81 FR 85229 - Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 227 (November 25, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 227 (November 25, 2016)
| Page Range | 85229-85231 | |
| FR Document | 2016-28334 |
[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)] [Notices] [Pages 85229-85231] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28334] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extended release capsules, entitled ``Draft Guidance on Cyclobenzaprine Hydrochloride.'' The recommendations provide specific guidance on the design [[Page 85230]] of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclobenzaprine hydrochloride extended release capsules. 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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 24, 2017. ADDRESSES: You may submit comments as follows: 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 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): 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 ``Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' will be publicly viewable at https://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 https://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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.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 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,'' which 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 to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of revised draft BE recommendations for generic cyclobenzaprine hydrochloride extended release capsules. FDA initially approved new drug application 021777 for AMRIX (cyclobenzaprine hydrochloride) extended release capsules in February 2007. In August 2008, FDA issued a draft guidance for industry on BE recommendations for generic cyclobenzaprine hydrochloride extended release capsules. We are now issuing a revised draft guidance for industry on BE recommendations for generic cyclobenzaprine hydrochloride extended release capsules (``Draft Guidance on Cyclobenzaprine Hydrochloride''). In June 2016, Teva Pharmaceuticals Industries, Ltd. and its wholly- owned subsidiaries, Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc., Teva Sales and Marketing, Inc., Teva Branded Pharmaceutical Products R&D, Inc., and Cephalon, Inc., submitted a citizen petition requesting that FDA take several actions with respect to ANDAs for cyclobenzaprine hydrochloride extended release oral capsules, including regarding the demonstration of BE for any ANDA referencing AMRIX. FDA has reviewed the issues raised in this citizen petition and is responding to the citizen petition separately in the docket for that citizen [[Page 85231]] petition (Docket No. FDA-2016-P-1873, available at https://www.regulations.gov/). This revised 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 current thinking of FDA on the design of BE studies to support ANDAs for cyclobenzaprine hydrochloride extended release capsules. 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. II. Electronic Access Persons with access to the Internet may obtain the revised draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov/. Dated: November 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28334 Filed 11-23-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 227 / Friday, November 25, 2016 / Notices 85229
for both types of establishments to unit, is an imperfect solution. For the The amendment process is specified in
benefit from this incentive. purpose of this revised draft guidance, the Technical Conformance Guide.
In order to implement a phased-in FDA has defined a product family for
approach, FDA intends to begin IV. Paperwork Reduction Act of 1995
finished drug products as any
collecting quality metrics data as part of combination of National Drug Code This revised draft guidance contains
a voluntary phase of the program. The (NDC) product code segments where the information collection provisions that
first phase of the quality metrics active pharmaceutical ingredient and are subject to review by the Office of
program outlined in the revised draft dose form is the same (i.e., a product Management and Budget (OMB) under
guidance would be fully voluntary. family could be multiple strengths or the Paperwork Reduction Act of 1995
After evaluating the results of the only a single strength). For APIs, the (44 U.S.C. 3501–3520). The collection of
voluntary phase of the quality metrics product family is defined by the NDC some of the information requested in the
program in 2018, FDA intends to initiate product code segment. Our intent is to revised draft guidance is covered under
notice and comment rulemaking under define product family in a way that was FDA regulations at 21 CFR parts 210
existing statutory authority to develop a likely consistent with how products are and 211 and approved under OMB
mandatory quality metrics reporting grouped for the Periodic Product control number 0910–0139. In
program. Review per 21 CFR 211.180(e) (e.g., accordance with the PRA, FDA intends
FDA carefully considered supporting Annual Product Review). We expect to solicit public comment and obtain
flexible data collection timeframes for that this approach will group similar OMB approval for any information
the purposes of reporting. In the context products with similar manufacturing collections recommended in this
of a program that required product- operations together. guidance that are new or that would
based reporting, such flexibility would There are also special considerations represent material modifications to
be feasible. However, in the context of with respect to product quality those previously approved collections of
the voluntary phase of the reporting complaints for OTC products. information found in FDA regulations or
program, FDA is proposing a common Manufacturers of OTC products guidances. Subject to OMB approval,
timeframe to facilitate publication of the typically receive much more frequent FDA anticipates that it will begin
quality metrics reporters list, and given communications from customers than collecting quality metrics data in
the need to identify duplicate data if manufacturers of prescription drug January 2018.
both the product reporting products, and the nature of these
establishment and site reporting V. Electronic Access
communications are quite different. The
establishment submit data. definition of a product quality Persons with access to the Internet
A Technical Specifications Document complaint is intended to cover any may obtain the draft guidance at either
entitled ‘‘Quality Metrics Technical possible or actual quality issue, while http://www.fda.gov/Drugs/Guidance
Conformance Guide, Version 1.0’’ was excluding preferential complaints. We ComplianceRegulatoryInformation/
published on June 27, 2016 (81 FR anticipate that our analytics will Guidances/default.htm, http://
41545). This guide provides technical account for this imbalance in reporting www.fda.gov/BiologicsBloodVaccines/
recommendations for the submission of type between prescription and OTC GuidanceComplianceRegulatory
quality metrics data. It is intended to drug products. Information/Guidances/default.htm, or
serve as the technical reference for https://www.regulations.gov/.
implementation of the quality metrics III. How To Report Quality Metrics
Data to FDA Dated: November 18, 2016.
program. FDA intends to publish
Leslie Kux,
Version 2.0 of the Technical FDA expects to encourage reporting
Associate Commissioner for Policy.
Conformance Guide soon after establishments to submit quality metrics
publication of the revised draft data reports where the data is [FR Doc. 2016–28332 Filed 11–23–16; 8:45 am]
guidance. We anticipate that the segmented on a quarterly basis BILLING CODE 4164–01–P
electronic submission platform will be throughout a single calendar year. At
available to test in 2017. present, FDA intends to open the
Reporting establishments will be able electronic portal in January 2018 to DEPARTMENT OF HEALTH AND
to submit 300 word text comments to receive voluntary submissions of data. HUMAN SERVICES
provide an explanation of submitted FDA expects to publish a Federal Food and Drug Administration
data or report plans for improvement. Register notice providing instructions
FDA may refer to the comments if on the submission of voluntary reports [Docket No. FDA–2007–D–0369]
unusual data or trends are identified or and specifying the dates that we intend
as preparation for an onsite inspection. to open the portal, published no fewer Bioequivalence Recommendations for
The submission of comments is than 30 days before the portal is opened Cyclobenzaprine Hydrochloride;
optional. In the future, FDA may (e.g., before December 1, 2017). FDA Revised Draft Guidance for Industry;
consider establishing a set of codes to expects to begin the data analysis once Availability
standardize the comments. the portal is closed and then publish AGENCY: Food and Drug Administration,
FDA also revised the draft guidance to initial findings and the quality metric HHS.
address the special complexities for reporters list on the FDA Web site. ACTION: Notice of availability.
grouping non-application drug To reduce discrepancies between site
products. Defining a ‘‘product’’ for the and product reporting, FDA is SUMMARY: The Food and Drug
asabaliauskas on DSK3SPTVN1PROD with NOTICES
purpose of grouping non-application proposing a defined, uniform reporting Administration (FDA, the Agency, or
drugs for the submission of quality period. we) is announcing the availability of a
metrics data proved challenging without In the rare instance that a reporting revised draft guidance for industry on
an application number. Using one establishment or covered establishment generic cyclobenzaprine hydrochloride
segment to group products, such as discovers an error in its submission, an extended release capsules, entitled
active pharmaceutical ingredient(s), amendment may be made with an ‘‘Draft Guidance on Cyclobenzaprine
manufacturing process, minor associated explanation via email to Hydrochloride.’’ The recommendations
formulation changes, or stock-keeping OPQ-OS-QualityMetrics@fda.hhs.gov. provide specific guidance on the design
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![Federal Register / Vol. 81, No. 227 / Friday, November 25, 2016 / Notices 85231
petition (Docket No. FDA–2016–P–1873, FDA by December 23, 2016. See sections Recommends classification of devices
available at https:// I and II of this document for further subject to its review into regulatory
www.regulations.gov/). details. Concurrently, nomination categories, (2) recommends the
This revised draft guidance is being materials for prospective candidates assignment of a priority for the
issued consistent with FDA’s good should be sent to FDA by December 23, application of regulatory requirements
guidance practices regulation (21 CFR 2016. for devices classified in the standards or
10.115). The draft guidance, when ADDRESSES: All statements of interest premarket approval category, (3) advises
finalized, will represent the current from industry organizations that wish to on formulation of product development
thinking of FDA on the design of BE participate in the selection process of protocols and reviews premarket
studies to support ANDAs for nonvoting industry representative approval applications for those devices
cyclobenzaprine hydrochloride nomination should be sent to Bryan to recommend changes in classification
extended release capsules. It does not Emery (see FOR FURTHER INFORMATION as appropriate, (4) recommends
establish any rights for any person and CONTACT). All nominations for exemption of certain devices from the
is not binding on FDA or the public. nonvoting industry representatives may application of portions of the FD&C Act,
You can use an alternative approach if be submitted electronically by accessing (5) advises on the necessity to ban a
it satisfies the requirements of the the FDA Advisory Committee device, and (6) responds to requests
applicable statutes and regulations. Membership Nomination Portal: https:// from the Agency to review and make
www.accessdata.fda.gov/scripts/ recommendations on specific issues or
II. Electronic Access
FACTRSPortal/FACTRS/index.cfm or by problems concerning the safety and
Persons with access to the Internet mail to Advisory Committee Oversight effectiveness of devices.
may obtain the revised draft guidance at and Management Staff, Food and Drug
either http://www.fda.gov/Drugs/ II. Selection Procedure
Administration, 10903 New Hampshire
GuidanceComplianceRegulatory Ave., Bldg. 32, Rm. 5103, Silver Spring, Any industry organization interested
Information/Guidances/default.htm or MD 20993–0002. Information about in participating in the selection of an
https://www.regulations.gov/. becoming a member of an FDA advisory appropriate nonvoting member to
Dated: November 18, 2016. committee can also be obtained by represent industry interests should send
Leslie Kux, visiting FDA’s Web site http:// a letter stating that interest to the FDA
Associate Commissioner for Policy.
www.fda.gov/AdvisoryCommittees/ contact (see FOR FURTHER INFORMATION
default.htm. CONTACT) within 30 days of publication
[FR Doc. 2016–28334 Filed 11–23–16; 8:45 am]
FOR FURTHER INFORMATION CONTACT: of this document (see DATES). Within the
BILLING CODE 4164–01–P
Bryan Emery, Division of Scientific subsequent 30 days, FDA will send a
Advisors and Consultants, CBER, 10903 letter to each organization that has
DEPARTMENT OF HEALTH AND New Hampshire Ave., Bldg. 71, Rm. expressed an interest, attaching a
HUMAN SERVICES 6128, Silver Spring, MD 20993–0002, complete list of all such organizations
240–402–8054, Fax: 301–595–1307, and a list of all nominees along with
Food and Drug Administration email: bryan.emery@fda.hhs.gov. their current resumes. The letter will
SUPPLEMENTARY INFORMATION: The also state that it is the responsibility of
[Docket No. FDA–2016–N–0001]
Agency intends to add a nonvoting the interested organizations to confer
Request for Nominations on the Blood industry representative(s) to the with one another and to select a
Products Advisory Committee following advisory committee: candidate, within 60 days after the
receipt of the FDA letter, to serve as the
AGENCY: Food and Drug Administration, I. CBER Blood Products Advisory nonvoting member to represent industry
HHS. Committee interests for the committee. The
ACTION: Notice. The Committee reviews and evaluates interested organizations are not bound
available data concerning the safety, by the list of nominees in selecting a
SUMMARY: The Food and Drug effectiveness, and appropriate use of candidate. However, if no individual is
Administration (FDA) is requesting that blood; products derived from blood and selected within 60 days, the
any industry organizations interested in serum or biotechnology intended for use Commissioner will select the nonvoting
participating in the selection of a in the diagnosis, prevention, or member to represent industry interests.
nonvoting industry representative to treatment of human diseases; and, as
serve on the Blood Products Advisory III. Application Procedure
required, any other product for which
Committee for the Center for Biologics FDA has regulatory responsibility. The Individuals may self-nominate and/or
Evaluation and Research (CBER) notify Committee then advises the an organization may nominate one or
FDA in writing. FDA is also requesting Commissioner of Food and Drugs of its more individuals to serve as a nonvoting
nominations for a nonvoting industry findings regarding screening, testing, industry representative. Contact
representative(s) to serve on the Blood and labeling of products on clinical and information, a current curriculum vitae,
Products Advisory Committee. A laboratory studies involving such and the name of the committee of
nominee may either be self-nominated products on the affirmation or interest should be sent to the FDA
or nominated by an organization to revocation of biological products Advisory Committee Membership
serve as a nonvoting industry licenses, as well as on the quality and Nomination Portal (see ADDRESSES)
asabaliauskas on DSK3SPTVN1PROD with NOTICES
representative. Nominations will be relevance of FDA’s research program within 30 days of publication of this
accepted for current vacancies effective that provides the scientific support for document (see DATES). FDA will forward
with this notice. regulating these agents. The Committee all nominations to the organizations
DATES: Any industry organization will function at times as a medical expressing interest in participating in
interested in participating in the device panel under the Federal Food, the selection process for the committee.
selection of an appropriate nonvoting Drug, and Cosmetic Act (the FD&C Act) (Persons who nominate themselves as
member to represent industry interests Medical Device Amendments of 1976. nonvoting industry representatives will
must send a letter stating that interest to As such, the Committee: (1) not participate in the selection process).
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Document Created: 2016-11-23 23:18:08
Document Modified: 2016-11-23 23:18:08
| 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 comments 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 January 24, 2017. | |
| 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 85229 |
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