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Withdrawn From Sale for Reasons of 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
51038 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 

reports of possible postmarketing 

adverse events. FDA has determined, 

under § 314.161, that Halflytely and 

Bisacodyl Tablets Bowel Prep Kit (10- 

mg bisacodyl) was withdrawn from sale 

for reasons of safety or effectiveness. 

Braintree discontinued this product 

containing a total dose of 10 milligrams 

of bisacodyl from sale after receiving 

approval from FDA on July 16, 2010, for 

NDA 21–551/S–013, Halflytely and 

Bisacodyl Tablets Bowel Prep Kit (PEG– 

3350, sodium chloride, sodium 

bicarbonate, and potassium chloride for 

oral solution and one bisacodyl delayed 

release tablet, 5 mg (5-mg bisacodyl)). 

The data available from a clinical study 

comparing the 10-mg version of 

Halflytely and Bisacodyl Tablets Bowel 

Prep Kit to a 5-mg version of the drug 

product showed that the Halflytley and 

Bisacodyl Tablets Bowl Prep Kit (5-mg 

bisacodyl) has comparable effectiveness 

to the 10-mg product and has a safety 

advantage over the 10-mg product 

because there is less abdominal fullness 

and cramping in the patients treated 

with the 5-mg product. Furthermore, the 

10-mg product may be associated with 

ischemic colitis. 

FDA has also reviewed the latest 

approved labeling for the 10-mg product 

and has determined that it would need 

to be updated with additional safety 

information if Braintree were to 

reintroduce the 10-mg product to the 

market. FDA has determined that 

additional clinical studies of safety and 

efficacy would be necessary before 

Halflytely and Bisacodyl Tablets Bowel 

Prep Kit (10-mg bisacodyl) could be 

considered for reintroduction to the 

market. Accordingly, the Agency will 

remove 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) from the list of drug products 

published in the Orange Book. FDA will 

not accept or approve ANDAs that refer 

to this drug product. 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20853 Filed 8–16–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0068; formerly 

Docket No. 2007D–0290] 

Draft Guidance for Industry: Cell 

Selection Devices for Point of Care 

Production of Minimally Manipulated 

Autologous Peripheral Blood Stem 

Cells; Withdrawal of Draft Guidance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of a draft guidance entitled 

‘‘Draft Guidance for Industry: Cell 

Selection Devices for Point of Care 

Production of Minimally Manipulated 

Autologous Peripheral Blood Stem Cells 

(PBSCs)’’ dated July 2007. 

DATES: August 17, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration (HFM–17), 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: In a notice 

published in the Federal Register of 

July 26, 2007 (72 FR 41080), FDA 

announced the availability of a draft 

guidance entitled ‘‘Draft Guidance for 

Industry: Cell Selection Devices for 

Point of Care Production of Minimally 

Manipulated Autologous Peripheral 

Blood Stem Cells (PBSCs).’’ 

FDA has carefully considered the 

comments received on the draft 

guidance and, since that document 

issued in 2007, has gained additional 

experience with point of care devices 

and the autologous cells selected by 

them. Based on these comments and 

experience, FDA believes that the draft 

guidance would not, if finalized in 

current form, reflect FDA’s current 

thinking. For these reasons, FDA is 

withdrawing the draft guidance entitled 

‘‘Draft Guidance for Industry: Cell 

Selection Devices for Point of Care 

Production of Minimally Manipulated 

Autologous Peripheral Blood Stem Cells 

(PBSCs).’’ 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20862 Filed 8–16–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0246] 

Guidance for Industry on Residual 

Drug in Transdermal and Related Drug 

Delivery Systems; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Residual Drug in Transdermal 

and Related Drug Delivery Systems.’’ 

This guidance provides 

recommendations to developers and 

manufacturers of transdermal drug 

delivery systems (TDDS), transmucosal 

drug delivery systems (TMDS), and 

topical patch products regarding use of 

an appropriate scientific approach 

during product design and 

development—as well as during 

manufacturing and product life-cycle 

management—to ensure that the amount 

of residual drug substance at the end of 

the labeled use period is minimized. 

The guidance is applicable to 

investigational new drug applications, 

new drug applications, abbreviated new 

drug applications, and supplemental 

new drug applications for TDDS, TMDS, 

and topical patch products. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Terrance Ocheltree, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 21, rm. 

1609, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–1988. 

SUPPLEMENTARY INFORMATION: 


Emcdonald on DSK2BSOYB1PROD with NOTICES