81 FR 69064 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 193 (October 5, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 193 (October 5, 2016)
| Page Range | 69064-69066 | |
| FR Document | 2016-24050 |
[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)] [Notices] [Pages 69064-69066] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24050] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 5, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: [[Page 69065]]Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2007-D-0369 for ``Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA's Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register on June 17, 2016 (81 FR 39672). This notice announces draft product- specific BE recommendations, either new or revised, that are posted on FDA's Web site. II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available FDA is announcing the availability of a new draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients: Table 1--New Draft Product-Specific BE Recommendations for Drug Products ------------------------------------------------------------------------ ------------------------------------------------------------------------- Acetaminophen; Oxycodone hydrochloride Alectinib hydrochloride Betamethasone dipropionate Betamethasone valerate Captopril Carbidopa; levodopa Cholic acid Clobetasol propionate (multiple reference listed drugs) Cobicistat; Elvitegravir; Emtricitabine; Tenofovir alafenamide fumarate Crotamiton (multiple reference listed drugs) Desonide Dexlansoprazole Elbasvir; grazoprevir Eltrombopag Olamine Esomeprazole magnesium Fluticasone propionate Halobetasol propionate Hydrocodone bitartrate (multiple reference listed drugs) Hydrocortisone valerate Ibuprofen Iron dextran Methylphenidate hydrochloride Morphine sulfate Olopatadine hydrochloride Oxymorphone hydrochloride Prochlorperazine [[Page 69066]] Pyrazinamide Rolapitant hydrochloride Triamcinolone acetonide (multiple reference listed drugs) Umeclidinium bromide ------------------------------------------------------------------------ III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing the availability of a revised draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients: Table 2--Revised Draft Product-Specific BE Recommendations for Drug Products ------------------------------------------------------------------------ ------------------------------------------------------------------------- Bacitracin Buprenorphine Clonidine Cyclosporine Dexlansoprazole Diclofenac Epolamine Erythromycin Estradiol (multiple reference listed drugs) Ethinyl Estradiol; Norelgestromin Fentanyl Granisetron Icosapent ethyl Lansoprazole Lidocaine Menthol; Methyl Salicylate Mesalamine Methylphenidate Morphine sulfate Nicotine Nitroglycerin (multiple reference listed drugs) Omega-3-acid ethyl esters Oxybutynin Oxycodone HCl Pantoprazole sodium Rivastigmine Rotigotine Scopolamine Selegiline Testosterone ------------------------------------------------------------------------ For a complete history of previously published Federal Register notices related to product-specific BE recommendations, go to http://www.regulations.gov and enter Docket No. FDA-2007-D-0369. These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: September 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-24050 Filed 10-4-16; 8:45 am] BILLING CODE 4164-01-P
![69064 Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices
Radiological Health’s (CDRH) Patient I. General Description of the information concerning such matters
Engagement Advisory Committee (the Committee’s Duties related to financial holdings,
PEAC or Committee). The Committee The PEAC provides relevant skills employment, and research grants and/or
provides relevant skills and and perspectives in order to improve contracts to permit evaluation of
perspectives in order to improve communication of benefits, risks, and possible sources of conflicts of interest.
communication of benefits, risks and This notice is issued under the
clinical outcomes and increase
clinical outcomes, and increase Federal Advisory Committee Act (5
integration of patient perspectives into
integration of patient perspectives into U.S.C. app. 2) and 21 CFR part 14,
the regulatory process for medical
the regulatory process for medical relating to advisory committees.
devices.
devices. It performs its duties by The PEAC provides advice on issues Dated: September 28, 2016.
identifying new approaches, promoting relating to medical devices, the Janice M. Soreth,
innovation, recognizing unforeseen risks regulation of devices, and their use by Acting Associate Commissioner, Special
or barriers, and identifying unintended patients. A variety of topics may be Medical Programs.
consequences that could result from considered by the PEAC, including [FR Doc. 2016–24100 Filed 10–4–16; 8:45 am]
FDA policy. Agency guidance and policies, clinical BILLING CODE 4164–01–P
FDA seeks to include the views of trial or registry design, patient
women and men, members of all racial preference study design, benefit-risk
and ethnic groups, and individuals with determinations, device labeling, unmet DEPARTMENT OF HEALTH AND
and without disabilities on its advisory clinical needs, available alternatives, HUMAN SERVICES
committees and, therefore, particularly patient reported outcomes and device-
encourages nominations of related quality of life or health status Food and Drug Administration
appropriately qualified candidates from issues. [Docket No. FDA–2007–D–0369]
these groups.
DATES: Nominations received by
II. Criteria for Voting Members
Product-Specific Bioequivalence
November 21, 2016, will be given first The Committee consists of a core of Recommendations; Draft and Revised
consideration for membership on the nine voting members including the Draft Guidances for Industry;
Committee. Nominations received after Chair. Members and the Chair are Availability
November 21, 2016, will be considered selected by the Commissioner of Food
for nomination to the Committee as later and Drugs or designee from candidates AGENCY: Food and Drug Administration,
vacancies occur. who are knowledgeable in areas such as HHS.
ADDRESSES: All nominations for clinical research, primary care patient ACTION: Notice of availability.
membership should be sent experience, healthcare needs of patient
SUMMARY: The Food and Drug
electronically by logging into the FDA groups in the United States, or are
Administration (FDA or Agency) is
Advisory Committee Membership experienced in the work of patient and
announcing the availability of
Nomination Portal: https:// health professional organizations,
additional draft and revised draft
www.accessdata.fda.gov/scripts/ methodologies for eliciting patient
product-specific bioequivalence (BE)
FACTRSPortal/FACTRS/index.cfm preferences, and strategies for
recommendations. The
please select Academician/Practitioner communicating benefits, risks, and
recommendations provide product-
in the drop down menu, to apply for clinical outcomes to patients and
specific guidance on the design of BE
membership, or by mail to Advisory research participants. Prospective
studies to support abbreviated new drug
Committee Oversight and Management members should also have an
applications (ANDAs). In the Federal
Staff, Food and Drug Administration, understanding of the broad spectrum of
Register of June 11, 2010, FDA
10903 New Hampshire Ave., Bldg. 32, patients in a particular disease area.
announced the availability of a guidance
Rm. 5103, Silver Spring, MD 20993– Members will be invited to serve for
for industry entitled ‘‘Bioequivalence
0002, or by FAX: 301–847–8640. overlapping terms of up to 4 years. Non-
Recommendations for Specific
Information about becoming a member Federal members of this Committee
Products’’ that explained the process
on an FDA advisory committee can also serve as Special Government
that would be used to make product-
be obtained by visiting FDA’s Web site Employees, with the exception of the
specific BE recommendations available
at http://www.fda.gov/ representatives from Industry.
to the public on FDA’s Web site. The BE
AdvisoryCommittees/default.htm. III. Nomination Procedures recommendations identified in this
FOR FURTHER INFORMATION CONTACT: notice were developed using the process
Any interested person may nominate
Letise Williams, Center for Devices and one or more qualified individuals for described in that guidance.
Radiological Health, Food and Drug membership on the Committee. Self- DATES: Although you can comment on
Administration, 10903 New Hampshire nominations are also accepted. any guidance at any time (see 21 CFR
Ave. Bldg. 66, Rm. 5441, 301–796–8398, Nominations should include a cover 10.115(g)(5)), to ensure that the Agency
FAX: 301–847–8510, letter; a current, complete resume or considers your comment on this draft
Letise.Williams@fda.hhs.gov. curriculum vitae for each nominee, guidance before it begins work on the
SUPPLEMENTARY INFORMATION: FDA is including a current business and/or final version of the guidance, submit
requesting nominations for voting home address, telephone number, and either electronic or written comments
asabaliauskas on DSK3SPTVN1PROD with NOTICES
members for the Committee. FDA seeks email address if available; and should on the draft guidance by December 5,
to include the views of women and specify the advisory committee for 2016.
men, members of all racial and ethnic which the nominee is recommended. ADDRESSES: You may submit comments
groups, and individuals with and Nominations should also as follows:
without disabilities on its advisory acknowledge that the nominee is aware
committees and, therefore, encourages of the nomination, unless self- Electronic Submissions
nominations of appropriately qualified nominated. FDA will ask potential Submit electronic comments in the
candidates from these groups. candidates to provide detailed following way:
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![69066 Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices
TABLE 1—NEW DRAFT PRODUCT-SPE- of the applicable statutes and Antigen Receptors’’ [HHS Reference No.
CIFIC BE RECOMMENDATIONS FOR regulations. E–021–2015/0–PCT–02] (and U.S. and
DRUG PRODUCTS—Continued foreign patent applications claiming
IV. Electronic Access
priority to the aforementioned
Pyrazinamide Persons with access to the Internet applications).
Rolapitant hydrochloride may obtain the draft guidance at either
Triamcinolone acetonide (multiple reference The patent rights in these inventions
http://www.fda.gov/Drugs/Guidance
listed drugs) have been assigned to the government of
ComplianceRegulatoryInformation/
Umeclidinium bromide the United States of America.
Guidances/default.htm or http://
www.regulations.gov. The prospective Exclusive Patent
III. Drug Products for Which Revised License territory may be worldwide and
Draft Product-Specific BE Dated: September 30, 2016.
the field of use may be limited to the
Recommendations Are Available Leslie Kux,
development, manufacture and
Associate Commissioner for Policy. commercialization of retrovirally-
FDA is announcing the availability of [FR Doc. 2016–24050 Filed 10–4–16; 8:45 am] engineered anti-CD70 chimeric antigen
a revised draft guidance for industry on BILLING CODE 4164–01–P receptor (CAR)-based autologous
product-specific BE recommendations
peripheral blood T cell therapy
for drug products containing the
products, as set forth in the Licensed
following active ingredients: DEPARTMENT OF HEALTH AND Patent Rights, for the treatment of CD70
HUMAN SERVICES expressing cancers in humans.
TABLE 2—REVISED DRAFT PRODUCT-
SPECIFIC BE RECOMMENDATIONS National Institutes of Health The present invention describes
FOR DRUG PRODUCTS certain CARs targeting CD70. CARs are
Prospective Grant of Exclusive Patent hybrid proteins comprised of
Bacitracin
License: Development of Anti-CD70 extracellular antigen binding domains
Buprenorphine Chimeric Antigen Receptors for the and intracellular signaling domains
Clonidine Treatment of CD70 Expressing designed to activate the cytotoxic
Cyclosporine Cancers functions of CAR-transduced T cells
Dexlansoprazole upon antigen stimulation.
Diclofenac Epolamine AGENCY: National Institutes of Health,
Erythromycin HHS. CD70 is a co-stimulatory molecule
Estradiol (multiple reference listed drugs) ACTION: Notice. that provides proliferative and survival
Ethinyl Estradiol; Norelgestromin cues to competent cells upon binding to
Fentanyl SUMMARY: The National Cancer Institute, its cognate receptor, CD27. Its
Granisetron National Institutes of Health, expression is primarily restricted to
Icosapent ethyl Department of Health and Human activated lymphoid cells; however,
Lansoprazole Services, is contemplating the grant of recent research has demonstrated that
Lidocaine an Exclusive Patent License to Kite several cancers, including renal cell
Menthol; Methyl Salicylate
Pharma, Inc. (‘‘Kite’’) located in Santa carcinoma, glioblastoma, non-Hodgkin’s
Mesalamine
Methylphenidate Monica, CA to practice the inventions lymphoma, and chronic myelogenous
Morphine sulfate embodied in the patent applications leukemia also express CD70 under
Nicotine listed in the SUPPLEMENTARY certain circumstances. Due to its limited
Nitroglycerin (multiple reference listed drugs) INFORMATION section of this notice. expression in normal tissues, CARs
Omega-3-acid ethyl esters DATES: Only written comments and/or targeting CD70 may be useful in
Oxybutynin applications for a license which are adoptive cell therapy protocols for the
Oxycodone HCl treatment of select cancers.
received by the NCI Technology
Pantoprazole sodium
Rivastigmine Transfer Center on or before October 20, This notice is made in accordance
Rotigotine 2016 will be considered. with 35 U.S.C. 209 and 37 CFR part 404.
Scopolamine ADDRESSES: Requests for copies of the The prospective Exclusive Patent
Selegiline patent applications, inquiries, and License will be royalty bearing and may
Testosterone comments relating to the contemplated be granted unless within fifteen (15)
Exclusive Patent License should be days from the date of this published
For a complete history of previously directed to: Andrew Burke, Ph.D., notice, the National Cancer Institute
published Federal Register notices Licensing and Patenting Manager, NCI receives written evidence and argument
related to product-specific BE Technology Transfer Center, 9609 that establishes that the grant of the
recommendations, go to http:// Medical Center Drive, RM 1E530 MSC license would not be consistent with the
www.regulations.gov and enter Docket 9702, Bethesda, MD 20892–9702 (for requirements of 35 U.S.C. 209 and 37
No. FDA–2007–D–0369. business mail), Rockville, MD 20850– CFR part 404.
These draft guidances are being 9702 Telephone: (240) 276–5530; Complete applications for a license in
issued consistent with FDA’s good Facsimile: (240) 276–5504; Email: the prospective field of use that are
guidance practices regulation (21 CFR andy.burke@nih.gov timely filed in response to this notice
asabaliauskas on DSK3SPTVN1PROD with NOTICES
10.115). These draft guidances, when SUPPLEMENTARY INFORMATION: United will be treated as objections to the grant
finalized, will represent the current States Provisional Patent Application of the contemplated Exclusive Patent
thinking of FDA on the product-specific No. 62/088,882, filed December 8, 2014, License. Comments and objections
design of BE studies to support ANDAs. entitled ‘‘Anti-CD70 Chimeric Antigen submitted to this notice will not be
They do not establish any rights for any Receptors’’ [HHS Reference No. E–021– made available for public inspection
person and are not binding on FDA or 2015/0–US–01]; and PCT Application and, to the extent permitted by law, will
the public. You can use an alternative No. PCT/US2015/025047 filed April 9, not be released under the Freedom of
approach if it satisfies the requirements 2015 entitled ‘‘Anti-CD70 Chimeric Information Act, 5 U.S.C. 552.
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Document Created: 2016-10-05 03:29:39
Document Modified: 2016-10-05 03:29:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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 December 5, 2016. | |
| Contact | Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850. | |
| FR Citation | 81 FR 69064 |
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