Mylan Institutional LLC et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction, 36598 [2020-13070]
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Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
burden of this collection of information
of 1,500 hours was too low and that the
commenter believes more violations
occur than 1,500. The commenter
pointed to the number of Warning
Letters and Civil Money Penalties FDA
issued in 2019 to support this statement.
(Response) After reviewing the PTVR
submissions again over the past 5 years
we have made an adjustment to our
burden estimate. The number of
complaints submitted by the public is
not reflective of the total number of
reported violations of the FD&C Act and
implementing regulations. In 2019, FDA
received over 3,000 annual PTVR
complaint reports and issued over
14,600 Warning Letters, 4,700 Civil
Money Penalties, and 17 No-TobaccoSale-Orders. Reports of potential
violations from the public are critical in
helping FDA enforce tobacco
regulations to protect America’s youth.
The PTVR form was designed to provide
the public with a means of reporting
violations of the FD&C Act to the Center
for Tobacco Products. FDA conducts our
own investigations and inspections to
followup on complaints that may be
submitted through PTVR submissions.
FDA evaluates each report submitted to
determine if the activity is a potential
violation of the FD&C Act or related
regulations before deciding what
followup action, if any, is necessary.
FDA now estimates we will receive
5,370 reports annually.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity and Form FDA 3779
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Reporting violations of the FD&C
Act, as amended by the Tobacco
Control Act via telephone, online
form, mail or email.
2,685
2
5,370
0.25 (15 minutes) .............................
1,343
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
khammond on DSKJM1Z7X2PROD with NOTICES
FDA estimates that submitting the
information (by telephone, online form,
mail or email) will take 0.25 hour (i.e.,
15 minutes) per response. This estimate
is based on the type and rate of
reporting that has been submitted
through the Potential Tobacco Violation
Report Form in the past.
FDA estimates the number of annual
respondents to this collection of
information will be 2,685, who will
each submit 2 reports by telephone,
online form, mail or email. Each report
is expected to take 0.25 hour to
complete and submit; therefore, total
burden hours for this collection of
information is estimated to be 1,343
hours (5,370 responses × 0.25 hour per
response).
We have adjusted our burden estimate
based on the updated number of reports
received to approximately 5,370 forms
annually, which more accurately
reflects the projected number of
submissions based on current trends.
Using these new figures, our estimated
burden for the information collection
signifies an overall increase to reflect
2,685 respondents per year and 1,343
hours.
Dated: June 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13071 Filed 6–16–20; 8:45 am]
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16:44 Jun 16, 2020
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0601]
Mylan Institutional LLC et al.;
Withdrawal of Approval of 16
Abbreviated New Drug Applications;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on March 9, 2020. The
document announced the withdrawal of
approval (as of April 8, 2020) of 16
abbreviated new drug applications
(ANDAs) from multiple applicants. The
document indicated that FDA was
withdrawing approval of the following
four ANDAs after receiving a
withdrawal request from Lupin
Pharmaceuticals, Inc., 111 South Calvert
St., Harborplace Tower, 21st Floor,
Baltimore, MD 21202: ANDA 065488,
Azithromycin Oral Suspension,
Equivalent to (EQ) 100 milligrams (mg)
base/5 milliliters (mL); EQ 200 mg base/
5 mL; ANDA 078410, Topiramate
Tablets, 25 mg, 50 mg, 100 mg, and 200
mg; ANDA 090441, Imipramine
Hydrochloride Tablets, 10 mg, 25 mg,
and 50 mg; and ANDA 200563,
Ciprofloxacin Oral Suspension, 250 mg/
5 mL and 500 mg/5 mL. Before FDA
withdrew the approval of these ANDAs,
Lupin Pharmaceuticals, Inc., informed
FDA that it did not want the approval
SUMMARY:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
of the ANDAs withdrawn. Because
Lupin Pharmaceuticals, Inc., timely
requested that approval of these ANDAs
not be withdrawn, the approval of
ANDAs 065488, 078410, 090441, and
200563 is still in effect.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Monday, March 9,
2020 (85 FR 13661), in FR Doc. 2020–
04691, the following correction is made:
On page 13661, in the table, the
entries for ANDAs 065488, 078410,
090441, and 200563 are removed.
Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13070 Filed 6–16–20; 8:45 am]
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Food and Drug Administration
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[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Page 36598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13070]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0601]
Mylan Institutional LLC et al.; Withdrawal of Approval of 16
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 March 9, 2020. The document
announced the withdrawal of approval (as of April 8, 2020) of 16
abbreviated new drug applications (ANDAs) from multiple applicants. The
document indicated that FDA was withdrawing approval of the following
four ANDAs after receiving a withdrawal request from Lupin
Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st
Floor, Baltimore, MD 21202: ANDA 065488, Azithromycin Oral Suspension,
Equivalent to (EQ) 100 milligrams (mg) base/5 milliliters (mL); EQ 200
mg base/5 mL; ANDA 078410, Topiramate Tablets, 25 mg, 50 mg, 100 mg,
and 200 mg; ANDA 090441, Imipramine Hydrochloride Tablets, 10 mg, 25
mg, and 50 mg; and ANDA 200563, Ciprofloxacin Oral Suspension, 250 mg/5
mL and 500 mg/5 mL. Before FDA withdrew the approval of these ANDAs,
Lupin Pharmaceuticals, Inc., informed FDA that it did not want the
approval of the ANDAs withdrawn. Because Lupin Pharmaceuticals, Inc.,
timely requested that approval of these ANDAs not be withdrawn, the
approval of ANDAs 065488, 078410, 090441, and 200563 is still in
effect.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, March 9,
2020 (85 FR 13661), in FR Doc. 2020-04691, the following correction is
made:
On page 13661, in the table, the entries for ANDAs 065488, 078410,
090441, and 200563 are removed.
Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13070 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P
