Agency Forms Undergoing Paperwork Reduction Act Review, 14021-14022 [2011-5919]

Download as PDF 14021 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices Examples of topical areas include infant, child, adolescent, parent, and family health, well-being, and knowledge, attitude, and behaviors; children with special health care needs (CSHCN); functioning; life course and social determinants of health; developmental delays and disabilities; acute and chronic conditions; immunizations; access to and use of health care; program participation; adoption; and changes in health insurance coverage and experiences. Users of SLAITS data include, but are not limited to, Congressional offices, Federal agencies, state and local reports of the National Academy of Sciences. Within DHHS, the Office of the Assistant Secretary for Planning and Evaluation and the Administration for Children and Families used SLAITS to collect data for the first nationally representative survey of adoptive families across adoption types for children with and without special health care needs, and to assess their post-adoption service use and unmet needs. There is no cost to respondents other than their time to participate. The total estimated annualized burden hours are 194,675. governments, schools of public health, colleges and universities, private industry, nonprofit foundations, professional associations, clinicians, researchers, administrators, advocates, and health planners, to evaluate content and/or programs. SLAITS data continue to be heavily used by Federal and state Maternal and Child Health Bureau Directors to evaluate programs and service needs. Several SLAITS modules provided data for multiple Congressionally-mandated reports on healthcare disparities and quality; at least one report to Congress on health insurance coverage among children; and ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Respondents Household screening ................................................................................................................... Household interview .................................................................................................................... Pilot work, pre-testing, and planning activities ............................................................................ Dated: March 9, 2011. Carol E. Walker, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2011–5920 Filed 3–14–11; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day 11–10GP] srobinson on DSKHWCL6B1PROD 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. 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) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Clostridium difficile Infection (CDI) Surveillance—New—National Center for Emerging and Zoonotic Infectious Diseases, (NCEZID), Centers for Disease Control and Prevention, (CDC). Background and Brief Description Steady increases in the rate and severity of Clostridium difficile infection (CDI) indicate a clear need to conduct longitudinal assessments of the impact of CDI in the United States. C. difficile is an anaerobic, spore-forming, gram positive bacillus that produces two pathogenic toxins: A and B. CDI ranges in severity from mild diarrhea to fulminant colitis and death. Transmission of C. difficile occurs primarily in healthcare facilities, where environmental contamination by C. difficile spores and exposure to antimicrobial drugs are common. No longer limited to healthcare environments, community-associated CDI is the focus of increasing attention. Recently, several cases of serious CDI have been reported in what have been considered low-risk populations, including healthy persons living in the community and peri-partum women. The surveillance population will consist of persons residing in the Average burden per response (in hours) Number of responses per respondent 1,800,000 306,000 12,300 1 1 1 2/60 25/60 35/60 catchment area of the participating Emerging Infections Program (EIP) sites. This surveillance poses no more than minimal risk to the study participants as there will be no interventions or modifications to the care study participants receive. EIP surveillance personnel will perform active case finding from laboratory reports of stool specimens testing positive for C. difficile toxin and abstract data on cases using a standardized case report form. For a subset of cases (e.g., communityassociated C. difficile cases) sites will administer a health interview. Remnant stool specimens from cases testing positive for C. difficile toxin will be submitted to reference laboratories for culturing, and isolates will be sent to CDC for confirmation and molecular typing. Outcomes of this surveillance project will include the populationbased incidence of community- and healthcare-associated CDI, and a description of the molecular characteristics of C. difficile strains and the epidemiology of this infection among the population under surveillance. There is no cost to respondents to participate in this program. The total annualized burden for this data collection is 5,840 hours. ESTIMATE OF ANNUALIZED BURDEN HOURS CDI Surveillance Case Report Form—Complete ...................................................... VerDate Mar<15>2010 16:50 Mar 14, 2011 Jkt 223001 PO 00000 Number of responses per respondent Number of respondents Respondent Frm 00054 Fmt 4703 Sfmt 4703 10 E:\FR\FM\15MRN1.SGM 437 15MRN1 Average burden per response (in hours) 1 14022 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued CDI Surveillance Case Report Form—Partial ........................................................... CDI Surveillance Health Interview ............................................................................. Dated: March 9, 2011. Carol Walker, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2011–5919 Filed 3–14–11; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Withdrawl of Publication This is to serve notice that the following Federal Register notice published on March 1, 2011, page 11250, is being rescinded: Dated: March 9, 2011. Robert Sargis, Reports Clearance Officer. [FR Doc. 2011–5845 Filed 3–14–11; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0554] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals AGENCY: Food and Drug Administration, srobinson on DSKHWCL6B1PROD with NOTICES 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. SUMMARY: VerDate Mar<15>2010 16:50 Mar 14, 2011 Jkt 223001 10 10 Fax written comments on the collection of information by April 14, 2011. DATES: 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 e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0359. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Submission for OMB Review: Comment Request Title: Child Care and Development Fund Tribal Plan Preprint—ACF–118– A. OMB No.: 0970–0198. The original notice published on February 9, 2011, pages 7218–7219 is still in effect. Number of responses per respondent Number of respondents Respondent Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Devices; Reports of Corrections and Removals—(OMB Control Number 0910–0359)—(Extension) The collection of information required under the reports of corrections and removals, part 806 (21 CFR part 806), implements section 519(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(g)), as amended by the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 301) (Pub. L. 105–115). Each device manufacturer or importer under § 806.10 shall submit a written report to FDA of any action initiated to correct or remove a device to reduce a risk to health posed by the device, or to remedy a violation of the FD&C Act caused by the device that may present a risk to health, within 10 working days of initiating such correction or removal. Each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA under § 806.20 shall keep a record of such correction or removal. The information collected in the reports of corrections and removals will be used by FDA to identify marketed PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 438 50 Average burden per response (in hours) 15/60 45/60 devices that have serious problems and to ensure that defective devices are removed from the market. This will assure that FDA has current and complete information regarding these corrections and removals and to determine whether recall action is adequate. Respondents to this collection of information are manufacturers and importers of medical devices. FDA reviewed reports of device corrections and removals submitted to the Agency for the previous 3 years as part of responding to the current request for approval of the information collection requirements for §§ 806.10 and 806.20. This information was obtained through the Agency’s voluntary recall provisions (i.e., 21 CFR part 7). The specific information requested was the total number of class I, II, and III recalls for the last 3 years. This information was obtained from the Agency’s Recall Enterprise System—a database of all recalls submitted to the Agency. This information is relevant since a § 806.10 report is required for all class I and II recalls. Although class III recalls are not required to be submitted to FDA (by § 806.10), a record must be kept in the firm’s § 806.20 file. Therefore, the number of class I and II recalls can be used to estimate the maximum number of reports that are required to be submitted under § 806.10. Also, the recordkeeping burden can be estimated based upon the number of class III recalls, which are not required to be reported, but must be retained in a § 806.20 file. FDA has determined that estimates of the reporting burden for § 806.10 should be revised to reflect a projected 7.3 percent increase (from the last PRA numbers) in reports submitted to FDA as class I and II. FDA also estimates the recordkeeping burden in § 806.20 should be revised to reflect a reduction of 6.8 percent (from the last PRA numbers) in records filed and maintained under § 806.20. The estimates of time needed to collect part 806 information have not changed. In the Federal Register of November 23, 2010 (75 FR 71446), FDA published a 60-day notice requesting public comment on the proposed collection of E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14021-14022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5919]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day 11-10GP]


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) 395-5806. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Clostridium difficile Infection (CDI) Surveillance--New--National 
Center for Emerging and Zoonotic Infectious Diseases, (NCEZID), Centers 
for Disease Control and Prevention, (CDC).

Background and Brief Description

    Steady increases in the rate and severity of Clostridium difficile 
infection (CDI) indicate a clear need to conduct longitudinal 
assessments of the impact of CDI in the United States. C. difficile is 
an anaerobic, spore-forming, gram positive bacillus that produces two 
pathogenic toxins: A and B. CDI ranges in severity from mild diarrhea 
to fulminant colitis and death. Transmission of C. difficile occurs 
primarily in healthcare facilities, where environmental contamination 
by C. difficile spores and exposure to antimicrobial drugs are common. 
No longer limited to healthcare environments, community-associated CDI 
is the focus of increasing attention. Recently, several cases of 
serious CDI have been reported in what have been considered low-risk 
populations, including healthy persons living in the community and 
peri-partum women.
    The surveillance population will consist of persons residing in the 
catchment area of the participating Emerging Infections Program (EIP) 
sites. This surveillance poses no more than minimal risk to the study 
participants as there will be no interventions or modifications to the 
care study participants receive. EIP surveillance personnel will 
perform active case finding from laboratory reports of stool specimens 
testing positive for C. difficile toxin and abstract data on cases 
using a standardized case report form. For a subset of cases (e.g., 
community-associated C. difficile cases) sites will administer a health 
interview. Remnant stool specimens from cases testing positive for C. 
difficile toxin will be submitted to reference laboratories for 
culturing, and isolates will be sent to CDC for confirmation and 
molecular typing. Outcomes of this surveillance project will include 
the population-based incidence of community- and healthcare-associated 
CDI, and a description of the molecular characteristics of C. difficile 
strains and the epidemiology of this infection among the population 
under surveillance.
    There is no cost to respondents to participate in this program. The 
total annualized burden for this data collection is 5,840 hours.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                Number of        Average burden
                       Respondent                            Number of        responses per    per response  (in
                                                            respondents         respondent           hours)
----------------------------------------------------------------------------------------------------------------
CDI Surveillance Case Report Form--Complete............                 10                437                  1

[[Page 14022]]

 
CDI Surveillance Case Report Form--Partial.............                 10                438              15/60
CDI Surveillance Health Interview......................                 10                 50              45/60
----------------------------------------------------------------------------------------------------------------


    Dated: March 9, 2011.
Carol Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2011-5919 Filed 3-14-11; 8:45 am]
BILLING CODE 4163-18-P
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