officer, HDS, ACD, CDC, 1600 Clifton Road NE., M/S E–67, Atlanta, Georgia 30333, telephone (404) 498–2320, email: LEL1@cdc.gov. 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 the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: December 18, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–31008 Filed 12–21–12; 4:15 pm] BILLING CODE 4163–18–P PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Average Burden per response (in hours) Number of respondents Type of respondent DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0176] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 25, 2013. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-New and title, ‘‘Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising.’’ Also include SUMMARY: E:\FR\FM\26DEN1.SGM 26DEN1

Agencies

[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76045-76046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31010]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-0573]


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 
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 days of this notice.

Proposed Project

    The National HIV Surveillance System (NHSS) (OMB No. 0920-0573, 
Expiration 01/31/2013)-Revision- National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC). This title is being changed from the 
previously approved title Adult and Pediatric HIV/AIDS Confidential 
Case Reports for National HIV/AIDS Surveillance in 2009.

Background and Brief Description

    The purpose of HIV surveillance is to monitor trends in HIV and 
describe the characteristics of infected persons (e.g., demographics, 
modes of exposure to HIV, clinical and laboratory markers of HIV 
disease, manifestations of severe HIV disease, and deaths among persons 
with HIV). HIV surveillance data are widely used at all government 
levels to assess the impact of HIV infection on morbidity and 
mortality, to allocate medical care resources and services, and to 
guide prevention and disease control activities.
    CDC, in collaboration with health departments in the 50 states, the 
District of Columbia, and U.S. dependent areas, conduct national 
surveillance for cases of HIV infection. National surveillance includes 
tracking critical data across the spectrum of HIV disease from HIV 
diagnosis, to AIDS, the end-stage disease caused by infection with HIV, 
and death. In addition, this national system provides essential data to 
estimate HIV incidence and monitor patterns in viral resistance and 
HIV-1 subtypes, as well as provide information on perinatal exposures 
in the U.S.
    The CDC surveillance case definition has been modified periodically 
to accurately monitor disease in adults, adolescents and children and 
reflect use of new testing technologies and changes in HIV treatment. 
Information is then updated in the case report forms and reporting 
software as needed. In 2012, CDC convened an expert consultation to 
consider revisions of various aspects of the case definition including 
criteria for reporting a potential case, criteria for reporting a 
confirmed case, and case classification (disease staging system). 
Recommendations for revisions in the case definition were adopted by 
the Council of State and Territorial Epidemiologists in June 2012 and 
the final case definition revision is planned for implementation in 
2013 after publication.
    The revisions requested include modifications to currently 
collected data elements and forms to align with anticipated changes in 
the case definitions for HIV surveillance to be published in 2012 and 
continuation of HIV surveillance activities funded under the new 
funding opportunity announcement CDC-RFA-PS13-1302 National HIV 
Surveillance System (NHSS). These include minor modifications of 
testing categories to accommodate new testing algorithms and 
modifications to staging criteria and non-substantial editorial changes 
aimed at improving the format and usability of the forms such as 
improved wording of terms and changes in the format of some response 
options. In addition, the number of data elements from the former 
enhanced perinatal surveillance (EPS) was reduced and the form modified 
for continuation in 2013 as Perinatal HIV Exposure Reporting (PHER). 
Surveillance data collection on variant and atypical strains (formerly 
variant, atypical and resistant HIV surveillance (VARHS)) will be 
continued as Molecular HIV Surveillance (MHS) with a reduced number of 
data elements previously approved under VARHS.
    CDC provides funding for 59 jurisdictions to conduct adult and 
pediatric HIV case surveillance. Health department staffs compile 
information from laboratories, physicians, hospitals, clinics and other 
health care providers in order to complete the HIV and pediatric case 
reports. Updates to case reports are also entered into enhanced HIV/
AIDS Reporting system (eHARS) by health departments, as additional 
information may be received from laboratories, vital statistics 
offices, or additional providers. Evaluations are also conducted by 
health departments on a subset of case reports (e.g. including re-
abstraction/validation activities and routine interstate de-
duplication) in all jurisdictions.
    Supplemental surveillance data are collected in a subset of areas 
to provide additional information necessary to estimate HIV incidence, 
to better describe the extent of HIV viral

[[Page 76046]]

resistance and quantify HIV subtypes among persons infected with HIV 
and to monitor and evaluate perinatal HIV prevention efforts. Health 
departments funded for these supplemental data collections obtain this 
information from laboratories, health care providers, and medical 
records. CDC estimates that 25 health departments will be reporting 
data elements containing HIV Incidence Surveillance (HIS) data, 53 
health departments will report additional data elements on HIV 
nucleotide sequences as part of MHS, and 35 areas will be reporting 
data as part of PHER annually. The total estimated annual burden hours 
are 53,700.

Estimated Annualized Burden Hours

                                Exhibit 12.A Estimates of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average Burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Health Departments....................  Adult...................              59           1,260           20/60
                                        HIV Case Report.........
Health Departments....................  Pediatric...............              59               6           20/60
                                        HIV Case Report.........
Health................................  Case Report.............              59             127           20/60
Departments...........................  Evaluations.............
Health Departments....................  Case Report Updates.....              59           1,469            2/60
Health Departments....................  Laboratory..............              59           5,876            1/60
                                        Updates.................
Health Departments....................  HIV.....................              25           2,729           10/60
                                        Incidence Surveillance
                                         (HIS).
Health Departments....................  Molecular HIV                         53             967            5/60
                                         Surveillance (MHS).
Health Departments....................  Perinatal HIV Exposure                35             114           30/60
                                         Reporting (PHER).
----------------------------------------------------------------------------------------------------------------


Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-31010 Filed 12-21-12; 4:15 pm]
BILLING CODE 4163-18-P
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