9946
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`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`This draft guidance refers to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`Draft Guidance for Industry on Drug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`availability of a revised draft guidance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 drug-
`therapeutic 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 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
`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 drug-
`therapeutic 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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`PAR1016
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`Page 1 of 2
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`

`
`Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices
`
`9947
`
`finalized, will represent the Agency’s
`current thinking on conducting drug
`interaction studies during drug
`development to support marketing
`approval. 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 requirement
`of the applicable statutes and
`regulations.
`II. Paperwork Reduction Act of 1995
`This revised 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
`201.57 have been approved under OMB
`control number 0910–0572.
`III. 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.
`IV. Electronic Access
`Persons with access to the Internet
`may obtain the document at either
`http://www.fda.gov/Drugs/Guidance
`ComplianceRegulatoryInformation/
`Guidances or http://
`www.regulations.gov.
`Dated: February 15, 2012.
`Leslie Kux,
`Acting Assistant Commissioner for Policy.
`[FR Doc. 2012–3958 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–2010–D–0500]
`
`Guidance for Industry: Early Clinical
`Trials With Live Biotherapeutic
`Products: Chemistry, Manufacturing,
`and Control Information; Availability
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`SUMMARY: The Food and Drug
`Administration (FDA) is announcing the
`availability of a document entitled
`‘‘Guidance for Industry: Early Clinical
`
`Trials With Live Biotherapeutic
`Products: Chemistry, Manufacturing,
`and Control Information ’’ dated
`February 2012. The guidance provides
`certain Investigational New Drug
`Application (IND) sponsors with
`recommendations in connection with
`the submission of INDs for early clinical
`trials with live biotherapeutic products
`(LBPs). The guidance announced in this
`notice finalizes the draft guidance of the
`same title dated September 2010.
`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
`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. Send one
`self-addressed adhesive label to assist
`the office in processing your requests.
`The guidance may also be obtained by
`mail by calling CBER at 1–800–835–
`4709 or 301–827–1800. 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:
`Benjamin A. Chacko, Center for
`Biologics Evaluation and Research
`(HFM–17), Food and Drug
`Administration, 1401 Rockville Pike,
`suite 200N, Rockville, MD 20852–1448,
`301–827–6210.
`SUPPLEMENTARY INFORMATION:
`I. Background
`FDA is announcing the availability of
`a document entitled ‘‘Guidance for
`Industry: Early Clinical Trials With Live
`Biotherapeutic Products: Chemistry,
`Manufacturing, and Control
`Information’’ dated February 2012. The
`guidance provides certain IND sponsors
`with recommendations in connection
`with IND submissions for early clinical
`trials for LBPs in the United States. The
`guidance focuses on the chemistry,
`manufacturing, and control information
`that should be provided in an IND for
`early clinical trials evaluating LBPs. The
`guidance is applicable to INDs of LBPs,
`whether clinical trials are conducted
`commercially, in an academic setting, or
`otherwise.
`In the Federal Register of October 14,
`2010 (75 FR 63188), FDA announced the
`
`availability of the draft guidance of the
`same title dated September 2010. FDA
`received a few comments on the draft
`guidance and those comments were
`considered as the guidance was
`finalized. In response to comments,
`changes incorporated in the final
`guidance include the addition of text
`related to the scope, definitions and
`background section of the guidance. In
`addition, editorial changes were made
`to improve clarity. The guidance
`announced in this notice finalizes the
`draft guidance dated September 2010.
`The guidance is being issued
`consistent with FDA’s good guidance
`practices regulation (21 CFR 10.115).
`The guidance represents FDA’s current
`thinking on this topic. 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
`requirements of the applicable statutes
`and regulations.
`II. Paperwork Reduction Act of 1995
`
`The guidance refers to previously
`approved collections of information
`found in FDA regulations. These
`collections of information 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 312 have been approved
`under 0910–0014.
`III. 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.
`IV. Electronic Access
`
`Persons with access to the Internet
`may obtain the guidance at either
`http://www.fda.gov/BiologicsBlood
`Vaccines/GuidanceCompliance
`RegulatoryInformation/Guidances/
`default.htm or http://
`www.regulations.gov.
`Dated: February 14, 2012.
`Leslie Kux,
`Acting Assistant Commissioner for Policy.
`[FR Doc. 2012–3957 Filed 2–17–12; 8:45 am]
`
`BILLING CODE 4160–01–P
`
`VerDate Mar<15>2010 17:29 Feb 17, 2012 Jkt 226001 PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 E:\FR\FM\21FEN1.SGM 21FEN1
`
`mstockstill on DSK4VPTVN1PROD with NOTICES
`
`PAR1016
`IPR of U.S. Patent No. 8,772,306
`Page 2 of 2