Draft Guidance for Industry on Providing Submissions in Electronic Format-Standardized Study Data; Availability, 9945-9946 [2012-3956]

Download as PDF Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices 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FDA has determined under § 314.161 that REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3 mg, were not withdrawn for reasons of safety or effectiveness.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no data or other information suggesting that REQUIP XL (ropinerole hydrochloride) extendedrelease tablets, 3 mg, were withdrawn for reasons of safety or effectiveness.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 We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.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AND HUMAN SERVICES Food and Drug Administration mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2012–D–0097] Draft Guidance for Industry on Providing Submissions in Electronic Format—Standardized Study Data; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA) is announcing the SUMMARY: VerDate Mar<15>2010 17:29 Feb 17, 2012 Jkt 226001 availability of a draft guidance for industry entitled ‘‘Providing Submissions in Electronic Format— Standardized Study Data.’’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 https:// 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 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 9945 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 https://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 E:\FR\FM\21FEN1.SGM 21FEN1 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 https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// 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 mstockstill on DSK4VPTVN1PROD with NOTICES [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. VerDate Mar<15>2010 17:29 Feb 17, 2012 Jkt 226001 ACTION: Notice. 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 https:// 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: SUMMARY: 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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 E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Pages 9945-9946]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3956]


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

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 https://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 https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/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

[[Page 9946]]

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 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://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
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