Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices 9945 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that REQUIP XL (ropinerole 

hydrochloride) extended-release tablets, 

3 mg, were not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that REQUIP XL 

(ropinerole hydrochloride) extendedrelease tablets, 3 mg, were withdrawn 

for reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

REQUIP XL (ropinerole hydrochloride) 

extended-release tablets, 3 mg, from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this product 

was withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list REQUIP XL (ropinerole 

hydrochloride) extended-release tablets, 

3 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. 

ANDAs that refer to REQUIP XL 

(ropinerole hydrochloride) extendedrelease tablets, 3 mg, may be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: February 14, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3954 Filed 2–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0097] 

Draft Guidance for Industry on 

Providing Submissions in Electronic 

Format—Standardized Study Data; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Providing 

Submissions in Electronic Format— 

Standardized Study Data.’’ This draft 

guidance establishes FDA’s 

recommendation that sponsors and 

applicants submit nonclinical and 

clinical study data in a standardized 

electronic format. The draft guidance 

recognizes that standardized study data 

promotes the efficient review of this 

information. The purpose of this draft 

guidance is to promote the use of data 

standards for study data, and increase 

the number of standardized study data 

submissions to the Center for Drug 

Evaluation and Research, the Center for 

Biologics Evaluation and Research, and 

the Center for Devices and Radiological 

Health. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by April 23, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft 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: Kieu 

Pham, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 21, Rm. 4677, Silver Spring, 

MD 20993–0002, 301–796–1616, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210, or 

Terrie Reed, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3324, 

Silver Spring, MD 20993–0002, 301– 

796–6130. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Providing Submissions in Electronic 

Format—Standardized Study Data.’’ 

FDA routinely receives submissions of 

the results of scientific studies, 

including clinical trials and animal 

studies. For many years, FDA has 

requested that clinical study data be 

submitted electronically because paper 

case report tabulations (CRTs) are 

universally recognized as being highly 

inefficient to support analysis and 

review. The data in paper CRTs are not 

machine-readable and therefore cannot 

be easily analyzed using modern 

analytic software. Although submission 

of clinical study data in electronic 

format has become relatively routine, 

these data are often submitted using 

nonstandard formats. 

FDA has long recognized the 

advantage of standardizing study data, 

as have many sponsors and applicants. 

Data submitted in a standard electronic 

format are easier to understand, analyze, 

and review. 

This draft guidance establishes FDA’s 

recommendation that sponsors and 

applicants submit clinical and 

nonclinical study data in a standard 

electronic format. As sponsors and 

applicants move toward standardized 

electronic study data submissions, there 

is a need to understand FDA’s 

expectations for such data submissions. 

This draft guidance provides FDA’s 

current thinking on the submission of 

study data in a standard electronic 

format. 

The draft guidance refers submitters 

to FDA’s Study Data Standards Resource 

Web page at http://www.fda.gov/For

Industry/DataStandards/StudyData

Standards/default.htm, where there is 

useful information describing which 

data standards to use and how to use 

them. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on submitting standardized study data 

in electronic format. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

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9946 Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 314 and 21 CFR part 312 have been 

approved under OMB control numbers 

0910–0001 and 0910–0014, respectively. 

The collections of information in 21 

CFR part 807, subpart E have been 

approved under 0910–0120; the 

collections of information in 21 CFR 

part 812 have been approved under 

0910–0078; and the collections of 

information in 21 CFR part 814 have 

been approved under 0910–0231. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm, or http:// 

www.regulations.gov. 

Dated: February 14, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3956 Filed 2–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–D–0036] (Formerly 

Docket No. 2006D–0344) 

Draft Guidance for Industry on Drug 

Interaction Studies—Study Design, 

Data Analysis, Implications for Dosing, 

and Labeling Recommendations; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised draft guidance 

for industry entitled ‘‘Drug Interaction 

Studies—Study Design, Data Analysis, 

Implications for Dosing, and Labeling 

Recommendations.’’ The revised draft 

guidance is intended to provide 

recommendations for sponsors of new 

drug applications (NDAs) and biologics 

license applications (BLAs) for 

therapeutic biologics regarding in vitro 

and in vivo studies of drug metabolism, 

drug transport, and drug-drug, or drugtherapeutic protein interactions. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this revised 

draft guidance before it begins work on 

the final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 21, 2012. 

ADDRESSES: Submit written requests for 

single copies of the revised draft 

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 selfaddressed 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 

draft 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: 

Shiew-Mei Huang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3188, 

Silver Spring, MD 20993–0002, 301– 

796–1541; or 

Lei Zhang, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3106, 

Silver Spring, MD 20993–0002, 301– 

796–1635. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Drug Interaction Studies— 

Study Design, Data Analysis, 

Implications for Dosing, and Labeling 

Recommendations.’’ Drug interactions 

can result when one drug alters the 

pharmacokinetics of another drug or its 

metabolites. Drug interactions also can 

reflect the additive nature of the 

pharmacodynamic effect of either drug 

when taken with the other drug. The 

main focus of this draft guidance is 

pharmacokinetic drug interactions. The 

revised draft guidance reflects the 

Agency’s view that the pharmacokinetic 

interactions between an investigational 

new drug and other drugs should be 

defined during drug development, as 

part of an adequate assessment of safety 

and effectiveness. It is important to 

understand the nature and magnitude of 

drug-drug interactions for several 

reasons. Concomitant medications, 

dietary supplements, and some foods, 

such as grapefruit juice, may alter 

metabolism and/or drug transport 

abruptly in individuals who previously 

had been receiving and tolerating a 

particular dose of a drug. Such an 

abrupt alteration in metabolism or 

transport can change the known safety 

and efficacy of a drug. 

The revised draft guidance provides 

recommendations for sponsors of NDAs 

and BLAs regarding in vitro and in vivo 

studies of drug metabolism, drug 

transport, and drug-drug, or drugtherapeutic protein interactions. 

Namely, the guidance describes in vitro 

study methodologies, criteria for in vivo 

studies, in vivo study design, and data 

analysis in the context of identifying 

potential drug interactions. The 

guidance also addresses the 

implications of drug interactions for 

dosing and labeling. 

In the Federal Register of September 

12, 2006 (71 FR 53696), FDA announced 

the availability of a draft guidance 

entitled ‘‘Drug Interaction Studies— 

Study Design, Data Analysis, and 

Implications for Dosing and Labeling.’’ 

Comments were received and have been 

considered during revision of the draft 

guidance. In addition, new 

developments in the field have been 

incorporated to reflect the Agency’s 

current thinking. The Agency is 

publishing the draft guidance as a 

revised draft guidance to collect 

additional public comments. The 

revised draft guidance includes detailed 

discussion of several major changes, 

including the following: (1) When 

transporter-mediated drug interaction 

information is needed (including 

decision-trees); (2) drug-therapeutic 

protein interactions, (3) the utility of 

pharmacogenetic data; and (4) the use of 

physiologically based pharmacokinetic 

modeling. 

This revised draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

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