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 

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: 

Type of respondents Form name Number of respondents 

Number of responses per 

respondent 

Average burden per response (in 

hours) 

Total burden 

(in hours) 

Health care providers and general 

public.

Screening Form ................................ 1,728 1 3/60 86 

Focus Group Discussion Guide ....... 864 1 2 1728 

Total ........................................... ........................................................... ........................ ........................ ........................ 1814 

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] 

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 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. 


Emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 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 (http://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

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

respondent 

(in hours) 

Total burden 

(in hours) 

Hospital Patients ............................... Screening Form ................................ 450 1 5/60 38 

Telephone interview ......................... 350 1 20/60 117 

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 

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. 

SUMMARY: 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 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6312, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: 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). 

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 (10- 

mg 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 


Emcdonald on DSK2BSOYB1PROD with NOTICES