83 FR 26481 - Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 110 (June 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 110 (June 7, 2018)
| Page Range | 26481-26482 | |
| FR Document | 2018-12220 |
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)] [Notices] [Pages 26481-26482] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12220] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0478] Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 23, 2018. The notice announced the voluntary withdrawal of approval of 24 abbreviated new drug applications (ANDAs) from multiple applicants, effective March 26, 2018. The notice indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, NJ 08540: ANDA 077483, Benazepril Hydrochloride and Hydrochlorothiazide Tablets, 5 milligrams (mg)/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. Before withdrawal of this ANDA became effective, however, Sun [[Page 26482]] Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 077483 is still in effect. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, February 23, 2018 (83 FR 8089), appearing on page 8089 in FR Doc. 2018-03700, the following correction is made: 1. On page 8090, the entry for ANDA 077483 in the table is removed. Dated: June 1, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12220 Filed 6-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26481
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
25.40(a) and (c) ................................................................... 5,832 1 5,832 80 466,560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The Estimated Annual Reporting Administration, 10903 New Hampshire CommitteesMeetingMaterials/Drugs/
Burden for Human Foods is no longer a Ave., Bldg. 31, Rm. 2417, Silver Spring, Pulmonary-AllergyDrugsAdvisory
part of this information collection. The MD 20993–0002; 301–796–9001, email: Committee/ucm107567.htm or by
burden has now been incorporated into PADAC@fda.hhs.gov. contacting the Designated Federal
OMB control number 0910–0541. SUPPLEMENTARY INFORMATION: Pursuant Officer (see FOR FURTHER INFORMATION
Our estimated burden for the to 41 CFR 102–3.65 and approval by the CONTACT). In light of the fact that no
information collection reflects an Department of Health and Human change has been made to the committee
overall increase of 453,834 hours Services pursuant to 45 CFR part 11 and name or description of duties, no
(currently approved 231,224) and a by the General Services Administration, amendment will be made to 21 CFR
corresponding increase of 7,108 annual FDA is announcing the renewal of the 14.100.
responses (currently approved 15,527). Pulmonary-Allergy Drugs Advisory This document is issued under the
The new estimated totals are 685,058 Committee (the Committee). The Federal Advisory Committee Act (5
hours and 22,635 annual responses. We Committee is a discretionary Federal U.S.C. app.). For general information
attribute this adjustment to an increase advisory committee established to related to FDA advisory committees,
in the number of EA submissions we provide advice to the Commissioner. please check https://www.fda.gov/
received since the last extension. The Committee advises the AdvisoryCommittees/default.htm.
Dated: June 1, 2018.
Commissioner or designee in Dated: June 1, 2018.
discharging responsibilities as they Leslie Kux,
Leslie Kux,
relate to helping to ensure safe and
Associate Commissioner for Policy. Associate Commissioner for Policy.
effective drugs for human use and, as
[FR Doc. 2018–12221 Filed 6–6–18; 8:45 am] [FR Doc. 2018–12219 Filed 6–6–18; 8:45 am]
required, any other product for which
BILLING CODE 4164–01–P
BILLING CODE 4164–01–P FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
effectiveness of marketed and
HUMAN SERVICES HUMAN SERVICES
investigational human drug products for
use in the treatment of pulmonary Food and Drug Administration
Food and Drug Administration
disease and diseases with allergic and/
[Docket No. FDA–2018–N–1860] or immunologic mechanisms and makes [Docket No. FDA–2018–N–0478]
appropriate recommendations to the
Advisory Committee; Pulmonary- Commissioner of Food and Drugs. Sebela Ireland, Ltd. et al.; Withdrawal
Allergy Drugs Advisory Committee, The Committee shall consist of a core of Approval of 24 Abbreviated New
Renewal of 11 voting members including the Drug Applications; Correction
Chair. Members and the Chair are AGENCY: Food and Drug Administration,
AGENCY: Food and Drug Administration, selected by the Commissioner or
HHS. HHS.
designee from among authorities ACTION: Notice; correction.
ACTION:Notice; renewal of advisory knowledgeable in the fields of
committee. pulmonary medicine, allergy, clinical SUMMARY: The Food and Drug
immunology, and epidemiology or Administration (FDA) is correcting a
SUMMARY: The Food and Drug notice that appeared in the Federal
statistics. Members will be invited to
Administration (FDA) is announcing the Register on February 23, 2018. The
serve for overlapping terms of up to 4
renewal of the Pulmonary-Allergy Drugs notice announced the voluntary
years. Almost all non-Federal members
Advisory Committee by the withdrawal of approval of 24
of this committee serve as Special
Commissioner of Food and Drugs (the abbreviated new drug applications
Government Employees. The core of
Commissioner). The Commissioner has (ANDAs) from multiple applicants,
voting members may include one
determined that it is in the public effective March 26, 2018. The notice
technically qualified member, selected
interest to renew the Pulmonary-Allergy indicated that FDA was withdrawing
by the Commissioner or designee, who
Drugs Advisory Committee for an approval of the following ANDA after
is identified with consumer interests
additional 2 years beyond the charter receiving a withdrawal request from
and is recommended by either a
expiration date. The new charter will be Sun Pharmaceutical Industries, Ltd., c/
consortium of consumer-oriented
in effect until May 30, 2020. o Sun Pharmaceutical Industries, Inc.
organizations or other interested
DATES: Authority for the Pulmonary- (Sun Pharmaceutical), 2 Independence
sradovich on DSK3GMQ082PROD with NOTICES
persons. In addition to the voting
Allergy Drugs Advisory Committee will members, the Committee may include Way, Princeton, NJ 08540: ANDA
expire on May 30, 2020, unless the one non-voting member who is 077483, Benazepril Hydrochloride and
Commissioner formally determines that identified with industry interests. Hydrochlorothiazide Tablets, 5
renewal is in the public interest. Further information regarding the milligrams (mg)/6.25 mg, 10 mg/12.5
FOR FURTHER INFORMATION CONTACT: most recent charter and other mg, 20 mg/12.5 mg, and 20 mg/25 mg.
Cindy Chee, Center for Drug Evaluation information can be found at https:// Before withdrawal of this ANDA
and Research, Food and Drug www.fda.gov/AdvisoryCommittees/ became effective, however, Sun
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![26482 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
Pharmaceutical informed FDA that it investigational new drug (IND) Instructions: All submissions received
did not want approval of the ANDA applications and biologics license must include the Docket No. FDA–
withdrawn. Because Sun applications (BLAs). This draft 2018–D–1774 for ‘‘Requests for
Pharmaceutical timely requested that guidance, when finalized, is intended to Feedback and Meetings for Medical
approval of this ANDA not be supersede the document entitled Device Submissions: The Q-Submission
withdrawn, the approval of ANDA ‘‘Requests for Feedback on Medical Program; Draft Guidance for Industry
077483 is still in effect. Device Submissions: The Pre- and Food and Drug Administration
FOR FURTHER INFORMATION CONTACT: Submission Program and Meetings with Staff.’’ Received comments will be
Trang Tran, Center for Drug Evaluation Food and Drug Administration Staff’’ placed in the docket and, except for
and Research, Food and Drug issued on September 29, 2017. This those submitted as ‘‘Confidential
Administration, 10903 New Hampshire draft guidance is not final nor is it in Submissions,’’ publicly viewable at
Ave., Bldg. 75, Rm. 1671, Silver Spring, effect at this time. https://www.regulations.gov or at the
MD 20993–0002, 240–402–7945. DATES: Submit either electronic or Dockets Management Staff between 9
SUPPLEMENTARY INFORMATION: In the written comments on the draft guidance a.m. and 4 p.m., Monday through
Federal Register of Friday, February 23, by August 6, 2018 to ensure that the Friday.
Agency considers your comment on this • Confidential Submissions—To
2018 (83 FR 8089), appearing on page
draft guidance before it begins work on submit a comment with confidential
8089 in FR Doc. 2018–03700, the
the final version of the guidance. information that you do not wish to be
following correction is made: made publicly available, submit your
1. On page 8090, the entry for ANDA ADDRESSES: You may submit comments comments only as a written/paper
077483 in the table is removed. on any guidance at any time as follows: submission. You should submit two
Dated: June 1, 2018. Electronic Submissions copies total. One copy will include the
Leslie Kux, information you claim to be confidential
Associate Commissioner for Policy.
Submit electronic comments in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2018–12220 Filed 6–6–18; 8:45 am]
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4164–01–P
https://www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
DEPARTMENT OF HEALTH AND
including attachments, to https:// second copy, which will have the
HUMAN SERVICES
www.regulations.gov will be posted to claimed confidential information
Food and Drug Administration the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
[Docket No. FDA–2018–D–1774] solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
Requests for Feedback and Meetings
confidential information that you or a Staff. If you do not wish your name and
for Medical Device Submissions: The
third party may not wish to be posted, contact information to be made publicly
Q-Submission Program; Draft
such as medical information, your or available, you can provide this
Guidance for Industry and Food and
anyone else’s Social Security number, or information on the cover sheet and not
Drug Administration Staff; Availability
confidential business information, such in the body of your comments and you
AGENCY: Food and Drug Administration, as a manufacturing process. Please note must identify this information as
HHS. that if you include your name, contact ‘‘confidential.’’ Any information marked
ACTION: Notice of availability. information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
SUMMARY: The Food and Drug comments, that information will be and other applicable disclosure law. For
Administration (FDA or Agency) is posted on https://www.regulations.gov. more information about FDA’s posting
announcing the availability of a draft • If you want to submit a comment of comments to public dockets, see 80
document entitled ‘‘Requests for with confidential information that you FR 56469, September 18, 2015, or access
Feedback and Meetings for Medical do not wish to be made available to the the information at: https://www.gpo.gov/
Device Submissions: The Q-Submission public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
Program; Draft Guidance for Industry written/paper submission and in the 23389.pdf.
and Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Staff.’’ This draft guidance document Submissions’’ and ‘‘Instructions’’). read background documents or the
provides an overview of the electronic and written/paper comments
mechanisms available to applicants Written/Paper Submissions
received, go to https://
through which they can request Submit written/paper submissions as www.regulations.gov and insert the
feedback from or a meeting with FDA follows: docket number, found in brackets in the
regarding potential or planned medical • Mail/Hand delivery/Courier (for heading of this document, into the
device investigational device exemption written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
(IDE) applications, premarket approval Management Staff (HFA–305), Food and and/or go to the Dockets Management
(PMA) applications, humanitarian Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
device exemption (HDE) applications, Lane, Rm. 1061, Rockville, MD 20852.
sradovich on DSK3GMQ082PROD with NOTICES
Rockville, MD 20852.
evaluation of automatic class III • For written/paper comments You may submit comments on any
designations (de novo requests), submitted to the Dockets Management guidance at any time (see 21 CFR
premarket notification (510(k)) Staff, FDA will post your comment, as 10.115(g)(5)).
submissions, Clinical Laboratory well as any attachments, except for An electronic copy of the guidance
Improvement Amendments (CLIA) information submitted, marked and document is available for download
Waiver by Application, Accessory identified, as confidential, if submitted from the internet. See the
Classification Requests, and certain as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION section for
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Document Created: 2018-06-07 00:50:05
Document Modified: 2018-06-07 00:50:05
| 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; correction. | |
| Contact | Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945. | |
| FR Citation | 83 FR 26481 |
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