81 FR 6867 - Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 26 (February 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 26 (February 9, 2016)
| Page Range | 6867-6868 | |
| FR Document | 2016-02516 |
[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)] [Notices] [Pages 6867-6868] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02516] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.'' This guidance document discusses information to be included in premarket notifications for zonisamide or lamotrigine assays. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: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: [[Page 6868]] 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-2010-D-0395 for ``Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Guidance for Industry and Food and Drug Administration Staff; Availability.'' 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. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ``Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Courtney Lias, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 4626, Silver Spring, MD 20993-0002, 301-796-5458. SUPPLEMENTARY INFORMATION: I. Background FDA is issuing this guidance document to describe its current thinking concerning issues that should be addressed in premarket notifications for assays intended to quantitate the anti-seizure drugs lamotrigine and zonisamide in serum. Some of the general concepts in this guidance may also be helpful in preparing 510(k) submissions for other therapeutic drug assays previously cleared by FDA, and classified within 21 CFR 862, subpart D. The draft guidance was available for comment on August 6, 2010. The comment period closed on November 4, 2010. No comments relating to the specific recommendation in the guidance were received. Minor revisions to the guidance have been made for clarifications and updates. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on Premarket Notifications for Lamotrigine and Zonisamide Assays. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays,'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1654 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This 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 addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB Control No. 0910-0120). The labeling provisions addressed in the guidance have been approved by OMB Control No. 0910-0485. V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov. Dated: February 4, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-02516 Filed 2-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 6867
DEPARTMENT OF HEALTH AND senior level regulatory project manager, DEPARTMENT OF HEALTH AND
HUMAN SERVICES can observe operations of HUMAN SERVICES
pharmaceutical manufacturing and/or
Food and Drug Administration packaging facilities, pathology/ Food and Drug Administration
[Docket No. FDA–2014–N–0179] toxicology laboratories, and regulatory
[Docket No. FDA–2010–D–0395]
affairs operations. Neither this tour nor
Training Program for Regulatory any part of the program is intended as Recommendations for Premarket
Project Managers; Information a mechanism to inspect, assess, judge, Notifications for Lamotrigine and
Available to Industry or perform a regulatory function, but is Zonisamide Assays; Guidance for
meant rather to improve mutual Industry and Food and Drug
AGENCY: Food and Drug Administration,
understanding and to provide an avenue Administration Staff; Availability
HHS.
for open dialogue. During the Site Tours
ACTION: Notice. Program, regulatory project managers AGENCY: Food and Drug Administration,
HHS.
SUMMARY: The Food and Drug will also participate in daily workshops
with their industry counterparts, ACTION: Notice of availability.
Administration’s (FDA’s) Center for
Drug Evaluation and Research (CDER) is focusing on selective regulatory issues SUMMARY: The Food and Drug
announcing the continuation of the important to both CDER staff and Administration (FDA) is announcing the
Regulatory Project Management Site industry. The primary objective of the availability of the guidance entitled
Tours and Regulatory Interaction daily workshops is to learn about the ‘‘Recommendations for Premarket
Program (the Site Tours Program). The team approach to drug development, Notifications for Lamotrigine and
purpose of this document is to invite including drug discovery, preclinical Zonisamide Assays.’’ This guidance
pharmaceutical companies interested in evaluation, tracking mechanisms, and document discusses information to be
participating in this program to contact regulatory submission operations. The included in premarket notifications for
CDER. overall benefit to regulatory project zonisamide or lamotrigine assays.
DATES: Pharmaceutical companies may managers will be exposure to project DATES: Submit either electronic or
submit proposed agendas to the Agency management, team techniques, and written comments on this guidance at
by April 11, 2016. processes employed by the any time. General comments on Agency
FOR FURTHER INFORMATION CONTACT: Dan pharmaceutical industry. By guidance documents are welcome at any
Brum, Center for Drug Evaluation and participating in this program, the time.
Research, Food and Drug regulatory project manager will grow ADDRESSES: You may submit comments
Administration, 10903 New Hampshire professionally by gaining a better as follows:
Ave., Bldg. 22, Rm. 5480, Silver Spring, understanding of industry processes and
MD 20993–0002, 301–796–0578, procedures. Electronic Submissions
dan.brum@fda.hhs.gov. Submit electronic comments in the
III. Site Selection following way:
SUPPLEMENTARY INFORMATION:
All travel expenses associated with • Federal eRulemaking Portal: http://
I. Background www.regulations.gov. Follow the
the Site Tours Program will be the
An important part of CDER’s responsibility of CDER; therefore, instructions for submitting comments.
commitment to make safe and effective selection will be based on the Comments submitted electronically,
drugs available to all Americans is including attachments, to http://
availability of funds and resources for
optimizing the efficiency and quality of www.regulations.gov will be posted to
each fiscal year. Selection will also be
the drug review process. To support this the docket unchanged. Because your
based on firms having a favorable
primary goal, CDER has initiated comment will be made public, you are
various training and development facility status as determined by FDA’s solely responsible for ensuring that your
programs to promote high performance Office of Regulatory Affairs District comment does not include any
in its regulatory project management Offices in the firms’ respective regions. confidential information that you or a
staff. CDER seeks to significantly Firms interested in offering a site tour third party may not wish to be posted,
enhance review efficiency and review or learning more about this training such as medical information, your or
quality by providing the staff with a opportunity should respond by anyone else’s Social Security number, or
better understanding of the submitting a proposed agenda to Dan confidential business information, such
pharmaceutical industry and its Brum directly (see DATES and FOR as a manufacturing process. Please note
operations. To this end, CDER is FURTHER INFORMATION CONTACT). that if you include your name, contact
continuing its training program to give Dated: February 3, 2016. information, or other information that
regulatory project managers the Leslie Kux,
identifies you in the body of your
opportunity to tour pharmaceutical comments, that information will be
facilities. The goals are to provide Associate Commissioner for Policy. posted on http://www.regulations.gov.
firsthand exposure to industry’s drug [FR Doc. 2016–02515 Filed 2–8–16; 8:45 am] • If you want to submit a comment
development processes, and a venue for BILLING CODE 4164–01–P with confidential information that you
sharing information about project do not wish to be made available to the
mstockstill on DSK4VPTVN1PROD with NOTICES
management procedures (but not drug- public, submit the comment as a
specific information) with industry written/paper submission and in the
representatives. manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
II. The Site Tours Program
In this program, over a 2- to 3-day Written/Paper Submissions
period, small groups (five or less) of Submit written/paper submissions as
regulatory project managers, including a follows:
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![6868 Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the requirements of the applicable statute
written/paper submissions): Division of docket number, found in brackets in the and regulations.
Dockets Management (HFA–305), Food heading of this document, into the
and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts III. Electronic Access
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets Persons interested in obtaining a copy
• For written/paper comments Management, 5630 Fishers Lane, Rm. of the guidance may do so by
submitted to the Division of Dockets 1061, Rockville, MD 20852. downloading an electronic copy from
Management, FDA will post your An electronic copy of the guidance
comment, as well as any attachments, the Internet. A search capability for all
document is available for download Center for Devices and Radiological
except for information submitted, from the Internet. See the
marked and identified, as confidential, Health guidance documents is available
SUPPLEMENTARY INFORMATION section for
if submitted as detailed in at http://www.fda.gov/MedicalDevices/
information on electronic access to the
‘‘Instructions.’’ DeviceRegulationandGuidance/
guidance. Submit written requests for a
Instructions: All submissions received single hard copy of the guidance GuidanceDocuments/default.htm.
must include the Docket No. FDA– document entitled ‘‘Recommendations Guidance documents are also available
2010–D–0395 for ‘‘Recommendations for Premarket Notifications for at http://www.regulations.gov. Persons
for Premarket Notifications for Lamotrigine and Zonisamide Assays’’ to unable to download an electronic copy
Lamotrigine and Zonisamide Assays; the Office of the Center Director, of ‘‘Recommendations for Premarket
Guidance for Industry and Food and Guidance and Policy Development, Notifications for Lamotrigine and
Drug Administration Staff; Center for Devices and Radiological Zonisamide Assays,’’ may send an email
Availability.’’ Received comments will Health, Food and Drug Administration, request to CDRH-Guidance@fda.hhs.gov
be placed in the docket and, except for 10903 New Hampshire Ave., Bldg. 66, to receive an electronic copy of the
those submitted as ‘‘Confidential Rm. 5431, Silver Spring, MD 20993– document. Please use the document
Submissions,’’ publicly viewable at 0002. Send one self-addressed adhesive number 1654 to identify the guidance
http://www.regulations.gov or at the label to assist that office in processing you are requesting.
Division of Dockets Management your request.
between 9 a.m. and 4 p.m., Monday IV. Paperwork Reduction Act of 1995
FOR FURTHER INFORMATION CONTACT:
through Friday.
• Confidential Submissions—To Courtney Lias, Center for Devices and This guidance refers to previously
submit a comment with confidential Radiological Health, Food and Drug approved collections of information
information that you do not wish to be Administration, 10903 New Hampshire found in FDA regulations. These
made publicly available, submit your Ave. Bldg. 66, Rm. 4626, Silver Spring, collections of information are subject to
comments only as a written/paper MD 20993–0002, 301–796–5458. review by the Office of Management and
submission. You should submit two SUPPLEMENTARY INFORMATION: Budget (OMB) under the Paperwork
copies total. One copy will include the Reduction Act of 1995 (44 U.S.C. 3501–
I. Background
information you claim to be confidential 3520). The collections of information
with a heading or cover note that states FDA is issuing this guidance addressed in the guidance document
‘‘THIS DOCUMENT CONTAINS document to describe its current have been approved by OMB in
CONFIDENTIAL INFORMATION.’’ The thinking concerning issues that should accordance with the PRA under the
Agency will review this copy, including be addressed in premarket notifications regulations governing premarket
the claimed confidential information, in for assays intended to quantitate the notification submissions (21 CFR part
its consideration of comments. The anti-seizure drugs lamotrigine and 807, subpart E, OMB Control No. 0910–
second copy, which will have the zonisamide in serum. Some of the 0120). The labeling provisions
claimed confidential information general concepts in this guidance may addressed in the guidance have been
redacted/blacked out, will be available also be helpful in preparing 510(k) approved by OMB Control No. 0910–
for public viewing and posted on submissions for other therapeutic drug 0485.
http://www.regulations.gov. Submit assays previously cleared by FDA, and
both copies to the Division of Dockets classified within 21 CFR 862, subpart D. V. Comments
Management. If you do not wish your The draft guidance was available for
name and contact information to be comment on August 6, 2010. The Interested persons may submit either
made publicly available, you can comment period closed on November 4, electronic comments regarding this
provide this information on the cover 2010. No comments relating to the document to http://www.regulations.gov
sheet and not in the body of your specific recommendation in the or written comments to the Division of
comments and you must identify this guidance were received. Minor revisions Dockets Management (see ADDRESSES). It
information as ‘‘confidential.’’ Any to the guidance have been made for is only necessary to send one set of
information marked as ‘‘confidential’’ clarifications and updates. comments. Identify comments with the
will not be disclosed except in docket number found in brackets in the
II. Significance of Guidance heading of this document. Received
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more This guidance is being issued comments may be seen in the Division
information about FDA’s posting of consistent with FDA’s good guidance of Dockets Management between 9 a.m.
comments to public dockets, see 80 FR practices regulation (21 CFR 10.115). and 4 p.m., Monday through Friday, and
mstockstill on DSK4VPTVN1PROD with NOTICES
56469, September 18, 2015, or access The guidance represents the Agency’s will be posted to the docket at http://
the information at: http://www.fda.gov/ current thinking on Premarket www.regulations.gov.
regulatoryinformation/dockets/ Notifications for Lamotrigine and Dated: February 4, 2016.
default.htm. Zonisamide Assays. It does not create or
Leslie Kux,
Docket: For access to the docket to confer any rights for or on any person
read background documents or the and does not operate to bind FDA or the Associate Commissioner for Policy.
electronic and written/paper comments public. An alternative approach may be [FR Doc. 2016–02516 Filed 2–8–16; 8:45 am]
received, go to http:// used if such approach satisfies the BILLING CODE 4164–01–P
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Document Created: 2018-02-02 14:30:27
Document Modified: 2018-02-02 14:30:27
| 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 | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Courtney Lias, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 4626, Silver Spring, MD 20993-0002, 301-796-5458. | |
| FR Citation | 81 FR 6867 |
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