Proposed Data Collections Submitted for Public Comment and Recommendations, 51036-51037 [2011-20919]

Download as PDF 51036 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices concept, message, and materials testing, one of which is focus groups. The purpose of focus groups is to ensure that the public and other key audiences, like health professionals, clearly understand cancer-specific information and concepts, are motivated to take the desired action, and do not react negatively to the messages. Information collection will involve focus groups to assess numerous qualitative dimensions of cancer prevention and control messages, including, but not limited to, knowledge, attitudes, beliefs, behavioral intentions, information needs and sources, and compliance to recommended screening intervals. Insights gained from the focus groups will assist in the development and/or refinement of future campaign messages and materials. Respondents will include health care providers as well as members of the general public. Communication campaigns will vary according to the type of cancer, the qualitative dimensions of the message described above, and the type of respondents. DCPC has developed a set of example questions that can be tailored to screen for targeted groups of respondents, and a set of example questions that can be used to develop Number of responses per respondent Screening Form ................................ 1,728 1 3/60 86 Focus Group Discussion Guide ....... ........................................................... 864 ........................ 1 ........................ 2 ........................ 1728 1814 Form name Health care providers and general public. Total ........................................... Dated: August 10, 2011. Daniel Holcomb, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2011–20920 Filed 8–16–11; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–11–0802] Emcdonald on DSK2BSOYB1PROD with NOTICES Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the 18:13 Aug 16, 2011 Average burden per response (in hours) Number of respondents Type of respondents VerDate Mar<15>2010 discussion guides for a variety of focus groups. The average burden for each focus group discussion will be two hours. DCPC will conduct or sponsor up to 72 focus groups per year over a three-year period. An average of 12 respondents will participate in each focus group discussion. A separate information collection request will be submitted to OMB for approval of each focus group activity. There are no costs to respondents except their time. The total estimated annualized burden hours are 1,814. Estimated Annualized Burden Hours: Jkt 223001 agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Active Bacterial Core Surveillance (ABCs) Projects—OMB 0920–0802, Expiration January 31, 2012 (Revision)—National Center for Immunization and Respiratory Disease (NCIRD), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is requesting a revision to the approved data collection instruments for Active Bacterial Core surveillance (ABCs), to add supplemental questions for invasive methicillin-resistant Staphylococcus aureus (MRSA). CDC requests OMB approval to collect supplemental information to assess risk factors for invasive MRSA among patients recently discharged from acute care hospitals. Seventeen acute care facilities in 7 ABCs/EIP sites (CA, CT, CO, GA, NY, MN, TN) will participate in the collection of supplemental information for ABCs MRSA. Preventing healthcare-associated invasive MRSA infections is one of CDC’s priorities. Essential steps in PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Total burden (in hours) reducing the occurrence of healthcareassociated invasive MRSA infections are to quantify the burden and to identify modifiable risk factors associated with invasive MRSA disease. The current ABCs MRSA surveillance has been essential to quantify the burden of invasive MRSA in the United States. Through this surveillance CDC was able to estimate that 94,360 invasive MRSA infections associated with 18,650 deaths occurred in the United States in 2005. The majority of these infections (58%) had onset in the community or within 3 days of hospital admission and occurred among individuals with recent healthcare exposures (healthcareassociated community-onset [HACO]). More recent data from the CDC’s EIP/ ABCs system have shown that two thirds of invasive HACO MRSA infections occur among persons who are discharged from an acute care hospital in the prior 3 months. Risk factors for invasive MRSA infections postdischarge have not been well evaluated, and effective prevention measures in this population remain uncertain. The goal of the supplemental questions to be added to ABCs MRSA surveillance is to assess risk factors for invasive healthcare-associated MRSA infections, which will inform the development of targeted prevention measures. This activity supports the HHS Action Plan for elimination of healthcare-associated infections. This change will result in minimal impact on the current public burden. E:\FR\FM\17AUN1.SGM 17AUN1 51037 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices An estimated total of 450 new patients (150 patients with HACO MRSA infection and 300 patients without HACO MRSA infection) will be contacted for the MRSA interview annually. This estimate is based on the numbers of MRSA cases reported by the EIP sites annually (https://www.cdc.gov/ abcs/reports-findings/survreports/ mrsa08.html) who are 18 years of age or older, had onset of the MRSA infection in the community or within 3 days of hospital admission, and history of hospitalization in the prior 3 months. There are no costs to respondents other than their time. The total response burden for the study is estimated as follows: The OMB-approved ABCs MRSA form (#0920–0802) will be used to identify patients to be contacted for a telephone interview. These 450 patients will be screened for eligibility and those considered to be eligible will complete the telephone interview. We anticipate that 350 of the 450 patients screened will complete the telephone interview across all 7 EIP sites per year. We anticipate the screening questions to take about 5 minutes and the telephone interview 20 minutes per respondent. TABLE—ESTIMATED BURDEN Number of responses per respondent Number of respondents Average burden per respondent (in hours) Type of respondents Form name Hospital Patients ............................... Screening Form ................................ Telephone interview ......................... 450 350 1 1 5/60 20/60 38 117 Total ........................................... ........................................................... ........................ ........................ ........................ 155 Dated: August 10, 2011. Daniel Holcomb, Reports Clearance Officer, Centers for Disease Control and Prevention. Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993–0002, 301– 796–3601. [FR Doc. 2011–20919 Filed 8–16–11; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–P–0507] Determination That Halflytely and Bisacodyl Tablets Bowel Prep Kit (Containing Two Bisacodyl Delayed Release Tablets, 5 Milligrams) Was Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that Halflytely and Bisacodyl Tablets Bowel Prep Kit (polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 milligrams (mg) (10-mg bisacodyl)) was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for bowel prep kits containing PEG–3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 mg. FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug Evaluation and Research, Food and Emcdonald on DSK2BSOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:22 Aug 16, 2011 Jkt 223001 In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Total burden (in hours) Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. On September 23, 2010, FDA received a citizen petition (Docket No. FDA– 2010–P–0507), submitted under § 10.30 (21 CFR 10.30), from Perrigo Company (Perrigo). The petition requests that the Agency determine whether Halflytely and Bisacodyl Tablets Bowel Prep Kit (PEG–3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 mg) (Halflytely and Bisacodyl Tablets Bowel Prep Kit (10mg bisacodyl)), manufactured by Braintree Laboratories, Inc. (Braintree), was withdrawn from sale for reasons of safety or effectiveness. Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) (NDA 21–551) was approved on September 24, 2007. Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) was indicated for the cleansing of the colon as preparation for colonoscopy in adults. Braintree informed FDA that it ceased to manufacture and market Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) as of July 17, 2010. The drug product was then moved to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. FDA has reviewed its records concerning the withdrawal of Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl). FDA has also independently evaluated relevant literature, data from clinical trials, and E:\FR\FM\17AUN1.SGM 17AUN1

Agencies

[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51036-51037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20919]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-11-0802]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to 
omb@cdc.gov.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Active Bacterial Core Surveillance (ABCs) Projects--OMB 0920-0802, 
Expiration January 31, 2012 (Revision)--National Center for 
Immunization and Respiratory Disease (NCIRD), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    CDC is requesting a revision to the approved data collection 
instruments for Active Bacterial Core surveillance (ABCs), to add 
supplemental questions for invasive methicillin-resistant 
Staphylococcus aureus (MRSA). CDC requests OMB approval to collect 
supplemental information to assess risk factors for invasive MRSA among 
patients recently discharged from acute care hospitals. Seventeen acute 
care facilities in 7 ABCs/EIP sites (CA, CT, CO, GA, NY, MN, TN) will 
participate in the collection of supplemental information for ABCs 
MRSA.
    Preventing healthcare-associated invasive MRSA infections is one of 
CDC's priorities. Essential steps in reducing the occurrence of 
healthcare-associated invasive MRSA infections are to quantify the 
burden and to identify modifiable risk factors associated with invasive 
MRSA disease. The current ABCs MRSA surveillance has been essential to 
quantify the burden of invasive MRSA in the United States. Through this 
surveillance CDC was able to estimate that 94,360 invasive MRSA 
infections associated with 18,650 deaths occurred in the United States 
in 2005. The majority of these infections (58%) had onset in the 
community or within 3 days of hospital admission and occurred among 
individuals with recent healthcare exposures (healthcare-associated 
community-onset [HACO]). More recent data from the CDC's EIP/ABCs 
system have shown that two thirds of invasive HACO MRSA infections 
occur among persons who are discharged from an acute care hospital in 
the prior 3 months. Risk factors for invasive MRSA infections post-
discharge have not been well evaluated, and effective prevention 
measures in this population remain uncertain.
    The goal of the supplemental questions to be added to ABCs MRSA 
surveillance is to assess risk factors for invasive healthcare-
associated MRSA infections, which will inform the development of 
targeted prevention measures. This activity supports the HHS Action 
Plan for elimination of healthcare-associated infections. This change 
will result in minimal impact on the current public burden.

[[Page 51037]]

    An estimated total of 450 new patients (150 patients with HACO MRSA 
infection and 300 patients without HACO MRSA infection) will be 
contacted for the MRSA interview annually. This estimate is based on 
the numbers of MRSA cases reported by the EIP sites annually (https://www.cdc.gov/abcs/reports-findings/survreports/mrsa08.html) who are 18 
years of age or older, had onset of the MRSA infection in the community 
or within 3 days of hospital admission, and history of hospitalization 
in the prior 3 months. There are no costs to respondents other than 
their time. The total response burden for the study is estimated as 
follows:
    The OMB-approved ABCs MRSA form (0920-0802) will be used 
to identify patients to be contacted for a telephone interview. These 
450 patients will be screened for eligibility and those considered to 
be eligible will complete the telephone interview. We anticipate that 
350 of the 450 patients screened will complete the telephone interview 
across all 7 EIP sites per year. We anticipate the screening questions 
to take about 5 minutes and the telephone interview 20 minutes per 
respondent.

                                             Table--Estimated Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
     Type of  respondents           Form name       respondents    responses per    respondent      (in hours)
                                                                    respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Hospital Patients.............  Screening Form..             450               1            5/60              38
                                Telephone                    350               1           20/60             117
                                 interview.
----------------------------------------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             155
----------------------------------------------------------------------------------------------------------------


    Dated: August 10, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-20919 Filed 8-16-11; 8:45 am]
BILLING CODE 4163-18-P
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