82 FR 49033 - Product-Specific Guidance for Methylphenidate Hydrochloride; New Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 203 (October 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 203 (October 23, 2017)
| Page Range | 49033-49034 | |
| FR Document | 2017-22891 |
[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)] [Notices] [Pages 49033-49034] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22891] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidance for Methylphenidate Hydrochloride; New Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets entitled ``Draft Guidance on Methylphenidate Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride oral extended-release tablets. DATES: Submit either electronic or written comments on the draft guidance by December 22, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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): 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 [[Page 49034]] identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2007-D-0369 for ``Draft Guidance on Methylphenidate Hydrochloride.'' 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 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.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 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 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 (HFD-600), 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 guidances available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process to develop and disseminate product-specific guidances and to provide a meaningful opportunity for the public to consider and comment on the guidances. This notice announces the availability of a new draft guidance for generic methylphenidate hydrochloride oral extended-release tablets. FDA initially approved new drug application 018029 for RITALIN-SR (methylphenidate hydrochloride oral extended-release tablets) in March 1982. We are now issuing a new draft guidance for industry on methylphenidate hydrochloride oral extended-release tablets (``Draft Guidance on Methylphenidate Hydrochloride''). In May 2016, KVK-Tech, Inc. (KVK-Tech) submitted a citizen petition requesting, among other things, that FDA not accept for filing any new ANDAs or approve any already received ANDAs for methylphenidate hydrochloride oral extended-release tablets unless certain BE criteria are met. FDA will consider any comments on the draft guidance on BE recommendations for generic methylphenidate hydrochloride oral extended-release tablets before responding to KVK-Tech's citizen petition. (Docket No. FDA-2016-P-1247, available at https://www.regulations.gov). The new draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The new draft guidance, when finalized, will represent the current thinking of FDA on the design of BE studies to support ANDAs for methylphenidate hydrochloride oral extended-release tablets. 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: October 17, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22891 Filed 10-20-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49033
ANDA procedure. ANDA applicants based on the information we have at this we) is announcing the availability of a
must, with certain exceptions, show that time, FDA has determined under new draft guidance for industry on
the drug for which they are seeking § 314.161 that ELAVIL (amitriptyline generic methylphenidate hydrochloride
approval contains the same active hydrochloride) oral tablets, 10 mg, 25 oral extended-release tablets entitled
ingredient in the same strength and mg, 50 mg, 75 mg, 100 mg, and 150 mg, ‘‘Draft Guidance on Methylphenidate
dosage form as the ‘‘listed drug,’’ which were not withdrawn for reasons of Hydrochloride.’’ The new draft
is a version of the drug that was safety or effectiveness. The petitioner guidance, when finalized, will provide
previously approved. ANDA applicants has identified no data or other product-specific recommendations on,
do not have to repeat the extensive information suggesting that these among other things, the design of
clinical testing otherwise necessary to products were withdrawn for reasons of bioequivalence (BE) studies to support
gain approval of a new drug application safety or effectiveness. We have abbreviated new drug applications
(NDA). carefully reviewed our files for records (ANDAs) for methylphenidate
The 1984 amendments include what concerning the withdrawal of ELAVIL hydrochloride oral extended-release
is now section 505(j)(7) of the Federal (amitriptyline hydrochloride) oral tablets.
Food, Drug, and Cosmetic Act (21 U.S.C. tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100
355(j)(7)), which requires FDA to DATES: Submit either electronic or
mg, and 150 mg, from sale. We have also
publish a list of all approved drugs. written comments on the draft guidance
independently evaluated relevant
FDA publishes this list as part of the by December 22, 2017 to ensure that the
literature and data for possible
‘‘Approved Drug Products With postmarketing adverse events. We have Agency considers your comment on this
Therapeutic Equivalence Evaluations,’’ found no information that would draft guidance before it begins work on
which is known generally as the indicate that this drug product was the final version of the guidance.
‘‘Orange Book.’’ Under FDA regulations, withdrawn from sale for reasons of ADDRESSES: You may submit comments
drugs are removed from the list if the safety or effectiveness. on any guidance at any time as follows:
Agency withdraws or suspends Accordingly, the Agency will Electronic Submissions
approval of the drug’s NDA or ANDA continue to list ELAVIL (amitriptyline
for reasons of safety or effectiveness or hydrochloride) oral tablets, 10 mg, 25 Submit electronic comments in the
if FDA determines that the listed drug mg, 50 mg, 75 mg, 100 mg, and 150 mg, following way:
was withdrawn from sale for reasons of in the ‘‘Discontinued Drug Product List’’ • Federal eRulemaking Portal:
safety or effectiveness (21 CFR 314.162). section of the Orange Book. The https://www.regulations.gov. Follow the
A person may petition the Agency to ‘‘Discontinued Drug Product List’’ instructions for submitting comments.
determine, or the Agency may delineates, among other items, drug Comments submitted electronically,
determine on its own initiative, whether products that have been discontinued including attachments, to https://
a listed drug was withdrawn from sale from marketing for reasons other than www.regulations.gov will be posted to
for reasons of safety or effectiveness. safety or effectiveness. ANDAs that refer the docket unchanged. Because your
This determination may be made at any to ELAVIL (amitriptyline hydrochloride) comment will be made public, you are
time after the drug has been withdrawn oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, solely responsible for ensuring that your
from sale, but must be made prior to 100 mg, and 150 mg, may be approved comment does not include any
approving an ANDA that refers to the by the Agency as long as they meet all confidential information that you or a
listed drug (§ 314.161 (21 CFR 314.161)). other legal and regulatory requirements third party may not wish to be posted,
FDA may not approve an ANDA that for the approval of ANDAs. If FDA such as medical information, your or
does not refer to a listed drug. determines that labeling for this drug anyone else’s Social Security number, or
ELAVIL (amitriptyline hydrochloride) product should be revised to meet confidential business information, such
oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, current standards, the Agency will as a manufacturing process. Please note
100 mg, and 150 mg, are the subject of advise ANDA applicants to submit such that if you include your name, contact
NDA 012703, held by AstraZeneca, and labeling. information, or other information that
initially approved on April 7, 1961. Dated: October 17, 2017.
identifies you in the body of your
ELAVIL is indicated for the relief of comments, that information will be
Leslie Kux,
symptoms of depression. ELAVIL posted on https://www.regulations.gov.
Associate Commissioner for Policy.
(amitriptyline hydrochloride) oral • If you want to submit a comment
tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 [FR Doc. 2017–22892 Filed 10–20–17; 8:45 am] with confidential information that you
mg, and 150 mg, are currently listed in BILLING CODE 4164–01–P do not wish to be made available to the
the ‘‘Discontinued Drug Product List’’ public, submit the comment as a
section of the Orange Book. In the written/paper submission and in the
Federal Register of June 16, 2006 (71 FR DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
34940), FDA announced that it was HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
withdrawing approval of NDA 012703, Food and Drug Administration Written/Paper Submissions
effective June 16, 2006.
Alembic Pharmaceuticals Limited [Docket No. FDA–2007–D–0369] Submit written/paper submissions as
submitted a citizen petition dated June follows:
5, 2017 (Docket No. FDA–2017–P– Product-Specific Guidance for • Mail/Hand delivery/Courier (for
3581), under 21 CFR 10.30, requesting Methylphenidate Hydrochloride; New written/paper submissions): Dockets
that the Agency determine whether Draft Guidance for Industry; Management Staff (HFA–305), Food and
ethrower on DSK3G9T082PROD with NOTICES
ELAVIL (amitriptyline hydrochloride) Availability Drug Administration, 5630 Fishers
oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
100 mg, and 150 mg, were withdrawn HHS. • For written/paper comments
from sale for reasons of safety or ACTION: Notice of availability. submitted to the Dockets Management
effectiveness. Staff, FDA will post your comment, as
After considering the citizen petition SUMMARY: The Food and Drug well as any attachments, except for
and reviewing Agency records and Administration (FDA, the Agency, or information submitted, marked and
VerDate Sep<11>2014 20:08 Oct 20, 2017 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\23OCN1.SGM 23OCN1](https://thefederalregister.org/doc/82_FR_49236/page/1.svg)
![49034 Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices
identified, as confidential, if submitted Hampshire Ave., Hillandale Building, guidance practices regulation (21 CFR
as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– 10.115). The new draft guidance, when
Instructions: All submissions received 0002. Send one self-addressed adhesive finalized, will represent the current
must include the Docket No. FDA– label to assist that office in processing thinking of FDA on the design of BE
2007–D–0369 for ‘‘Draft Guidance on your requests. See the SUPPLEMENTARY studies to support ANDAs for
Methylphenidate Hydrochloride.’’ INFORMATION section for electronic methylphenidate hydrochloride oral
Received comments will be placed in access to the draft guidance document. extended-release tablets. It does not
the docket and, except for those FOR FURTHER INFORMATION CONTACT: establish any rights for any person and
submitted as ‘‘Confidential Xiaoqiu Tang, Center for Drug is not binding on FDA or the public.
Submissions,’’ publicly viewable at Evaluation and Research (HFD–600), You can use an alternative approach if
https://www.regulations.gov or at the Food and Drug Administration, 10903 it satisfies the requirements of the
Dockets Management Staff between 9 New Hampshire Ave., Bldg. 75, Rm. applicable statutes and regulations. This
a.m. and 4 p.m., Monday through 4730, Silver Spring, MD 20993–0002, guidance is not subject to Executive
Friday. 301–796–5850. Order 12866.
• Confidential Submissions—To SUPPLEMENTARY INFORMATION:
submit a comment with confidential II. Electronic Access
information that you do not wish to be I. Background
Persons with access to the internet
made publicly available, submit your In the Federal Register of June 11, may obtain the draft guidance at either
comments only as a written/paper 2010 (75 FR 33311), FDA announced the https://www.fda.gov/Drugs/
submission. You should submit two availability of a guidance for industry GuidanceCompliance
copies total. One copy will include the entitled ‘‘Bioequivalence RegulatoryInformation/Guidances/
information you claim to be confidential Recommendations for Specific default.htm or https://
with a heading or cover note that states Products,’’ which explained the process www.regulations.gov.
‘‘THIS DOCUMENT CONTAINS that would be used to make product-
CONFIDENTIAL INFORMATION.’’ The Dated: October 17, 2017.
specific guidances available to the
Agency will review this copy, including public on FDA’s Web site at https:// Anna K. Abram,
the claimed confidential information, in www.fda.gov/Drugs/ Deputy Commissioner for Policy, Planning,
its consideration of comments. The GuidanceCompliance Legislation, and Analysis.
second copy, which will have the RegulatoryInformation/Guidances/ [FR Doc. 2017–22891 Filed 10–20–17; 8:45 am]
claimed confidential information default.htm. BILLING CODE 4164–01–P
redacted/blacked out, will be available As described in that guidance, FDA
for public viewing and posted on adopted this process to develop and
https://www.regulations.gov. Submit disseminate product-specific guidances DEPARTMENT OF HEALTH AND
both copies to the Dockets Management and to provide a meaningful HUMAN SERVICES
Staff. If you do not wish your name and opportunity for the public to consider
contact information to be made publicly and comment on the guidances. This Performance Review Board Members
available, you can provide this notice announces the availability of a
information on the cover sheet and not Title 5, U.S.C. Section 4314(c)(4) of
new draft guidance for generic the Civil Service Reform Act of 1978,
in the body of your comments and you methylphenidate hydrochloride oral
must identify this information as Public Law 95–454, requires that the
extended-release tablets. appointment of Performance Review
‘‘confidential.’’ Any information marked FDA initially approved new drug
as ‘‘confidential’’ will not be disclosed Board Members be published in the
application 018029 for RITALIN–SR
except in accordance with 21 CFR 10.20 Federal Register. The following persons
(methylphenidate hydrochloride oral
and other applicable disclosure law. For may be named to serve on the
extended-release tablets) in March 1982.
more information about FDA’s posting Performance Review Boards or Panels,
We are now issuing a new draft
of comments to public dockets, see 80 which oversee the evaluation of
guidance for industry on
FR 56469, September 18, 2015, or access methylphenidate hydrochloride oral performance appraisals of Senior
the information at: https://www.gpo.gov/ extended-release tablets (‘‘Draft Executive Service members of the
fdsys/pkg/FR-2015-09-18/pdf/2015- Guidance on Methylphenidate Department of Health and Human
23389.pdf. Hydrochloride’’). Services.
Docket: For access to the docket to In May 2016, KVK-Tech, Inc. (KVK- Employee Name
read background documents or the Tech) submitted a citizen petition
electronic and written/paper comments requesting, among other things, that Barry, Daniel
received, go to https:// FDA not accept for filing any new Barlow, Amanda
www.regulations.gov and insert the ANDAs or approve any already received Coughlin, Janis
docket number, found in brackets in the ANDAs for methylphenidate Fantinato, Jessica
heading of this document, into the hydrochloride oral extended-release Gentile, John
‘‘Search’’ box and follow the prompts tablets unless certain BE criteria are
met. FDA will consider any comments Johnson, Jeffrey
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, on the draft guidance on BE Katz, Ruth
Rockville, MD 20852. recommendations for generic Kretschmaier, Michon
You may submit comments on any methylphenidate hydrochloride oral Lewis, Lisa
ethrower on DSK3G9T082PROD with NOTICES
guidance at any time (see 21 CFR extended-release tablets before McDaniel, Eileen
10.115(g)(5)). responding to KVK-Tech’s citizen Novy, Steve
Submit written requests for single petition. (Docket No. FDA–2016–P–
copies of the draft guidance to the Sample, Allen
1247, available at https://
Division of Drug Information, Center for www.regulations.gov). Skeadas, Christos
Drug Evaluation and Research, Food The new draft guidance is being Tobias, Constance
and Drug Administration, 10001 New issued consistent with FDA’s good Weber, Mark
VerDate Sep<11>2014 20:08 Oct 20, 2017 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\23OCN1.SGM 23OCN1](https://thefederalregister.org/doc/82_FR_49236/page/2.svg)
Document Created: 2017-10-21 02:35:55
Document Modified: 2017-10-21 02:35:55
| 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 the draft guidance by December 22, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850. | |
| FR Citation | 82 FR 49033 |
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