Source: https://regulations.justia.com/regulations/fedreg/2017/12/26/2017-27786.html
Timestamp: 2020-06-01 16:44:17
Document Index: 621342222

Matched Legal Cases: ['§ 60', '§ 60', '§ 10', 'art 1', 'art 314', 'art 314', '§ 314', 'art 314', 'art 314']

Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability, 61011-61013 [2017-27786] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability, 61011-61013 [2017-27786]
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability, 61011-61013 [2017-27786]
Download as PDF Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product ZYKADIA (ceritinib). ZYKADIA is indicated for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received patent term restoration applications for ZYKADIA (U.S. Patent Nos. 7,964,592 from Novartis AG and and 8,377,921 from IRM LLC), and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ZYKADIA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. ethrower on DSK3G9T082PROD with NOTICES II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ZYKADIA is 1,271 days. Of this time, 1,144 days occurred during the testing phase of the regulatory review period, while 127 days occurred during the approval phase. These periods of time were derived from the following dates: VerDate Sep<11>2014 20:21 Dec 22, 2017 Jkt 244001 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: November 7, 2010. FDA has verified the applicants’ claims that November 7, 2010, is the date the investigational new drug application became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 24, 2013. FDA has verified the applicants’ claims that the new drug application (NDA) for ZYKADIA (NDA 205755) was initially submitted on December 24, 2013. 3. The date the application was approved: April 29, 2014. FDA has verified the applicants’ claims that NDA 205755 was approved on April 29, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In their applications for patent extension, these applicants seek 472 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24 ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 61011 Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27745 Filed 12–22–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1245] Waiver of In Vivo Bioavailability and Bioequivalence Studies for ImmediateRelease Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ‘‘Waiver of In Vivo Bioavailability and Bioequivalence Studies for ImmediateRelease Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.’’ This guidance finalizes recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/ or bioequivalence (BE) study requirement. SUMMARY: The announcement of the guidance is published in the Federal Register on December 26, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or E:\FR\FM\26DEN1.SGM 26DEN1 61012 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices ethrower on DSK3G9T082PROD with NOTICES anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–D–1245 for ‘‘Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this VerDate Sep<11>2014 20:21 Dec 22, 2017 Jkt 244001 information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov /fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, 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. FOR FURTHER INFORMATION CONTACT: Mehul Mehta, Center for Drug Evaluation and Research (HFD–860), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–1573. SUPPLEMENTARY INFORMATION: solid oral dosage forms during the IND period, and (2) in vivo BE studies of IR solid oral dosage forms in NDAs, ANDAs, and supplements to these applications. This guidance finalizes the guidance for industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, published on May 6, 2015 (80 FR 26058), and explains when biowaivers can be requested for IR solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). While many positive comments were received on the published draft guidance, several requests were made for additional clarification regarding the biowaivers for BCS class 3 drug substances, and specific issues pertaining to dissolution and permeability categories. In response, this guidance includes biowaiver extension to BCS class 3 drug products, and additional modifications, such as criteria for high permeability and high solubility. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. I. Background II. Paperwork Reduction Act of 1995 FDA is announcing the availability of a guidance for industry entitled ‘‘Waiver of In Vivo Bioavailability and Bioequivalence Studies for ImmediateRelease Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.’’ This guidance provides recommendations for sponsors of INDs, and applicants who submit NDAs, ANDAs, and supplements to these applications for IR solid oral dosage forms, and who wish to request a waiver of an in vivo BA and/or BE study requirement. These recommendations are intended to apply to waivers requested during the IND period and the NDA stage or for ANDAs, i.e.: (1) Subsequent in vivo BA or BE studies of formulations after the initial establishment of the in vivo BA of IR This 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 part 314 (21 CFR part 314), including §§ 314.50 and 314.94, have been approved under OMB control number 0910–0001. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 III. Electronic Access Persons with access to the internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. E:\FR\FM\26DEN1.SGM 26DEN1 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27786 Filed 12–22–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1069] Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the blood establishment registration and product listing requirements in the Agency’s regulations and Form FDA 2830. SUMMARY: Submit electronic or written comments on the collection of information by February 26, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 26, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ethrower on DSK3G9T082PROD with NOTICES DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. VerDate Sep<11>2014 20:21 Dec 22, 2017 Jkt 244001 Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–N–1069 for ‘‘Blood Establishment Registration and Product Listing, Form FDA 2830.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 61013 claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance E:\FR\FM\26DEN1.SGM 26DEN1
[Pages 61011-61013]
[FR Doc No: 2017-27786]
[Docket No. FDA-2015-D-1245]
Waiver of In Vivo Bioavailability and Bioequivalence Studies for
Classification System; Guidance for Industry; Availability
the availability of a guidance for industry entitled ``Waiver of In
Vivo Bioavailability and Bioequivalence Studies for Immediate-Release
Solid Oral Dosage Forms Based on a Biopharmaceutics Classification
System.'' This guidance finalizes recommendations for sponsors of
investigational new drug applications (INDs), and applicants who submit
new drug applications (NDAs), abbreviated new drug applications
(ANDAs), and supplements to these applications for immediate-release
(IR) solid oral dosage forms, and who wish to request a waiver of an in
vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.
Register on December 26, 2017.
FDA-2015-D-1245 for ``Waiver of In Vivo Bioavailability and
Based on a Biopharmaceutics Classification System.'' Received comments
FOR FURTHER INFORMATION CONTACT: Mehul Mehta, Center for Drug
Evaluation and Research (HFD-860), Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993, 301-796-1573.
entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies
Biopharmaceutics Classification System.'' This guidance provides
recommendations for sponsors of INDs, and applicants who submit NDAs,
ANDAs, and supplements to these applications for IR solid oral dosage
forms, and who wish to request a waiver of an in vivo BA and/or BE
study requirement. These recommendations are intended to apply to
waivers requested during the IND period and the NDA stage or for ANDAs,
i.e.: (1) Subsequent in vivo BA or BE studies of formulations after the
initial establishment of the in vivo BA of IR solid oral dosage forms
during the IND period, and (2) in vivo BE studies of IR solid oral
dosage forms in NDAs, ANDAs, and supplements to these applications.
This guidance finalizes the guidance for industry on Waiver of In
System, published on May 6, 2015 (80 FR 26058), and explains when
biowaivers can be requested for IR solid oral dosage forms based on an
approach termed the Biopharmaceutics Classification System (BCS). While
many positive comments were received on the published draft guidance,
several requests were made for additional clarification regarding the
biowaivers for BCS class 3 drug substances, and specific issues
pertaining to dissolution and permeability categories. In response,
this guidance includes biowaiver extension to BCS class 3 drug
products, and additional modifications, such as criteria for high
permeability and high solubility.
current thinking of FDA on Waiver of In Vivo Bioavailability and
Based on a Biopharmaceutics Classification System. It does not
3520). The collections of information in part 314 (21 CFR part 314),
including Sec. Sec.  314.50 and 314.94, have been approved under OMB
control number 0910-0001.
[FR Doc. 2017-27786 Filed 12-22-17; 8:45 am]